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J&J Sold Unapproved Transvaginal Mesh Products

Johnson & Johnson sold a transvaginal mesh implant for three years before the device was officially approved by the U.S. Food & Drug Administration.

Multi-national pharmaceutical and biotech giant Johnson & Johnson sold a transvaginal mesh implant for three years before the device was officially approved by the U.S. Food & Drug Administration (FDA). The product, known as the Gynecare Prolift, is currently the subject of more than 550 lawsuits filed on behalf of women who claim it injured them. Over the past several years, vaginal mesh implants have been linked to a large number of serious side effects including infections, bladder and bowel perforation, vaginal scarring, mesh erosion, and persistent urinary problems.

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. Click here to learn more.


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. Click here to learn more.

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). Click here to learn more.

Vaginal Mesh Lawsuit Update 5/16/12: The first trial date in the federal litigation involving women allegedly injured by vaginal mesh products manufactured by C.R. Bard has been set for early next year. Although the specific lawsuit has yet to be selected, the trial will involve a claim filed on behalf of a woman who allegedly suffered injuries after being implanted with a Bard vaginal mesh product. Click here to learn more.

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

What’s the problem?

In March 2005, Johnson & Johnson began marketing the Gynecare Prolift as an ‘innovative and effective surgical option’ for women suffering from pelvic organ prolapse (POP) and stress urinary incontinence (SUI). But it wasn’t until 2007 that the FDA learned about the device, when J&J filed for approval of a similar product. Both devices were cleared for use on the U.S. market in May 2008. Between 2005 and the time of its clearance, the Prolift had been linked to at least 123 reports of malfunctions and serious injuries.

J&J argued that it could market the Prolift without prior approval from the FDA because the device was virtually identical to another product already on the market, the Gynecare Gynemesh. However, the administration disagreed with this assertion, and concluded that the distribution of the Prolift began without appropriate clearance.

J&J’s conduct raises questions about the FDA’s controversial 510(K) approval process, which allows companies to market products without human testing if the administration decides they’re similar to existing products (so-called predicate devices) already for sale. Congress has been pushing to overhaul 510(K) in response to a large number of nationwide recalls, including the 2010 recall of 93,000 DePuy hip implant devices which were found to fail at alarmingly high rates.

In July 2011, an FDA report identified a shocking fivefold increase in deaths, injuries and malfunctions tied to transvaginal mesh products. Two months later, an independent advisory panel urged the administration to reclassify vaginal mesh as ‘high risk’ devices requiring additional human testing. In January 2012, the FDA required vaginal mesh manufacturers to study organ damage and other side effects related to their products.

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Do You Have a Transvaginal Mesh 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 transvaginal mesh lawsuits. We are handling individual litigation nationwide and currently accepting new infection, bladder and bowel perforation, vaginal scarring, mesh erosion, and urinary problem cases in all 50 states.

Free Transvaginal Mesh Lawsuit Evaluation: If you or a loved one has been injured by a vaginal mesh product, you should contact our law firm immediately. You may be entitled to compensation by filing a transvaginal mesh injury suit and we can help.

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