Yourlawyer.com (Defective Medical Devices News)

West Virginia Selected as Venue for Transvaginal Mesh Lawsuits

Thu, 09 Feb 2012 00:00:00 -0800

Three transvaginal mesh multidistrict litigations involving various devices made by Boston Scientific, American Medical Systems and Johnson & Johnson’s Ethicon Inc. have been transferred to the federal Court in Charleston West Virginia and assigned to Chief Judge Joseph R. Goodwin.

A fourth MDL, involving C.R. Bard's Avaulta mesh products, had already been transferred to Judge Goodwin. In a Transfer Order dated February 7, the U.S. Judicial Panel on Multidistrict Litigation stated that the Southern District of West Virginia will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the transvaginal mesh litigation.

Transvaginal mesh products are implanted to provide support for a woman’s organs in the pelvis, which drop, fall, bulge or protrude (prolapse) into the vaginal wall due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes. In July, the U.S. Food & Drug Administration (FDA) said in a safety communication that it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, and pain during sexual intercourse, organ perforation, and urinary problems. Recently, the FDA ordered more than 30 manufacturers of transvaginal mesh products to conduct studies of their safety.

FDA staff has proposed that such devices be moved to the agency's high -risk medical device category, which does not allow 510(k) clearances. Under the FDA proposal, transvaginal mesh devices already on the market would be allowed to remain, but manufacturers would have to conduct studies to asses their safety and effectiveness.

Long-Term Health Concerns Continue to Mount for Metal-on-Metal Hip Implants

Wed, 08 Feb 2012 00:00:00 -0800

The news just keeps getting worse for recipients of metal-on-metal hip replacement devices, including those with DePuy Orthopaedics' recalled ASR Hip Resurfacing System and ASR Acetabular System, as well people implanted with an all-metal version of the company's Pinnacle Hip Implant system. Mounting evidence continues to indicate that patients with metal-on-metal hip implants face not only a high threat of early failures, but the risk of sustaining long-term health problems, even if they have defective devices removed.

"This is a serious problem in the USA," said Mathias Bostrom, an orthopedic surgeon at the Hospital for Special Surgery in New York City. "Some implants have a worse record than others, but almost all the metal-on-metal implants have issues."

According to a report in USA Today, Bostrom was attending the American Academy of Orthopaedic Surgeons in San Francisco, where the issues surrounding metal-on-metal hip implants is a hot topic of discussion.

The research discussed at the conference linking metal-on-metal hip implants to serious health problems includes:

A study out of the Netherlands which found that 202 of 614 (32%) metal-hip implant recipients had suffered adverse reactions in soft tissue.
An English study which 24% of metal-on-metal hip implant patients who had revision surgery after a metal-on-metal implant had "worsening symptoms." A third of those had revision, and disease progression "was confirmed in all cases of re-revision," the authors wrote.
An orthopedic surgeon from the Hospital for Special Surgery reported that a study he participated in found that 98% of the cups and 93% of the balls showed "moderate to severe scratching" in 46 retrieved metal-on-metal implants.

Concerns have been growing for some time that metal-on-metal hip implants could pose long-term health risks. Last year, the U.S. Food & Drug Administration (FDA) directed 21 makers of all-metal hip implants, to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients. This shedding of metal debris could cause tissue damage, premature device failure, the need for revision surgery, and even long-term health problems, including heart and nervous system damage.

Problems with all-metal hip implants have also led to a growing number of lawsuits against the makers of such devices. At last count, DePuy had been named in more than 3,500 U.S. lawsuits over the recalled ASR devices. At least 900 complaints have been filed against the all-metal version of its Pinnacle hip replacement device, with plaintiffs claiming it is similar in design to the ASR implants and should have been recalled as well.

Long-Term Health Concerns Continue to Mount for Metal-on-Metal Hip Implants

Wed, 08 Feb 2012 00:00:00 -0800

The research discussed at the conference linking metal-on-metal hip implants to serious health problems includes:

A study out of the Netherlands which found that 202 of 614 (32%) metal-hip implant recipients had suffered adverse reactions in soft tissue.
An English study which 24% of metal-on-metal hip implant patients who had revision surgery after a metal-on-metal implant had "worsening symptoms." A third of those had revision, and disease progression "was confirmed in all cases of re-revision," the authors wrote.
An orthopedic surgeon from the Hospital for Special Surgery reported that a study he participated in found that 98% of the cups and 93% of the balls showed "moderate to severe scratching" in 46 retrieved metal-on-metal implants.

Long-Term Health Concerns Continue to Mount for Metal-on-Metal Hip Implants

Wed, 08 Feb 2012 00:00:00 -0800

The research discussed at the conference linking metal-on-metal hip implants to serious health problems includes:

A study out of the Netherlands which found that 202 of 614 (32%) metal-hip implant recipients had suffered adverse reactions in soft tissue.
An English study which 24% of metal-on-metal hip implant patients who had revision surgery after a metal-on-metal implant had "worsening symptoms." A third of those had revision, and disease progression "was confirmed in all cases of re-revision," the authors wrote.
An orthopedic surgeon from the Hospital for Special Surgery reported that a study he participated in found that 98% of the cups and 93% of the balls showed "moderate to severe scratching" in 46 retrieved metal-on-metal implants.

Study Cites Problem with Tibial Component Used with Zimmer NexGen Knee

Tue, 07 Feb 2012 00:00:00 -0800

This week, a study will be presented at the American Academy of Orthopaedic Surgeons meeting highlighting a possible problem with the Zimmer NexGen Knee Replacement when it is used with a specific tibial component. According to a report from Dow Jones Newswires, the problem caused failures in some Zimmer NexGen Knee Replacement patients who received that component.

The study was performed by researchers at the Mayo Clinic. According to an abstract obtained by Dow Jones, a total of 1,373 people who Zimmer NexGen knee with the specific type of tibial component were included in the study. All of them had undergone total knee replacement at a single center between 2000 and 2011. Failures occurred in 3.9% of cases for various reasons.

According to the study, half of the failures seen were the result of the implant coming loose from the surrounding bone. Of those cases, 80% were the result of isolated debonding, where the implant comes loose from cement. A similar debonding problem wasn't seen among other implants used at the center.

While the Dow Jones Newswires report did not specify the tibial component cited in the study, a Zimmer spokesperson said that the component represents 1.2% of Zimmer's tibial sales.

Could Cancer Be a Possible Metal-on-Metal Hip Implant Side Effect?

Mon, 06 Feb 2012 00:00:00 -0800

A study that could be unveiled next month in Britain is likely to raise more concerns about the safety of metal-on-metal hip implant devices. According to a report from The Telegraph, the study, conducted by researchers at the University of Bristol, reportedly found evidence linking all-metal hip implants to an increased risk of cancer.

According to The Telegraph, the study involved 72 patients with metal-on-metal hip implants, and found that 17 had sustained genetic damage to cells of the bladder. Atypical cells could be a precursor to cancer, and even more alarming, at least three patients did actually developed full-blown cancer. The study hasn't been published yet, but could be presented next month at the annual British Hip Society conference.

The Bristol University metal-on-metal hip implant study was launched after British regulators warned patients there undergo annual checks, including scans and blood tests if doctors find symptoms that suggest their hips are shedding unsafe levels of metal debris. For several years now, concern has been building that the wearing of metal debris could allow toxic metal shards to make their way into the blood stream, and cause inflammation that destroys tissue and bone.

The concerns have U.S. regulators worried as well. Last year, the U.S. Food & Drug Administration (FDA) directed 21 makers of all-metal hip implants, to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients.

Several specific models of metal-on-metal hip implants have also raised safety concerns in the U.S. and abroad. For example, in August 2010, DePuy Orthopaedics issued a worldwide recall of its ASR Hip Resurfacing System and the DePuy ASR Acetabular System, after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it. Recently, a new study - also conducted in Britain - found up to a 50 percent failure rate at six years for those who received a DePuy ASR hip implant in a total hip replacement procedure. Among those implanted with the more limited resurfacing treatment, one in four products failed within the same period, according to the study.

In the U.S., DePuy, a division of Johnson & Johnson, faces more than 3,500 product liability lawsuits over the ASR hip implants. The company faces another 900 over an all-metal version of its Pinnacle hip implant, as well.

Medtronic Infuse Shareholder Lawsuit Witness Must Testify, Judge Says

Fri, 03 Feb 2012 00:00:00 -0800

A former Medtronic Inc. employee won't be able to avoid testifying in a shareholder lawsuit involving the device maker's alleged illegal promotion of off-label uses for its Infuse bone graft product. Yesterday, a federal judge in Minnesota ordered the unnamed witness to testify and turn over a key Infuse document, ruling that he had waived his 5th Amendment protections.

In August 2009, the Minneapolis Firefighters’ Relief Association and other institutional investors alleged in an amended complaint that Medtronic had deliberately promoted the Infuse system for off-label uses and failed to disclose that its sales were largely dependent on unapproved uses. The lawsuit sought class action status on behalf of holders of the company's stock who purchased or acquired their shares between November 2006 and November 2008 and suffered financial losses.

Yesterday, U.S. District Judge Paul Magnuson affirmed a magistrate judge's order for the confidential witness, known in court filings as CW2. In doing so, Judge Magnuson said the decision to sign a declaration in support of one of Medtronic's earlier court filings disqualified him from such protection.

“Given the conclusion that CW2 testified as to the subject matter of the document in question in his declaration, Chief Magistrate Judge Boylan’s conclusion that he waived any Fifth Amendment privilege as to that document is indisputedly correct,” Magnuson said.

Infuse is a recombinant human Bone Morphogenetic Protein (rhBMP-2) that is widely used in spinal fusion surgery, however, it has only been approved by the U.S. Food & Drug Administration (FDA) for use in anterior-approach lumbar fusion. The FDA issued a safety alert for rhBMP products in 2008, after their off-label use in cervical spine (neck) surgeries had been associated with serious, and sometimes life-threatening complications.

Medtronic is facing a mountain of legal trouble over Infuse, including several product liability lawsuits claiming it caused serious complications in patients. Over the summer, The Spine Journal raised serious questions about the validity of the research that was used to gain FDA approval of Infuse. In November, a prominent researcher warned that Infuse may be associated with a higher risk of developing cancer.

In addition to lawsuits, the U.S. Justice Department, the U.S. Senate Finance Committee and the California attorney general are all investigating Infuse.

Cancer, Other Safety Worries Point to Dim Future for Medtronic Infuse

Thu, 02 Feb 2012 00:00:00 -0800

Medtronic Inc.'s sales of its Infuse (rhBMP-2) product have taken a hit in recent months, thanks to concerns that the bone growth protein may be associated with cancer and other serious side effects. Now one analyst is raising doubts as to whether Medtronic can salvage Infuse and convince doctors to start to start using it again.

"Someone who is a very poor healer, someone who is in a revisional surgery, someone who is older and not in child-bearing age … some doctors still see an (Infuse) application in treating these hard -to-treat people,” Caroline Corner, an analyst with investment bank MLV & Co, told MedCityNews.com. “But doctors in general are definitely shying away from using Infuse (most of the time).”

Medtronic's Infuse sales are certainly showing evidence of this. According to a press release issued by the company in November, its core spinal revenue declined by 3 percent in the second quarter compared to last year. At the same time, the biologics portion of Medtronic’s spine business declined by 4 percent, thanks to a drop in Infuse sales. Medtronic blamed the decline on the June 2011 publication of articles in The Spine Journal, which called the safety of Infuse into questions. According to the journal, Medtronic-paid surgeons had failed to report serious complications from Infuse, including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. The article said complications occurred in 10 to 50 percent of patients who got the product in 13 Medtronic-funded clinical trials between 2000 and 2010.

Medtronic's latest Infuse hit came in November, when Dr. Eugene Carragee - also the author of the damning article in The Spine Journal - presented an analysis of another Medtronic-study in which he raised serious concerns about a cancer risk posed by rhBMP-2. That analysis involved a Medtronic trial for its Amplify product, which contains a higher dose of rhBMP-2. Though both the research team and Medtronic were aware of data linking the product to cancer and informed the U.S. Food & Drug Administration (FDA), the clinical trial results were never made public, Carragee said.

