FDA stops selling all transvaginal mesh devices because they do not meet safety requirements – after years of protests from tens of thousands of women who have become lame and in pain
- In 2016, the agency had reclassified the mesh as class III or as high risk
- That required manufacturers to approve and approve the FDA's most stringent device review path to further market the products
- The move came after years of protest from women who had been injured by the devices
- On Tuesday, the FDA concluded that there was not enough evidence to prove the safety of meshes
The US Food and Drug Administration on Tuesday ordered the makers of transvaginal surgical mesh implants to immediately stop the sale and distribution of the products in the United States.
The FDA said that makers of products such as Boston Scientific Corp and Coloplast A / S did not provide reasonable assurance about the safety and effectiveness of these devices in their pre-market applications.
The devices, made of synthetic or biological material, are often implanted in women to repair weakened or damaged tissue and provide support in cases of pelvic floor subsidence (POP).
On Tuesday, the FDA concluded that there was not enough evidence to prove the safety of meshes
Sagging occurs when the muscles and tissues supporting the pelvic organs – the uterus, bladder or rectum – become weak or loose, causing one or more of the pelvic organs to fall or press in or out of the vagina.
In 2016, the agency had reclassified the mesh as class III or high risk, which required its makers to approve and approve the FDA's strictest device review route to continue marketing the products.
The companies now have 10 days to submit their plan to remove these products from the market, the agency said in a statement
Boston Scientific said it & # 39; deeply disappointed & # 39; was by the decision of the FDA and will work with the agency to determine the next steps.
& # 39; The inaccessibility of these products will severely limit treatment options for the 50 percent of women in the United States who will suffer from pelvic floor collapse during their lifetime & # 39 ;, the company said in an email statement.
Shares of Boston Scientific dropped 4.6 percent $ 36.04 in afternoon trading.
Coloplast was not immediately available for comment.
The agency also instructed Boston Scientific and Coloplast to continue the follow-up of topics already enrolled in their 522 mesh studies.