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FDA Ups Transvaginal Mesh Warning Label as “High Risk Devices”

According to the U.S. Food and Drug Administration (FDA), the popular plastic transvaginal mesh device that has been used to repair pelvic organ prolapse (POP) transvaginally, or through the vagina, will have to undergo rigorous safety studies before being available to be used in patients.

The FDA issued two final orders to vaginal mesh manufacturers and notified the public that the agency is strengthening the medical data requirements for surgical mesh.

Trans Vaginal Mesh AttorneyFDA Classifies Plastic Vaginal Mesh as High Risk

The FDA reclassified these medical devices from class II, or moderate-risk devices, to class III, or high-risk devices.

The FDA also issued a second order that requires the plastic mesh manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

FDA Will Now Require Rigorous Mesh Medical Studies

The FDA will require mesh manufacturers to address safety concerns, including severe pelvic pain and vaginal and internal organ perforation, through medical studies to demonstrate safety and effectiveness.

The actions apply only to mesh devices marketed for the transvaginal repair of POP and not stress urinary incontinence (SUI) or abdominal repair of POP.

What is Vaginal Surgical Mesh?

Surgical mesh has been used by gynecologists over the past 40 years for the abdominal repair of POP and since the 1990s, for the transvaginal repair of POP. Surgical vaginal mesh is made of biological materials or synthetic materials like polypropylene, polytetrafluoroethylene, polyester fibers or stainless steel. The size, shape, thickness and flexibility vary based on the surgeon’s needs.

In 2002, the first mesh device with this indication was cleared for use as a class II moderate-risk device, and there are five manufacturers who are currently marketing this product.

Severe Pelvic Pain and Perforation Mesh Side Effects

Over the past five years, there has been a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair.

Manufacturers of surgical mesh to treat POP transvaginally will have 30 months, as required by federal law, to submit a PMA for devices that are already on the market. Manufacturers of new devices must submit a PMA before those devices can be approved for marketing.

What is Pelvic Organ Prolapse?

POP occurs when the muscles and tissue of the pelvic floor become stretched, torn or weakened and can no longer support pelvic organs such as the bladder, bowel or uterus; as a result, the organs drop from their normal position and bulge (prolapse) into the vagina.

Women affected with POP experience low back pain or pelvic pressure, painful intercourse, constipation or urinary problems such as leakage or a chronic urge to urinate.

Thousands of Women with Mesh Related Complications

FDA has received thousands of reports of complications involving the use of mesh for transvaginal POP repair. The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.

Vaginal Mesh Litigation

Most of the vaginal mesh side effect litigation has been filed in the federal court system, where all cases are consolidated for pretrial proceedings as part of a multidistrict litigation (MDL).

U.S. District Judge Joseph Goodwin in the Southern District of West Virginia is overseeing the litigation since February 2012. Judge Goodwin has presided over more than 100,000 transvaginal mesh and bladder sling lawsuits filed against various manufacturers, including C.R. Bard, Boston Scientific, American Medical Systems, Johnson and Johnson’s Ethicon subsidiary, Coloplast, and others.

Several cases have gone to trial with significant jury verdicts. To date the only major mesh manufacturer to settle is American Medical Systems. Bard and Boston Scientific are in settlement discussions but Ethicon is the lone holdout with bellwether trials set for later in 2016.

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