Yourlawyer.com (Composix Kugel Patch News)

Man Killed by Kugel Mesh Hernia Patch, Family Wants to Warn Others

Tue, 10 Jun 2008 00:00:00 -0700

Aaron Menendez endured two years following implantation of a Bard Composix Kugel mesh hernia patch before he suffered a serious infection and died this past September. Soon after his implantation, the patch was recalled. Menendez’s autopsy results confirm that the Bard Composix Kugel mesh was the cause of death. Now, Menendez’s family want others to know about this potentially fatal medical device.

Over 700,000 hernia repair surgeries are performed in the U.S. annually. Hernias are areas where an organ breaks through weakened or torn tissue. Before the Davol Composix Kugel Mesh Hernia Patch, repair was conducted by tension repair surgery, which could cause problems if muscle tissue re-tore. The patch—developed to reduce re-tears—is constructed of two mesh pieces surrounding a plastic ring. The surgeon makes a tension-free repair using a small incision and places the folded patch behind the hernia. The spring-like ring opens the patch where it lays flat behind the incision allowing internal tissue to grow and repair the tear or weakness, resolving the hernia.

Bard, Davol’s parent company, knew about severe injuries caused by the device although they claim they acted responsibly and didn’t take the product off the market because the number of complaints were small given the number of patches sold and problems cited were too random. In all, patches were recalled three times by the US Food and Drug Administration (FDA) who received nearly 100 reports of problems related to the patch, several involving death. Davol, received reports of up to 10 complications from the patches, with one possible fatality, yet Davol delayed reporting a massive recall for months because initial complaints all came from Germany, with three from one doctor. Davol concluded ring breaks were due to physician error, halted production of some patches, trained German doctors, revised physician instructions, and continued distributing other patches. Davol was wrong; problems continued.

The problem was not with a doctor but is in the Bard Composix Kugel mesh hernia patch ring. Tests run on a failed patch indicated a ring weld defect, meaning that the ring can break, exposing shards that have caused bowel perforations and obstructions, serious infections, and chronic fistulae (abnormal connections between intestines and organs). Despite this and despite Class I recalls (indicating a serious danger), Davol recommended that products continuing to function properly should not be replaced as there could be greater risk in removing a properly functioning device. Requesting replacement surgery is not an option.

The FDA ordered Davol to investigate and correct procedures and accused Davol of knowingly keeping defective patches on the market and understating their severe and dangerous complications. An inspection at Davol unearthed other problems: Serious flaws in their complaint tracking system (systems incompatibility); shoddy procedures (an inability to handle everything from complaint investigation to recall actions determination); and an absence of testing documentation on the manufacture of Salute Reusable Fixation devices (for attaching mesh in laparoscopic and open hernia repair and pelvic floor reconstruction). The FDA said Davol’s procedures were to blame for delays in dealing with the problems; that Davol did not accurately report complaint severity; and problems found during inspection could be symptomatic of serious underlying issues in their quality assurance system.

Kugel Mesh Hernia Patch Used At Virginia Hospitals Long After Recall

Mon, 09 Jun 2008 00:00:00 -0700

The defective Kugel Mesh Hernia Patch - recalled several years ago - was mistakenly implanted in seven patients at two Virginia hospitals. At least one woman who received a recalled Kugel Mesh Hernia Patch at one of the two hospitals owned by Sentara Health Systems says she has been living in excruciating pain since her surgery, and is worried that the medical device might be putting her life in danger.

When it was first introduced, the Kugel Mesh Hernia Patch was heralded as an innovation in hernia treatment. Unfortunately, by 2005, the Food & Drug Administration (FDA) was receiving more and more reports of failure with the Kugel Patch. The reports were so alarming that the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch. Apparently, the recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems. A Class I recall means that the recalled product poses a serious danger to patients still using it. The FDA warned doctors to quit using the patch. The FDA also warned patients who received the patch to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. By February 2007, the Kugel Patch recall had been expanded twice - in 2006 and 2007 - to include several other sizes of the device.

Apparently, not all hospitals have gotten the word on the Kugel Mesh Hernia Patch recall - at least not in the case of Sentara Virginia Beach General Hospital and Sentara Leigh Hospital. Officials from the Virginia health system admitted last week that four patients at the Virginia Beach location, and three others at Leigh were implanted with the dangerous hernia patch.

Sentara was first alerted to the problem when Virginia Beach's Judith Coyne, who had hernia surgery last June - six months after the final Kugel Mesh Hernia Patch recall was announced - related her story to a Virginia TV station. Coyne said shortly after her surgery, she began having excruciating abdominal pain. When she and her son got her medical records, using the product code and lot number, they determined that the Kugel Mesh Hernia Patch which was implanted in her during surgery was recalled. According to WAVY.com, Coyne says doctors now tell her that the mesh is stuck to her organs and aren't willing to operate because it could kill her. But Coyne lives in fear that the Kugel Mesh Hernia Patch inside her body will put her life in danger if it should break.

At first, Sentara insisted that Coyne's Kugel Mesh Patch was not the same lot number as the one recalled, but later released a statement conceding that the patch was, in fact, subject to recall. The statement said that Sentara had "contacted Ms. Coyne's surgeon and requested that he conduct a follow up examination and evaluation so that we can provide any assistance possible to address her pain issues."

Late last week, Sentara announced that Coyne was not the only patient implanted with a recalled Kugel patch. Sentara's Vice President Of Medical Affairs, Dr. Tom Thames told Fox 43 that the recalled patches were implanted in 7 people at the hospitals "as a result of human error." While Davol did inform Sentara of the Kugel Mesh Hernia Patch recall, Dr. Thames said that because the recall occurred in stages, it was confusing.

Sentara is in the process of notifying all of the patients who received the recalled Kugel Mesh Hernia Patch, and says it will offer assistance to those patients. Anyone with questions can call the health system at 1-800-SENTARA, weeknights until 11:30 p.m.

Defective Medical Devices Show Need for More Regulation

Fri, 08 Feb 2008 00:00:00 -0800

Defective medical devices like Stryker hip implants, Medtronic Defibrillators and the Kugel Mesh Hernia Patch have injured countless people. Now researchers from the University of California, San Francisco (UCSF) have asserted that medical devices are not subject to the same rigorous review process as pharmaceuticals and this needs to change to improve health outcomes. The team analyzed the problem and proposed solutions in a "Perspectives" article in the January 2008 issue of the Journal of General Internal Medicine. UCSF researchers Mitchell D. Feldman, MD, MPhil, and Jeffrey A. Tice, MD, edited the issue.

The team found once a device receives Food and Drug Administration (FDA) approval, an independent technology review could help identify which devices are beneficial. According to the team, this data would improve health professionals' awareness of "the potential promise and pitfalls of new technology.” Feldman, professor of medicine at UCSF said, "These days, patients are asking their doctors for the newest technologies from genetic tests to specific radiation treatments and many physicians don't know where to turn for the latest evidence-based information. Sometimes, the only information out there is what the manufacturer provides."

The UCSF analysis evaluated the federal review process, how devices come to market, how scientific literature reports on clinical trials involving medical devices, and the effectiveness of independent review boards in improving a technology's medical benefit. Out of thousands of medical technology applications submitted annually to the FDA, less than 100 undergo the scrutiny required for new drugs. Most new applications are approved through an expedited FDA process that considers new devices similar to those already approved. Also, the FDA relies on manufacturers and clinical investigators to initiate recalls and failure reports when a technology is not beneficial or is potentially harmful to patients.

