FDA Issues Stronger Requirements for Vaginal Mesh Implants to Address Significant Safety Risks

On January 4, 2016, the U.S. Food and Drug Administration (FDA) moved to strengthen regulations on the use of transvaginal mesh implants, a problematic medical device doctors have used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). POP and SUI are two conditions that cause problems in women after childbirth, menopause or a hysterectomy. Pelvic organ prolapse involves the weakening of a woman’s pelvic muscles, which allows the pelvic organs, including the bladder, rectum and uterus, to fall down into the vagina.

The FDA has reclassified the vaginal mesh medical devices from Class II, which is a moderate risk, to Class III, which is high risk. In addition, the FDA will now require vaginal mesh manufacturers to submit a premarket approval application (PMA) which supports the safety and effectiveness of their surgical mesh product for the transvaginal repair of POP.

“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 post-market surveillance measures.”

The FDA has received thousands of reports of complications related to vaginal mesh products which included vaginal erosion, infection, pain, and perforations of the bladder, bowel or blood vessels. The FDA also reported three deaths associated with the mesh products in July 2013.

Doctors have implanted the mesh through the vagina—trans-vaginally because it is faster, easier and less invasive than implanting it through an incision in the abdomen. Implanting the polypropylene device through the vagina also shortened the patient’s recovery time.

While the vaginal mesh products were designed to solve the challenges of POP and SUI, some are not safe and some have been defective and have led to serious complications including infections, erosion of the vaginal tissues and organ perforation.

Tens of thousands of lawsuits have been filed against vaginal mesh manufacturers by women who have been injured by these vaginal mesh products that have been implanted in their bodies to repair one problem, but seemed to then cause complications and the need for additional revision surgery.

Common complications from implanted transvaginal mesh products include:

• Pain
• Nerve damage
• Infections
• Bleeding
• Vaginal shrinkage and scarring
• Painful intercourse
• Recurrence of prolapse or incontinence

Women who have had vaginal mesh products implanted and are experiencing complications that have caused them to have revision surgery may want to consider scheduling a consultation with a Jackson or Memphis personal injury attorney from the law firm of Bailey & Greer, PLLC. To schedule a consultation, please fill out our contact form.