FDA Halts All Sales of Vaginal Mesh Products

Alicia Farmer
April 18, 2019

Boston Scientific was ordered by the Food and Drug Administration on Tuesday to halt sales of controversial vaginal mesh products used in surgeries, saying the company had not proved they were safe to use.

According to the announcement, the FDA determined that "manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of the safety and effectiveness of these devices". In order to continue selling the devices in the US, the two device makers had to submit and obtain approval through a different device review pathway. "That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term", said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health.

Though not a recall, the two companies now have 10 days to provide the FDA with their plans for withdrawing the products from the market.

The FDA move, its toughest action yet against the devices, comes after tens of thousands of women have filed lawsuits against mesh manufacturers claiming injuries including bleeding and pain. The organization had petitioned (PDF) the FDA in 2011 to stop the marketing of all non-absorbable surgical mesh products in the indication, and to order a full recall as well.

The applications were required as part of a 2016 FDA decision to up the regulatory authority over transvaginal mesh, moving it into the highest-risk Class III device category. Several other major manufacturers, including Johnson & Johnson, previously stopped making the mesh. The FDA issued new recommendations for use in July 2011, and later that year ordered manufacturers to conduct new postmarket studies, after which most companies elected to stop selling the products.

"Over the past several years, the FDA has seen a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP fix". In the 1990s, gynecologists began implanting surgical mesh for the transvaginal fix of the condition and in 2002, the first mesh device specifically for this goal was cleared for use by the FDA, according to the agency's statement.

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At February's panel, Boston Scientific pitched its Uphold Lite Vaginal Support and Xenform Soft Tissue Repair systems and Coloplast presented on its Restorelle DirectFix Anterior product, touting new and improved product design. The surgical meshes were the topic of a "60 Minutes" investigation in 2018.

Wang compared the agency's decision regarding transvaginal mesh to those it made on silicone-gel-filled breast implants, which were also subject to a reclassification by the FDA after concerns arose about safety.

Zuckerman says the agency should require clinical trials for all mesh used in surgeries. According to a "60 Minutes" report from last May, more than 48,000 lawsuits relating to the devices have been filed. Those states claim that pelvic mesh maker Johnson & Johnson did not fully disclose safety risks, the AP has reported.

The agency said the women who have had transvaginal mesh used for their condition don't need to take any action if they are satisfied with their surgeries and don't have any symptoms.

Those who do have complications or symptoms - such as persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex - should see their health care provider, the agency added.

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