"FDA approval should be the start of the process toward clinical application, not the end," Feldman said. "Physicians and patients just aren't aware of the limitations of the FDA process of initial assessment and oversight of new medical technologies. Assessments by objective entities are a necessary addition to FDA approval, so that deficiencies in clinical evidence, and patient safety issues that may arise after approval, are recognized before widespread adoption into clinical practice." The purpose of independent review organizations is to provide transparent, objective evaluations, Feldman said. Some, like the California Technology Assessment Forum (CTAF) conduct open, public meetings. Among others, their review board is filled with experts in medicine, representatives from medical professional societies, technology manufacturers, policy maker,s and insurance providers. The UCSF Division of General Internal Medicine currently subcontracts with CTAF to provide technology assessments.

"In order to be considered in an assessment, CTAF requires that information already be published or accepted by a peer-reviewed journal. This encourages companies to make their trial results available to the public," said Tice, attending physician in the Division of General Internal Medicine at UCSF. "CTAF also requires improvements in patient-oriented outcomes, not surrogate markers. For example, we want to see improvements in disease-free survival and patient quality of life, not just a reduction in tumor size."

Eventually, the authors suggest, independent review boards should summarize their findings into uncomplicated take-home messages that patients can easily find on their own.

Court Expands Kugel Mesh Hernia Patch Litigation

Mon, 28 Jan 2008 00:00:00 -0800

The maker of the defective Kugel Mesh Hernia Patch will now have to face even more lawsuits over faulty hernia patches. Earlier this month, a Federal Court charged with hearing all claims related to the Kugel Mesh Hernia Patch ruled the proceedings would be expanded to include claims against any of Davol Inc’s defective mesh patches, even those that were not involved in the original Kugel Mesh Hernia Patch recall.

When it was first introduced, the Kugel Mesh Hernia Patch was heralded as an innovation in hernia treatment. Unfortunately, by 2005, the Food & Drug Administration (FDA) was receiving more and more reports of failure with the Kugel Patch. The reports were so alarming that the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch. Apparently, the recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems. A Class I recall means that the recalled product poses a serious danger to patients still using it. The FDA warned doctors to quite using the patch. The FDA also warned patients who received the patch to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. By February 2007, the Kugel Patch recall had been expanded twice to several other sizes of the device.

In April 2007, the FDA issued a warning to Davol after an inspection of its Rhode Island headquarters uncovered serious problems with the quality assurance programs used in the manufacture of the Kugel Mesh Patch. Among the problems cited during the inspection where those found in the system Davol used to track complaints. The FDA said that the system was so inadequate that Davol was unable to conduct timely complaint investigations. The FDA said that the lack of these procedures was to blame for Davol’s delays in dealing with the Kugel Mesh Patch problems.

The defective Kugel Mesh Hernia Patch spawned so many lawsuits against Davol and Bard, that last fall, the Judicial Panel on Multidistrict Litigation of the United States Courts consolidated all federal cases regarding the defective Kugel Mesh Hernia Patch and transferred them to the District of Rhode Island for all pretrial proceedings.

Now it appears that the quality problems the FDA found at Davol did not impact only Kugel Mesh patch memory recall. The FDA has received reports about problems connected with other Davol patches since at least 2000, and many lawyers involved in Kugel Patch litigation have heard complaints from people injured by some of Davol’s other hernia devices. For that reason, the Federal Court in Rhode Island has agreed to expand the Kugel Mesh proceedings to include any lawsuits that involve an injury caused by Davol patches not included in the Kugel recall, or that do not involve problems with the memory recoil ring.

Man Sues Maker of Kugel Mesh Hernia Patch for Infections Following Hernia Surgery

Fri, 04 Jan 2008 00:00:00 -0800

An Arkansas man is suing the makers of the Kugel Mesh Hernia Patch, alleging that a hernia patch made by Davol and its parent company Bard caused a massive infection that forced him to undergo surgery to have the patch replaced. Though the complaint does not say if the hernia patch responsible for his injuries was one of the recalled Davol patches, Marion Teague’s story is consistent with others who have been harmed by the faulty Kugel Mesh Hernia Patch.

The Kugel Mesh Hernia Patch was supposed to offer hernia patients relief from an extremely painful condition. But by 2005, it was evident that something had gone terribly wrong with the device. Apparently, the recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems. The reports were so alarming that the Food & Drug Administration (FDA) issued a Class I recall, its most serious type of recall, of the Bard Composix Kugel Mesh X-Large Patch. Doctors where warned to stop using that version of the Kugel Mesh Hernia Patch, and patients who received the patch were told to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. By February 2007, the Kugel Patch recall had been expanded twice to several other sizes of the device.

Following the Kugel Mesh Hernia Patch recalls, the FDA issued Davol a warning letter that cited serious problems at Davol’s Cranston headquarters. The FDA found that Davol did not have an adequate system to handle everything from complaint investigation to the determination of actual recall actions. What’s more, the FDA blamed these inadequacies for Davol’s delays in dealing with the Kugel Patch’s problems.

Marion Teague’s lawsuit, which was filed in the Texarkana Division of the Eastern District of Texas, claims that after having several surgeries to repair hernias, he began to experience abdominal pain and inflammation. Teague claims the Davol-made mesh patch used to repair the hernias had become infected, requiring additional surgery to remove the patch. Teague alleges his injuries are caused by the defective design, manufacture and marketing of the Davol hernia patches. The suit claims the makers of the patch were negligent for designing an unreasonably dangerous product, failing to reduce patch malfunction in the product design, failing to provide adequate warnings or instructions and failing to monitor its manufacturing process to prevent the defective patch from reaching consumers.

Teague is seeking more than $75,000 in damages for past and future physical pain, mental anguish, disfigurement, physical impairment, medical expenses, lost wages, lost earning capacity, and loss of household services.

Kugel Mesh Hernia Patch Defects Put Patients at Risk, Yet Davol Waited Before Issuing Recall

Wed, 14 Nov 2007 00:00:00 -0800

The recalled Kugel Mesh Hernia Patch was supposed to eliminate dangerous complications from hernia surgeries. Before the Davol Composix Kugel Mesh Hernia Patch, repair was conducted by tension repair surgery, which could cause problems if muscle tissue re-tore. Unfortunately, design flaws inherent in the defective Kugel Mesh Hernia Patch led to even more serious complications and injuries for many patients.

Over 700,000 hernia repair surgeries are performed in the U.S. annually. Hernias are areas where an organ breaks through weakened or torn tissue. The Kugel Mesh Hernia Patch—developed to reduce re-tears—is constructed of two mesh pieces surrounding a plastic ring. The surgeon makes a tension-free repair using a small incision and places the folded patch behind the hernia. The spring-like ring opens the Kugel Mesh Hernia Patch where it lays flat behind the incision allowing internal tissue to grow and repair the tear or weakness, resolving the hernia.

Bard, Davol’s parent company, knew about severe injuries caused by the device. Although they claim they acted responsibly, the Kugel Mesh Hernia Patch was not taken off the market because Bard felt the number of complaints were small given the number of patches sold and problems cited were too random.

The company received reports of up to 10 complications from the patches, with one possible fatality. The company delayed reporting a massive recall for months because initial complaints all came from Germany, with three from one doctor. Davol concluded ring breaks were due to physician error, halted production of some Kugel Mesh Hernia patches, trained German doctors, revised physician instructions, and continued distributing other patches. Davol was wrong; problems continued.

The problem with the Kugel Mesh Hernia Patch is in the ring. Tests run on a failed patch indicated a ring weld defect. This means that the ring can break, exposing shards that have caused bowel perforations and obstructions, serious infections, and chronic fistulae (abnormal connections between intestines and organs). Despite this and Class I recalls (indicating a serious danger), Davol recommended that products continuing to function properly should not be replaced as there could be greater risk in removing a properly functioning device. Requesting replacement surgery is not an option.