Last year, the FDA declined to approve Amplify because of its association with cancer. But, the findings have important implications for Infuse, as doctors often administer that product significantly above the recommended dosages when it is used in off-label procedures. Many times, those doses exceed the amount of rhBMP-2 found in a dose of Amplify, Carragee said.

Medtronic is, of course, desperate to save its once-promising Infuse product, and has gone so far as commission Yale University to conduct a review of its clinical trial data. But Corner doubts even a total vindication of Infuse would be enough to get sales back on track.

“Given that we’ve already had the proverbial eyebrow raised about Infuse, will they (doctors) go back to it, I don’t think so,” she said.

Metal-on-Metal Hip Implants May Pose Risk of

Mon, 30 Jan 2012 00:00:00 -0800

Fears are rising in Britain that all-metal hip implants, including DePuy Orthopaedic's recalled ASR Hip Replacement devices, could be causing more harm to patients than previously thought. According to a report from the Sunday Telegraph, advisors to the Medicines and Healthcare products Regulatory Agency (MHRA) are growing increasingly concerned that microscopic metal particles shed by the devices could cause "systemic toxicity” in the body.

For now, the MHRA continues to advise that people fitted with metal-on-metal hip implants should undergo annual check-ups for five years following surgery. It also said that those experiencing pain should be given tests to check the levels of cobalt and chromium in their blood, and an MRI or ultrasound scan to check for soft tissue reactions. That advice was issued in 2010, amid concerns that shedding of toxic metal shards could make their way into the blood stream, and cause inflammation that destroys tissue and bone.

According to the Sunday Telegraph, advisors to the MHRA are now concerned the metal shedding could slowly poison nervous system, heart and lungs. There are also concerns that increased cobalt and chromium levels in the blood could be toxic to kidneys and, in the case of pregnant women, be passed on to the unborn child.

There are also concerns that the recalled DePuy ASR hip implants might be failing at a much higher rate than thought, the Sunday Telegraph said. In August 2010, DePuy Orthopaedics, a division of Johnson & Johnson, issued a worldwide recall of its ASR Hip Resurfacing System and the DePuy ASR Acetabular System, after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it. But a new study conducted in Britain found up to a 50 percent failure rate at six years for those who received a DePuy ASR hip implant in a total hip replacement procedure. Among those implanted with the more limited resurfacing treatment, one in four products failed within the same period, according to the study.

Johnson & Johnson Sets Aside Funds for DePuy ASR Hip Implant Settlements

Thu, 26 Jan 2012 00:00:00 -0800

It looks like Johnson & Johnsons may be getting ready to settle some of the lawsuits filed over its DePuy Orthopaedics unit's recalled ASR hip implants. According to its earnings statement for the fourth quarter of 2011, Johnson & Johnson has taken a quarterly charges of more than $3 billion, mostly related to the DePuy ASR Hip Implant recall.

Among other things, the charge will allow Johnson & Johnson to set aside money for patients and lawyers involved in product liability litigation sparked by the worldwide DePuy ASR Hip Implant recall issued in 2010, The New York Times said. Of the total, $800 million was set aside to cover the medical costs of the recall.

According to a Reuters report, Morningstar analyst Damien Conover predicted that "J&J is getting ready to offer some settlements" to people injured by the defective hip implants. Roughly 93,000 ASR Hip Implants were placed in patients before they were recalled.

That charge, along with others taken in relation to recent recalls of over-the-counter drugs made by its McNeil Consumer Healthcare division and other issues, weighed on Johnson & Johnson's bottom line. In its fourth quarter earnings statement, Johnson & Johnson said the company earned $218 million in the quarter compared with the $1.9 billion it earned just a year earlier.

"The hip recalls worry me because their eventual costs are unknown," said Jeff Jonas, an analyst at Gabelli & Company, according to The New York Times.

Type or paste your English text here and click on the "Check Text" button.

Congressional Hearings Sought for Transvaginal Mesh, Lap-Band Devices

Mon, 23 Jan 2012 00:00:00 -0800

U.S. Rep. Harry Waxman of California and three other Democrats on the House Energy and Commerce Committee have asked the Republican who control the committee to hold hearings on the safety of transvaginal mesh, as well as Allergan's Lap-Band surgical weight loss device. The four Democratic lawmakers are making the request for the second time since last October, after Republicans failed to schedule any hearings on the safety of transvaginal mesh products and the Lap-Band device.

"The committee should hold hearings to examine whether FDA (Food & Drug Administration) device regulation has been ineffective in protecting the public from dangerous medical devices like the Lap-Band and intravaginal mesh,” Waxman and his colleagues wrote in their latest letter. “We need to understand the safety of devices on the market, the tactics device manufacturers and others use to market these devices, and the extent to which these tactics may increase risks.”

According to Waxman's letter the FDA approved the “Lap-Band” device for obese patients. It is designed to reduce the size of the stomach and cause patients to eat less and lose weight. Allergan is seeking to have the FDA expand its approval for use in children as young as 14, despite concerns among some physicians that the procedure is too drastic or “extreme” for a young person’s developing body.

However, while the Lap-band is effective, the FDA says it can pose serious risks including erosion of the band through the stomach wall, stretching the esophagus, stretching the stomach pouch, stomach pain, gastroesophageal reflux disease, difficulty swallowing, nausea and vomiting. Several studies have also raised questions about its safety and effectiveness, including one published last week in the Archives of Surgery raised questions about the effectiveness of gastric banding, finding that after six years, nearly 50% of patients had either not lost weight or had needed the device to be removed and that over 40% of patients experienced long-term complications.

Transvaginal mesh products are implanted to provide support for a woman’s organs in the pelvis, which drop, fall, bulge or protrude (prolapse) into the vaginal wall due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes. In July, the U.S. Food & Drug Administration (FDA) said in a safety communication that it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, and pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods. FDA staff has proposed that such devices be moved to the agency's high -risk medical device category, which does not allow 510(k) clearances. Recently, the FDA ordered more than 30 manufacturers of transvaginal mesh products to conduct studies of their safety.

According to the Democrats' letter, an investigation of the transvaginal mesh and Lap-Band issues is vital as Congress considers an overhaul of FDA rules for medical devices.

Group Seeks Wingspan Brain Stent Recall

Fri, 06 Jan 2012 00:00:00 -0800

A study finding that patients treated with the Wingspan Brain Stent System are more likely to suffer a stroke or death has prompted Public Citizen to petition the U.S. Food & Drug Administration (FDA) to recall the device. The consumer group has been joined in its petition by a former official from the FDA.

According to Public Citizen's Dr. Sidney Wolf, the Wingspan Stent System "was able to gain marketing approval based on a single, uncontrolled trial of just 45 patients that was not designed to demonstrate whether the device was more effective or even safer than medical therapy alone." That's because the system was approved in 2005 under the FDA's Humanitarian Device Exemption program, which allows for clearance without proof that a device is safe or effective. The device was cleared for use in patients who have had one stroke and are at risk for additional strokes.

In September, the New England Journal of Medicine published results from a study funded by the National Institutes of Health that found a 2.5-fold increase in stroke or death with the Wingspan stent system compared to those treated with blood-thinning medications. The study began in November 2008, but ended early last April, due to safety concerns.

“The message from the trial could not be clearer: The risks of this intervention substantially outweigh any potential benefit to patients,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “The device poses an imminent threat of serious harm to patients and should be pulled from the market without further delay.”

Professor Larry Kessler joined Public Citizen in filing the petition with the FDA.

"With the conclusion of the recent (clinical) trial showing that Wingspan has a much higher complication rate than modern medical management, it is imperative that the FDA take swift and decisive action," said Kessler, former director of the FDA's Center for Device Evaluation and Radiologic Health (CDRH) Office of Surveillance and Biometrics, former director of the CDRH Office of Science and Engineering Laboratories and currently a professor in the University of Washington's School of Public Health.

FDA Orders Transvaginal Mesh Studies

Thu, 05 Jan 2012 00:00:00 -0800

As part of its ongoing safety review of transvaginal mesh devices, the U.S. Food & Drug Administration (FDA) has asked 33 manufactures of such products to conduct safety studies assessing their use in procedures to repair pelvic organ proplapse (POP) and stress urinary incontinence (SUI). According to various media reports, Johnson & Johnson, C.R. Bard Inc., Endo Pharmaceuticals Holding Inc., Boston Scientific Corp. and other companies have been sent letters from the FDA requesting the studies. They have 30 days to respond.

"We believe there are certain uses of mesh where we need additional data to help guide the clinical community," William Maisel, deputy director of science for the FDA's device-approval center, told Bloomberg News. "Our goal is to make sure the right women use it at the right time."

In its letters, the FDA asks the manufacturers to collect as much as three years of data on the safety and effectiveness of the implants.

Patient advocates cheered the FDA's action.

"Now these companies are going to have to tell the truth," said Lana Keeton, the Austin, Texas, founder of Truth In Medicine, an advocacy group for mesh patients

Transvaginal products are implanted to provide support for a woman’s organs in the pelvis, which drop, fall, bulge or protrude (prolapse) into the vaginal wall due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes. In July, the U.S. Food & Drug Administration (FDA) said in a safety communication that it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, and pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods.

FDA staff has proposed that such devices be moved to the agency's high -risk medical device category, which does not allow 510(k) clearances. Under the FDA proposal, transvaginal mesh devices already on the market would be allowed to remain, but manufacturers would have to conduct studies to asses their safety and effectiveness.

Maker of Defective French Silicone Breast Implants Warned by FDA in 2000

Tue, 27 Dec 2011 00:00:00 -0800

The French company that manufactured silicone breast implants now at the center of worldwide cancer panic has also had run-ins with U.S. regulators. According to a report from Reuters, the U.S. Food & Drug Administration (FDA) sent Poly Implant Prothese (PIP) a warning letter in 2000 regarding manufacturing problems at the French facility where it made saline implants. The PIP saline breast implants have also been named in lawsuits by U.S. women who received them in the late 1990s.

The FDA letter, dated June 22, said the PIP saline breast implants were "adulterated" and cited at least 11 deviations from good manufacturing practices, Reuters said. The FDA's letter was cited in a lawsuit filed in the U.S. District Court for the Southern District of Texas on behalf of U.S. patients who received the saline implants in the late 1990s, and one who received them as recently as 2000.   The plaintiffs said that the implants deflated several years later. The FDA letter, dated June 22, 2000, cited PIP's failure to investigate the deflation of its saline implants and a failure to report more than 120 complaints in France and elsewhere to the FDA, Reuters said.

While the problems cited by the FDA had to do with PIP's saline implants, the same manufacturing facility also made the silicone breast implants at the center of the recent scandal. PIP silicone breast implants, which were already among the cheapest and most fragile on the market, were recalled last year after it was learned that they contained industrial, rather than medical grade, silicone.    Those implants ignited cancer fears last month, after one woman with ruptured implants died from aplastic large cell lymphoma (ALCL), a rare cancer. At least eight cases of ALCL have been reported among French women with the PIP implants.

So far, investigators haven't been able to prove the implants caused the cancer. Nevertheless, the French health ministry last week urged women to have them removed because they may rupture. French health officials also said the government would cover the cost of removal in women who received PIP silicone breast implants for reconstructive surgery.

As many as 300,000 women throughout the world received PIP silicone breast implants.   The company faces a French criminal probe for misreporting the type of silicone used in the implants. Some 2,000 French women, and 250 in Britain, have filed legal claims against the implant maker.

The PIP silicone breast implants were never sold in the U.S. But the saline variety that sparked the FDA warning letter were brought to the U.S. market in 1996 via the agency's 510(k) approval process, which does not require human testing. In 2000, however, concerns over complications prompted the FDA to finally require all implant companies to submit formal applications for saline breast implants. In the end, the FDA refused to approve the PIP's saline implants, and they haven't been sold in the U.S. since.

It isn't known why the FDA's 2000 warning letter didn't trigger greater scrutiny of PIP's activities by regulators in France and elsewhere, Reuters said.

