The Food and Drug Administration ordered Tuesday Boston Scientific and Coloplast to stop the sale of surgical mesh for some peilevic operations.
Manufacturers were required to submit applications with the FDA and obtain approval to sell the devices in the United States after they were reclassified by the agency in 2016. The agency wanted to show evidence that they worked better than surgery without using the mesh. to repair the pelvic organic atmosphere, Jeffrey Shuren, director of the FDA's Radiological Devices and Health Center, said in a statement.
"This evidence was lacking in these pre-market applications, and we were unable to ensure that these devices were safe and effective in the long term," he said.
The mesh was used for transplant repair of pelvic organs, a condition in which the muscles supporting the pelvic organs become weak or loose, allowing the organs to fall into or out of a female vagina. Surgical mesh was used to fix the condition since the 1950s. In recent years, however, the FDA has warned of the risks associated with the devices.
Boston Scientific was the subject of a "60 Minutes" CBS investigation last spring which examined how the manufacturer dealt with 48,000 cases of law requiring his mesh "pain and injury can be changed."
The FDA said that about 1 in 8 women have surgery to repair the condition, and a subset of these surgeries is tragically completed with surgical mesh. However, in recent years the percentage of women undergoing transvaginal POP mesh procedures has decreased after the FDA issued warnings on procedural risks.
2012 & Johnson stopped selling its mesh products in 2012, citing "variable market dynamics."