Mirena® putting women at risk of suffering serious side effects
Women who opt for Mirena® as a contraceptive method are putting themselves at risk of very serious and sometimes life-threatening side effects. Mirena® is an intrauterine contraceptive that's implanted in women and is designed to stay in the uterus for up to five years. Regularly, the Mirena® IUD releases the hormone … [Read more...]
Zimmer receiver FDA warning over manufacturing, testing processes at Puerto Rico facility
Medical device maker Zimmer Holdings Inc. has received a federal regulatory warning over invalid manufacturing and testing procedures being conducted on one of its hip implants. The company is currently engaged in ongoing legal battles over its allegedly defective line of NexGen knee implants. According to a Reuters report this … [Read more...]
DePuy ASR Hip Implant Lawsuit Filed by Connecticut Woman
The first Connecticut lawsuit against the maker of the recalled, defective DePuy ASR hip implant has been filed. Patricia Sorrentino-Galello underwent a second hip replacement just three years after her original surgery at Milford Hospital, the CT Post reports. Revision surgeries are painful and more complex than original … [Read more...]
Triad Group Shuts Down Line That Made Tainted Wipes
After several recalls, one nationwide; Bacillus cereus contamination; and links to a number of illnesses and one death, the Triad Group of Harland, Wisconsin is shutting down the line that manufactured tainted alcohol prep products, pads, wipes, and swabs. As we’ve previously written, use of Triad’s recalled, contaminated alcohol … [Read more...]
Recalled DePuy Hip Implant May Be Failing at Much Higher Rate than First Thought
How likely are premature failures of the DePuy ASR XL Acetabular Hip Replacement System? When DePuy Orthopedics issued recalls for the ASR XL Acetabular Hip Replacement System and the ASR Hip Resurfacing System last August, the company said data from the National Joint Registry of England and Wales indicated that 1 out of every 8 … [Read more...]
Johnson & Johnson’s Animas Unit Recalls Insulin Pump Cartridges
Following a year of unprecedented recalls, another unit of embattled drug giant, Johnson & Johnson, is issuing a medical device recall, this time, for 2.0 mL Animas Insulin Pump Cartridges. Some 2.0 mL insulin cartridges shipped between November 30, 2010 and January 4, 2011, can leak insulin. This defect can result in under-dosing … [Read more...]
CT Scan Radiation Overdoses Reported at Cabell Huntington Hospital in West Virginia
Another large hospital is at the center of a scandal involving radiation overdoses from CT scans. According to The New York Times, the CT scan radiation overdoses occurred at Cabell Huntington Hospital in Huntington, West Virginia for more than a year, before the botched brain scans ended last November. According to The New York … [Read more...]
Smith & Nephew Recalls IV PREP Antiseptic Wipes for Possible Bacterial Contaminati
Smith & Nephew's Advanced Wound Management division just announced a U.S. voluntary nationwide recall of selected lots of its IV PREP Antiseptic Wipes (product number 59421200) that were manufactured by The Triad Group. This recall follows a prior nationwide recall initiated by The Triad Group for alcohol prep products, pads, wipes, … [Read more...]
Davol XenMatrix Surgical Graft Named in Class I Recall
Davol Inc.'s recall of its XenMatrix Surgical Graft, which we reported in January, has been deemed a Class I recall by the U.S. Food & Drug Administration (FDA), it's most serious recall classification. XenMatrix, made from pig tissue, is used in hernia and abdominal wall repair. According to the recall notice, Davol, a unit … [Read more...]
DePuy ASR Hip Implant Lawsuit Filed by Seven Forced to Undergo Revision Surgery
A DePuy ASR hip implant lawsuit was recently filed by seven Rochester, New York residents who say they were forced to undergo revision surgery after their ASR hip failed prematurely. The DePuy ASR hip implant was recalled in August, but the Rochester lawsuit claims DePuy Orthopaedics, a division of Johnson & Johnson, knew the … [Read more...]
Cook Inc. Recalls Central Venous Catheter Trays for Leak Issue
Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays and Single and Double Lumen PICC Peripheral Inserted Central Venous Catheter Trays are being recalled, the U.S. Food and Drug Administration (FDA) just announced. Cook, Inc., located at 750 Daniels Way 
Bloomington, Indiana 47404-9120, is conducting the Venous … [Read more...]
Questionable Breast Implant Lymphoma Info Removed from Groups’ Websites
Two plastic surgery groups have removed information that downplayed the risks of a rare type of lymphoma linked to breast implants, following a discussion with the U.S. Food & Drug Administration (FDA). The group Public Citizen had complained to the FDA about the way the American Society of Plastic Surgeons (ASPS) and the American … [Read more...]
Heart Device Studies Fail to Include Enough Women
A new study has found that the vast majority of heart devices, including heart valves, pacemakers, defibrillators and stents, approved for use in the U.S. were not adequately tested in women. This is a problem because differences between men and women in size and bleeding tendencies can impact how these heart devices perform, … [Read more...]
