J&J Ethicon Pulls Dangerous Pelvic Mesh Products From Market Following FDA Notices and Pending Litigation
Posted June 5th, 2012
In a previously unannounced move, Johnson & Johnson subsidiary Ethicon has informed courts overseeing pelvic mesh litigation that the company is ceasing commercialization and halting sales of most pelvic mesh products in the United States.
Copied on the letter to the courts is law firm partner Bryan Aylstock who was recently appointed as co-lead counsel for the committee representing all plaintiffs in the federal multidistrict litigation. Also copied is lawyer Renee Baggett, also of Aylstock, Witkin, Kreis & Overholtz, who was recently appointed as co-lead plaintiffs’ counsel over the Ethicon/J&J arm of the federal multidistrict litigation consolidated in West Virginia.
The affected products, known as pelvic mesh, vaginal mesh, or transvaginal mesh, include:
• GYNECARE TVT SECUR™ system,
• GYNECARE PROSIMA™ Pelvic Floor Repair System,
• GYNECARE PROLIFT™ Pelvic Floor Repair System, and
• GYNECARE PROLIFT+M™ Pelvic Floor Repair System
The lawyers of Aylstock, Witkin, Kreis & Overholtz have been among the firms leading the litigation of numerous lawsuits against Ethicon and other pelvic mesh manufacturers in state and federal courts.
New FDA Warning Outlines Risks Associated
With Vaginal Mesh and Pelvic Mesh Devices
On July 13, 2011, after receiving over 1500 adverse event reports relating to serious injuries caused by the implantation of polypropylene transvaginal device/mesh, the FDA issued a comprehensive medical alert to physicians warning that, in most instances, the risk of serious injury outweighed all purported benefits associated with the use of these devices. Specifically, the FDA found that traditional procedures, which did not utilize polypropylene devices/mesh, should be the primary course of treatment and that implantation of these devices should limited to procedures of last resort.
The attorneys with The TransVaginal Litigation Group are actively litigating cases nationwide. Female attorneys and staff are available to discuss individual cases and the best course of action for victims of failed transvaginal implants.
Recent Research Indicates Serious Risks and Complications
Victims of defective transvaginal mesh and pelvic/bladder support products are filing suit against the manufacturers nationwide following the shocking results of a clinical study. The study was stopped before completion because the problems they were seeing in patients were too severe to continue the research. More than 15 percent of women in the study experience the dangerous and painful condition known as “erosion,” in which the skin splits and the mesh protrudes.
The transvaginal products (mesh, tape and sling devices) are manufactured by several companies, including Ethicon/Gynecare/Johnson & Johnson and C.R.Bard, Inc., and are marketed as solutions for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Many patients have reported experiencing serious problems, including: pain (during urination/intercourse and/or localized); infection; migration; erosion and corrective surgeries. According to a recent article in the Journal of Obstetrics and Gynecology, patients would have been better off with traditional treatment.
Among the defective devices, the Mentor ObTape and Bard’s synthetic and/or biologic Avaulta mesh have been associated with serious complications. In 2006, after numerous reports of adverse events surfaced, Mentor discontinued sales of its ObTape. More recently, adverse reports regarding the Bard Avaulta product line, marketed as the Avaulta Solo™ Synthetic and Avaulta Anterior and Posterior Biosynthetic Support Systems, have caught the attention of the medical community and the FDA. However, all synthetic and biologic devices sold in the United States are under investigation regarding problems with device degradation, infection and vaginal wall erosion.
Prior Transvaginal Mesh Warnings From the FDA
In 2008, the FDA issued a Safety Alert to doctors and the public. This alert reported that the most frequent complications included:
- Mesh erosion through vaginal wall or other body parts
- Urinary problems
- Recurrence of prolapse and/or incontinence
- Bladder, bowel or vessel perforation
- Vaginal scarring
- Pain during sexual intercourse
- Other problems that led to a significant decrease in patient quality of life due
to discomfort and pain.