The Food and Drug Administration (FDA) ordered Davol to investigate and correct procedures and accused Davol of knowingly keeping defective Kugel Mesh Hernia Patches on the market and understating their severe and dangerous complications. An FDA inspection at Davol unearthed other problems: serious flaws in their complaint tracking system (systems incompatibility); shoddy procedures (an inability to handle everything from complaint investigation to recall actions determination); and an absence of testing documentation on the manufacture of Salute Reusable Fixation devices (for attaching mesh in laparoscopic and open hernia repair and pelvic floor reconstruction). The FDA said Davol’s procedures were to blame for delays in dealing with the problems; that Davol did not accurately report complaint severity; and problems found during inspection could be symptomatic of serious underlying issues in their quality assurance system.

In addition to patch recalls, the FDA recalled some of the company’s Salute devices and warned that Davol was in serious violation of the law and that they could take further regulatory steps without notice, including inventory seizure, injunctions preventing product sale, or monetary penalties.

In all, Kugel Mesh Hernia Patches have been recalled three times by the FDA who received nearly 100 reports of problems related to the patch, several involving death.

Kugel Mesh Hernia Patch Lawsuits Head to Court in Rhode Island

Fri, 26 Oct 2007 00:00:00 -0700

Kugel Mesh Hernia Patch lawsuits stemming from Davol, Inc’s 2005 recall of the defective medical device are shining a spotlight on the US District Court in Providence, Rhode Island that will decide many of the Kugel Patch cases. Recently, the Judicial Panel on Multidistrict Litigation of the United States Courts consolidated all federal cases regarding the defective Kugel Mesh Hernia Patch and transferred them to the District of Rhode Island for all pretrial proceedings and possible settlement.   It is the first time that the US District Court in the small state has been given such a task by the Judicial Panel.

The Judicial Panel on Multidistrict Litigation of the United States Courts was created in 1968. Since then, it has consolidated hundreds of thousands of lawsuits that involved high numbers of plaintiffs, including litigation over asbestos, breast implants and other matters.   According to the Providence Journal, the judicial panel has consolidated and transferred more than 100 Kugel Mesh Hernia Patch lawsuits to the US District Court in Rhode Island, and that number is expected to climb as more than 100,000 people were implanted with the defective Kugel Mesh Hernia Patch. Davol Inc, the maker of the Kugel Mesh Hernia Patch, has its corporate headquarters in Cranston, Rhode Island.

The Kugel Mesh Hernia Patch was supposed to offer hernia patients relief from an extremely painful condition. But by 2005, it was evident that something had gone terribly wrong with the device. Apparently, the recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems. The reports were so alarming that the Food & Drug Administration (FDA) issued a Class I recall, its most serious type of recall, of the Bard Composix Kugel Mesh X-Large Patch. Doctors where warned to stop using that version of the Kugel Mesh Hernia Patch, and patients who received the patch were told to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. By February 2007, the Kugel Patch recall had been expanded twice to several other sizes of the device.

Following the Kugel Mesh Hernia Patch recalls, the FDA issued Davol a warning letter that cited serious problems at Davol’s Cranston headquarters.   The FDA found that Davol did not have an adequate system to handle everything from complaint investigation to the determination of actual recall actions. What’s more, the FDA blamed these inadequacies for Davol’s delays in dealing with the Kugel Patch’s problems.

Now, hundreds of people are suing Davol over their Kugel Mesh Hernia Patch injuries. They claim that Davol took too long to issue the Kugel Mesh Hernia Patch recall, allowing the device to seriously injure far more people.   This past March, the New York Times published an article that backed up those claims. According the New York Times, Davol had received its first Kugel patch complaints in 2002, but it was determined that the “few” number of reports did not warrant public notification.   But in 2005, Davol received 10 reports about ring breakage over a three month period. At that time, Davol tried blaming doctors for implanting the device improperly. But in December of that year, tests run by the company showed that the source of the Kugel Mesh Hernia Patch problems was not doctor error, but failure of the ring weld on the device itself.

Now, it will be up to the US District Court in Rhode Island to decide if Davol was negligent in informing patients and physicians of problems with the Kugel Mesh Hernia Patch.

Defective Kugel Mesh Hernia Patch Can Still Cause Serious Injury

Wed, 17 Oct 2007 00:00:00 -0700

With the Kugel Mesh Hernia patch recall now nearing its second anniversary, it is important to note that not all hernia patients implanted with the patch have had it removed. Understandably, those who have not experienced patch failure would not want to undergo the invasive surgical procedure required to replace a Kugel Mesh Hernia Patch. But these patients must realize that their Kugel Patch could still fail, and it is important that they recognized the symptoms associated with such failure.

Hernias are an extremely painful condition where one part of the body bulges between the muscles surrounding it (for instance, the stomach could bulge through a fissure in the abdominal muscles). Hernias cause extreme pain and discomfort and can greatly reduce a patient’s quality of life. Surgery is the only way to permanently repair a hernia. A patch, like the Kugel Mesh Patch is supposed to close the fissure and prevent the bulge.

Unfortunately, in 2005, the Food & Drug Administration (FDA) began receiving reports of failures with the Bard Composix Kugel Mesh X-Large Patch. Once the device was implanted, the wire recoil ring that opened the patch was prone to breaking. When this happened, patients often experienced serious problems like bowel perforations. In December 2005, the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch. A Class I recall means that the recalled product poses a serious danger to patients still using it. In April 2006, the Class I recall was expanded to the “mid-line” size of the patch. The recall was expanded for a third time in February of 2007 to include the large size patch.

Many patients had to have their Kugel patch replaced as a result of coil ring breakage, and at least one patient is known to have died from complications of a defective patch. Even now, the FDA continues to receive reports of serious injuries caused by the failure of a Kugel Mesh Hernia Patch. Since the first recall of the Kugel Mesh Hernia Patch in December 2005, hundreds of people have undergone emergency surgery to remove this defective medical device.

Unfortunately, some patients may not even be aware that their hernia surgery involved the use of a Kugel Patch. Patients in this situation should contact their doctors to find out if they have one of the recalled patches. All Kugel Patch patients should know that the ring can break at any time, and should seek medical help if they experience unexplained fever, persistent abdominal pain or tenderness at the incision site. These could be a sign that the recoil ring has broken, and only immediate attention can prevent more serious health consequences.

Many Kugel Mesh Hernia Patch Lawsuits to Be Consolidated in Rhode Island

Wed, 05 Sep 2007 00:00:00 -0700

The recalled Kugel Mesh Hernia Patch, which has injured hundreds of people, has spawned countless lawsuits against its manufacturer, Davol Inc. and Davol’s parent company, C. R. Bard. Inc.   So many in fact, that the Judicial Panel on Multidistrict Litigation of the United States Courts consolidated all federal cases regarding the defective Kugel Mesh Hernia Patch and transferred them to the District of Rhode Island for all pretrial proceedings. In doing so, the Panel has created Master Docket Number 1:07-md-01842-ML-LDA.

The Kugel Mesh Hernia Patch was supposed to offer hernia patients relief from an extremely painful condition. But by 2005, it was evident that something had gone terribly wrong with the device. That year, the Food & Drug Administration (FDA) began receiving many reports of failure with the Kugel Patch. Apparently, the recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems. The reports were so alarming that the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch. A Class I recall means that the recalled product poses a serious danger to patients still using it. The FDA warned doctors to quit using the patch. The FDA also warned patients who received the patch to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. By February 2007, the Kugel Patch recall had been expanded twice to several other sizes of the device.

