Patient Safety News: FDA Deliberates Taking Women’s Surgical Mesh Off the Market

The FDA is now considering whether synthetic surgical mesh products used to treat pelvic organ prolapse should remain available to patients. There have been 10,390 reports of injury and 77 deaths linked to the product, also commonly known as vaginal mesh.

Thousands of women have filed lawsuits against the medical device manufacturers Boston Scientific and Coloplast Corp, citing the faulty product is responsible for causing pain, sexual dysfunction, scarring and other complications. Further, many patients are forced to undergo multiple re-operations to repair the damage.

Vaginal mesh has been available in the United States since 1996. In light of the thousands of complaints the FDA invited medical experts to testify on the safety of the product in February. These physicians recommended that the FDA consider more than doctor complaints and include self-reports from women about their experiences as it weighs whether the synthetic mesh should remain on the market.

“Too many women have suffered painful complications from faulty vaginal mesh,” said Berman & Simmons attorney Susan Faunce. “The FDA needs to take action immediately so no more women suffer needlessly. And the manufacturers need to be held accountable for knowingly allowing a dangerous medical device to be on the market.”

Attorney Susan Faunce leads the firm’s mass tort practice and is pursuing claims for compensation on behalf of patients who have developed serious complications from dangerous drugs and medical devices.




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