FDA halts sale of all transvaginal mesh devices because they do not meet safety requirements – after years of protests from tens of thousands of women left crippled and in agony
- In 2016, the agency had reclassified the mesh as class III or high risk
- That required makers to submit and obtain approval from the FDA’s most stringent device review pathway in order to continue marketing the products
- The move came after years of protests from women who’d been injured by the devices
- On Tuesday the FDA concluded there was not enough evidence to prove safety of meshes
The US Food and Drug Administration on Tuesday ordered makers of transvaginal surgical mesh implants to immediately stop sale and distribution of the products in the United States.
The FDA said makers of the products such as Boston Scientific Corp and Coloplast A/S did not demonstrate a reasonable assurance of safety and effectiveness of these devices in their premarket applications.
The devices, made of synthetic or biological material, are commonly implanted in women to repair weakened or damaged tissue and provide support in cases of pelvic organ prolapse (POP).
On Tuesday the FDA concluded there was not enough evidence to prove safety of meshes
The prolapse occurs when the muscles and tissues supporting the pelvic organs – the uterus, bladder, or rectum – become weak or loose, resulting in one or more of the pelvic organs to drop or press into or out of the vagina.
In 2016, the agency had reclassified the mesh as class III or high risk, requiring its makers to submit and obtain approval from the FDA’s most stringent device review pathway in order to continue marketing the products.
The companies will now have 10 days to submit their plan to withdraw these products from the market, the agency said in a statement here
Boston Scientific said it was ‘deeply disappointed’ by the FDA’s decision and will work with the agency to determine the next steps.
‘The inaccessibility of these products will severely limit treatment options for the 50 percent of women in the U.S. who will suffer from pelvic organ prolapse during their lives,’ the company said in an emailed statement.
Shares of Boston Scientific slumped 4.6 percent $36.04 in afternoon trading.
Coloplast was not immediately available for comment.
The agency also ordered Boston Scientific and Coloplast to continue follow-up of subjects already enrolled in their 522 studies for the mesh.