French-Made Silicone Breast Implant at Center of Cancer Scare

Thu, 22 Dec 2011 00:00:00 -0800

Fears that a recalled silicone breast implant could cause a rare form of cancer are spreading around the world. According to a report in The New York Times, regulator in at least a half dozen countries are trying to ease fears among women who have received silicone breast implants made by Poly Implant Prosthese (PIP), a now-defunct French company.

The fears are most acute in France, where 30,000 women received PIP silicone breast implants before they were pulled from the market last year. The company faces a criminal probe there for using industrial silicone, rather than medical-grade material, in the implants. French regulators have received about 1,000 reports of PIP silicone breast implants rupturing. But most worrisome, at least 8 cases of a rare cancer called anaplastic large cell lymphoma (ALCL), including one death, have been reported in French women who received the implants.

So far, investigators haven't been able to prove the implants caused the cancer. Nevertheless, the French health ministry said yesterday it would recommend that the government there cover the cost of removal in women who received PIP silicone breast implants for reconstructive surgery.

Alexandra Blachere, the leader of a French PIP implant patient group, told Reuters that en from Italy and Spain had been in touch with her with worries about their implants, and she'd seen reports of problems in other countries, including in Venezuela and Brazil.

"It's not just France that's concerned. We're looking at 300,000 to 400,000 potential victims in the world," Blachere said.

According to CNN, PIP never sought approval from the U.S. Food & Drug Administration (FDA) to sell the silicone breast implants in the U.S., so they were never available to women here. In March 2000, the FDA decided not to approve saline PIP implants for sale here.

Medtronic Infuse Concerns Prompt Questions from Senators

Mon, 19 Dec 2011 00:00:00 -0800

Medtronic Inc. is taking more heat over its controversial Infuse bone graft product. Now, three U.S. Senators are asking questions about Infuse, and want to know if research for the bone growth protein downplayed serious side effects, including cancer, associated with it.

Infuse is a recombinant human Bone Morphogenetic Protein (rhBMP-2) that is widely used in spinal fusion surgery. However, it has only been approved by the U.S. Food & Drug Administration (FDA) for use in anterior-approach lumbar fusion. The FDA issued a safety alert for rhBMP products in 2008, after their off-label use in cervical spine (neck) surgeries had been associated with serious, and sometimes life-threatening complication.

In their letter, Senators Charles Grassley, R-Iowa, Herb Kohl, D-Wis., and Richard Blumenthal, D-Conn. inquire about Medtronic's tracking of safety information for devices once they have been released to the market. But the Senators also ask specifically about side effects linked to Infuse.

"A researcher at Stanford University School of Medicine found a higher risk of cancer associated with Infuse, and there have been allegations that researchers who received funds from Medtronic, sometimes millions of dollars, did not report negative findings from clinical trials," the letter states.

The researcher mentioned in the letter is Dr. Eugene Carragee, who published a highly critical analysis of Infuse clinical trials in The Spine Journal this summer. According to the article, Medtronic-paid surgeons had failed to report serious complications from Infuse, including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. The article said complications occurred in 10 to 50 percent of patients who got the product in 13 Medtronic-funded clinical trials between 2000 and 2010.

Then just last month, during a presentation at the North American Spine Society, Carragee said a new analysis he performed of another Medtronic clinical trial raised serious concerns about a cancer risk posed by rhBMP-2. That analysis involved a Medtronic trial for its Amplify product, which contains a higher dose of rhBMP-2. Earlier this year, the FDA declined to approve Amplify because of its association with cancer.

In an interview with The New York Times, Carragee said the cancer findings could have serious implications for people receiving Infuse. Doctors often administered Infuse off-label at levels significantly above the recommended dosages, ones that approach or exceed the amount of rhBMP-2 found in a dose of Amplify, he said.

St. Jude Recalls Riata Leads, Says Defect Rate Higher Than Thought

Fri, 16 Dec 2011 00:00:00 -0800

A year after stopping sales of its Riata family of defibrillator leads, St. Jude Medical Inc. is officially recalling the defective devices. The ST. Jude Riata defibrillator lead recall has been deemed Class I by the U.S. Food & Drug Administration (FDA), meaning the leads pose a risk of serious injury or death.

According to the recall notice, Riata and Riata St. Silicone leads are being recalled because the wires can penetrate their insulation. When this occurs, the implantable defibrillator may not deliver shocks to the heart when it's needed. In other cases, the defibrillator may deliver unnecessary shocks.

Last December, when St. Jude announced it was phasing out the Riata leads, it said the abrasion rate was around 0.047 percent. In a letter sent on November 28 to doctors, the company acknowledged that the defect is more prevalent than first thought, and increased the abrasion rate to 0.063.

Despite the phase-out, Riata leads remain implanted in an estimated 79,000 U.S. patients. Around 227,000 Riata defibrillator leads were sold worldwide.

So far, two deaths and one serious injury have been reported in connection with attempts by doctors to remove Riata lead wires. In addition, one patient death and one serious injury in patients with externalized conductors were reported, but were determined not to be due to the presence of externalized conductors, St. Jude said.

The company has advised doctors to continue monitoring their patients' implanted defibrillator systems and use X-rays or fluoroscopy if there is evidence of a lead electrical failure. The potential risks associated with externalized conductors as well as the potential risks and benefits of management options should be considered and discussed with patients. St. Jude isn't advising doctors on whether or not defective leads should be removed.

“At this time, no blanket statement can be made about clinical recommendations. Until more data are collected, physicians should follow standard practice of care to manage their patients with Riata silicone leads,” said Dr. Anne Curtis, professor and chair of Medicine at the University at Buffalo, former Heart Rhythm Society (HRS) president and a member of St. Jude Medical’s Medical Advisory Board (MAB).

Medtronic Discloses California Infuse Investigation

Thu, 08 Dec 2011 00:00:00 -0800

Medtronic continues to be plagued by investigations into its controversial Infuse bone growth product. According to its most recent 10-Q filing with the Securities and Exchange Commission (SEC), the California Attorney General issued a subpoena to the company in October seeking information regarding Infuse.

According to the filing, the California Attorney General is just the latest state or federal official to express an interest in Infuse:

"On October 6, 2008, the Company received a subpoena from the United States Attorney’s Office for the District of Massachusetts pursuant to HIPAA requesting production of documents relating to Medtronic’s INFUSE Bone Graft product. The Company has since received supplemental subpoenas or document requests in connection with the INFUSE Bone Graft product, including a December 18, 2008 civil investigative demand from the Massachusetts Attorney General’s Office, an October 14, 2011 subpoena issued by the California Attorney General’s office, and several inquiries from the United States Senate Finance Committee. The Company is fully cooperating with these investigations."

Medtronic also revealed that Infuse sales fell 16 percent in the second quarter, something it blamed on the June 2011 publication of articles in The Spine Journal, which called the safety of Infuse into questions. According to the journal, Medtronic-paid surgeons had failed to report serious complications from Infuse, including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. The article said complications occurred in 10 to 50 percent of patients who got the product in 13 Medtronic-funded clinical trials between 2000 and 2010.

Medtronic Discloses California Infuse Investigation

Class I Status Given to CooperVision Avaira Sphere Contact Lens Recall

Wed, 07 Dec 2011 00:00:00 -0800

Like the previous Avaira Toric contact lens recall announced in August, the U.S. Food & Drug Administration (FDA) has decided to classify CooperVision's Avaira Sphere contact lens recall Class I, its most serious type of recall action. Class I recalls involve situations in which the FDA has determined there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The CooperVision Avaira Sphere contact lens recall was announced on November 15. It involved over 6 million Avaira Sphere contact lenses, 4.9 million of which were shipped to consumers. The recall was an expansion of an August action that involved roughly 800,000 Avaira Toric contact lenses, including 600,000 in the U.S. That recall was announced in August, and deemed Class I by the FDA in October.

Both recalls were issued because of the possible presence of a silicone residue on the lenses. CooperVision was heavily criticized for its handling of the original Avaira Toric contact lens recall, after only notifying U.S. and Canadian distributors and health care practitioners who sold the lenses. However, after coming under pressure from the FDA, CooperVision issued a wider notification to consumers in October.

CooperVision has also been accused of at first downplaying eye problems caused by the lenses, after characterizing them as mostly reports of "hazy vision." But according to media reports, users of the recalled contact lenses suffered eye problems that required emergency medical attention, including eye pain, corneal abrasions and torn corneas. As of November 15, the FDA had received 40 reports of problems associated with various CooperVision contact lenses. Of those, at least 15 mentioned Avaira Toric and at least two mentioned Avaira Sphere.

Contact lens wearers should visit the CooperVision recall web page at www.coopervision.com/recall, and enter the package lot number to determine whether the lenses have been recalled or contact the toll-free consumer hotline at 1-855-526-6737.

Consumers should return their lenses to their eye care practitioner or point of purchase if they have the affected contact lenses. In addition, if a consumer who is wearing Avaira Toric contact lenses and experiences any symptoms, it is recommended that they stop wearing the lenses immediately and contact their eye care practitioner for advice.

Study Raises More Metal-on-Metal Hip Implant Concerns

Wed, 30 Nov 2011 00:00:00 -0800

The authors of a newly-published study say the makers of metal-on-metal hip implants have no basis for their claims that these devices offer any advantages over traditional metal-on-polyethylene or ceramic-on-polyethylene hip implants. According to the study, which is published in the British Medical Journal, people with all-metal hip implants are doubly at risk of requiring a repeat procedure.

All-metal hip implants have been under scrutiny for some time. In May, the U.S. Food & Drug Administration (FDA) asked DePuy Orthopaedics and 20 other manufacturers of metal-on-metal hip implants to conduct safety studies aimed at determining how often they fail prematurely, and if these devices are shedding dangerous amounts of metallic debris in patients. It is believed excess shedding of metal debris can lead to tissue damage, premature device failure, the need for revision surgery, and even long-term health problems.

The FDA order followed the August 2010 worldwide recall of DePuy's ASR hip implant, an all-metal hip implant. The DePuy ASR hip implant recall followed complaints that the devices failed years earlier than expected in many patients.

And in September, a British hip replacement registry found more widespread evidence of early failure for the metal-on-metal devices.

This new study, which was sponsored by the FDA, looked at 18 studies including more than 3,000 patients as well as outcomes from 830,000 hip replacement surgeries reported to various national registries. Data from the three largest registries - from Australia, New Zealand, and England and Wales - revealed evidence of higher rates of early implant failure associated with metal-on-metal devices, compared to metal-on-polyethylene implants. The study found no evidence that newer hip replacements, including all-metal hip implants, offered any advantage over those made with traditional materials.

"A large and high-quality randomized controlled trial of bearing surfaces in total hip replacement needs to be conducted before any claims of benefit are made," the journal article stated.

Transvaginal Mesh Not a Good Choice for Most Women in POP Repair, Medical Groups Warn

Tue, 22 Nov 2011 00:00:00 -0800

Two prominent physician groups have recommended that transvaginal mesh devices not be used in the majority of women who undergo surgical repair for pelvic organ prolapse (POP). According to a joint statement issued by the American College of Obstetricians and Gynecologists and (the College) the American Urogynecologic Society (AUGS), transvaginal placement of surgical mesh may cause some women to suffer "permanent and life-altering problems, including pelvic pain and painful sexual intercourse because the mesh erodes through the vaginal wall."

In their joint statement, the two groups issued the following recommendations:

•    Continued audit and review of outcomes as well as the development of a surveillance registry for all current and future vaginal mesh implants;
•    Outcome reporting for prolapse surgical techniques clearly defining success, complications, and total reoperation rates;
•    Surgeon training for vaginal mesh placement specific to each device, including surgical experience with reconstructive surgery and thorough understanding of pelvic anatomy;
•    Rigorous comparative effectiveness trials of synthetic mesh and native tissue repair and long-term follow-up;
•    Patient counseling that there are alternative native tissue repairs and that synthetic mesh is permanent, as well as discussion of the risks, benefits, and alternatives to the procedure;
•    Limiting use of POP vaginal mesh repair to high-risk women for whom the benefit may justify the risk;
•    Adoption of new mesh products and devices only with clinical long-term data demonstrating equal or improved safety and efficacy compared with existing products and devices.

