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Posted on May 26, 2015
The Food and Drug Administration is stepping in to make sure over the counter sales of the controversial Allergan’s IPAA (internal pelvic antireflux procedures) transvaginal mesh no longer include it. That’s according to a statement sent to Reuters, which said Allergan Inc AGN.N, the maker of the device, should stop selling the mesh in the U.S. because of “lifesaving” risks.
Reuters says that FDA Commissioner Scott Gottlieb issued the new guidance after his agency’s nearly two-year investigation into the market for the mesh.
The public has long been aware of the possibility of harm from the mesh, says Reuters, but there had been no formal warning of those risks. Allergan has had a dominant market share in the products.
In a statement, the company said it was “concerned” about the FDA’s action. “We believe the primary purpose of this guidance is to prematurely restrict the use of a surgical product, before any meaningful research has been conducted into patient outcomes and risks of complications,” the company said.
Even if the FDA takes the agency’s action a step further and bans devices like the one designed to stop the flow of urine when it flows from the bladder into the vagina, the mesh is already ubiquitous in pelvic area surgery.
About 20 percent of women who have a hysterectomy eventually undergo an operation to repair pelvic organ prolapse, The Wall Street Journal says, and the mesh is popular