Further investigation into the defective Kugel Mesh Hernia Patch revealed that Davol, Inc. had known about injuries associated with the recoil ring long before the FDA learned of them.   According to an article in the New York Times this past March, Davol had received its first Kugel patch complaints in 2002. All of the reports involved injuries, some of them serious, caused by the X-large size patch.    According to Davol’s parent company, C. R. Bard, Inc., it was determined that the “few” number of reports did not warrant public notification.   But by 2005, Davol received 10 reports about ring breakage over a three month period. At that time, Davol tried blaming doctors for implanting the device improperly. But by the end of 2005, Davol concluded that it had been wrong about its assessment of Kugel patch problems.   In December of that year, tests run by the company showed that the source of the problem was not doctor error, but failure of the ring weld on the device itself.

Following the Kugel Mesh Hernia Patch recalls, the FDA issued Davol a warning letter. The FDA said that it found serious problems in the methods, facilities and controls used in the manufacture, storage, packing or installation of a company’s products.   The FDA found that Davol did not have an adequate system to handle everything from complaint investigation to the determination of actual recall actions. What’s more, the FDA blamed these inadequacies for Davol’s delays in dealing with the Kugel Patch’s problems.

An FDA warning letter is a serious issue, and is evidence that Davol mishandled the safety issues surrounding its defective Kugel Mesh Hernia Patch. More information on Davol’s handling of the Kugel Mesh Hernia Patch recall will doubtless come to light as lawsuits against the company make their way through the courts.

Davol Silent on Kugel Mesh Hernia Patch Injury Reports Prior to Recall

Fri, 24 Aug 2007 00:00:00 -0700

When a medical device like the Kugel Mesh Hernia Patch is put on the market, most consumers expect that the device manufacturer will carefully monitor the use of their product, and inform the public of any safety issues in a timely manner. Unfortunately, as the sad story of the defective Kugel Mesh Hernia Patch illustrates, this is not always the case.

The Kugel Mesh Hernia Patch was supposed to offer hernia patients a good option for treating their painful condition.   But by 2005, the Food & Drug Administration (FDA) was receiving more and more reports of failure with the Kugel Patch. Apparently, the recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems. The reports were so alarming that the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch. A Class I recall means that the recalled product poses a serious danger to patients still using it. The FDA warned doctors to quite using the patch. The FDA also warned patients who received the patch to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. By February 2007, the Kugel Patch recall had been expanded twice to several other sizes of the device.

According to an article in the New York Times this past March, Davol, Inc. had known of problems with the hernia patch long before the 2005 recall. In fact Davol had received its first Kugel patch complaints in 2002. All of the reports involved injuries, some of them serious, caused by the X-large size patch.    According to Davol’s parent company, C. R. Bard, Inc., it was determined that the “few” number of reports did not warrant public notification.

But in 2005, Davol received 10 reports about ring breakage over a three month period. At that time, Davol blamed doctors for implanting the device improperly. The company started work on new instructions for implanting the patch, and held training session for some physicians.   But the Kugel Mesh Hernia Patch remained on the market.

By the end of 2005, Davol concluded that it had been wrong about its assessment of Kugel patch problems.   In December of that year, tests run by the company showed that the source of the problem was not doctor error, but failure of the ring weld on the device itself.    Finally, Davol recalled the X-Large Kugel Mesh Hernia Patch. Recalls of the other sizes would soon follow. In the end, the Kugel patch would be blamed for more than 80 injuries and at least three fatalities.

The recalls resulted in an FDA inspection of Davol’s Rhode Island headquarters.   The inspection did not reflect well on the company. The FDA issued Davol a warning letter after finding serious problems in the methods, facilities and controls used in the manufacture, storage, packing or installation of a company’s products.   During its inspection, the FDA found a number of problems, but the most troubling were problems found with the system the company uses to track complaints. The FDA found that Davol did not have an adequate system to handle everything from complaint investigation to the determination of actual recall actions. What’s more, the FDA blamed these inadequacies for Davol’s delays in dealing with the Kugel Patch’s problems.

Since the FDA issued its warning letter, Davol has said that it has addressed the agency’s complaints. But for the many patients injured by the defective Kugel Mesh Hernia Patch, Davol’s penance comes too little, too late.

Kugel Mesh Hernia Patch Maker's Shoddy Quality Program Put Thousands at Risk For Serious Injury

Fri, 03 Aug 2007 00:00:00 -0700

Davol Inc., the maker of the Kugel Mesh Hernia Patch, was the subject of a Food and Drug Administration (FDA) warning letter as a result of a recall of the device. The letter, which followed an inspection of Davol’s Rhode Island headquarters, provides insight into the company’s shoddy quality assurance systems that allowed problems with the Kugel Mesh Hernia Patch to continue for some time.

When it was first introduced, the Kugel Mesh Hernia Patch was heralded as an innovation in hernia treatment. Unfortunately, by 2005, the FDA was receiving more and more reports of failure with the Kugel Patch. The reports were so alarming that the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch. Apparently, the recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems. A Class I recall means that the recalled product poses a serious danger to patients still using it. The FDA warned doctors to quite using the patch. The FDA also warned patients who received the patch to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. By February 2007, the Kugel Patch recall had been expanded twice to several other sizes of the device.

An FDA warning letter is serious business. They are only issued when an inspection finds serious problems in the methods, facilities and controls used in the manufacture, storage, packing or installation of a company’s products. During its inspection, the FDA found a number of problems at the Davol headquarters, but the most troubling were problems found with the system the company uses to track complaints. The FDA found that Davol did not have an adequate system to handle everything from complaint investigation to the determination of actual recall actions. What’s more, the FDA blamed these inadequacies for Davol’s delays in dealing with the Kugal Patch’s problems.

The FDA ordered Davol to investigate and promptly correct the quality procedures. The FDA also warned that Davol was in serious violation of the law, and threatened further regulatory steps against the company without notice. These steps could include fines, seizure of product inventories, court injunctions preventing Davol from selling its products.

Scores of patients had to undergo the ordeal of having their Kugel Patch replaced as a result of coil ring breakage, and at least one patient is known to have died from complications of a defective patch. Because Davol employed poor quality assurance practices, thousands of people who received the device still run a very high risk of serious injury. Companies like Davol have an obligation to employ the highest quality standards when they manufacture a medical device. Had Davol used such standards, many hernia patients would have been spared great misery.

The Kugel Mesh Hernia Patch: A Disturbing History

Mon, 30 Jul 2007 00:00:00 -0700

Since 2005, Kugel Mesh Hernia Patches have been recalled three separate times by the Food and Drug Administration (FDA) due to a malfunction with the memory recoil ring that often caused patients to suffer serious injury.

Before the Kugel Mesh Hernia Patch was introduced to us, hernias were fixed through a process known as “tension repair.” The tension repair process caused problems in patients when the muscle tissue would tear open again after the procedure was finished. Dr. Robert D. Kugel created the Kugel Mesh Patch to help out with the recovery process after surgeries and cut back on reappearing hernias. Today, more than 700,000 surgeries are performed each year in the U.S. to repair hernias, which can develop in the groin, near the navel or anywhere a surgical incision is at.

The Kugel Mesh Patch was supposed to let surgeons make a tension-free repair by placing a folded patch behind the hernia with a small incision. The memory recoil ring would act like a spring and open the patch to its full size where the patch would lay flat behind the incision. Unfortunately, the memory recoil ring could break inside a patient causing bowel perforation, bowel obstruction, serious infections or intestinal fistulae (which are abnormal connections or passageways between the intestines and other organs.) Symptoms of a broken memory recoil ring include fever, persistent or unexplained abdominal pain, or tenderness at the site where the implant is located.

