FDA Refuses to Ban Vaginal Mesh But Agrees It is “High-Risk”

July 22, 2014 — The U.S. Food and Drug Administration (FDA) has rejected (PDF) a petition to completely ban vaginal mesh and order recalls.

Public Citizen, a consumer advocacy group, filed the petition in August 2011. Just one month earlier, the FDA published a Safety Communication warning that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.”

Public Citizen also asked the FDA to order manufacturers to recall all vaginal mesh products and re-classify the implants as a Class III (“high-risk”) device with rigorous pre-market approval requirements.

The FDA refused to ban vaginal mesh because they believe there are potential benefits. The agency also refused to recall the devices because there is not enough evidence that all vaginal mesh products will cause severe side effects.

However, the FDA has “tentatively” agreed that re-classifying the devices as Class III is appropriate. They also want to strengthen pre-market approval requirements for new devices. The agency believes that enhanced approval requirements for new devices will provide a reasonable assurance of safety while they continue to assess the risks and benefits. These changes were proposed in May 2014.

According to the agency:

“FDA believes that the appropriate approach at this time is to propose to up-classify the device and require the filing of premarket approval applications. The agency does not believe that a ban is warranted at this time.”

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