More Deaths Associated with Negative Pressure Wound Therapy, FDA Says
The U.S. Food and Drug Administration (FDA) just issued another warning about Negative Pressure Wound Therapy (NPWT) systems. This warning is an update to two earlier device safety notices, said MedPageToday. The FDA is not changing its labeling on these devices at this time. The agency first announced its concerns about NPWT … [Read more...]
Full-Body X-Rays of Infants at Brooklyn Hospital Prompts Investigation
A Brooklyn, New York hospital is under scrutiny for performing full-body X-rays of infants up until 2007. According to The New York Times, such X-rays, known as "babygrams" occurred at the State University of New York (SUNY) Downstate Medical Center. The use of such X-rays on infants was discredited long ago because the radiation can … [Read more...]
DePuy Hip Implant Class Action Filed in Australia
Another DePuy ASR Hip Replacement lawsuit, this time, a class action, has been initiated in Australia, reports The Herald Sun. Eight parties have been registered in the action; the case will be heard in the Federal Court in Sydney, Australia. The lawsuit involves two types of DePuy devices that were manufactured in Great Britain … [Read more...]
Accu-Check Flexlink Plus Infusion Sets Recalled
The Accu-Chek® FlexLink Plus infusion set is being recalled by Roche Insulin Delivery Systems because the cannula can become bent or kinked when inserting the device, according to the U.S. Food and Drug Administration (FDA). If this happens, patients may receive too little insulin, leading to elevation of blood glucose levels, and a … [Read more...]
CT Scans Increase Cancer Risk in Dialysis Patients
Medical procedures involving radiation, especially from CT scans, could increase cancer risks for dialysis patients. A new study published in the Journal of the American Society of Nephrology advises that doctors consider scaling back the number of diagnostic CT scans they order for dialysis patients. This study, conducted by … [Read more...]
FDA Approves Expanded Use of Lap-Band With Little Review
With much fanfare, the popular Lap-Band device for weight loss was recently approved for expanded use by the U.S. Food and Drug Administration (FDA), despite a lack of safety data. The LA Times also points out that it appears as if the agency did not take into consideration the device maker's illegal marketing tactics for its … [Read more...]
Breast Implants Gave Me Lymphoma, Breast Cancer Survivor Says
A Florida woman believes the breast implants she received in the wake of a mastectomy caused her to develop another form of cancer. Sherry Kellogg, a 48-year-old breast cancer survivor from North Palm Beach was diagnosed with anaplastic large cell lymphoma (ALCL) in 2008. Kellogg told The Palm Beach Post that she first received … [Read more...]
X-Rays, CT Scans for Pregnant Women, Babies, Up Childhood Cancer Risks
X-rays and CT Scans have long been linked to adverse side effects. Now, The Scotsman is citing a study published in the British Medical Journal that cautions care when using these scans on pregnant women and babies. X-Rays performed on women and babies could potentially lead to Increased Childhood Cancer Risks, according to the … [Read more...]
Breast Implant Cancer Risk May be Downplayed by Plastic Surgeons, Group Says
The link between breast implants and a rare form of lymphoma may be being downplayed by some plastic surgeons, according to a leading consumer advocacy group. According to a letter from Public Citizen to the head of the U.S. Food & Drug Administration (FDA), "presidents of the two leading plastic surgery organizations, the … [Read more...]
New DePuy ASR Hip Implant Lawsuit Filed by California Man
Another alleged victim of the defective DePuy ASR hip implant has filed suit against DePuy Orthopaedics. According to this new DePuy ASR hip replacement lawsuit, the plaintiff was forced to undergo revision surgery a little over a year after receiving the defective implant. Since receiving his DePuy ASR hip implant, the plaintiff … [Read more...]
Johnson & Johnson Unit Recalls Dermabond Wound Product, Securestrap Hernia Product
The Wall Street Journal just reported that Johnson & Johnson’s Ethicon unit has issued a recall of 700,000 vials of its Dermabond Wound Product, a liquid wound-sealing product, following reports of discoloration and delayed setting times. The drug maker also recalled a new hernia-treatment product—its Securestrap Hernia … [Read more...]
FDA Metal-on-Metal Hip Implant Website Details Risks
The U.S. Food & Drug Administration (FDA) has set up a website for metal-on-metal hip implants, which among other things, details the potential risks posed by these devices. The new website comes months after DePuy Orthopaedics, a subsidiary of Johnson & Johnson, issued a worldwide recall of two ASR hip implants, which were … [Read more...]
Medtronic SynchroMed Infusion Pumps Linked to 8 Deaths, Recall Issued
Medtronic Inc. has issued a Class I recall for the SynchroMed II Programmable Pump, SynchroMed EL Infusion System and Refill Kits. These defective medical devices have been linked to 8 deaths. The SynchroMed II Programmable Pump and the SynchroMed EL Infusion System are used in patients undergoing therapy that requires the … [Read more...]
