The U.S. 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).
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 .
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 per cent of women in the U.S. who will suffer from pelvic organ prolapse during their lives,” the company said in an emailed statement.
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.
The FDA action does not apply to mesh products used to treat other conditions such as hernias or incontinence.
The Implant Files, a joint investigation between CBC with Radio-Canada, the Toronto Star and the Washington-based International Consortium of Investigative Journalists, heard traumatic stories from women across Canada.
In Canada and the U.S., thousands of women reported that the plastic-covered mesh eroded inside them, causing intense pelvic pain and autoimmune symptoms.
Health Canada said Tuesday that it is performing a comprehensive review of transvaginal mesh products, which is expected to be completed in May.
Of the products identified by the FDA, Health Canada said these devices are available in Canada:
- Uphold LITE Vaginal Support System with Capio SLIM (Medical Device licence: 98223) from Boston Scientific.
- Restorelle Polypropylene mesh (Medical Device licence: 87285) from Coloplast. This license has two trade names: Restorelle Direct FIX Anterior (Device identifier 50450) and Restorelle DirectFix Posterior (device identifier 501460)
Health Canada added it is also reviewing mesh implants used in the treatment of stress urinary incontinence in women.
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