The U.S. Food and Drug Administration has rejected a petition from the Public Citizen’s health resource group, which aimed to ignite a global transvaginal mesh recall. Despite the FDA’s refusal to issue a recall, the agency acknowledged serious concerns with mesh devices, ordering 126 manufacturers to review the safety of their products and proposing to reclassify the devices as “high risk.”
More than 60,000 transvaginal mesh lawsuits have been filed against manufacturers alleging that the devices caused serious injuries. Among the most common transvaginal mesh complications are severe pain and erosion of the mesh into visceral organs such as the bladder and rectum. Tens of thousands of women have require revision surgery to fix transvaginal mesh side effects.
Several mesh manufacturers, including Johnson & Johnson, C.R. Bard and Boston Scientific have already issued transvaginal mesh recalls for their devices after thousands of women complained of injuries. Some companies have paid hundreds of millions of dollars in transvaginal mesh lawsuit settlements.