Lubricating Jelly Named in Latest Triad Group Recall
Triad Group is recalling lubricating jelly products sold under the brand names Allegiance, Select Medical Products, Novaplus, Triad, Triad Plus, IMCO, McKesson Medi-Pak Performance, and Henry Schein because of possible sterility issues. Triad Group is the same manufacturer that recently recalled alcohol prep pads, alcohol swabs, and … [Read more...]
CT Scan Radiation Overdose Lawsuit Filed in Canada
A Canadian man is claiming that he received a radiation overdose thanks to a botched CT scan. The victim has filed a lawsuit in British Columbia against the hospital where the CT scan was performed, as well as General Electric Canada, the maker of the CT scanner. According to the CT scan radiation overdose lawsuit, the plaintiff … [Read more...]
Tainted Alcohol Swabs Prompt in Wrongful Death Lawsuit
Tainted alcohol swabs made by Triad group are being named in medical device litigation concerning the wrongful death of a toddler. As we reported previously, the products were involved in a medical device recall of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad Group because concerns with … [Read more...]
Recalled Medical Devices Often Subject to Streamlined Approval
A new study finds that the majority of high-risk medical device recalls over the past five years involved products subject to the U.S. Food & Drug Administration's (FDA) streamlined 510(K) approval process. The study is posted online on The Archives of Internal Medicine website. To be eligible for the 510(K) approval process, … [Read more...]
Syphilis Tests Often Wrong
The U.S. Centers for Disease Control and Prevention (CDC) just announced that a study of five U.S. labs found that hundreds of patients who were told they had syphilis did not have the dangerous, sexually transmitted disease, reports The Associated Press (AP). The defective syphilis test has been in use since the 1980s, said the AP, … [Read more...]
DePuy ASR Hip Implant Lawyers Wrangle over Removed Devices
The DePuy hip replacement recall litigation involving the recalled DePuy ASR hip implant is focusing on the handling of devices removed during hip revision surgery. The removed hip replacements will be vital evidence in the many DePuy lawsuits that have already been filed, as well as the many others that will be filed in the … [Read more...]
Could DePuy ASR Hip Implant Recipients Face More Health Woes in Future?
Could it be that the DePuy ASR hip implant nightmare is only just beginning? It's very possible that we have yet to see the full fallout from the defective DePuy ASR hip implant. DePuy hip replacement recipients who haven't yet experienced problems with their ASR implant could still be vulnerable to health issues in the … [Read more...]
TMJ Implants Face Scrutiny
Defective medical devices, sadly, are nothing new. Now, jaw implants are under scrutiny for pain issues. The LA Times just reported that the U.S. Food and Drug Administration (FDA) has mandated that three temporomandibular joint—TMJ—implant makers study how long these implants are effective before they must be removed due to TMJ … [Read more...]
Lymphoma Latest Breast Implant Worry
Breast implants, especially the silicone variety, have long been the subject of safety concerns. Now there's a new one - a type of lymphoma called anaplastic large cell lymphoma (ALCL). According to the U.S. Food & Drug Administration (FDA), 60 cases of this rare cancer have been reported in breast implant patients. The FDA … [Read more...]
B. Braun Recalls Infusion System
B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES has been recalled in what the U.S. Food and Drug Administration (FDA) is listing as a Class I Recall. According to the FDA, the hardware in the defective medical device may become unresponsive. Class 1 recalls are the most serious type of recall and involve … [Read more...]
Andres Alonso Named to DePuy Hip Implant Litigation Plaintiffs’ Steering Committee
Andres F. Alonso, Esq., a partner of the national personal injury law firm, has been named to the Plaintiffs' Steering Committee in the federal litigation surrounding DePuy ASR XL Acetabular System. The appointment was made by U.S. District Judge David A. Katz, the federal judge overseeing the DePuy ASR Hip Implant multidistrict … [Read more...]
Alcohol Pads Recalled by Various Firms
Contaminated Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks manufactured by Triad Group were recently recalled because of concerns with Bacillus cereus. Use of any of these products could lead to life-threatening infections, especially in at-risk populations, such as the immune suppressed and surgical patients. NASDAQ … [Read more...]
Breast Implants May Cause Rare Cancer, FDA Warns
Breast implants, both silicone, and saline may be associated with a rare form of cancer called anaplastic large cell lymphoma (ALCL). The U.S. Food & Drug Administration (FDA) announced yesterday that it will be working with breast implant manufacturers in the coming months to update their product labeling to address this cancer … [Read more...]
First DePuy ASR Hip Implant Lawsuit Hearing Convened
The first hearing for federal DePuy ASR hip implant lawsuits was held earlier this week. The status conference was convened to determine which defective medical device lawyers would serve on the plaintiffs' steering committee for the DePuy hip implant multidistrict litigation. Johnson & Johnson's DePuy Orthopaedics unit issued … [Read more...]