The FDA recalled the Bard Composix Kugel Extra Large Oval Patches for the first time in December 2005. Shortly after, in March 2006, the Bard Composix Kugel Oval Patches were recalled and a warning letter was also sent out to hospital administrators to let them know about the defect of the device. Most recently, in January 2007 the Bard Composix Kugel Large Oval and Large Circle patches were recalled.

The maker of the Kugel Mesh Patch, Davol Inc., received a letter from the FDA in 2006 regarding problems with the manufacturing process of the patches. The letter informed Davol that those problems had to be investigated and fixed or regulatory actions could be taken. The FDA has received nearly 100 reports of problems related to the Kugel Mesh Patch. Several of those reports have included fatalities.

Kugel Mesh Hernia Patch Still Has Potential to Injure Many Patients

Wed, 18 Jul 2007 00:00:00 -0700

The Kugel Mesh Hernia Patch, which has been the subject of several Food & Drug Administration (FDA) recalls, has not been removed from all the patients who received it. Patients with the device who have not experienced symptoms of patch failure still need to be aware of the problems that can occur with the Kugel Mesh patch. If a Kugel Mesh patient experiences any of those symptoms, they must seek medical attention immediately.

Hernias are an extremely painful condition where one part of the body bulges between the muscles surrounding it (for instance, the stomach could bulge through a fissure in the abdominal muscles). The extreme pain and discomfort caused from a hernia can greatly reduce a patient’s quality of life. Surgery is the only way to permanently repair a hernia. A patch, like the Kugel Mesh Patch is supposed to close the fissure and prevent the bulge.

The FDA first began receiving reports of failures with the Bard Composix Kugel Mesh X-Large Patch in 2005. Once the device was implanted, the wire recoil ring that opened the patch was prone to breaking. When this happened, patients often experienced serious problems like bowel perforations. At that time, the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch. A Class I recall means that the recalled product poses a serious danger to patients still using it. In April 2006, the Class I recall was expanded to the “mid-line” size of the patch. The recall was expanded for a third time in February of 2007 to include the large size patch.

Not long after expanding the recall of the Bard Composix Kugel Mesh Patch, the FDA issued a warning letter to Davol Inc., the patch’s manufacturer, citing serious regulatory problems with quality assurance systems used in the manufacture of the Kugel patches. The letter, which was dated April 24, 2007, came after the FDA conducted an inspection of the company’s Cranston, Rhode Island headquarters.

Many patients had to have their Kugel patch replaced as a result of coil ring breakage, and at least one patient is known to have died from complications of a defective patch. Understandably, patients who have not had problems were told to take a “wait and see” approach towards their patches. Some patients may not even be aware that their hernia surgery involved the use of a Kugel Patch. Patients in this situation should contact their doctors to find out if they have one of the recalled patches. All Kugel Patch patients should know that the ring can break at any time, and should seek medical help if they experience unexplained fever, persistent abdominal pain or tenderness at the incision site. These could be a sign that the recoil ring has broken, and only immediate attention can prevent more serious health consequences.

Defective Kugel Mesh Hernia Patch maker Davol Inc. Ignored Problems Leaving Many Patients at Risk for Serious Injury and Untimely Death

Wed, 11 Jul 2007 00:00:00 -0700

Despite knowing of problems with the Bard Composix Kugel Mesh Hernia Patch as far back as the summer of 2005, Davol Inc. allowed its defective product to remain on the market for months. Even when it issued a recall for the extra-large size Kugel Mesh Patch in December 2005, other versions were still being used in hernia surgeries. As a result, thousands of people may have been exposed to serious injury. In the end, it would take two more Food & Drug Administration (FDA)-ordered recalls to warn doctors and their patients about other defective Kugel Mesh Hernia Patches.

By the summer of 2005, Davol Inc. had plenty of evidence that the recoil ring that opened the hernia patch could break, leading to serious problems like bowel perforations. By then, the company had reports of at least 10 injuries – one of them fatal – linked to the Kugel Mesh Patch. Still, it took until December for the FDA to order a Class I recall of the Bard Composix Kugel Mesh X-Large Hernia Patch. A Class I recall means that a device runs the risk of causing serious injury in patients using it. Doctors were advised to stop using the device, and patients were told to seek medical attention if they experienced symptoms like unexplained fever, abdominal pain and tenderness at the incision site. The recall would need to be expanded twice – once in April 2006 for the mid-line size of the patch, and again this past January for the large patch. The FDA has accused Davol of understating the problems with the patch.

In April 2007, the FDA issued a warning to Davol after an inspection of its Rhode Island headquarters uncovered serious problems with the quality assurance programs used in the manufacture of the Kugel Mesh Patch. Among the problems cited during the inspection where those found in the system Davol used to track complaints. The FDA said that the system was so inadequate that Davol was unable to conduct timely complaint investigations. The FDA said that the lack of these procedures was to blame for Davol’s delays in dealing with the Kugel Mesh Patch’s problems.

Davol Inc. has been criticized for a lack of quality assurance procedures with some of its other devices. Some versions of the company’s Salute Reusable Fixation devices were also recalled by the FDA in 2006. This device is used to attach mesh during hernia repair. The FDA’s investigation into the Salute device found that Davol had no documentation of any testing done on the device to insure that it performed to specifications.

Because Davol chose to ignore concerns about the safety of the Kugel Mesh Patch, thousands of people who received the device run a very high risk of serious injury. Hundreds have had to undergo painful and traumatic medical procedures to have their devices replaced. Much of this misery could have been avoided had Davol acted on the reports it received during the summer of 2005.

Composix Kugel Hernia Mesh Patch Left on the Market Even After Maker Davol Inc. had Knowledge That Defective Spring Could Cause Death

Mon, 18 Jun 2007 00:00:00 -0700

Considering how dangerous a hernia can turn out, the public needs to be aware of the treatment options available. One way to treat it is to operate on and repair the afflicted area followed by applying a Composix Kugel Mesh Patch that will act as a mechanism to aid in the stretching and movement of muscle. The process is painful and difficult to go through.

Unfortunately, those suffering from this debilitating condition are being done an injustice by the company Davol, Inc. based out of Rhode Island. Davol makes the Bard Composix Kugel Hernia Mesh Patch which is used to treat hernias that usually occur where a previous incision has been made on the body. The patch has a recoil spring that helps it to be folded and inserted, after which it is supposed to spring open and flatten. Davol, Inc. began recalling the patches in January of 2007 after the springs in the patches began to break. The breaking of the spring caused serious and fatal injuries including bowel perforation and death.

Despite the fact that people began reporting injuries from the company's defect in December 2005 when an initial recall was sounded, the recall did not greatly expand until January of this year. This kind of chronological oversight meant many lives were in jeopardy and the FDA even classified it as a "Class 1 because the defect associated with the use or exposure to (the patch) has a reasonable probability to cause serious adverse health consequences, including death." The FDA has accused Davol, Inc. of knowingly keeping their defective patches on the market for too long, insisting that Davol officials understated the severe and dangerous complications associated with the patches.

In the summer of 2005, the company received reports of up to 10 complications from the patches, resulting in one possible fatality and yet the company did not report a massive recall until December of that same year. However, the shady company had had reports of people becoming injured long before the summer of '05. As early as 2002, shortly after its product was introduced, Davol had received its first reports of the patch defects. There is no reason good enough to get Davol, Inc. off the hook for essentially ignoring a small public outcry. Perhaps if they'd acted more quickly, fewer people would have been spared the painful experience of recovering from a hernia. And if recovering from a hernia wasn't enough, imagine doing it with a defective product with the potential to kill.

