F.D.A. Halts U.S. Sales Of Pelvic Mesh For POP, Citing Safety Concerns For Women

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The U.S. Food and Drug Administration (FDA) has halted the sale of pelvic mesh products across the United States for use in transvaginal repair due to pelvic organ prolapse (POP). Doctors implant the mesh to reinforce a weakened vaginal wall for repair to help re-strengthen muscles that hold up the bladder, uterus, and other organs that sag into the vaginal area. POP is a condition that sometimes happens after childbirth, according to WebMD.

However, the two major makers of the mesh devices – Boston Scientific and Coloplast – have so far failed to prove any long-term safety measures of the benefit of the devices, according to the FDA. Both companies will have about 10 days to withdraw their products from the markets.

Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health said in a statement to the press, “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term."

There have been several lawsuits in the states of Washington, California, Kentucky, and Mississippi, citing that the makers of the pelvic mesh did not fully disclose their safety risks. Some health professionals have opposed the lawsuits, saying that the procedure does work for women. Some of the reported side effects of having the mesh inserted to help repair POP have included permanent incontinence, severe discomfort, and in some cases, the inability to have sex.

"Surgical mesh has been used by surgeons since the 1950s to repair abdominal hernias. In the 1970s, gynecologists began implanting surgical mesh for abdominal repair of POP and, in the 1990s, for the transvaginal repair of POP," the FDA release reads.

It was previously thought that vaginal mesh was a safe and effective treatment option for POP, which was first introduced as an option in 2002 when it was "cleared for use as a class II moderate-risk device," according the the FDA.

However, vaginal mesh surgeries have concerned many health professionals because of the increase number of complications that have been reported post-surgery. There have also been a lot of misconceptions that have led women to think twice about their treatment options for pelvic organ prolapse.

Women who have had the procedures in the past are advised to have routine checkups, although no additional measures are needed if there are no complications or symptoms.

"Patients should notify their health care professionals if they have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex," the FDA suggests.

The agency advises anyone who was planning to have the transgavinal placement of the mesh for POP repair to discuss other possible treatment options with their doctors.

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