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J&J Transvaginal Mesh Granted (510)K Approval Based on Recalled Products

Pharmaceutical giant Johnson & Johnson is facing nearly 300 lawsuits over a transvaginal mesh device that was approved by the FDA based on a similar product that was recalled from the market nearly a decade ago over safety concerns.

Pharmaceutical giant Johnson & Johnson (J&J) is facing nearly 300 lawsuits over a transvaginal mesh device that was approved by the FDA based on a similar product that was recalled from the market nearly a decade ago over safety concerns. The claims are the latest to implicate the administration’s controversial 510(k) approval process, which has cleared numerous products and devices that were later found to be defective. Under 510(k), once a device is approved by the FDA, other similar devices need little if any testing in patients before being cleared for sale on the U.S. market.

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 Suit 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 lawsuit and we can help.

What’s the problem?

October 19, 2011 – According to Bloomberg News, the U.S. Food & Drug Administration justified its approval of dozens of transvaginal mesh devices based on their similarity to Boston Scientific’s ProteGen, even though it was pulled from the market after being found to be defective. The manufacturers of these implants are currently facing more than 600 lawsuits from women around the country who claim to have been injured by the devices.

Vaginal mesh products, which are designed to treat incontinence and pelvic organ prolapse (POP), were allowed on the market through the FDA’s 510(k) approval process, which “… is used to obtain marketing clearance for a device that is ‘substantially equivalent’ in safety and effectiveness to another lawfully marketed device or to a standard recognized by the FDA when used for the same intended purpose(s).”

Following a year of controversy over defective hip prosthetics, the FDA has been under increasing pressure to overhaul 510(k). In July, the administration issued a press release admitting that it was unclear whether vaginal mesh provided any substantial benefit over safer, more traditional methods of treatment. Additionally, an independent advisory panel recommended last month that the FDA should demand more clinical testing of transvaginal mesh products before being allowed to enter the market.

“We learn from experience,” Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health said in an interview. “What you’re seeing now is the agency taking very targeted actions against specific devices where we have new information to suggest we should be taking a different approach.”

The series of approvals that began with Boston Scientific’s ProteGen highlights the fundamental flaw in the FDA’s approval process. Under 510(k), manufacturers win clearance for a product by citing its similarity to a device already on the market, which is known as a ‘predicate.’ Once the second device is on the market, it can be used as the basis for the approval of a third device, which in turn can be used for a fourth and so on down the line. Making matters worse, if a predicate is later recalled by the FDA, the administration doesn’t necessarily go back and look at the devices it was used to approve.

Despite these glaring problems, the FDA uses the 35-year-old 510(k) process to review 90% of its device applications each year. In addition to vaginal mesh products, 510(k) was also used to approve nearly 100,000 artificial hip implants which were subsequently recalled by J&J due to high failure rates. All in all, nearly 30% of devices cleared through 510(k) have been pulled off the market, yet they remain available to cite as proof of new products’ safety.

The FDA finally acknowledged concern about its approval process in a report released in January, stating that 510(k) could potentially “put patients at risk.” The administration said it was considering a number of changes to the system this year, including more stringent specifications for products intended to be based on new devices.

At last month’s hearing, the 17-member independent advisory panel recommended that certain transvaginal mesh products be reclassified as high-risk devices requiring new studies to stay on the market. Colin Pollard, director of the FDA’s obstetrics and gynecology devices branch, stated that this process could take as long as three years, and until then current models will stay on the market.

That’s too late for many women, said Amy Allina, a policy director at the National Women’s Health Network.

“There are women who have these products inside of them and are living with the harm that was done to them,” she said. “It’s a terrifying thing to roll the dice with.”

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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 injury cases in all 50 states.

Free Vaginal Mesh Suit 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 lawsuit and we can help.

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