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FDA recommends placing transvaginal mesh patch in highest-risk category

September 10th, 2011

A Food and Drug Administration advisory panel has recommended that the agency place the transvaginal mesh patch in its highest-risk category of medical devices. The panel has also directed two of the largest surgical mesh manufacturers—Johnson & Johnson and C.R. Bard—to carry out additional testing to prove their products are safe.

The FDA panel’s review of transvaginal mesh patches came after the agency received reports of numerous injuries and several deaths linked to the device. Patients who have suffered complications from surgical mesh patches have experienced vaginal mesh erosion, severe pain, infection, pain during sex and other side effects. In many cases, these patients were forced to undergo additional surgery to correct the problems with the transvaginal mesh patch.

More than 500 transvaginal mesh lawsuits have been filed by patients who have experienced complications from the device. In spite of the stronger safety classification proposed by the FDA, the agency has not announced any plans to recall the transvaginal mesh patch.

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