The US Food and Drug Administration (FDA) has ordered manufacturers of transvaginal surgical mesh to stop selling and distributing in the country following safety concerns.
The order was issued following the FDA’s review of premarket approval (PMA) applications submitted by Boston Scientific and Danish medical device maker Coloplast. Boston Scientific submitted PMAs for Uphold LITE Vaginal Support System and Xenform Soft Tissue Repair System, while Coloplast sought approval for its Restorelle DirectFix Anterior device.
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The regulator said that the companies’ products did not show an adequate assurance of long-term safety and effectiveness when compared to surgical tissue repair without using mesh.
The FDA asked the companies to submit plans for market withdrawal in ten days.
Surgical mesh implants are typically used to repair abdominal tissue in cases of pelvic organ prolapse (POP). In 2016, the regulatory agency reclassified the mesh as high-risk (class III).
The FDA’s Center for Devices and Radiological Health director Jeffrey Shuren said: “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective in the long-term.”
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By GlobalDataThe agency asked Boston Scientific and Coloplast to follow-up on patients that participated in the companies’ 522 studies.
In response to the FDA’s order, Boston Scientific said: “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.
“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 meshes have been linked to multiple adverse events over the last several years. In July last year, the UK imposed an immediate ban on the use of surgical vaginal meshes.
