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FDA plays hard ball with transvaginal mesh makers

As lawsuits against the makers of the transvaginal mesh mount, the U.S. Food and Drug Administration wished the manufacturers a Happy New Year by imposing stricter regulatory oversight of their products.

The agency Jan. 4 announced that it had issued two new orders to corporations that have made and marketed the transvaginal mesh. One order reclassified transvaginal mesh to a higher risk category - moving the mesh from category II to category III - which heightens the level of regulatory monitoring. The other order requires transvaginal mesh makers to submit an application for pre-market approval, a PMA, which puts the onus on the corporations to prove that their mesh products are safe when they are used to repair a condition known as pelvic organ prolapse, or POP.

POP occurs when pelvic floor muscles become weak or otherwise unable to support pelvic organs, including the bowel, bladder and uterus, thus the organs bulge, or prolapse, into the vagina.

Transvaginal mesh has been surgically implanted in women for the treatment of POP since the 1990s; nevertheless, the FDA cleaned the slate and required proof of safety and effectiveness for devices that already have been on the market. The manufacturers have 30 months, as required by federal law, to submit a PMA to prove device safety.

"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," FDA scientist and physician Dr. William Maisel said. "We intend to continue monitoring how women with this device are faring months and years after surgery through continued post-market surveillance measures."

The performance of these devices will be scrutinized to a greater extent, to include reports of injuries. And the number of injuries is by no standard small. Actually, the FDA said in July 2011 that "serious complications associated with surgical mesh for transvaginal repair of POP are not rare."

"Doctors may perform surgery on women with POP who have significant symptoms, often using a minimally invasive transvaginal technique to reduce recuperation time," the FDA wrote in its Jan. 4 statement. "Surgical mesh may be permanently implanted during this surgery to reinforce the weakened pelvic floor muscles and repair POP, but over the past several years the 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."

The FDA's latest transvaginal mesh orders came four years, almost to the day, since the agency ordered the manufacturers to conduct "post-market surveillance studies" in order to determine how safe the mesh is when it is used to treat POP.

Federal and state courts across the country have received transvaginal mesh lawsuits. At the federal level alone, a panel of judges centralized about 73,000 pending cases filed against seven corporations before a single West Virginia judge for collective pretrial management. The most federal transvaginal mesh lawsuits, indeed more than 28,000, have been filed against Ethicon.

"Like many of the already-centralized actions," the panel wrote in one of its Dec. 9 orders, "the actions at bar involve factual questions arising from allegations that Ethicon and related entities defectively designed, manufactured, and marketed pelvic surgical mesh products, resulting in serious injuries, and that defendants failed to provide appropriate warnings and instructions regarding the risks and dangers posed by the devices."

If you have suffered complications that may be linked to the implantation of a transvaginal mesh, you have experienced product liability attorneys at Reich & Binstock prepared to evaluate your circumstances, without charge, and determine whether you may be entitled to compensation for medical expenses and for other losses.

Click this link or call toll-free 1-866-LAW-2400 for a free consultation. Reich & Binstock operates in all 50 states.

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