Though the FDA has warned about the risk of vaginal mesh injuries for years, the agency is now taking steps to cut down on the likelihood of injury.

The U.S. Food and Drug Administration (FDA) recently announced that vaginal mesh products, also known as surgical mesh, will now be classified as a class III medical device, indicating its high risk.

The FDA has also announced that it will require manufacturers of vaginal mesh products to seek and receive premarket approval for the safety and effectiveness of their devices in order to continue selling the products.

According to the FDA, “These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse. We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”

Vaginal Mesh Background

Vaginal mesh is a product commonly used to treat Pelvic Organ Prolapse, or POP, a condition that causes weak pelvic floor muscles to let pelvic organs sink into the vagina.

POP causes serious pelvic pain and urinary issues, as well as pain and other problems during intercourse.

A 2002 study published in the American Journal of Obstetrics and Gynecology showed that over 40 percent of women over the age of 60 who had not had a hysterectomy had developed POP.

Though vaginal mesh was approved in 2002, it was classified as a class II or moderate-risk device for the treatment of POP. However, this classification came before the agency began receiving adverse event reports from women who had suffered from severe vaginal mesh injuries.

Vaginal Mesh Injuries

Vaginal mesh injuries reported by women across the country include, but are not limited to:

• Severe pelvic pain
• Infection
• Bleeding
• Organ perforation
• Urinary problems
• Vaginal scarring
• Pain during intercourse

The FDA reported in 2008 that, in the six years since the approval of vaginal mesh, the agency had received over a thousand reports of vaginal mesh injuries.

By 2011, the FDA had received around 2,000 more reports of vaginal mesh injuries, and noted that they were no longer to be considered rare complications.

In a warning issued in 2011, the FDA noted that the most common of vaginal mesh injuries was mesh erosion through the vagina. Erosion will often require multiple surgeries to fix.

Lawsuits Over Vaginal Mesh Injuries

Halfway through 2014, nearly 60,000 women had filed lawsuits over vaginal mesh injuries against the device manufacturers. In some cases, pelvic mesh failure lawsuits have led to financial damages of millions of dollars.

Thousands of these pelvic mesh lawsuits have already been consolidated into a multidistrict litigation, or MDL.

As information about the vaginal mesh injuries associated with these devices becomes more widespread, an increasing number of women are filing pelvic mesh failure lawsuits over their own complications. 

If you or someone you love has experienced vaginal mesh injuries such as organ perforation or bleeding, you may be able to file a pelvic mesh failure lawsuit.