The US Food and Drug Administration (FDA) has ordered manufacturers of transvaginal surgical mesh to halt sales and distribution in the country following safety concerns.
This order was issued following an FDA review of premarket approval applications submitted by Boston Scientific and Coloplast. The regulator said that long term safety and effectiveness of these products could not be demonstrated in comparison to surgical tissue repair without using mesh. The FDA has asked the companies to submit plans for market withdrawal in ten days and to follow-up on patients that participated in the companies’ 522 studies.
Surgical mesh implants ten to be used to repair abdominal tissue in pelvic organ prolapse. In 2016, these were reclassified as high-risk (class III).
“We are deeply disappointed by this decision and believe the inaccessibility of these products will severely limit treatment options for the 50% of women in the US who will suffer from POP during their lives,” said Boston Scientific. “We have been working with the FDA for many years to develop the clinical evidence necessary to keep these important treatment options available. Unfortunately, today’s announcement by the FDA removes that possibility for the foreseeable future.”
Transvaginal surgical mesh has been linked to multiple adverse events over the last few years. In July of last year, the UK imposed an immediate ban on the use of these products.