Hernias are a painful condition in which an organ abnormally bulges out through the tissues that surround it. Usually occurring in the abdomen, a hernia can cause major problems for the afflicted individual. Hernias cause extreme pain and discomfort which ultimately decreases mobility, severely inhibiting a person's ability to walk, stand, or bend.

If left untreated, a hernia can cause something called strangulation where the portion of the organ which is protruding out of the body, experiences a blockage of blood-flow. Should this blockage occur, a necrosis or decaying of the organ and tissue will happen and must be immediately operated on.

Bard Composix Kugel Mesh Hernia Patch Maker Davol Inc. in 'Serious Violation' Warns FDA

Tue, 12 Jun 2007 00:00:00 -0700

Not long after expanding the recall of the Bard Composix Kugel Mesh Patch, the FDA issued a warning letter to Davol Inc., the patch’s manufacturer, citing serious regulatory problems with quality assurance systems used in the manufacture of the Kugel patches, as well as its Salute Reusable Fixation devices. The letter, which was dated April 24, 2007, came after the FDA conducted an inspection of the company’s Cranston, Rhode Island headquarters. The inspection took place from January 23 through March 13, 2007.

Problems with the Kugel Hernia Mesh patches first came to light in 2005. At that time, the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch because the memo recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems. A Class I recall means that the recalled product poses a serious danger to patients still using it. The FDA warned doctors to quite using the patch. The FDA also warned patients who received the patch to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. In April 2006, the patch Class I recall was expanded to the “mid-line” size of the patch. The recall was expanded for a third time in February of 2007 to include the large size patch.

The FDA issues warning letters when an inspection finds serious problems in the methods, facilities and controls used in the manufacture, storage, packing or installation of a company’s products. During its inspection, the FDA found a number of problems at the Davol headquarters, but the most troubling were problems found with the system the company uses to track complaints. The letter states that the facility lacked procedures to handle everything from complaint investigation to the determination of actual recall actions. The FDA said that the lack of these procedures where to blame for Davol’s delays in dealing with the Kugal Patch’s problems.

The FDA letter also cited problems with the company’s manufacture of its Salute Reusable Fixation devices. This device is used for attaching mesh in laparoscopic and open hernia repair and pelvic floor reconstruction. During its inspection, the FDA found no documentation that any testing was performed to ensure that the Salute device met the company’s own specifications. The FDA recalled some of these devices in December, 2006.

The FDA letter stated that the problems found during its inspection could be symptomatic of serious underlying problems in the company’s quality assurance system. The FDA ordered Davol to investigate and promptly correct the quality procedures. The FDA also warned that Davol was in serious violation of the law, and as a result, the FDA could take further regulatory steps against the company without notice. These steps could include seizure of product inventories, court injunctions preventing Davol from selling its products, or monetary penalties.

Parker Waichman Alonso LLP Retained by Hundreds to Investigate Injuries Caused by Recalled Composix Kugel Mesh Patch

Mon, 30 Apr 2007 00:00:00 -0700

Parker Waichman Alonso LLP (www.yourlawyer.com) announced that it has been retained by hundreds of clients who have been injured by defective Composix Kugel Mesh Patch manufactured by Davol, a division of C.R. Bard (NYSE: BCR). The company first recalled the Composix Kugel Mesh Patch in December 2005 because the "memory recoil ring", that is used to open the device once it has been inserted, could break. In March 2006, the company recalled additional sizes and batches of Kugel Mesh. In January 2007, the FDA expanded the recall to a Class 1 recall after deciding that the defective device can cause serious life threatening injuries, including bowel perforations and/or chronic intestinal injuries. Parker Waichman Alonso LLP is currently assessing hundreds of additional inquiries.

If you or a loved one were injured by a defective hernia mesh patch, you can request a free case evaluation by visiting http://www.herniapatchinjuries.com or http://www.yourlawyer.com/topics/overview/Composix_Kugel_Mesh_X_Large_Patch . Case evaluations are also available by calling Parker Waichman Alonso LLP at 1-800-LAW-INFO (1-800-529-4636).

The following batches of Composix Kugel Patches have been recalled:

January 2007 Expanded Recall and Market Withdrawal:

Bard® Composix® Kugel® Large Sized Patch Class I Recall and Market Withdrawal
Bard® Composix® Kugel® Large Oval, 5.4" x 7.0", Product Code: 0010202
Bard® Composix® Kugel® Large Circle, 4.5", Product Code: 0010204

March 24, 2006 recall:

Bard® Composix® Kugel® Oval, 6.3" x 12.3", all lot numbers
Bard® Composix® Kugel® Large Oval, 5.4" x 7", lot numbers 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****
Bard® Composix® Kugel® Large Circle, 4.5", lot numbers 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****

December 2005 recall:

Bard® Composix® Kugel® Extra Large Oval, 8.7" x 10.7", all lot numbers
Bard® Composix® Kugel® Extra Large Oval, 10.8" x 13.7", all lot numbers
Bard® Composix® Kugel® Extra Large Oval, 7.7" x 9.7", all lot numbers

An article appearing in the March 16, 2007 edition of the New York Times questions the conduct of C.R. Bard after the company became aware that the Kugel mesh patch was defective. The article criticizes the company’s executives for not recalling the product sooner even though they knew about the injuries it was causing patients. The critique from the New York Times was based on information the reporter received under the Freedom of Information Act.

This information showed that in early 2006 inspectors reported “discrepancies” and “inconsistencies” in how Davol tracked and analyzed device-related complaints. The FDA said Davol did not accurately report the possible severity of complaints to the agency. FDA inspectors reported that company officials had also understated, in several reports to the agency, the potential severity of device-related injuries, including three reports involving injuries and one report involving a possible device-related death.

About Parker Waichman Alonso LLP

Parker Waichman Alonso LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker Waichman Alonso LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medical devices and medications. The firm is currently representing individuals injured by Guidant and Medtronic Defibrillators, Drug Coated Coronary Stents, Ortho Evra, Ketek, ReNu with MoistureLoc, and many other defective drugs and medical devices. For more information on Parker Waichman Alonso LLP, please visit: www.yourlawyer.com or call (800) LAW-INFO.

CONTACT: Parker Waichman Alonso LLP

David Krangle, Esq.

(800) LAW-INFO

(800) 529-4636

info@yourlawyer.com

www.yourlawyer.com

New York Times Article Critical of C.R. Bards Handling of Kugel Hernia Mesh Recall

Fri, 16 Mar 2007 00:00:00 -0700

An article in today’s New York Times questioned the behavior of Davol, a division C.R. Bard, after it became aware of defects in its Kugel Hernia Mesh product. The FDA has received reports of more than 80 injuries and other problems possibly related to it, including several fatalities. In late 2005, Bard recalled certain versions of the mesh because a plastic component could break and cut through a patient’s internal organs and tissue. The article claims that Bard executives said they knew about some serious injuries potentially caused by the device.

In a recent statement statement Bard officials said the company acted responsibly and that they didn’t take the product off the market earlier because there weren’t enough complaints to warrant such actions. However, in a copy of an inspection report obtained by The New York Times under the Freedom of Information Act shows, in early 2006 inspectors reported “discrepancies” and “inconsistencies” in how Davol tracked and analyzed device-related complaints. The FDA also said Davol did not accurately report the possible severity of complaints to the agency.