Four Transvaginal Device Manufacturers Implicated
Johnson & Johnson®
- Ethicon® TVT
- Gynecare® TVT
- Gynecare® Prosima
- Gynecare® Prolift
- Gynemesh® PS
- Advantage™ Sling System
- Obtryx® Curved Single
- Obtryx® Mesh Sling
- Prefyx Mid U™ Mesh Sling System
- Prefyx PPS™ System
- Avaulta Plus™ BioSynthetic Support
- Avaulta Solo™ Synthetic Support
- Faslata® Allograft
- Pelvicol® Tissue
- PelviSoft® Biomesh
- Pelvitex™ Polypropylene Mesh
American Medical Systems®
Legal claims are being made NOW.
Get compensated for your injuries. Contact our lawyers about defective medical devices.
If a medical devicemanufacturer learns of a potential serious side effect caused by its products, it has a responsibility to notify the physicians who prescribe the devices in order to protect the safety of the patients. If a device manufacturer does not provide the proper notifications and patients are harmed by its products, the harmed patients may be entitled to compensation.
Our attorneys are experts in handling cases of negligence by large drug companies and medical device manufacturers. They have successfully represented and obtained substantial compensation for a number of patients who have been harmed by medical devices and pharmaceutical drugs.
More Vaginal Mesh News from our Blog
February 28, 2013 - Following the $3.35 million verdict for compensatory damages, a New Jersey jury has added another $7.76 in punitive damages to a South Dakota woman injured by a Johnson & Johnson vaginal mesh product. Read More >>
February 27, 2013 - In the first verdict of approximately 2,000 cases filed in New Jersey against J&J/Ethicon, the jury has awarded at least $3.35 million to a South Dakota woman who endured 18 surgeries to correct problems caused by the company’s vaginal mesh product. Read More >>
February 25, 2013 - A New Jersey Superior Court found Johnson & Johnson/Ethicon liable for selling its defective Prolift transvaginal mesh product. The jury found that J&J/Ethicon failed to warn regarding the risks of the product and had fraudulently misrepresented the risks and benefits of the mesh to the Plaintiff Linda Gross. The jury awarded $3.35 million dollars in compensatory damages, with punitive damages to follow. Read More >>
February 22, 2013 - Johnson & Johnson (JNJ), the world’s largest seller of health-care products, disclosed separate government investigations into possible false claims related to its hip devices and the marketing of its surgical mesh. Read More >>
August 21, 2012 - The FDA has allowed thousands of unnecessary injuries from faulty medical devices and needs to overhaul the Agency’s process for reviewing medical devices to ensure public safety, according to two Members of Congress who are appealing to the FDA to make changes. Read More >>
June 26, 2012 - Johnson & Johnson ignored an FDA order to stop selling certain vaginal mesh product, and continued to sell the products for nine months after the order, according to court records recently made public by a state court in Atlantic City, New Jersey. Read More >>
June 4, 2012 - The first news report of Ethicon’s move to halt sales of certain pelvic mesh products was reported by Bloomberg, in a four paragraph story. Read More >>
June 4, 2012 - The following is the full text of two letters sent by Johnson & Johnson’s Ethicon division on June 4, 2012, to judges presiding over pelvic mesh litigation, notifying the courts of the company’s plan to halt sales of certain pelvic mesh products at issue in pending litigations. Read More >>
June 4, 2012 - Johnson & Johnson (JNJ)’s Ethicon unit told a federal judge in West Virginia it intends to stop selling four vaginal mesh implants after being sued by more than 600 women who say the products caused internal injuries. Read More >>
June 4, 2012 - In a previously unannounced move, Johnson & Johnson subsidiary Ethicon has informed courts overseeing pelvic mesh litigation that the company is ceasing commercialization and halting sales of most pelvic mesh products in the United States. Read More >>
March 21, 2012 - Johnson & Johnson sold a vaginal mesh implant for three years before U.S. regulators approved the device, now the subject of more than 550 lawsuits by women who claim it injured them. Read More >>
January 18, 2012 - One lot of PROCEED surgical mesh was recalled by manufacturer Ethicon because there is a potential for delamination in one lot of PROCEED surgical mesh. Read More >>
September 12, 2011 - A U.S. Food and Drug Administration (FDA) advisory panel on Sept. 8 called for additional clinical studies and tighter regulations of transvaginal mesh to treat pelvic organ prolapse (POP). Read More >>
September 8, 2011 - The Food and Drug Administration’s advisory panel on Thursday urged the FDA to reclassify plastic surgical mesh used to repair pelvic organ prolapse. Read More >>