Vaginal Mesh Classified as a High-Risk Device

Following years of scrutiny by regulators and mounting lawsuits, the U.S. Food and Drug Administration is strengthening requirements for surgical mesh devices designed to repair a condition called pelvic organ prolapse (POP). FDA tightens rules for mesh device use

The products will now be reclassified as high risk vs. moderate risk, and the FDA will require all manufacturers to submit detailed data to support the effectiveness and safety of the devices before they go to market. According to the FDA, the actions apply only to mesh devices marketed for the transvaginal repair of POP – also known as transvaginal mesh – and do not apply to surgical mesh for other indications, like stress urinary incontinence (SUI) or abdominal repair of POP.

Transvaginal mesh is a net like device typically made of porous absorbable or non-absorbable synthetic material or absorbable biologic material. The term “transvaginal” means through the vagina – and refers to the surgery used to implant the mesh. Related information

“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. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.” Press announcements

Surgical mesh has been used since the 1950s to repair abdominal hernias. During the 1970s, gynecologists began implanting surgical mesh for the abdominal repair of POP and, in the 1990s, for the transvaginal repair of POP.

Over the past several years, the FDA has seen a surge in the number of reported adverse effects associated with the use of surgical mesh for transvaginal POP repair. As a result, in 2011 an advisory panel of experts recommended in 2011 that more data is needed to establish the safety of the device. FDA tightens clinical requirements

POP happens when the muscles and tissue of the pelvic floor become loose, torn or weakened and no longer able to support pelvic organs such as the bladder, bowel or uterus. The result: organs drop and prolapse into the vagina.

Surgical mesh may be implanted to reinforce the weakened pelvic muscles and repair POP, but over the past several years the FDA has received thousands of reports of complications – such as infection, bleeding, urinary problems and more – related to the use of  transvaginal mesh.

To warn doctors and patients about the use of surgical mesh for transvaginal POP repair, the FDA has issued multiple safety communications warning doctors and consumers about an increase in adverse event reports related to mesh used for urogynecological procedures. FDA announcements