The Kugel hernia patch is made of two pieces of mesh that surround a flexible plastic ring. To implant it, a doctor folds a patch, places it at the site of the hernia, which is a spot where an organ pops through internal tissue that has become weak or torn. The released ring then springs back into its original shape, flattening the patch. The meshlike material then serves as a substrate that allows internal tissue to grow and resolve the hernia.

Davol, which is based in Cranston, R.I., makes the patch in various sizes and shapes. And it was not long after it introduced the largest units in 2002, F.D.A. records show, that company officials began to receive a small but disproportionately high number of complaints about broken rings in those “extra large” versions of the device.Bard officials said that the initial numbers were small given the number of patches sold, and the problems cited were too random to form a troubling pattern.

But in mid-2005, Bard said, Davol received 10 complaints about ring breaks over a three-month period starting that June. Six of those reports, including one involving a possible fatality, came from Germany, half of them from the same doctor there. Bard said that Davol officials initially had concluded, based on their review, that the ring breaks were occurring because doctors were improperly folding the patch while implanting it.

As a result, Davol halted production in August 2005 of the extra-large patches, began to hold training sessions for doctors in Germany and started work on revising its instructions to doctors elsewhere about how to implant the device, Bard said. But the company kept distributing the patch and doctors kept implanting it. That allowed the problem to continue because Davol’s assessment proved wrong.

In early December 2005, tests run by the company on a failed patch “suggested for the first time that the source of the ring break was caused by a failure at the ring weld,” according to Bard.Davol soon recalled the extra-large versions of the patch and, several weeks later, expanded that recall to include large versions of the device. It was after that initial patch recall that F.D.A. officials went to Davol’s headquarters in early 2006 to do an inspection.

What they found there, their report indicates, was a range of problems, including flaws in the system used by Davol to track complaints. For example, while Davol had purchased a new tracking system in 2004, that program was incompatible with the earlier one it had been using, resulting in significant “discrepancies” in how problems were recorded and reviewed, agency inspectors reported.

Davol officials disagreed, that same report shows, saying they cross-checked complaints by hand. But inspectors also reported that company officials had also understated in several reports to the agency the potential severity of device-related injuries, including three reports involving injuries and one report involving a possible device-related death.In a statement, Bard said that it had not submitted those reports to mislead the agency but said that the company had incorrectly categorized the complaints based on the information it had at the time.

FDA Updates Recall Information About Bard Surgical Patch

Thu, 01 Feb 2007 00:00:00 -0800

On Thursday, the U.S. Food and Drug Administration (FDA) informed medical professionals that the recall of the Bard Composix Kugel Mesh Large Patch is now classified as a “Class 1” recall, meaning that the recalled product may pose serious danger to patients who are still using it.

The FDA noted that “the defect associated with the use or exposure to the Bard Composix Kugel Mesh Large Patch has a reasonable probability to cause serious adverse health consequences, including death. Customers should stop using the recalled product and return unused units to the company.”

The recall by Bard, a subsidiary of Davol Inc., was originally initiated in December of 2005 and has been expanded several times since then. The original recall applied to Bard Composix Kugel Extra Large Oval, 8.7” x 10.7”, Bard Composix Kugel Extra Large Oval, 10.8” x 13.7”, and Bard Composix Kugel Extra Large Oval, 7.7” x 9.7”. In March of 2006, the voluntary recall was expanded to include Bard Composix Kugel Oval, 6.3” x 12.3”, and it was expanded again in January of 2007 to include Bard Composix Kugel Large Oval, 5.4” x 7.0” and Bard Composix Kugel Large Circle, 4.5”.

According to the FDA, “The ‘memory recoil ring’ that opens the Bard Composix Kugel Mesh Patch can break under the stress of placement of the large-sized products in the intra-abdominal (inside the belly area) space. This can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs).”

The agency recommends that “surgeons and hospitals should stop using the recalled product and return unused units to the company. Patients who have who have been implanted with one of the recalled devices should seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site, or other unusual symptoms.”

FDA Recalls Additional Bard Composix Kugel Hernia Patches

Mon, 03 Apr 2006 00:00:00 -0700

The US Food and Drug Administration (FDA) and Davol, Inc (a subsidiary of C.R. Bard, Inc), have notified healthcare professionals regarding the expansion of a class 1 recall for a ventral hernia repair device (Bard Composix Kugel Mesh Patch) to include all lots of the oval "midline" size (product code 0010209), and lots manufactured before 2004 of the large oval (0010202) and large circle (0010204) products. The recall previously affected only the extra-large oval patch.

The recall is due to the potential for breakage of the "memory recoil ring" under the stress of placement into the intraabdominal space, leading to bowel perforation and/or chronic enteric fistulae, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.

Surgeons and hospitals are advised to cease using the products with codes and lots affected by the recall and to return unused units to the company. Patients who have received one of the recalled devices should seek immediate medical attention if they experience symptoms such as unexplained or persistent abdominal pain, fever, tenderness at the implant site, or other unusual symptoms potentially related to ring breakage.

Further information for customers is available by contacting the company by phone at 1-800-FOR-BARD (1-800-367-2273) or by e-mail to bard.helpline@crbard.com. Physicians may contact the company's medical services and support division by phone at 1-800-227-3357 or e-mail to medical.services@crbard.com. Additional information regarding patient management is also available online at http://www.davol.com/HTMLFiles/hernia/recall.htm.

The device is indicated for the repair of ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The "memory recoil ring" allows it to spring open and lie flat behind the defect after having been folded for insertion through a small incision.

Healthcare professionals are encouraged to report adverse events related to use of the ventral hernia repair patches to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Class 1 Recall: Bard Composix Kugel Mesh X-Large Patch

Thu, 22 Dec 2005 00:00:00 -0800

Product: Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE with the following lot numbers:

41XMXXXX – M = 2002
41XNXXXX – N = 2003
43XMXXXX – M = 2002
43XNXXXX – N = 2003
43XOXXXX – O = 2004
43XPXXXX – P = 2005

(If the lot number does not contain either M, N, O or P as the 4th character the lot is not affected by this recall.)

Use: The Composix Kugel Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

Recalling Firm:
Davol, Inc., Sub. C.R. Bard, Inc.
100 Sockanossett Crossroad
Cranston , RI 02920

Reason for Recall: The "memory recoil ring" that opens the Composix Kugel Mesh Patch after it has been inserted into the intra-abdominal space can break. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

Public Contact: Robin Drago
VP Regulatory and Clinical Affairs
Davol, Inc., Sub. C.R. Bard, Inc.
100 Sockanossett Crossroad
Cranston , RI 02920
401-463-7000 x2389

FDA District: New England

FDA Comments: Davol, Inc. (a subsidiary of C.R. Bard) notified U.S. customers of the recall by letter on 12/27/05 via Federal Express. Customers should stop using the recalled product and return unused units to the company. For more information, customers can contact Bard Customer Service at 1-800-FOR-BARD or bard.helpline@crbard.com . Physicians may contact bard Medical Services and Support at 800 227-3357 or medical.services@crbard.com.

Class 1 Recall: Bard Composix Kugel Mesh X-Large Patch

Thu, 22 Dec 2005 00:00:00 -0800

Date Recall Initiated:
December 22, 2005

Product:
Bard® Composix® Kugel® Mesh X-Large Patch Oval with ePTFE with the following lot numbers:

    * 41XMXXXX – M = 2002
    * 41XNXXXX – N = 2003
    * 43XMXXXX – M = 2002
    * 43XNXXXX – N = 2003
    * 43XOXXXX – O = 2004
    * 43XPXXXX – P = 2005

(If the lot number does not contain either M, N, O or P as the 4th character the lot is not affected by this recall.)

