response to thousands of reports of adverse events and increased concern among
doctors and FDA regulators, the FDA
has reclassified transvaginal meshes used to repair pelvic organ
prolapse from moderate-risk devices (class II) to high-risk devices (class
addition, the FDA is requiring surgical mesh manufacturers to address
well documented safety concerns by demonstrating the devices'
effectiveness and safety for transvaginal repair. “These stronger clinical
requirements will help to address the significant risks associated with
surgical mesh for repair of pelvic organ prolapse,” said William Maisel, M.D.,
M.P.H., deputy director of science and chief scientist for the FDA’s Center for
Devices and Radiological Health.
complications have included bleeding, infection, organ perforation, pain
during intercourse, severe pelvic pain, and urinary difficulties caused by mesh
eroding into adjacent tissue. Both new devices and those currently on the
market will be subject to the new requirements. Unfortunately, these
new requirements come too late for the millions of women who already have
transvaginal meshes implanted. For those women, additional surgeries and legal
action remain the only remedies.