The move came after tens of thousands of patients in the U.S. and across the world have reported serious complications, including intense pain and bleeding, after they were implanted the medical device, which is commonly used to prevent the bladder and uterus from dropping or pressing into the vaginal area.
“Patient safety is our highest priority, and women must have access to safe medical devices,” said Dr. Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health, in a press release from the agency. “The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices.”
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The FDA’s decision requires Boston Scientific and Coloplast, the two manufacturers of mesh products sold to treat organ prolapse in the United States, to present a plan within the next 10 days for pulling their brands of vaginal mesh from the market.
Vaginal mesh is one of a dozen or so devices that featured prominently in the Implant Files, a global investigation by the International Consortium of Investigative Journalists. ICIJ’s investigation found that many medical devices later blamed for high numbers of injuries and even deaths, including mesh, were approved in the U.S. without first undergoing clinical trials.
Other countries have previously taken action to restrict vaginal mesh, including Australia, where mesh for prolapse has been banned, and the United Kingdom and Ireland, where it has been suspended from use.
In 2016, the FDA switched the device to its highest risk category and directed manufacturers to conduct clinical trials if they wanted to keep selling it.
At the February hearing, Boston Scientific and Coloplast researchers presented studies that they said showed that mesh performed better at treating prolapse than alternative treatments and with similar rates of complications.
Tuesday’s decision reflects the FDA’s verdict that it found these studies to be unconvincing. The agency stated in its announcement that the companies had failed to prove the long-term safety or effectiveness of vaginal mesh used for organ prolapse.
Other surgical mesh products, such as those used to treat hernias or incontinence, are unaffected by the decision. Women who currently have vaginal mesh implants for prolapse are advised not to take additional action unless they experience complications or other symptoms.