FREE Case Review (866) 588-0600

In Wake of Landmark Vaginal Mesh Award, J&J Pulls Gynecare Off Market

This week’s news that a groundbreaking vaginal mesh lawsuit verdict had been reached in California came on the heels of a recent nationwide recall by Johnson & Johnson of its Gynecare line of surgical mesh.

July 27, 2012 – This week’s news that a groundbreaking vaginal mesh lawsuit verdict had been reached in California came on the heels of a recent nationwide recall by Johnson & Johnson (J&J) of its Gynecare line of surgical mesh. A Kern County jury awarded $5.5 million in damages to a woman who suffered incontinence and chronic pain after being implanted with an Avaulta Plus vaginal mesh device, which was manufactured by C. R. Bard. The recent claim is just one of hundreds of vaginal mesh lawsuits filed in courthouses around the country against Bard, J&J, Boston Scientific, and American Medical Systems (AMS).

Ethicon Gynecare Transvaginal Mesh Update 8/22/12: Transvaginal mesh lawsuits included in the consolidated Gynecare litigation have been subjected to an order in which Johnson & Johnson subsidiary Ethicon was required to produce all communications it had with the U.S. Food & Drug Administration (FDA). In pursuant with the case management order, Ethicon must turn over all related correspondences with the FDA to plaintiffs in the Gynecare transvaginal mesh litigation. Click here to learn more.

Transvaginal Mesh Lawsuit Update 8/1/12: According to a plaintiff’s attorney in what appears to be the latest in a string of transvaginal mesh (TVM) lawsuits filed around the country over the past several months, Boston Scientific Corporation knew – or should have known – about the health risks associated with its products. The plaintiff, from Tennessee, was reportedly implanted with a Boston Scientific Obtryx Tansobturator Mid-Urethral Sling System, and subsequently suffered debilitating personal injuries. Click here to learn more.

Free Vaginal Mesh Lawsuit Evaluation: If you or a loved one has been injured by a vaginal mesh device, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the mesh and we can help.

What’s the problem?

Last month, Johnson & Johnson’s Ethicon unit sent letters to two judges presiding over consolidated litigation involving the company’s vaginal mesh products, stating that they intend to “stop commercialization” of several such devices that are involved in the lawsuits. In the letters, Ethicon indicated that it would be recalling the following products nationwide:

  • Gynecare Prolift Pelvic Floor Repair System
  • Gynecare Prolift+M Pelvic Floor Repair System
  • Gynecare Prosima Pelvic Floor Repair System
  • Gynecare TVT Secur System

“Ethicon has no present intention to commercialize these products in the future, but it has requested that FDA allow it 120 days to cease commercialization,” the letters state. “This time period would permit Ethicon to notify its customers, and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients.”

Additionally, J&J has asked the U.S. Food & Drug Administration (FDA) to excuse it from conducting safety studies related to vaginal mesh implants. The FDA imposed the requirement on manufacturers earlier this year after an abnormally high number of adverse event reports (AERS) connected to the devices were submitted to the administration. At the time the requirement was imposed, the FDA had received nearly 3,500 reports of serious complications associated with vaginal mesh.

These side effects are now widely known throughout the medical community. The most commonly reported complication associated with transvaginal mesh is erosion of the device (also referred to as exposure, extrusion or protrusion) into the vagina. Other side effects have been found to include:

  • pain
  • infection
  • bleeding
  • pain during sexual intercourse
  • organ perforation
  • urinary problems

According to the FDA, these complications are not rare, and there is little evidence to suggest that vaginal mesh surgery offers any real benefit over safer, more traditional methods of treatment.

Curiously, news of J&J’s Gynecare vaginal mesh recall coincides with the first jury verdict in favor of a woman who suffered complications after being implanted with a similar device made by another company.

Last Friday, a jury ruled that medical technology giant C.R. Bard and a doctor must pay a total of $5.5 million in damages over a vaginal mesh implant that left a woman with persistent pain and potentially irreversible injuries. The panel found that Bard executives were negligent in their handling of the devices, which are used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The landmark case is the first to go to trial among hundreds of lawsuits alleging that vaginal mesh implants made by Bard, Johnson & Johnson, and Boston Scientific caused severe organ damage and other serious injuries.

Do I Have a Vaginal Mesh Lawsuit?

The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in vaginal mesh lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.

Free Vaginal Mesh Lawsuit Evaluation: If you or a loved one suffered a serious injury after being implanted with a vaginal mesh device, you should contact our law firm immediately. You may be entitled to compensation by filing a vaginal mesh injury suit and we can help.

Free Confidential Case Evaluation

Verified 100% Secure SiteTo contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 588-0600.
*
*
*

Awards & recognition