Several advocacy groups in the U.S. are urging the Food and Drug Administration (FDA) to reclassify transvaginal mesh as a Class III medical device. A Class III device is one for which “insufficient information exists to assure safety and effectiveness” that is evident in a Class I or Class II device.
Consumers Union, which is the advocacy arm of Consumer Reports has cited the lack of clear clinical evidence for safety or effectiveness in mesh devices used to treat pelvic organ prolapse and stress urinary incontinence. Several transvaginal mesh manufacturers have had to issue mesh recalls for their devices after tens of thousands of patients have complained of transvaginal mesh side effects.
Mesh manufacturers including Johnson & Johnson, C.R. Bard and Boston Scientific are facing thousands of transvaginal mesh lawsuits alleging that the company’s devices caused serious injuries. Transvaginal mesh has been found to fail at a high rate, often leading to tissue damage, internal bleeding, and severe pain requiring revision surgery.