FDA Classifies Transvaginal Mesh as a High Risk Medical Device

After thousands of lawsuits and countless stories of nightmarish experiences, the U.S. Food and Drug Administration has announced that surgical mesh used to treat pelvic organ prolapse or POP will be reclassified as a class III or high-risk medical device. In addition, manufacturers of these vaginal mesh implants will have to receive premarket approval for safety and effectiveness to continue selling the product.

The FDA has warned women about the risks presented by transvaginal mesh for years now. However, it is only now that the agency has taken definitive action to limit the use of this popular, but potentially dangerous product.

The High Risk of Vaginal Mesh

POP is a common condition in women, which can occur when the muscles of the pelvic floor weaken. This condition is caused by excess weight, aging, childbirth, a hysterectomy and other risk factors that allow pelvic organs like the bladder, bowels or uterus to descend into the vagina causing pain, urinary issue and problems during intercourse. About 40 percent of women over 60 tend to suffer this condition. The FDA cleared the use of surgical mesh to treat POP in 2002.

Beginning in 2008, the agency began to get numerous complaints about the mesh devices including pelvic pain, infection, bleeding, urinary problems, vaginal scarring and organ perforation. By 2011, the FDA had received nearly 2,000 more reports. The most common side effect was the erosion of mesh through the vagina. This can take multiple surgeries to resolve, if at all it is resolved. By 2014, there were nearly 60,000 pending mesh lawsuits.

Product Liability Issues

A number of consumers who filed lawsuits against these companies had no idea that these devices could have devastating side effects. The manufacturers of these devices didn’t even bother to warn consumers about the significant risks they were facing. Patients were often told that the surgery is minimally invasive and that their problems would be fixed after they receive the implant.

But for thousands of women that was not how things ended. Their problems worsened. Women found that they continued to have the problems they had before surgery. And they had many more problems now including chronic pain and inability to have sexual intercourse. These dangerous and defective products have left thousands of women physically, emotionally and financially devastated. It’s about time the FDA took action with regard to these transvaginal mesh implants. If you would like to discuss a possible case, please contact our trans-vaginal mesh attorneys at 800-561-4887.