June 5, 2012 – Ethicon, a subsidiary of Johnson & Johnson, has announced plans to recall its Gynecare line of transvaginal mesh devices nationwide in response to a high number of injuries that have been linked to the products. To date, hundreds of Ethicon Gynecare Transvaginal Mesh lawsuits have been filed in courthouses around the country on behalf of women who allegedly suffered mesh erosion, infections, and severe pelvic pain after having the devices surgically implanted. Ethicon has also stated that it plans to update the product labeling for the Gynecare Gynemesh PS to remove the indication for transvaginal use, restricting the product to use during abdominal sacrocolpopexy procedures.
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.
Vaginal Mesh Lawsuit Update 7/26/12: 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 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.
Transvaginal Mesh Update 6/26/12: Healthcare behemoth Johnson & Johnson (J&J) continued to sell its controversial Gynecare Prolift transvaginal mesh patch for nine months after the FDA ordered it to stop, according to court records. In a letter sent Aug. 24, 2007, the administration asked the company to halt sales of the Prolift until it could determine whether the device was ‘substantially equivalent’ to other products on the market.
Transvaginal Mesh Lawsuit Update 6/21/12: A judge has lifted the discovery stay in the federal transvaginal mesh (TVM) litigation, as scores of new cases continue to be filed on behalf of women in courthouses around the country. All discovery was stayed earlier this year in federal lawsuits involving transvaginal mesh products used for surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Free Ethicon Gynecare Transvaginal Mesh Recall Lawsuit Evaluation: If you or a loved one has been injured by an Ethicon Gynecare Transvaginal Mesh Device, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against Ethicon and we can help.
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What’s the problem?
This week, Ethicon sent letters to two judges presiding over consolidated litigation involving the company’s pelvic mesh products stating that they intend to “stop commercialization” of several transvaginal mesh 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.”
Last year, the U.S. Food & Drug Administration (FDA) issued a warning about the risks associated with vaginal mesh, especially when used to treat pelvic organ prolapse (POP). The FDA stated that it could find no benefit in using the products when compared to older, safer methods of treatment. Between 2008 and 2010, the administration received over 1,500 adverse event reports (AERs) of serious transvaginal mesh side effects, which included:
- erosion of the mesh into the vagina
- contraction or shrinkage of the mesh
- pelvic pain
- urinary problems
- vaginal scarring
- other complications
In addition to the Ethicon transvaginal mesh devices affected by this recall, a number of other manufacturers of similar devices are facing product liability lawsuits. Among them, American Medical Systems (AMS), C.R. Bard and Boston Scientific face claims that they failed to adequately research their products before bringing them to market, and promoted them as superior alternatives to other safe methods of treatment for POP.
Ethicon Mesh Bellwether Trial Delayed
Product liability lawsuits involving vaginal mesh slings manufactured by Ethicon Inc. have been delayed, after the judge presiding over the multidistrict litigation (MDL) postponed the next pending bellwether trial until the new year. No reason was given for the delay, but the judge also issued a second order the same day requesting a joint status conference for all litigation involving transvaginal mesh products on Jan. 29, 2015. Click here to learn more.
Do I Have an Ethicon Gynecare Transvaginal Mesh Recall Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Ethicon Gynecare Transvaginal Mesh recall lawsuits. We are handling individual litigation nationwide and currently accepting new side effects cases in all 50 states.
Free Ethicon Gynecare Transvaginal Mesh Recall Lawsuit Evaluation: If you or a loved one has been injured by an Ethicon Gynecare Transvaginal Mesh Device, you should contact our law firm immediately. You may be entitled to compensation by filing an Ethicon Gynecare Transvaginal Mesh injury suit and we can help.