Use:
The Composix® Kugel® Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

Recalling Firm:
Davol, Inc., Sub. C.R. Bard, Inc.
100 Sockanossett Crossroad
Cranston , RI 02920

Reason for Recall:
The "memory recoil ring" that opens the Composix® Kugel® Mesh Patch after it has been inserted into the intra-abdominal space can break. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

FDA Comments:
Davol, Inc. (a subsidiary of C.R. Bard) notified U.S. customers of the recall by letter on 12/27/05 via Federal Express. Customers should stop using the recalled product and return unused units to the company. For more information, customers can contact Bard Customer Service at 1-800-FOR-BARD or bard.helpline@crbard.com . Physicians may contact bard Medical Services and Support at 800 227-3357 or medical.services@crbard.com.

Kugel Mesh Patch Lawyer Recall Side Effects Injury Attorney Hernia Lawsuit

Thu, 22 Dec 2005 00:00:00 -0800

Kugel Mesh Hernia Patch - Free Case Review By Our Kugel Mesh Patch Side Effects / Injury Lawyers and Attorneys.

Keywords: Kugel Mesh Patch Lawyer Recall Side Effects Injury Attorney Hernia Lawsuit

The Kugel Mesh Hernia Patch injury lawyers at our firm are working hard to make sure that victims of the defective Bard Composix Kugel Mesh Hernia Patch receive just compensation for their injuries. The poor design of the Kugel Mesh Hernia Patch has resulted in painful and sometimes life threatening injuries, including bowel perforations, chronic enteric fistulas and infections, in thousands of recipients. In most instances, the injuries caused by the Kugel Mesh Hernia Patch have required patients to undergo even more painful surgeries. Even with surgical intervention, many victims of the Kugel Mesh Hernia Patch will not completely recover from their injuries. Our Kugel Mesh Hernia Patch lawyers are dedicated to making sure that the makers of the Kugel Mesh Hernia Patch are held accountable for these serious injuries.

The Kugel Mesh Hernia Patch was implanted in thousands of patients before Davol finally removed the defective device from the market. Thousands of people still live with the Kugel Mesh Hernia Patch, and the device could fail at any time. Patients with any type of hernia patch – but especially those with a Kugel Mesh Hernia Patch – should seek medical help if they experience unexplained fever, persistent abdominal pain or tenderness at the incision site. These could be a sign that the recoil ring has broken, and only immediate attention can prevent more serious health consequences. Because of the continuing danger posed by the Kugel Mesh Hernia Patch, our medical device lawyers will continue aiding victims of the Kugel Mesh Hernia Patch as long as a need exists.

Our Kugel Mesh Hernia Patch injury lawyers are also offering free consultations to anyone who received other Davol hernia patches and suffered injuries or infections as a result of patch failure. In January 2008, the Federal Court charged with hearing all claims related to the Kugel Mesh Hernia Patch ruled the proceedings would be expanded to include claims against any of Davol Inc’s defective mesh patches, even those that were not involved in the original Kugel Mesh Hernia Patch recall. Our Kugel Mesh Hernia Patch lawsuit lawyers want to hear from anyone who sustained a serious injury as a result of any Davol-manufactured mesh hernia patch.

Kugel Mesh Hernia Patch Recall

The Bard Composix Kugel Mesh Hernia Patch has been the subject of several Food & Drug Administration (FDA) Class I recalls. The FDA only issues a Class I recall when a device poses a serious risk to patients still using it. Our Kugel Mesh Hernia Patch injury lawyers have determined that Davol Inc. and its parent, C.R. Bard, were too slow in issuing the Kugel Mesh Hernia Patch recalls, and needlessly exposed thousands of patients to serious injuries.

The first Bard Composix Kugel Mesh Hernia Patch recall was issued in December 2005. At that time, the company recalled its Bard Composix Kugel Mesh X-Large Patch. At that time, the FDA also warned patients who received the Kugel Mesh Hernia Patch to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. In April 2006, the Kugel Mesh Hernia Patch Class I recall was expanded to the mid-line sizes of the patch. The Kugel Mesh Hernia Patch recall was expanded for a third time in February of 2007 to include the large size patch.

Unfortunately, the thousands of patients who received the Kugel Mesh Hernia Patch were left with few alternatives, other than to wait to see if their patches malfunctioned. Many of these patients received the Kugel Mesh Hernia Patch long after Davol received the first reports of Kugel Mesh Hernia Patch failure. The Kugel Mesh Hernia Patch lawyers at our firm believe that many patients could have been saved from both serious injuries and anxiety if Davol had moved more quickly to deal the patch safety issues.

Kugel Hernia Patch Problems Ignored by Davol

Davol had received its first Kugel Mesh Hernia Patch complaints in 2002. All of the complaints revolved around the Kugel Mesh Hernia Patch recoil ring. The Kugel Mesh Hernia Patch is constructed with a spring-like recoil ring that opens the Kugel Mesh Hernia Patch after insertion. The recoil ring design was supposed to reduce the incidences of re-tears, but as our Kugel Mesh Hernia Patch injury lawyers have discovered during their investigation, the recoil ring was defective and has caused serious and painful injuries to many Kugel Mesh Hernia Patch patients.

Davol did nothing when it started receiving reports of recoil ring failures causing serious injuries in patients who received the X-large Kugel Mesh Hernia Patch. Davol claims that the “few” number of Kugel Mesh Hernia Patch injury reports did not warrant public notification. But in 2005, Davol received 10 reports about recoil ring breakage over a three month period. Still, Davol did not take responsibility for its defective device and blamed doctors for implanting the device improperly. All Davol did was to start work on new instructions for implanting the Kugel Mesh Hernia Patch, and offer training session for some physicians. But the Kugel Mesh Hernia Patch remained on the market.

It wasn't until 2005 that Davol quit denying that the Kugel Mesh Hernia Patch was defective. In December, Davol ran tests and discovered that the source of the Kugel Mesh Hernia Patch problems was not doctor error, but failure of the ring weld on the device itself. It was then that Davol decided to issue a recall of the X-Large Kugel Mesh Hernia Patch, but by then this dangerous device had been implanted in thousands of unsuspecting patients. The Kugel Mesh Hernia Patch lawyers at our firm have seen the results of Davol’s negligence, and we know how devastating injuries from the Kugel Mesh Hernia patch can be. We have committed ourselves to insuring that the victims of the Kugel Mesh Hernia Patch receive the justice they deserve.

Davol Inc. FDA Warning Letter

The FDA undertook an inspection of the Davol company headquarters in Cranston, Rhode Island in early 2007, following the Kugel Mesh Hernia Patch recall. That inspection resulted in the FDA issuing a scathing warning letter to Davol. The FDA issues warning letters when an inspection finds serious problems in the methods, facilities and controls used in the manufacture, storage, packing or installation of a company’s products.

The warning letter, dated April 24, 2007, states that the Davol facility lacked procedures to handle everything from complaint investigation to the determination of actual recall actions. The FDA said that the lack of these procedures where directly to blame for Davol’s delays in dealing with the Kugel Mesh Hernia Patch’s problems. The Kugel Mesh Hernia Patch injury lawyers at our firm consider this April 2007 FDA warning letter yet another example of Davol’s negligence in regards to the Kugel Mesh Hernia Patch.

Legal Help for Victims of the Kugel Mesh Hernia Patch

If you or a loved one were injured by a Kugel Mesh Hernia Patch, or any of Davol Inc.’s other defective mesh hernia patches, you have valuable legal rights. Please fill out our online form or call 1-800-LAW-INFO (1-800-529-4636) for a free consultation with a Kugel Mesh Hernia Patch lawsuit lawyer.