Surgical pelvic mesh products are implanted to provide support for a woman’s organs in the pelvis, which drop, fall, bulge or protrude (prolapse) into the vaginal wall due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes. In July, the U.S. Food & Drug Administration (FDA) said in a safety communication that it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, and pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods.

FDA staff has proposed that such devices be moved to the agency's high -risk medical device category, which does not allow 510(k) clearances. Under the FDA proposal, transvaginal mesh devices already on the market would be allowed to remain, but manufacturers would have to conduct studies to asses their safety and effectiveness.

In many cases, women require surgical excision to remove defective transvaginal mesh devices, and may even require two or three additional surgeries. Despite removal of the mesh, complications may not be reversed, and women continue to suffer with vaginal pain and an impaired quality of life.

6 Million Avaira Sphere Contact Lenses Added to CooperVision Recall

Wed, 16 Nov 2011 00:00:00 -0800

A month after it came under fire for its handling of the Avaira Toric contact lens recall, CooperVision Inc. is expanding the recall to include another Avaira brand. The expansion involves 6 million Avaira Sphere contact lens, 4.9 million of which were shipped to consumers.

According to a statement from the company, CooperVision is expanding the recall because it identified certain lots of Avaira Sphere lenses that did not meet its updated quality requirements due to the level of a silicone oil residue.

The presence of the silicone residue also prompted CooperVision's earlier recall of 778,000 Avaira Toric lenses. Those contact lenses were recalled after dozens of users reported eye injuries, including corneal tears and corneal abrasions that required emergency care. The U.S. Food & Drug Administration (FDA) deemed the Avaira Toric recall a Class I recall, meaning it had determined that there was a reasonable probability that using the recalled Avaira Toric lenses will cause serious injuries or death.

CooperVision was criticized in October when the first Avaira Toric contact lens recall came to light, for issuing in August what some referred to as a "stealth" recall. CooperVision only issued the original notification letter to U.S. and Canadian distributors and health care practitioners who sold the lenses, and some users complained they never heard about the recall prior to experiencing a problem. The company didn't widen its notification of the recall until October, under pressure from the FDA.

Contact lens wearers should visit the CooperVision recall web page at www.coopervision.com/recall, and enter the package lot number to determine whether the lenses have been recalled or contact the toll-free consumer hotline at 1-855-526-6737.

Consumers should return their lenses to their eye care practitioner or point of purchase if they have the affected contact lenses. In addition, if a consumer who is wearing Avaira Toric contact lenses and experiences any symptoms, it is recommended that they stop wearing the lenses immediately and contact their eye care practitioner for advice.

Medtronic Infuse Associated with Higher Rate of Cancers than First Believed, Researcher Claims

Fri, 04 Nov 2011 00:00:00 -0700

Dr. Eugene Carragee, a Stanford University School of Medicine professor and editor of The Spine Journal. has raised more questions about Medtronic Inc.'s Infuse bone growth product. According to Carragee, Infuse may be more strongly associated with cancer than previously thought.

In June, a Spine Journal article authored by Carragee reported that Medtronic-paid surgeons had failed to report serious complications from Infuse, including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. The article said complications occurred in 10 to 50 percent of patients who got the product in 13 Medtronic-funded clinical trials between 2000 and 2010.

Yesterday, during a presentation at North American Spine Society meeting in Chicago on Thursday, Carragee said a new analysis he performed of another Medtronic clinical trial raised serious concerns about a cancer risk posed by rhBMP-2, the bone growth protein found in Infuse. According to Carragee, his analysis of a Medtronic-funded study that involved 239 patients who got the company's Amplify product and 224 who got a conventional graft of their own hip bone indicated a strong connection between the protein and cancer. At roughly three-year follow-up, 5% of those who got Amplify were diagnosed with a new cancer, compared with 1.3% who got the hip bone graft. After two to three years of follow-up, Amplify patients were four to five times more likely to develop at least one new malignancy.

Like Infuse, Amplify is made with rhBMP-2, but at higher dose. In March, the U.S. Food & Drug Administration (FDA) declined to approve Amplify because of cancer concerns. However, when the Amplify study analyzed by Carragee was published in 2009, the text never mentioned the cancer cases, and they were only noted in an accompanying table. The authors - who had received millions in royalties for other Medtronic products - claimed they weren't statistically significant, something Carragee disputes. By his reckoning, patients who received rhBMP-2 were three to five times more likely to develop cancer within a few years of implantation.

In an interview with The New York Times, Carragee said the cancer findings could have serious implications for people receiving Infuse. Doctors often administered Infuse off-label at levels significantly above the recommended dosages, ones that approach or exceed the amount of rhBMP-2 found in a dose of Amplify, he said. Carragee also voiced particular concern about the use of Infuse in certain patients like smokers or those with genetic factors that put them at higher risk for cancer, the Times said.

CooperVision Contact Lens Recall Given Class 1 Status

Mon, 17 Oct 2011 00:00:00 -0700

The Food & Drug Administration (FDA) has assigned its most serious recall classification - Class 1 - the recent CooperVision Avaira Toric contact lens recall. It also seems that the U.S. CooperVision contact lens recall involves more lenses than first thought, 778,301 to exact.

In a notification sent to distributors and eye care professionals on August 19, CooperVision stated only around 600,000 lenses were involved in the Avaira Toric contact lens recall. Of course, the company also indicated that the problems reported by users of the defective contact lenses were limited to hazy vision.

But we now know, thanks to a report from MSNBC, that problems reported by users of the contacts included corneal tears and corneal abrasions, sometimes forcing victims to rush to the emergency. According to the FDA, it's received 15 reports of serious eye injuries linked to the Avaira Toric lenses. The Class I status means the FDA has determined that there is a reasonable probability that using the recalled Avaira Toric lenses will cause serious injuries or death.

Consumers should return their lenses to their eye care practitioner or point of purchase if they have the affected contact lenses. In addition, if a consumer who is wearing Avaira Toric contact lenses and experiences any symptoms, it is recommended that they stop wearing the lenses immediately and contact their eye care practitioner for advice.

The FDA is advising contact lens wearers to go to the CooperVision recall web page at www.coopervision.com/recall, and enter the package lot number to determine whether the lenses have been recalled or contact the toll-free consumer hotline at 1-855-526-6737.

The U.S. Avaira Toric recall was part of a worldwide action that involved 8 million lenses. According to MSNBC, some consumers have reported eye problems with other brands of CooperVision contact lenses, but no others have been recalled.

CooperVision Widens Contact Lens Recall Notification

Thu, 13 Oct 2011 00:00:00 -0700

Yesterday, CooperVision Inc. reannounced its Avaira Toric contact lens recall, following criticism that its initial notification had downplayed the serious risks posed by the defective lenses. In a press release issued yesterday, CooperVision also acknowledge that some users of the contact lenses had suffered "severe pain" - a more serious symptom than the hazy vision and mild discomfort it reported in its original recall announcement.

When it first announced the Avaira Toric contact lens recall on August 19, CooperVision focused the notification on retailers, including Costco, Wal-Mart and LensCrafters, and eye care professionals who sold them. As a result, many consumers were not aware of the recall.

Earlier this week, MSNBC reported that it had heard from more than a dozen people who suffered injuries that were far more serious than CooperVision had noted in its original recall notice. Injuries included torn corneas and corneal abrasions that required emergency care.

Because of the shoddy way CooperVision handled the first recall announcement, the U.S. Food & Drug Administration (FDA) had threatened to issue its own public warning. This seems to have pushed CooperVision to step up its notification efforts, thus the press release issued yesterday.

In that release, that some contact lens users experienced “severe eye pain," and advises that "not everyone experiences the same symptoms." It further recommended that affected users seek medical care.

The FDA is reviewing this latest notification attempt, but an agency spokesperson told MSNBC that it could still issue a separate public communication if concerns haven't been resolved.

The CooperVision Avaira Toric contact lens recall included 600,000 lenses sold or issued as samples in the U.S. It was part of a larger international action that involved 8 million lenses.

According to the latest MSNBC reports, some reports from contact lens users have indicated problems could involve other CooperVision brands, but that hasn't been confirmed

Contact lens users seeking more information on this recall can visit the CooperVision recall web page. Information is also available at 1-855-526-6737).

Gynecare Prolift Transvaginal Mesh Named in Lawsuit

Tue, 11 Oct 2011 00:00:00 -0700

Johnson & Johnson continues to be named in lawsuits alleging its Gynecare Prolift transvaginal mesh left women with permanent and painful injuries. The most recent lawsuit was filed by Linda Gross, 46, of Watertown, South Dakota, who received Gynecare Prolift transvaginal mesh in 2006 to repair pelvic organ prolapse (POP).

Since her initial surgery, gross say she has suffered urinary complications and constant pain due to her body's rejection of the Gynecare Prolift device. According to her complaint, Gross has undergone 12 additional surgeries, but has had no relief. Today, Gross says she cannot sit for longer than 20 minutes, cannot have sex with her husband, and she can’t be active for more than a few minutes at a time.

In July, the U.S. Food & Drug Administration (FDA) said in a safety communication that it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, and pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods.

Last month, FDA staff proposed that such devices be moved to the agency's high -risk medical device category, which does not allow 510(k) clearances. Under the FDA proposal, transvaginal mesh devices already on the market would be allowed to remain, but manufacturers would have to conduct studies to asses their safety and effectiveness. An FDA panel of outside experts has backed both proposals.

Attorneys report that they are receiving an "amazing number of calls" from women who allegedly suffered transvaginal mesh complications following surgery to repair POP. As we've reported previously, about 300,000 women in the U.S. had POP surgeries last year, including more than 70,000 who received transvaginal mesh.

FDA Logging More DePuy Pinnacle Hip Implant Complaints

Fri, 07 Oct 2011 00:00:00 -0700

Complaints to the U.S. Food & Drug Administration (FDA) involving DePuy Pinnacle Hip Implants with metal liners have spiked in recent months. A recent review of the FDA's Adverse Event Reports (AERS) Database found that:

In the past three months (July-September), 709 Pinnacle Hip Implant AERs were made. Of these, 201 involved implants with metal liners.
So far in 2011, the FDA has received 1,266 AERS involving the DePuy Hip Implant, 450 of which were confirmed to be the version with a metal liner.
If this trend continues, the FDA could receive 1,700 Pinnacle AERs this year. It could be expect that more than 600 of those will be confirmed to involve the metal liner version.

There have definitely been more DePuy Pinnacle Implant complaints to the FDA this year than in the past. In all of 2010, the DePuy Pinnacle Hip Implant was named in 557 Pinnacle AERs (271 confirmed metal). In 2009, just 315 (135 confirmed metal) AERs were made involving the Pinnacle Hip Implant.

DePuy Pinnacle Hip Implants are also sold with ceramic and polyethylene liners. But these versions don't appear to be attracting the same number of complaints. Only one of the 709 DePuy Pinnacle Hip Implant AERs in the last three months identified a polyethylene liner. In the last decade, only six AERs have identified a polyethylene liner (one in 2006, two in 2010, and three in 2011.) In the same period, only one - in 2011 - identified a ceramic liner.

Lawsuits Seek Damages for Wright Profemur Hip Implant Failures

Mon, 26 Sep 2011 00:00:00 -0700

Lawsuits involving the Wright Profemur Total Hip Replacement System continue to pile up. Since August, at least two more have been filed by plaintiffs in Canada and the U.S. claiming the Wright Profemur Hip Implant is prone to premature failure.

The Canadian lawsuit was filed on September 13 on behalf of a class of all Canadian residents who were implanted with a Wright Profemur Hip Implant System since 2001. The complaint was brought by two lead plaintiffs, both residents of Nova Scotia. Ken Taylor received his Wright Profemur hip implant in June 2007, but had to undergo revision surgery in September 2009, after the neck of his left femoral Profemur Hip Implant fractured. Taylor required more surgery in February 2010, including a bone graft, because bone was not growing around the previous prosthesis.

