The FDA is increasing regulation for medical devices known as transvaginal mesh (TVM). These mesh devices are used for a number of reasons including, pelvic organ prolapse and stress urinary incontinence. Going forward TVM will be classified as high-risk when used to treat pelvic organ prolapse (POP).
Pelvic organ prolapse is a condition where the pelvic muscles and tissue become weakened and/or stretched. The muscles may reach a point where they can no longer support certain organs as the bladder, bowel or uterus, which may drop and protrude into the vagina. This condition often causes low back pain, pelvic pressure, “painful intercourse, constipation or urinary problems such as leakage or a chronic urge to urinate.” Women may opt to have surgery performed if they suffer from significant symptoms. TVM, when implanted is designed to reinforce the weakened pelvic muscles, and help keep organs from dropping.
TVM devices to treat POP were reclassified from class II, which usually includes moderate-risk devices, to class III, which normally includes high-risk devices. The FDA is also requiring manufacturers to apply for premarket approval (PMA) to support the safety and effectiveness of surgical mesh for the transvaginal repair of pelvic organ prolapse. As part of the FDA order, manufacturers of TVM devices to treat POP will have 30 months, to submit a PMA for devices that are on the market. Going forward, manufacturers of new TVM devices must submit for PMA before those devices can be approved for marketing.
Many of TVM devices currently on the market were approved through an accelerated review known as the 510(k) process. In a 510(k), manufacturers can gain approval for a medical device by showing that a product is substantially similar to one already on the market. That procedure for approval will no longer be available for TVM devices designed to treat POP. The new PMA requirements will necessitate manufacturers to address safety concerns, which led to many women with the inserted devices to file lawsuits. To address the significant risks of TVM surgery the FDA will monitor how women are managing years after surgery through continued post-market surveillance.
In 2002, the first mesh device to treat POP was cleared for use as a class II moderate-risk device, and there are several manufacturers who are currently marketing this product, including: Johnson & Johnson, Boston Scientific, Bard, Coloplast and AMS. Over the past few years, the FDA has received thousands of reports of adverse events from TVM insertion surgery. The most common adverse events include “severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.”
We have already filed suit the major TVM manufacturers and have begun to resolve many of our cases. If you were treated with a Transvaginal Mesh implant call the lawyers at Rheingold, Giuffra, Ruffo & Plotkin LLP, at (212) 684-1880. You can also contact us online here. Protect your rights today by speaking with a knowledgeable medical device product liability attorney today.