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FDA Orders New Transvaginal Mesh Tests


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Transvaginal Mesh LawsuitJanuary 4, 2012 – This week, federal health regulators from the U.S. Food & Drug Administration (FDA) issued an order requiring manufacturers of vaginal mesh to study the risks associated with their products. The move comes after the devices have been linked to thousands of reports of serious injuries including cases of mesh erosion, infection, and severe pain. Leading manufacturers of transvaginal mesh products include Boston Scientific, C.R. Bard, and W.L. Gore & Associates.

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.

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.

Transvaginal Mesh Update 3/22/12: 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. Click here to learn more.

FDA 510(K) Approval Process Update 2/14/12: House Democrats have overwhelmingly supported the notion that federal health regulators should have the authority to block medical devices that are based on past products with safety issues from entering the market. A bill introduced earlier this month would close the FDA’s controversial 510(k) loophole that lets manufacturers win swift approval for devices like the much-beleaguered transvaginal mesh implants made by Johnson & Johnson and C.R. Bard inc. Click here to learn more.

Free Transvaginal 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 and we can help.

What’s the problem?

The FDA’s move to order additional studies on the side effects associated with vaginal mesh is similar to an action taken by the agency last year, when it ordered the manufacturers of metal-on-metal hip implant devices to conduct further patient studies. Both transvaginal mesh and artificial hips were cleared for sale on the U.S. market under the controversial 501(k) approval process, which requires little safety information and only some data concerning the products’ efficacy.

Back in 2008, the FDA issued a press release warning the public about the increased risk of complications linked to transvaginal mesh, but stated that such side effects were rare. However, over the next two years, adverse event reports associated with the devices increased fivefold.

In 2010, nearly 200,000 women were implanted with surgical mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Later that year, a study published in the medical journal Obstetrics and Gynecology found that approximately 15% of women treated with transvaginal mesh experienced serious side effects. The research also found that mesh failed to provide any tangible benefit over safer, more conventional methods of treatment.

Over the past year, the FDA has ordered a large number of manufacturers to conduct emergency studies concerning the safety of questionable devices and products. But the effectiveness of the FDA’s actions in preventing injuries to the public is marginal due to the fact that by the time the order is issued by the administration, the product has been on the market for years and used on thousands of patients.

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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 vaginal mesh 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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