The second Canadian plaintiff, Judy Rowter, received a Wright Profemur Hip Implant in January 2007. According to the complaint, Rowter was informed by her surgeon in March 2010 that she should discontinue working due to numerous reports concerning the risk of fracture and susceptibility to personal injury resulting from such a fracture of the Profemur Long Neck component of the Profemur Hip Implant System.

The Canadian lawsuit alleges Wright Medical and other defendants knew a high number of their Profemur Z Stems were failing and harming patients, but failed to disclose or warn patients about the significant risks posed by the devices.

The U.S. lawsuit was filed on behalf of Terrance Allore and his wife, Rebecca, on August 17 in U.S. District Court, Eastern District of Michigan. It names Wright Medical Group, Wright Medical Technology and Wright Medical Europe as defendants. According to the complaint, Terrance Allore received the Wright Profemur Hip Implant in 2008. In November 2010, the femoral neck of his implant broke, causing severe problems. Allore was forced to undergo revision surgery to replace his hip implant.

The Allores have charged the defendants with defective manufacturing, defective design, failure to warn, misrepresentation, negligence, breach of warranty, and fraud. Rebecca Allore is also suing for loss of consortium.

Medtronic Infuse Lawsuit Claims Off-Label Use Caused Uncontrolled Bone Growth

Tue, 20 Sep 2011 00:00:00 -0700

Jennifer English of Lake Worth, Florida, claims Medtronic's Infuse Bone Growth product left her in severe pain, and forced her to undergo two surgeries, including one emergency procedure. According to a lawsuit she filed this week, English received Infuse during a posterior-approach lumbar spine surgery, an off-label use of Infuse.

Infuse is a recombinant human Bone Morphogenetic Protein (rhBMP-2) that is widely used in spinal fusion surgery, however, it has only been approved by the U.S. Food & Drug Administration (FDA) for use in anterior-approach lumbar fusion. The FDA issued a safety alert for rhBMP products in 2008, after their off-label use in cervical spine (neck) surgeries had been associated with serious, and sometimes life-threatening complications.

English claims Infuse caused her to develop ectopic, or uncontrolled, bone growth in her spine, compressing nerves and leading to chronic and ongoing severe pain. Her complaint alleges that due to Infuse, English suffers continuous pain in her back and legs from ordinary everyday activities, such as sitting or standing for extended periods of time.

Over the summer, Infuse was linked to more serious side effects when The Spine Journal published an entire issue dedicated to (rhBMP-2). One of the articles included in the issue asserted that in 13 Medtronic-funded studies conducted between 2000 and 2010, side effects – including male sterility, infection, bone loss and unwanted bone growth - occurred 10 to 50 times more than what was stated in the final, peer-reviewed published articles. According to that study, every large Infuse study involved at least one researcher who received at least $10 million in royalties from Medtronic.

At the time, Larry Biegelsen, an analyst with Wells Fargo told Forbes Magazine the issues uncovered by The Spine Journal could lead to a wave of lawsuits against Medtronic.

More Women Seek Legal Recourse for Transvaginal Mesh Injuries

Fri, 16 Sep 2011 00:00:00 -0700

The U.S. Food & Drug Administration's (FDA) recent safety alert for transvaginal mesh devices has sparked a surge in inquiries to personal injury lawyers, according to a report from Bloomberg News. Attorneys report that they are receiving an "amazing number of calls" from women who allegedly suffered transvaginal mesh complications following surgery to repair pelvic organ prolapse (POP).

According to Bloomberg, about 300,000 women in the U.S. had POP surgeries last year, including more than 70,000 who received transvaginal mesh. Women who have inquired about filing transvaginal mesh lawsuits complain that complications have left them unable to work, exercise, or enjoy sex.

At least 600 transvaginal mesh lawsuits are currently pending across the country, though none have gone to trial yet. Johnson & Johnson, which Bloomberg says is a global leader in mesh, has been named in roughly 270 complaints. American Medical Systems, C.R. Bard and Boston Scientific have also been named in transvaginal mesh lawsuits.

In July, the FDA said in a safety communication that it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods.

Transvaginal mesh devices were approved for POP surgery under the FDA's 510(k) approval process. This clearance protocol is reserved for "moderate risk" devices that are substantially equivalent to devices that have already been brought to market. 510(k) clearances do not require that medical devices undergo clinical trials involving humans be conducted before they are approved.

Last month, FDA staff proposed that such devices be moved to the agency's high -risk medical device category, which does not allow 510(k) clearances. Under the FDA proposal, transvaginal mesh devices already on the market would be allowed to remain, but manufacturers would have to conduct studies to asses their safety and effectiveness. Just last week, an FDA panel of outside experts backed both proposals. While the agency is not required to follow the advice of its advisory panels, it does so in most cases.

British Report Finds Metal-on-Metal Hip Implants Failing Faster

Fri, 16 Sep 2011 00:00:00 -0700

A new report from the United Kingdom finds that premature failures of DePuy Orthopaedic’s ASR hip implant, as well as other metal-on-metal hip implants, are increasing. The report focuses on U.K recipients of all-metal hip implants, but according to The New York Times, its findings do not bode well for U.S. hip implant recipients, as some 500,000 are estimated to have received all-metal devices In fact, about 40,000 of the 90,000 ASR hip implants sold worldwide prior to its August 2010 recall were used in this country.

The report draws data from National Joint Registry for England and Wales. According to a statement issued from the registry, while all of the non-metal prostheses types reported a less than 1 percent increase in revision rates, the metal-on-metal group climbed 4.11 percent. The registry also found that women were experiencing the highest rates of metal-on-metal hip implant failure. At five years, revision rates for a 60-69-year old female were 7.34 percent for traditional hip replacement with metal-on-metal devices. Meanwhile, the same statistics for men with all-metal devices came in 5.48 percent the report said.

DePuy's ASR hip implant, which was recalled last year because of an unexpectedly high number of early failures, was associated with the highest rate of early failure. According to The New York Times, the British Registry is following 2,100 ASR patients who received the implant in traditional hip replacement surgery, which is how the devices were used in the U.S. The registry found that 29 percent of those who received the implant six years ago experienced failure, while 17 percent who received the ASR five years ago had failures. A hip implant should last for 15 years.

It is believed all-metal hip implants can shed dangerous amounts of cobalt and chromium through wear, leading to tissue damage, premature device failure, the need for revision surgery, and even long-term health problems. In May, the U.S. Food & Drug Administration (FDA) asked DePuy and 20 other manufacturers of metal-on-metal hip implants to conduct safety studies aimed at determining how often they fail prematurely, and if these devices are shedding dangerous amounts of metallic debris in patients. However, it will likely be years before those studies are completed.

In August, the Times reported that since January, the FDA received around 5,000 adverse event reports related to all-metal hip replacements, more than it received in the previous four years combined.

Parker Waichman LLP Joins Push for Transvaginal Mesh Recall

Thu, 15 Sep 2011 00:00:00 -0700

Parker Waichman LLP is adding its voice to those pushing for a recall of transvaginal mesh devices used in pelvic organ prolapse (POP) surgery. In a statement released yesterday, the national law firm also voiced support for a U.S. Food & Drug Administration (FDA) proposal to reclassify transvaginal mesh for POP surgery as a high-risk medical device.

"In light of the staggering number of serious complications reported among women who have received transvaginal mesh devices for POP repair, Parker Waichman LLP urges the FDA to implement its proposal to reclassify these devices as soon as possible," the statement said. “Parker Waichman LLP also calls on the FDA to order a recall of all transvaginal mesh devices currently being marketed for POP repair until their safety and effectiveness can be established."

Transvaginal mesh devices were approved for POP surgery under the FDA's 510(k) approval process. This clearance protocol is reserved for "moderate risk" devices that are substantially equivalent to devices that have already been brought to market. 510(k) clearances do not require that medical devices undergo clinical trials involving humans be conducted before they are approved.

In July, the FDA said in a safety communication that it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods.

Earlier this month, FDA staff released an Executive Summary proposing that transvaginal mesh devices for POP surgery be reclassified and placed in the agency's highest risk category, Class III. This would mean that manufacturers could not utilize the 510(k) process, and would need to conduct human tests before applying to the FDA for approval. The same report also proposed requiring the makers of currently approved devices to conduct postmarketing studies to assess their safety and effectiveness in POP surgery. However, the agency report did not propose recalling these devices while the studies are conducted, so they would be allowed to remain on the market.

During a meeting last Thursday and Friday, in spite of the absence of a formal vote, a majority on the FDA’s Obstetrics and Gynecology Devices Advisory Panel backed the FDA proposals. While the agency is not required to follow the advice of its advisory panels, it does so in most cases.

Parker Waichman LLP is not alone in calling for a recall of transvaginal mesh devices. Some of those testifying at last week's advisory panel meeting also called for a ban on the devices. In August, the prominent consumer advocacy group Public Citizen filed a petition with the FDA calling for such a recall, asserting that transvaginal mesh devices “offer no significant benefits but expose patients to serious risks and the potential for permanent life-altering harm.”

SynchroMed II Infusion Pumps Recalled by Medtronic Over Battery Defect

Tue, 13 Sep 2011 00:00:00 -0700

Medtronic Inc.’s Model 837 SynchroMed II Infusion pumps have been named in a Class I recall, according to the U.S. Food & Drug Administration (FDA). The affected SynchroMed II Infusion pumps could suffer from reduced battery function, leading to the sudden loss of therapy and the return of underlying symptoms and/or withdrawal symptoms.

This recall includes the SynchroMed II Implantable Infusion Pump models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011. The pumps involved in this recall are indicated to deliver morphine sulfate, ziconotide and baclofen for the treatment of chronic pain, severe chronic pain and severe spasticity, respectively. They are also indicated for delivery of floxuridine and methotrexate for the treatment of primary or metastatic cancer, the FDA said.

According to the agency, Medtronic’s analysis of the battery problem indicates it is related to the formation of a film within the pump battery. The company is encouraging patients to carry their patient identification cards with them at all times and to contact their physicians immediately if they experience a return of symptoms or hear a device alarm. Medtronic is not recommending that patients with the recalled pumps implanted have them removed due to the low occurrence rate of the battery problem, as well as the risks associated with replacement surgery.

Medtronic sent an urgent medical device correction letter to clinicians in July 2011 informing them of this problem, citing 55 confirmed cases of malfunction among some 139,653 devices implanted worldwide. A news release was also issued on July 8, 2011.

SynchroMed II infusion pumps were recalled for the same battery issue in July 2009.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

100+ Women Sue Over GyneCare Prolift Transvaginal Mesh Injuries

Mon, 12 Sep 2011 00:00:00 -0700

More than 100 women throughout the U.S. have filed suit against Johnson & Johnson's Ethicon unit over injuries they allegedly sustained as a result of Gynecare Prolift transvaginal mesh. Gynecare Prolift transvaginal mesh lawsuits charge Ethicon with negligence, and claim that the device was defectively designed. Plaintiffs seek both compensatory and punitive damages.

The Gynecare Prolift device is just one of many transvaginal mesh products that have been named in lawsuits that allege injury following implantation of the devices during surgery to treat pelvic organ prolapse (POP). In addition to Johnson & Johnson, American Medical Systems, C.R. Bard and Boston Scientific have been named in similar legal claims. Transvaginal mesh lawsuits claim women suffered a variety of complications, including mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. The lawsuits further allege that transvaginal mesh complications have caused victims to suffer debilitating pain that is, in many cases, permanent.

In a safety communication released on July 13, 2011, the FDA reported that between 2008 and 2010, it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair. The agency also noted that its review found that transvaginal POP repair with mesh does not offer any additional benefits over traditional non-mesh repair.

"It's horrible. There are unknown amounts of the mesh still in me. I have extreme pain. It feels like the inside of my vaginal wall is on fire," Linda Gross, 46, a plaintiff in a Gynecare Prolift lawsuit who received the implant in 2006, told ABCNews. "I wouldn't wish this on anyone."

Gross and other plaintiffs in Gynecare Prolift transvaginal mesh lawsuits claim the device was not subjected to adequate testing before doctors began using it in POP surgery. Gross' lawyer pointed out to ABC News that Prolift didn't receive FDA clearance for POP until 2008, which he said means the device she and others received may have been sold without FDA clearance.

