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 on 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. The FDA cited the ‘potential high risk for organ perforation’ when the Prolift is inserted vaginally to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
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.
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.
Free Transvaginal Mesh Lawsuit Evaluation: If you or a loved one has been injured by a transvaginal mesh device, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the transvaginal mesh and we can help.
What’s the problem?
June 26, 2012 – In May 2008, the U.S. Food & Drug Administration (FDA) approved the Gynecare Prolift transvaginal mesh device without ordering sanctions after nearly a year of negotiations with J&J’s Ethicon unit. Since then, the company has been slapped with more than 1,400 lawsuits filed on behalf of women who claim the Prolift caused organ perforation, severe pain, scarring, and nerve damage. Industry insiders have said that the device’s questionable approval history may increase J&J’s cost to resolve the litigation.
“You may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval, the administration told J&J in the 2007 letter. “If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.”
In 2005, Johnson & Johnson began marketing the Prolift without filing a new application after it determined on its own that the product was virtually identical to the company’s Gynemesh device, an FDA-approved vaginal mesh system. According to a company spokesman, J&J relied on FDA guidance for when companies must submit new applications to the administration.
The FDA disagreed with the company’s actions, and required a new application to be filed which prompted the 2007 letter. J&J faced no sanctions at the time because the FDA ultimately determined the company had interpreted the guidance in good faith, and because it ‘promptly complied’ with the administration’s orders, an FDA spokesperson said.
The controversy surrounding the Prolift highlights “the industry’s ability to shrug off FDA enforcement,” said Erik Gordon, a business professor at the University of Michigan. “If companies can get away with selling products they aren’t supposed to sell, the FDA is a sheriff packing a water pistol.”
The senate is scheduled to vote today on changes to the FDA’s beleaguered 510(k) device approval system, which has drawn widespread criticism for allowing devices like transvaginal mesh on the market with absolutely no human testing. The proposed bill increases funding for reviews and for the administration’s power to order safety studies after a product has been approved for sale on the U.S. market. The House of Representatives approved the measure last week.
Do I 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 side effects cases in all 50 states.
Free Transvaginal Mesh Lawsuit Evaluation: If you or a loved one has suffered a serious injury after being implanted with a transvaginal mesh device, you should contact our law firm immediately. You may be entitled to compensation by filing a transvaginal mesh injury suit and we can help.