FDA Orders Manufacturers of Surgical Mesh for Transvaginal Repair to Stop Selling Product

PUBLISHED: Apr 16, 2019
Relevant to: All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) has ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the U.S. immediately. The order is the latest in a series of escalating safety actions related to protecting the health of the thousands of women each year who undergo surgery transvaginally to repair POP.

The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices, which is the premarket review standard that now applies to them since the agency reclassified them in class III (high risk) in 2016. As part of the 2016 reclassification, manufacturers were required to submit and obtain approval of premarket approval (PMA) applications, the agency's most stringent device review pathway, in order to continue marketing their devices in the U.S. The companies will have 10 days to submit their plan to withdraw these products from the market.

Women who have had transvaginal mesh placed for the surgical repair of POP should continue with their annual and other routine check-ups and follow-up care. According to the FDA there is no need to take additional action if they are satisfied with their surgery and are not having complications or symptoms. Patients should notify their health care professionals if they have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex. They should also let their health care professional know if they have surgical mesh, especially if they plan to have another surgery or other medical procedures. Women who were planning to have mesh placed transvaginally for the repair of POP should discuss other treatment options with their doctors.

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 repair. As a result, the agency has taken several, escalating actions:

  • July 2011: FDA issued an FDA Safety Communication, which identified concerns and issued new recommendations about the use of surgical mesh for transvaginal repair of POP.
  • September 2011: FDA convened a public meeting of the Obstetrics and Gynecology Devices Panel to discuss the benefits and risks of this use. Subsequently, the FDA issued 131 orders to conduct postmarket surveillance studies (“522 orders”) to 34 manufacturers of surgical mesh for transvaginal repair of POP. Most manufacturers elected to stop marketing surgical mesh for transvaginal repair of POP after receiving their 522 orders.
  • January 2016: The FDA completed its reclassification of surgical mesh for transvaginal repair of POP into the highest risk class of devices (class III), which requires premarket approval (PMA) applications, the agency's most stringent device review pathway, in order to stay on the market.
  • July 5, 2018: This was the deadline for applications to be filed for premarket approval for any surgical mesh marketed for transvaginal POP repair. Manufacturers that did not file PMAs by this deadline were required to withdraw their products from the market. Those that did were allowed to keep their products on the market while the FDA reviewed their PMAs.
  • February 12, 2019: The FDA convened an advisory committee meeting to share the available evidence and seek expert opinion on how to evaluate the risks and benefits of these devices. The committee was asked to provide scientific and clinical input on assessing the effectiveness, safety, and benefit-risk of mesh placed transvaginally in the anterior vaginal compartment, as well as identifying the appropriate patient population and physician training needed for these devices.

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