Like all other transvaginal mesh devices, Gynecare Prolift was approved for POP surgery under the FDA's 510(k) approval process. This clearance protocol is reserved for "moderate risk" devices that are substantially equivalent to devices that have already been brought to market. 510(k) clearances do not require that medical devices undergo clinical trials involving humans be conducted before they are approved.

Last month, FDA staff issued a report proposing that transvaginal mesh devices for POP surgery be reclassified and placed in the agency's highest risk category, Class III. This would mean that manufacturers could not utilize the 510(k) process, and would need to conduct human tests before applying to the FDA for approval. The same report also proposed requiring the makers of currently approved devices to conduct postmarketing studies to assess their safety and effectiveness in POP surgery. However, the agency report did not propose recalling these devices while the studies are conducted, so they would be allowed to remain on the market.

Last week, during a two-day meeting to investigate the safety of transvaginal mesh in POP repair, a panel of FDA advisors backed the agency's proposals.

Transvaginal Mesh for POP Repair Should be Classified "High Risk," FDA Panel Says

Fri, 09 Sep 2011 00:00:00 -0700

An advisory panel for the U.S. Food & Drug Administration (FDA) voiced support for an agency proposal to reclassify transvaginal mesh devices used to repair pelvic organ prolapse (POP) as high risk, or Class III. If the FDA does go forward with the change, manufacturers of would be required to conduct premarket clinical trials of transvaginal mesh devices before they could be marketed for POP surgery.

Currently, transvaginal mesh devices are marketed as moderate risk, or Class II medical devices. They are eligible for the FDA’s 510(k) approval process, which means they don’t have to be subjected to human testing before they are brought to market. But a growing number of serious complications, including mesh erosion, infection, pain, dyspareunia, vaginal scarring, urinary retention or urinary incontinence, have been associated with transvaginal mesh, especially when it is used in POP repair.

Since 2009, the FDA has received roughly 2,800 complaints about transvaginal mesh complications, of which more than 1,500 involved use of the mesh in POP repair. In many of these instances, additional surgery was required, and even then, many women did not experience complete relief of their symptoms. At least seven deaths have been connected to the devices.

The FDA proposed reclassifying transvaginal mesh as a high risk device in a staff report released last week. Yesterday, during the first of a two-day meeting to assess the safety of the devices in POP repair, a majority of outside advisors on the agency’s Obstetrics-Gynecology Devices Panel voiced support of the move, though no formal vote was taken. The panel also backed the agency’s proposal that manufacturers conduct postmarket studies of devices currently on the market.

POP is painful condition which occurs when the femal pelvic organs drop from its normal position, usually due to weakening of the vaginal wall from childbirth, hysterectomy or menopause. About 75,000 women undergo POP repair with transvaginal mesh every year, though there are other procedures that also treat the problem. In a July alert, the FDA voiced doubts as to whether transvaginal mesh devices offered any additional benefit over other POP procedures.

The growing numbers of transvaginal mesh complications have led to more than 500 lawsuits against companies that market such products including Johnson & Johnson, Boston Scientific, American Medical Systems and C.R. Bard.

Transvaginal Mesh Failures Prompt Lawsuits, FDA Review

Thu, 08 Sep 2011 00:00:00 -0700

Women around the country continue to file lawsuit over transvaginal mesh device failures following surgery to repair pelvic organ prolapse (POP). In addition to hundreds of legal claims, the makers of transvaginal mesh products also face a regulatory review that could lead to tighter restrictions on their products.

According to Bloomberg News, surgeons began using mesh products to repair abdominal hernias in the 1950s. In 1996, the first transvaginal mesh device was approved to repair stress urinary incontinence, and the devices were cleared for POP repair in 2002.

In the short time since they were approved for POP repair, transvaginal mesh devices have been associated with thousands of serious complications. For example, in July the U.S. Food & Drug Administration (FDA) said it had received more than 2,800 complaints about transvaginal mesh complications since 2009. Of those, more than 1,500 were associated with POP repair, and three involved fatalities.

According to Bloomberg, an FDA review of more than 100 studies involving nearly 12,000 women implanted with transvaginal mesh showed 10 percent had erosion within a year. In addition to mesh erosion, other serious complications associated with these devices include infection, pain, dyspareunia, vaginal scarring, urinary retention or urinary incontinence.

As we've reported previously, transvaginal mesh for POP repair was approved under the FDA’s 510(k) clearance process, which is reserved for devices that are "“substantially equivalent” to others already on the market. Generally, 510(k) approvals don't require human testing.

Plaintiffs in transvaginal mesh lawsuits claim the devices weren't subjected to enough testing before they were brought to market.

“It wasn’t carefully tried and tested before it was implanted into me,” Marci Sutin Levin, told Bloomberg News. “I was told that it was a real improvement, that this would be great and I would be back at work in two weeks. It was irrevocable, what they did to me.”

Levin, 65, received a transvaginal mesh product made by Johnson & Johnson in 2007 during surgery to repair POP. Now, she says she is in constant pain that has left her unable to work, have sex with her husband, or even sleep through the night, Bloomberg said.

Last week, FDA staff released report that actually calls for the revocation of 510(k) clearance for transvaginal mesh devices used in POP repair. The report goes on to state that the “rate and severity of mesh-specific adverse events following vaginal POP repair with mesh calls into question the safety of these devices.” If 510(k) approvals are revoked, manufacturers of devices already on the market may have to conduct new clinical trials in order to keep their clearance for POP surgery.

Today marks the start of a two-day meeting of the Obstetrics-Gynecology Devices Panel to determine whether transvaginal mesh for POP repair is safe and effective. No formal votes will be taken at the end of the hearing. However, the panel will be polled on whether to reclassify the devices and gather thoughts on how to conduct clinical studies.

Transvaginal Mesh Products May Face Tougher Scrutiny

Tue, 06 Sep 2011 00:00:00 -0700

The U.S. Food & Drug Administration (FDA) is considering a proposal to revoke 510(k) approvals for transvaginal mesh devices. If the agency follows through, makers of transvaginal mesh devices currently on the market might have to submit new data to the agency in order to keep them there.

Transvaginal mesh products are used in the surgical treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The devices were used in 75,000 transvaginal surgeries last year, according to the FDA. The mesh products are made by at least nine companies, including Boston Scientific and Johnson & Johnson.

The FDA's 510(k) approval process is reserved for new medical devices that are substantially similar to products already on the market, and doesn't require that new devices undergo human testing. In recent months, 510(k) approvals have come under increasing criticism. For example, a study published over the summer in the journal Archives of Internal Medicine found that of 113 serious medical device recalls issued between 2005 and 2009, 80 had undergone 510(k) approvals. In July, in a report commissioned by the FDA, the Institute of Medicine recommended the agency scrap the 510(k) process entirely, finding that such approvals offered patients no assurance of safety.

A report issued last Thursday by FDA staff expressed concern that the "rate and severity of mesh-specific adverse events following vaginal POP repair with mesh calls into question the safety of these devices." According to the report, the most common complications associated with transvaginal mesh devices included mesh erosion, infection, pain, dyspareunia, vaginal scarring, urinary retention or urinary incontinence, and recurrence of POP and/or SUI.

In addition to ending 510(k) approvals for transvaginal mesh products, the report also recommended that news studies involving current products be conducted. However, the agency would consider a grace period for companies to submit premarket approval applications.

Since 2008, the FDA has issued two warnings for transvaginal mesh. In its latest warning, released in July, the agency said that complications associated with transvaginal mesh products used in POP are not rare. According to the alert, the FDA had received more than 2,800 complaints about transvaginal mesh complications since 2009. Of those, more than 1,500 were associated with pelvic organ prolapse repair, and three involved fatalities. The most recent alert also stated that it is “not clear that transvaginal POP repair with mesh is any more effective than traditional [transvaginal surgery without mesh] … and may expose patients to greater risk.'

This Thursday, the FDA will convene a two-day meeting of its Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee to discuss the safety record of transvaginal mesh. Among other things, the panel will be asked to provide input on the risks and benefits of surgical mesh used for POP and SUI repair. The panel will also be asked if the devices should be reclassified as high-risk devices.

FDA Backs Silicone Breast Implants, Despite Safety Concerns and Lack of Data from Safety Studies

Thu, 01 Sep 2011 00:00:00 -0700

It looks like silicone breast implants aren't going anywhere anytime soon. Yesterday, the U.S. Food & Drug Administration (FDA) announced the controversial devices would stay on the market, while their makers continue safety studies meant to assess their risks.

Silicone breast implants have long been suspected of causing serious complications, including capsular contracture, implant rupture, wrinkling, uneven appearance (asymmetry), scarring, pain, and infection. The devices were actually restricted buy the FDA for about a decade until 2006. When those restrictions were lifted, the FDA stipulated that manufactures of silicone breast implants - Allergan and Mentor - conduct safety studies to monitor for any increased risks.

Most recently, silicone and saline implants were connected to a rare form of lymphoma called anaplastic large cell lymphoma (ALCL). In January, the FDA warned that silicone breast implants, as well as saline implants, might increase a woman's risk o developing ALCL. At the time, the FDA said that 60 cases of ALCL had been reported among the 5 to 10 million patients with both silicone and saline breast implant. In contrast, the cancer normally occurs in the breast in only 3 in 100 million women in the general population.

In June the FDA issued another safety communication stating that silicone breast implants should not be considered lifetime devices, and that complications often result in additional surgeries to fix or replace them.

This week, the FDA convened the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to take a look at the safety studies manufacturers have been conducting for silicone breast implants. According to a report from MSNBC, during the two-day meeting, advisors heard “compelling” testimony from women who said they suffered numerous complications from their implants.

At the meeting's conclusion yesterday, William Maisel, the FDA's chief scientist and deputy director in the agency's device division, announced that despite their "significant complication rate," the agency "continues to believe currently approved devices are safe and effective." The devices will remain on the market, he said.

One of the problems with tracking implant safety is that many participants in the studies being conducted by implant makers haven’t been followed. According to MSNBC, Mentor has three-year data for only one out of every five women in its study, while Allergan has two-year data for three out of every five, according to the FDA.

A report from Dow Jones News Service pointed out that the FDA has the authority to revoke approval of the devices if the required follow-up studies are not done or conducted properly. But Maisel said yesterday that rather than exercising that authority, the FDA wants to work with the companies and groups representing patients and doctors to find ways to boost study participation.

Complaints Associated with DePuy ASR Hip Implant, Other All-Metal Devices, Mount

Wed, 24 Aug 2011 00:00:00 -0700

The U.S. Food & Drug Administration (FDA) has recorded a big spike in complaints related to all-metal hip implants. According to a report from The New York Times, some experts now fear all-metal hip implants could become one of the biggest and most costly medical implant problems in recent history.

According to The New York Times' analysis, the FDA has received around 5,000 adverse event reports related to all-metal hip replacements, more than it received in the previous four years combined. The device with the most complaints, not surprisingly, is DePuy Orthopaedics' recalled ASR hip implant. That one device was responsible for 75 percent of the reports made to the FDA since January. Between 2007 and this June, the DePuy ASR hip implant was the subject of 7,500 complaints to the FDA.

Other hip implants were also named in the complaints. During the same period, about 1,600 complaints related to the Durom Cup were filed with the agency. The all-metal version of DePuy's Pinnacle implant was the subject of 200 complaints, while another 400 noted metal-related problems in Pinnacle devices. It's not clear how many of those were associated with all-metal devices, as the Pinnacle is sold in several versions, the Times said.

Complaints involved cases were an all-metal device had failed within just a few years of implantation, despite the fact that they're designed to last 15 years or so. In most cases, patients had undergone, or were preparing to undergo, revision surgery.

According to the Times, all-metal hip implants were once very popular, with nearly one-third of the estimated 250,000 replacements performed each year. According to one estimate, some 500,000 patients have received an all-metal replacement hip. But since concerns about their safety have grown, they've fallen out of favor, and now are used in about only 5 percent of all hip implant surgeries.

