FDA Sets More Strict Requirements for Transvaginal Mesh Implant Devices for Pelvic Organ Prolapse Repair

The U.S. Food and Drug Administration (FDA) has taken action to warn consumers about the risks involved with surgical mesh devices that are implanted to repair pelvic organ prolapse (POP). On January 4, 2016, the FDA issued two final order to manufacturers of these devices. The first was to re-classify transvaginal mesh devices from class II for moderate risk devices to class III for high risk devices. The second order was to require manufacturers of vaginal mesh devices to submit a premarket approval (PMA) application which would support the safety and effectiveness of their vaginal mesh products that are used to repair POP.

Pelvic organ prolapse is a fairly common health condition in women. In the United States about 24 percent of women are reported to have had some form of POP, most commonly after childbirth or menopause, according to Healthy Women.org. POP occurs when one or more of the organs in a woman’s pelvis, the uterus, bladder or urethra is no longer supported by the pelvic floor muscles and they begin to shift down and protrude from the vaginal canal. In order to repair POP, a physician would insert the vaginal mesh device through the vaginal opening to repair those weakened muscles and support the pelvic organs.

What the FDA is warning about is that the placement of the vaginal mesh through the vaginal canal puts women at greater risk for complications than when the device is implanted through an incision in the abdomen. The FDA has received more than 1,000 adverse event reports from women who had the vaginal mesh device implanted between 2008 and 2010, with an additional 2,874 reports associated with POP repair since that then. In 2011 the FDA issued a safety warning about the serious complications associated with the transvaginal placement of the mesh implants, and earlier in 2008 the FDA issued a Public Health Notification notifying consumers that the complications associated with these implants were not rare.

Some of the complications that women have complained about after having the mesh implanted vaginally include:

• Infection
• Erosion of the mesh implant
• Bleeding
• Perforation of the bladder, bowel or urethra
• Painful intercourse

Some of these complications require a second, revision surgery to repair the damage caused by the initial vaginal mesh implant. Sometimes doctors are unable to remove the mesh entirely, which leave the patient with ongoing symptoms such as pain, bleeding and discomfort on sitting, standing walking and painful intercourse.

The FDA is advising doctors to inform patients of the increased risk of complications with the mesh implants, discuss the benefits and risks of ono-surgical options and to consider surgeries that do not utilize the mesh implants and to consider the option of placing the mesh abdominally.

Thousands of women have filed lawsuits against the manufacturers of the pelvic mesh implant products in order to recover financial compensation for their medical bills, pain and suffering, lost wages and other losses including the cost of revision surgery.