Vaginal Mesh Manufacturers Face Questions About Device Safety

In the face of mounting vaginal mesh lawsuits, the federal government is taking a closer look at the way the safety of these devices are monitored.

The U.S. Senate recently announced the proposal of a new piece of legislation which would require the makers of certain medical devices, including vaginal mesh implants, to conduct enhanced safety monitoring of these products after they receive approval from the U.S. Food and Drug Administration. Lawmakers believe that additional oversight is necessary since the safety of the mesh implants is being challenged by a growing number of lawsuits which claim these devices caused serious pain, infection, tissue damage and other adverse health conditions.

The senators sponsoring the bill also drafted letters to the Johnson & Johnson Company and C.R. Bard requesting more information about how transvaginal mesh devices are tracked and how recalls of these devices are handled. Johnson & Johnson is currently face hundreds of lawsuits involving its Ethicon Gynecare mesh system while Bard is being sued of its Avaulta mesh implants. Other companies involving in the ongoing litigation include American Medical Systems and Boston Scientific.

Vaginal mesh implants first received FDA approval in 1996 as a means of treating stress incontinence in women who suffer from pelvic organ prolapse. This condition causes the pelvic floor muscles to weaken, which can lead to some of the internal organs sagging or even protruding outward from the vaginal opening.

Since 2008, the FDA has reportedly received thousands of complaints from women who claim they experienced serious side effects after receiving one of these implants. It’s estimated that around 300,000 women receive a transvaginal mesh device annually, leading medical and legal experts to speculate that the number of injury lawsuits involving the implants will continue to increase.

In initiating the proposed legislation, the senate has also drawn attention to problems with the FDA’s current approval system for medical devices. Under the current 510(k) system, medical devices may be approved if their manufacturer can prove that a similar product is already on the market. Using the now-recalled Protogen system developed by Boston Scientific as a predicate, Johnson & Johnson was able to get approval for its Ethicon Gynecare system under this rule.

Women who have received one of these implants are being urged by legal professionals and consumer health advocates to seek the advice of an experienced personal injury attorney to protect their rights. National law firm Nadrich & Cohen LLP is currently investigating claims from women in all 50 states who say they were injured by a mesh device. Free initial case evaluations are available by calling 1-800-722-0765 or by visiting the firm’s online Vaginal Mesh Resource Center.

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