It is believed all-metal hip implants can shed dangerous amounts of cobalt and chromium through wear, leading to tissue damage, premature device failure, the need for revision surgery, and even long-term health problems. In May, the FDA asked DePuy Orthopaedics and 20 other manufacturers of metal-on-metal hip implants to conduct safety studies aimed at determining how often they fail prematurely, and if these devices are shedding dangerous amounts of metallic debris in patients. However, it will likely be years before those studies are completed.

Johnson & Johnson Hiring of Contractor for DePuy ASR Implant Recall Raises Questions

Tue, 23 Aug 2011 00:00:00 -0700

It appears Johnson & Johnson is handling the DePuy ASR hip implant recall in an unusual way. The company has hired a third-party contractor, Broadspire Services Inc., to administer all patient claims for out-of-pocket medical costs associated with the defective device, according to a Reuters report.

The unusual arrangement is causing concern on a number of fronts. For one thing, Johnson & Johnson and its DePuy Orthopaedic division are requiring that doctors from Broadspire - not a patient’s own physician - determine whether a DePuy ASR hip implant recipient should undergo revision surgery. If Broadspire says no, DePuy won't reimburse the patient. Because Broadspire's physicians are paid by DePuy, some see a conflict-of -interest.

"Doctors who are evaluating these cases are being paid indirectly by DePuy, and research suggests that even when we are very well-intentioned we can be influenced by conflicts of interest," Kristin Smith-Crowe, associate professor of management at the University of Utah, who specializes in business ethics, told Reuters. "This is a bit of a red flag in terms of the way this situation is set up."

Lawyers representing patients in lawsuits against DePuy and Johnson & Johnson also say the amount of information being collected by Broadspire is excessive, according to Reuters. Last August, DePuy wrote to orthopedic surgeons asking that they give their patients a package of information about the ASR hip implant recall. A DePuy-written letter, purported to be from doctor to patient, urged patients to set up an appointment with their doctor to discuss the ASR implant. The letter also instructed patients to bring with them a signed medical release giving the physician permission to share information with DePuy. The letter stated this information was important to get a claim processed efficiently. Doctors were paid a $50 incentive for every completed form they returned to DePuy said.

"J&J (Johnson & Johnson) is reaching out to doctors and asking them to use their influence with their patients in the hope that the doctor will help identify potential claimants in a lawsuit," one plaintiffs attorney told Reuters. The lawyer, with 35 years of experience in the field, called the maneuver "unprecedented."

An official with DePuy disputed that characterization, insisting its handling of the recall is "standard practice."

Some doctors, however, told Reuters they have never been asked by a product manufacturer to persuade patients to give up their privacy rights, never mind being paid to do so.

"It made me uncomfortable,” Mark Barba, an orthopedic surgeon at Rockford Orthopedic Associates, a surgical center in Rockford, Illinois, told Reuters. "I've never faced anything like that before. Never."

MDL Ordered for Zimmer NexGen knee Replacement Lawsuits

Wed, 10 Aug 2011 00:00:00 -0700

A multidistrict litigation (MDL) has been established in U.S. District Court for the Northern District of Illinois for lawsuits involving Zimmer NexGen CR-Flex femoral components, Zimmer NexGen MIS Tibial components or Zimmer NexGen LPS-Flex femoral components. An MDL allows lawsuits associated with a particular product to be coordinated under one judge for pretrial litigation to avoid duplicative discovery, inconsistent rulings and to conserve the resources of the parties, witnesses and the court.

According to a Transfer Order issued by the U.S. Judicial Panel on Multidistrict Litigation (JPML), the original motion to consolidate the Zimmer NexGen knee replacement lawsuits encompassed 28 cases filed in 13 federal districts. Since then, more than 45 other such lawsuits have been filed.

The panel chose the Northern District of Illinois for the MDL venue because 10 of the 28 constituent actions are pending in that district, and the district is relatively close to Zimmer’s Indiana headquarters. Judge Rebecca R. Pallmeyer, who the panel referred to as “an experienced and highly-regarded jurist,” will preside over the litigation.

All of the lawsuits in the litigation allege that allege that the Zimmer CR-Flex, LPS-Flex and/or MIS Tibial components are prone to premature loosening, causing affected individuals pain and loss of movement, and often forcing them to undergo revision surgery. The actions also raise factual issues as to whether the Zimmer high-flex components (CR-Flex and LPS-Flex) actually provide an individual with any increase in flexion.

In opposing the MDL consolidation, Zimmer had argued that the involved NexGen components are “quite distinct, and thus discovery would not significantly overlap among the actions.’ However, the JPML did not find the device maker’s arguments persuasive, stating its review of the record indicated that the distinctiveness of the various components is not as clear-cut as Zimmer contends.

The consolidated litigation is titled IN RE: ZIMMER NEXGEN KNEE IMPLANT PRODUCTS LIABILITY LITIGATION (MDL No. 2272).

AMS Sued Over Transvaginal Mesh Complications

Thu, 14 Jul 2011 00:00:00 -0700

American Medical Systems (AMS), the manufacturer of Perigee, Apogee and Elevate surgical mesh products used in transvaginal pelvic organ prolapse (POP) surgery, has been named in a lawsuit alleging one of its transvaginal mesh implants caused a Texas woman to suffer serious complications.

AMS is just one of several companies that have been named in transvaginal mesh lawsuits over the past several years. According to a report from Newsinferno.com, litigation involving C.R. Bard’s Avaulta mesh was consolidated as part of a multidistrict litigation for pretrial proceedings in the U.S. District Court for the Southern District of West Virginia last October. Last year, settlements were reached in a number of Mentor ObTape vaginal mesh lawsuits. At least two other transvaginal mesh lawsuits are pending against AMS in Delaware.

According to her lawsuit, Laura Jones had transvaginal mesh implanted in 2009 during POP surgery. Not long after the procedure, Jones began experiencing prolonged unexplained pain and urinary complications. Apparently, the device had eroded, shrunk, and partially extruded into her vagina. Jones was forced to undergo additional surgical procedures to have the device removed. Her lawsuit alleges that AMS failed to warn the public about the inherent risks of vaginal mesh side effect.

Unfortunately, Jones is not alone in suffering these types of transvaginal mesh complications. According to a notice issued by the U.S. Food & Drug Administration (FDA) yesterday, more than 2,800 women have suffered from mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems as a result of transvaginal mesh. Yesterday's notice was an update to another the FDA had issued in October 2008, when it said it had received 1,000 reports of such complications.

According to the FDA, 1,503 of the new reports were associated with POP repairs and 1,371 were associated with procedures to repair stress urinary incontinence. The agency noted that the number of adverse event reports associated with POP procedures was five times as many as the FDA received from 2005 to 2007. The FDA said its safety review also found that 10 percent of women who have the mesh placed transvaginally experience mesh erosion within 12 months of surgery and that more than half of them require additional surgeries to remove the mesh.

In a change from its 2008 position, the FDA said complications following POP surgery that involved transvaginal mesh are not rare. It also cautioned doctors that it was not clear that POP repair involving transvaginal mesh was better than traditional non-mesh procedures, and may actually expose patients to greater risk of complications.

DePuy Hip Implant Lawsuits Just Keep Coming

Fri, 08 Jul 2011 00:00:00 -0700

Lawsuits against DePuy over their metal-on-metal hip implant devices increase as more plaintiffs step forward claiming the ASR hip implant caused them to suffer from numerous injuries. The Johnson & Johnson unit faces over 1,000 suits in both federal and state court claiming DePuy knew of the problems with the device.

A majority of the plaintiffs contend in 2007, DePuy was warned about the high rates of failure and complications associated with the ASR hip implant systems through an Australian medical-device registry which tracks patient complaints, reported the Wall Street Journal. If the company knew of the problem in 2007 and did not immediately recall the product, DePuy could perhaps face punitive damages, said John Coffee, a Columbia University law professor.

However, a spokeswoman for DePuy said although they use the Australian database to track the safety of their products, subsequent information from a British registry prompted them to recall the parts.

Many of the plaintiffs also claim the device caused them to suffer from infection and inflammation. In 2006, Lavonne Gordon received two DePuy implants and ever since, her medical tests revealed high levels of chromium and cobalt in her blood. Gordon sued the company and claims the device gave her “weird problems” such as urinary tract infections and fevers, reported the Journal.

A panel of federal judges has consolidated many of the suits in federal court in Ohio. Several plaintiffs are seeking class certification arguing their claims are similar to other cases. The plaintiffs allege the hip implant was defective, causing them to require revision surgery and suffer from various health complications. Some plaintiffs say the metal components of the implant shed into their bloodstreams and subsequent blood tests revealed elevated levels of metals.

A Wells Fargo analyst predicts the litigation could expose DePuy to over $1 billion in potential liability and other costs, reported the Journal.

In 2010, DePuy issued a worldwide voluntary recall of the ASR implant after the National Joint Registry of England and Wales reported 1 out of 8 implant patients (12%-13%) required revision surgery. Unlike the average hip implant which is estimated to last fifteen years, DePuy ASR implant recipients needed surgery within five years of receiving the device.

The company estimates more than 93,000 patients worldwide were fitted with the implant and one-third are U.S. patients. DePuy will cover the cost of all medical care associated with the device, including replacement surgery, says the Journal.

The company also faces lawsuits over the Pinnacle implant, which is still on the market. In May 2011, the U.S. Judicial Panel on Multidistrict Litigation consolidated all product liability lawsuits over the device. The DePuy spokeswoman said the company stands behind the product, calling it “one of the most widely used and clinically successful” hip implant devices on the market, reported the Journal.

Expect Big Fallout from Medtronic Infuse Scandal, Analyst Says

Thu, 07 Jul 2011 00:00:00 -0700

The latest furor over Medtronic Inc.'s Infuse bone growth product will likely lead to increased regulatory scrutiny of the spine device, as well as possible class action lawsuits, a Wall Street analyst says. According to a Forbes report, Larry Biegelsen of Wells Fargo says the fallout could lead Medtronic to sell its spine business.

Last week, The Spine Journal published an entire issue dedicated to Medtronic’s Infuse product, a recombinant human Bone Morphogenetic Protein (rhBMP-2) that is widely used in spinal fusion surgery. One of the articles included in the issue asserted that in 13 Medtronic-funded studies conducted between 2000 and 2010, side effects – including male sterility, infection, bone loss and unwanted bone growth - occurred 10 to 50 times more than what was stated in the final, peer-reviewed published articles. According to that study, every large Infuse study involved at least one researcher who received at least $10 million in royalties from Medtronic.

Even before this, the Infuse product was the subject of a Senate Finance Committee inquiry and a U.S. Justice Department investigation. According to Biegelsen, the Infuse side effect revelations could cause the U.S. Food & Drug Administration (FDA) to launch a safety review of the product. On top of that, the disclosures could spark a wave of Infuse class action lawsuits filed by people who sustained injuries linked to the product.

In his report, Biegelsen wrote:

"We think The Spine Journal papers could lead to the following outcomes: (1) a significant reduction in the sales of MDT’s spine biologics franchise; (2) a reduction in the sales of MDT’s spinal instrumentation business; (3) a potential FDA review of Infuse, including an Advisory Committee meeting, which could lead to more limited use of Infuse; (4) potentially larger criminal penalties in the Department of Justice (DOJ) investigation of the off-label promotion of Infuse; (5) the potential emergence of class action lawsuits; and (6) the potential sale of the entire spine business.'

Biegelsen said the controversy could turn healthcare providers against Infuse, leading to as much as a 50 percent drop in sales. He also warned that settlements in potential Infuse class action lawsuits could cost Medtronic as much as $1.2 billion.

Biegelsen also said that competing products, such as NuVasive and Orthofix, could benefit from Infuse’s problems.

Victim of Zimmer Durom Cup Files Lawsuit

Wed, 06 Jul 2011 00:00:00 -0700

Another metal-on-metal hip implant is the subject of a personal injury lawsuit. According to a complaint filed last month in Louisiana federal court, Francoie Stephens had to have his Zimmer Durom Cup hip implant removed just three years after he received it due to complications that included metal contamination of his blood.

