The Food and Drug Administration recently took action to protect older women and women who have had children. Earlier this week, the FDA proposed reclassifying pelvic mesh as a “high-risk” medical device. The plastic mesh is used in surgery to repair pelvic collapse.
As many New Jersey women who have had pelvic mesh surgery know, the implants can lead to infections, pain and bleeding. The FDA’s own study of the mesh shows that 10 percent of women who have the surgery experience mesh erosion within a year; more than half of those women then need another surgery to remove the material.
The mesh is used to bolster the pelvic wall in cases in which reproductive organs or the bladder drop down into the vagina. Because the mesh is often put in place via surgical insertion through the vagina, it is many times referred to as “vaginal mesh.”
If the FDA’s plan is implemented, it would require mesh makers to submit evidence that the product is safe for patients before it is sold to medical professionals.
“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse,” said the agency’s chief scientist for its device center.
When pelvic mesh devices were first introduced, they got quick FDA approval, which considered the products similar to ones successfully used to treat hernias. That fast-track treatment meant companies weren’t forced to undertake rigorous testing of the implants; testing the devices would now be subject to if the new proposal is adopted.
Anyone who has been harmed by a defective medical device should speak with a medical malpractice attorney experienced in this complex area of law.
