FDA announces new regulations for pelvic mesh makers

On Jan. 4, the U.S. Food and Drug Administration announced that manufacturers of pelvic mesh implants must reapply for the agency’s approval of their products. The implants, which are used to treat pelvic collapse in women in Tennessee and elsewhere, have reportedly caused thousands of injuries to their users.

Plastic pelvic mesh was first introduced in the 1990s as a way to speed recovery for women who suffer pelvic organ prolapse, which occurs when the uterus, bladder or other organs slip out of place. The condition can cause pain, urinary problems and constipation. However, patients have complained that pelvic mesh worsened their condition, causing pain, infections and bleeding. Some women have been forced to undergo multiple surgeries to reposition the mesh, remove it or repair damage. Mesh makers Endo and Johnson & Johnson have been slapped with tens of thousands of lawsuits, claiming pain, infections and bleeding. Ireland-based Endo agreed to pay out $800 million to settle 20,000 claims in 2014.

The new FDA rules gives mesh manufacturers with devices already on the market 30 months to submit new applications proving their products are safe and effective. New manufacturers will have to obtain FDA approval before they can sell their devices. The agency also announced it has classified pelvic mesh as a “high-risk” medical product, meaning it will be subject to more stringent regulations.

Patients who have suffered injuries due to a dangerous product, such as pelvic mesh, may experience chronic pain, loss of function and other physical problems. In addition, they could be left with steep medical bills. However, in such cases, they may want to meet with an attorney who has experience with defective product litigation to determine the recourse that may be available.

Source: ABC News, “FDA Sets New Rules for Injury-Prone Pelvic Mesh,” Matthew Perrone, Jan. 4, 2016