All-metal hip implants have come under increasing scrutiny since the recall last August of the DePuy ASR hip implant. That device was recalled because of a high number of early failures. In some cases, wearing of the implants’ metal components has caused it to shed high levels of cobalt and chromium into recipients’ bloodstream. Earlier this year, the growing concern over all-metal hip implants prompted the U.S. Food & Drug Administration (FDA) to order DePuy, Zimmer and 19 other implant makers to conduct safety studies of their metal-on-metal hip implants.

In July 2008, Zimmer suspended US sales of the Durom Cup following complaints about device failures due to loosened components that required revision surgery. Stephens received his implant a year before that occurred, in 2007. Such complications, including elevated levels of chromium and cobalt in his blood, forced Stephens to undergo revision surgery to have the Zimmer Durom Cup removed. He alleges that the device contained one or more defects that made it unreasonably dangerous and unfit for its intended use.

In 2008, Zimmer’s own estimates suggested that some doctors in the US experienced failure rates as high as 5.7 percent with the Durom Cup. However, some Zimmer Durom Cup lawsuits claim the failure rate could be as high as 30 percent.

C.R. Bard to Settle Most Kugel Mesh Hernia Patch Lawsuits

Tue, 05 Jul 2011 00:00:00 -0700

Nearly six years after the first Composix Kugel Mesh Hernia Patch recall was announced by the U.S. Food & Drug Administration (FDA), C.R. Bard says it has reached an agreement to settle most of the personal injury lawsuits involving the defective device. According to its most recent quarterly filing with the Securities and Exchange Commission (SEC), the company will take a $184 million charge to cover the cost of the Kugel Mesh Hernia Patch settlements.

C.R. Bard and its Davol Inc. subsidiary face over 3,500 lawsuits involving the Kugel Mesh Hernia Patch. More than 1,300 are pending in a multidistrict litigation in the U.S. District Court for the District of Rhode Island, where two cases have already been tried. Though the jury in the first trial found the Kugel Mesh Hernia Patch had been negligently designed, it determined that the plaintiff had not proven that the design of the device had caused or contributed to his injuries. The second trial ended with a $1.5 million verdict for the plaintiffs.

In addition to the federal multidistrict litigation, C.R. Bard faces another 1,700 lawsuits n Rhode Island Superior Court.

The settlement agreement announced in C.R. Bard's quarterly filing does not cover any potential class action lawsuits. The company could face at least two in the U.S. and four in Canada, though none have been certified.

The first Kugel Mesh Hernia Patch recall was issued in December 2005, after the FDA received reports of the device's recoil ring breaking, which in some cases caused bowel perforations and other serious problems. Additional Class I recalls were issued in 2006 and 2007.

Medtronic Infuse Disclosures Put Medical Journals in Spotlight

Tue, 05 Jul 2011 00:00:00 -0700

Some medical journals are facing fire again over their conflicts-of-interest policies in the wake of the latest Medtronic Infuse scandal. The latest Medtronic Infuse controversy indicates that many prestigious medical journals aren't doing enough to spot obvious financial bias.

Last week, The Spine Journal published an entire issue dedicated to Medtronic’s Infuse product, a recombinant human Bone Morphogenetic Protein (rhBMP-2) that is widely used in spinal fusion surgery. One of the articles included in the issue asserted that in 13 Medtronic-funded studies conducted between 2000 and 2010, side effects – including male sterility, infection, bone loss and unwanted bone growth - occurred 10 to 50 times more than what was stated in the final, peer-reviewed published articles. According to that study, every large Infuse study involved at least one researcher who received at least $10 million in royalties from Medtronic.

Over the past several years, medical journals have made a lot of noise about beefing up their financial disclosure policies. But according to a report from ProPublica, the information provided by these disclosures is often less than complete. For instance, the New England Journal of Medicine, Journal of the American Medical Association, and the Annals of Internal Medicine use the same disclosure form developed in 2009 that that requires authors to disclose what types of payments they've received, but they don’t need to reveal how much they’ve been paid, ProPublica said. And while they must name the companies paying them, authors do not have to identify the drugs or devices that relate to the payments.

By contrast, The Spine Journal requires dollar amounts to be reported within ranges and makes the information available to readers.

Eugene Carragee, a professor of orthopedic surgery at Stanford University and editor of the Spine Journal told ProPublica readers "absolutely" need to be informed of the dollar amounts that doctors are receiving from industry.

Journal Questions Integrity of Medtronic Infuse Studies

Wed, 29 Jun 2011 00:00:00 -0700

A major medical journal is slamming studies for Medtronic Inc.'s Infuse Bone Graft product, asserting that information regarding side effects was omitted from final published articles. The Spine Journal questions whether researchers’ financial relationships with Medtronic influenced what it characterizes as misleading and biased Infuse studies.

Infuse contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation. Infuse has a troubled history, and has already been the subject of investigations by the U.S. Senate Finance Committee and the U.S. Justice Department.

The Spine Journal took the unusual step of devoting an entire issue to the Infuse controversy.

"The history of rhBMP-2 research is a cautionary tale for all medical professionals, researchers and patients," Christopher M. Bono, MD of Brigham & Women's Hospital in Boston, MA and acting editor in chief of this issue of The Spine Journal, said in a statement. "As this matter demonstrates, the spine care field is currently at a precarious intersection of professionalism, morality and public safety. As physicians and journal editors, we felt an obligation to present a thorough examination of this controversial issue."

One of The Spine Journal articles asserts that in 13 Medtronic-funded studies conducted between 2000 and 2010, side effects – including male sterility, infection, bone loss and unwanted bone growth - occurred 10 to 50 times more than what was stated in the final, peer-reviewed published articles. According to that study, every large Infuse study involved at least one researcher who received at least $10 million in royalties from Medtronic.

According to The New York Times, Medtronic earned an estimated $900 million from Infuse in its most recent fiscal year, and the product is used in an estimated 432,000 spinal fusions performed in the U.S. each year. In 2009, the U.S. Food & Drug Administration (FDA) warned that Infuse and similar products had caused serious and potentially life-threatening problems when they were used off-label in cervical spine (neck) surgeries.

Last week, advance word of The Spine Journal's revelations prompted Senator Max Baucus (D-Montana), the chairman of the Senate Finance Committee, and Senator Chuck Grassley (R-Iowa), the committee's ranking Republican, to send Medtronic a letter demanding records of payments made to doctors who authored Infuse studies.

Former Swimmer Claims DePuy ASR Hip Implant Compromised Her Quality of Life

Tue, 28 Jun 2011 00:00:00 -0700

DePuy Orthopaedics faces another lawsuit over its ASR Hip Resurfacing System. On Tuesday, Charlotte Mustard filed a suit in a U.S. federal court against the company alleging the implant caused her to suffer various injuries. The ASR Hip Resurfacing System is a metal-on-metal hip implant made of chromium and cobalt often used in total hip replacements.

In January 2008, Mrs. Mustard underwent hip replacement surgery using the DePuy ASR hip implant device while living in the United Kingdom. Prior to surgery, Mrs. Mustard, who now lives in the U.S., was told the implant would last 20 years and that the metal-on-metal design was superior to other devices available on the market. However, the ASR hip implant did not live up to this claim because after implantation, Mrs. Mustard suffered from severe and debilitating injuries, such as hip pain, stiffness, twinges, heart palpitations and vision problems.

She alleges the ASR hip implant compromised “her quality of life.” As a result of the surgery, Mrs. Mustard, a well-known athlete and former world record holder, is physically unable to participate in competitive swimming, says the complaint.

“The testing of the ASR system was completely inadequate. The design of the ASR was fundamentally flawed…” said Mrs. Mustard’s attorney.

In August 2010, DePuy issued a worldwide recall of its ASR Hip Resurfacing System and DePuy ASR Acetabular System after the National Joint Registry of England and Wales reported 1 out of 8 implant patients (12%-13%) required revision surgery. Since the ASR hip implant systems were recalled, more than 1,000 lawsuits have been filed against DePuy Orthopaedics and its parent, Johnson & Johnson. Hundreds of such claims have been consolidated in a multidistrict litigation in U.S. District Court for the Northern District of Ohio.

DePuy is also facing numerous U.S. lawsuits over its Pinnacle hip implant device, another all-metal hip implant device, which plaintiffs claim is similar in design to the ASR implants and poses many of the same problems. Last month, the U.S. Judicial Panel on Multidistrict Litigation consolidated at least 57 product liability lawsuits over the Pinnacle device. Like those who have filed suit over the ASR implants, plaintiffs in the DePuy Pinnacle lawsuits claim the device is defective and causes metal particles to shed when the components rub together, thus making the implants prone to early failure.

In May, the U.S. Food and Drug Administration issued an order for DePuy and 20 other companies that produce metal-on-metal hip implants to conduct studies of implant recipients to determine whether the devices were shedding high level of metallic debris. The agency’s action was in response to thousands of consumer complaints that such implants were defective and posed risk of early failure.

FDA Issues Update on Breast Implant Safety

Thu, 23 Jun 2011 00:00:00 -0700

Five years after re-approving silicone gel breast implants for augmentation, the U.S. Food & Drug Administration (FDA) is updating the public on the safety issues posed by the devices. The FDA's update is based on preliminary results of studies that Allergan and Mentor were ordered to conduct in the wake of the 2006 re-approval. The studies involved some 40,000 women.

According to the FDA, women who receive silicone breast implants should know that there is a good chance that, at some point, the devices will need to be removed or replaced because of complications, including capsular contracture, implant rupture, wrinkling, uneven appearance (asymmetry), scarring, pain, and infection. Because of these risks, patients with silicone breast implants will need to be monitored with the rest of their lives.

One in 5 patients who received implants for breast augmentation will need them removed within 10 years of implantation. For patients who received implants for breast reconstruction, as many as 1 in 2 will require removal within 10 years of implantation, the agency said.

The good news is that so far, the studies have provided no evidence linking silicone breast implants with breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, the agency cautioned that studies conducted so far have been too small to reach definitive conclusions on these issues.

On particularly troubling risk faced by recipients of both silicone and saline implants is the small possibility that they will develop a rare type of lymphoma - anaplastic large cell lymphoma or ALCL – near their implant. Earlier this year, the FDA warned that 60 cases of ALCL have been reported among the 5 to 10 million patients with both silicone and saline breast implant. In contrast, the cancer normally occurs in the breast in only 3 in 100 million women in the general population.

Defective Medical Device Lawsuits, Medical Equipment Injury Attorneys | Manufacturer Defect, FDA, Lawyers

Thu, 23 Jun 2011 00:00:00 -0700

Defective Medical Device Lawsuit Lawyer

Every year millions of people use a variety of medical devices such as Transvaginal Mesh, Hip Replacements, Pacemakers, etc believing they are safe and that there is little chance of serious health risk, allowing them to live healthier and more effective lives. Yet defective medical devices can leave users at risk for a variety of debilitating injuries. The risk from defective medical devices is especially high for people who require their long-term use. Parker Waichman LLP is a leading personal injury law firm with experienced medical device attorneys on staff. We are contimually evaluating cases involving product liability from defective medical devices throughout the United States. To view more information involving a specific medical device, please click on one of the links listed below.

If you have been harmed by a defective medical device, we urge you to please complete the contact us form at the right for a free case evaluation by one of our qualified defective medical device attorneys or call us at 1-800-LAW-INFO (1-800-529-4636) today.

Medical equipment must be approved by the U.S. Food & Drug Administration (FDA), but the manufacturer of the device is ultimately responsible to ensure the safety of the product. When a medical device is discovered to be defective, the manufacturer is responsible to inform the FDA and the public about the flaw and any potential risks. If the manufacturer of the medical device does not properly inform the public and the FDA in a timely manner about the defect it is can be considered an act of negligence and is liable for any injuries, illnesses or deaths that occur.

Defective Medical Device Victims - Legal Help

The defective medical device attorneys at Parker Waichman LLP are available for a free case evaluation if you or your loved one have been harmed by a defective medical device. Please feel free to contact us by completing the form at the right or call us at 1-800-LAW-FIRM (1-800-529-4636).

If the defective medical device you are looking for is not listed in the links below, please Visit our Defective Medical Devices Archives Page for additional articles about defective medical device lawsuits that Parker Waichman LLP has defended for our clients.