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Bill Seeks to Close Controversial FDA 510(K) Loophole

A bill introduced earlier this month would close the FDA’s 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.

February 14, 2012 – 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 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. The proposed legislation would require companies to explain why their products are different from recalled versions.

Free Transvaginal Mesh Lawsuit Evaluation: If you or a loved one has suffered an 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 suit against the manufacturer of the transvaginal mesh and we can help.

What’s the problem?

The controversy surrounding the FDA’s 510(k) approval process was sparked last year after the administration issued a public health alert for vaginal mesh implants, which had been reported to cause hundreds of women severe internal injuries. Vaginal mesh products were cleared for use on the U.S. market through 510(k), which lets technologies earn approval without human testing if the FDA determines them to be similar to other existing products. In October 2011, Bloomberg News published an article reporting that the approval of a number of mesh implants could be traced back to a Boston Scientific device that was recalled for safety issues in 1999.

“If an automobile is recalled for a major safety problem, we wouldn’t allow future models to repeat this same flaw, and the same should be true for the medical devices used in our bodies,” Massachusetts Rep. Edward Markey said in the statement. The bill would ensure “that devices do not mimic the mistakes made by other products.”

Current laws state that the FDA must approve a product for sale on the U.S. market if it is ‘substantially equivalent’ to a previously-approved device known as a predicate. The new legislation would allow the administration to deny the approval if the predicate device was recalled from the market, or if it was in the process of being recalled. The bill would also require the FDA to determine whether any have recalls in their ‘device lineage.’ A comprehensive report on these issues would be required to be submitted to Congress within 36 months of enacting the legislation.

Transvaginal mesh products were implanted in approximately 300,000 women a year to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Last month, the FDA ordered manufacturers of these devices to conduct more in-depth studies on the safety of their products.

Do You Have a Transvaginal Mesh Lawsuit?

The Medical Device 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 transvaginal mesh injury 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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