Lawmakers Say Tougher Approval Standards Needed for Vaginal Mesh Devices

Following a push by certain House Democrats asking for congressional hearings on the safety of vaginal mesh, lawmakers have now proposed a bill which would make it more difficult for these devices to gain FDA approval.

A bill proposed earlier this month by Democratic lawmakers would prevent transvaginal mesh implants and other medical devices from being approved under the U.S. Food and Drug Administration’s 510(k). Under this system, a medical device manufacturer may seek FDA approval for a product by proving that the device is substantially similar to a product that is already on the market. The system does not require additional safety testing of these devices.

The 510(k) system has become the target of increasing criticism in light of numerous lawsuits filed against vaginal mesh manufacturers, which allege that these devices have caused pain, scarring, swelling, infection and other serious side effects. A number of transvaginal mesh device implants currently on the  market were approved using a Boston Scientific product as a predicate. This device has since been recalled.

In January of this year, the FDA announced that it would require 33 vaginal mesh manufacturers to conduct post-market safety studies of mesh implants to determine their safety and effectiveness. This announcement came after a July 2011 safety communication in which the FDA indicated that the risks associated with these devices may outweigh their benefits.

Following the 2011 safety communication, numerous women have filed lawsuits in connection with a failed vaginal mesh implant. The targets of these lawsuits include the Johnson & Johnson Company, C.R. Bard, American Medical Systems and Boston Scientific. The plaintiffs claim that the vaginal mesh caused numerous adverse side effects and that the manufacturers knew of the risks but failed to adequately warn consumers of the dangers.

A number of federal lawsuits involving C.R. Bard’s Avaulta Pelvic Mesh were consolidated into a multidistrict litigation in 2010. Earlier this month, cases filed against Johnson & Johnson, AMS and Boston Scientific were also consolidated and are scheduled to be heard by the same judge presiding over the Avaulta cases, the Honorable Joseph R. Goodwin.

The FDA plans to continue its ongoing safety review of vaginal mesh devices but it remains unclear how or if it will be affected by the pending legislation. Woman who are considering a vaginal mesh implant to treat pelvic organ prolapse or stress urinary incontinence are urged to speak with their doctor to discuss the potential risks. Patients who have suffered complications after receiving a transvaginal mesh implant are also encouraged to contact an experienced vaginal mesh attorney to determine whether they have grounds for an injury claim.

Nadrich & Cohen, LLP is currently investigating vaginal mesh injury claims in all 50 states. For more information on filing a claim, call 1-800-718-4658.

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