FDA Scrutinizing Vaginal Mesh used in Pelvic Surgeries

The U.S. Food and Drug Administration is warning medical providers who use surgical mesh to repair pelvic prolapse that the vaginal mesh is endangering women’s health by causing serious complications and even permanent damage that could be actionable in vaginal mesh lawsuits.

Pelvic organ prolapse is a condition for women in which the bladder or other organs begin slipping out of place and bulging into the vagina after childbirth, menopause, hysterectomy, or simply as they age. As a result, this frequently leads to urinary incontinence. Surgical mesh can be inserted directly through the vaginal tissues to treat the condition by holding the organs in their proper place.

FDA Issues Warning about Vaginal Mesh

The FDA first warned providers about complications with vaginal mesh devices in 2008, noting that it had received over 1,000 reports from nine surgical mesh manufacturers of complications associated with the devices.

Those complications include erosion through vaginal epithelium – in which the mesh protrudes through the vaginal wall – infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. Also reported were bowel, bladder, and blood vessel perforation during insertion, as well as vaginal scarring and mesh erosion. Women experience a significant decrease in quality of their life due to painful sexual intercourse and other problems.

Continued Vaginal Mesh Problems

In July 2011, an updated warning was issued, noting that since the original warning, the FDA has received 2,874 more reports of complications associated with the vaginal mesh devices. The FDA said it is “concerned that the number of adverse event reports remains high,” and is continuing to evaluate the effects of using surgical mesh to repair urinary incontinence in particular.

Some of the concerns include unnecessary use of the devices, or health care providers inserting them without proper training. Erosion of mesh through the vagina is still of particular concern to the FDA, as multiple surgeries can be required to repair mesh erosion, and even then, those might not ultimately fix the problem.

Vaginal Mesh Lawsuits

Women are coming forward with accounts of serious problems after they undergo placement of vaginal mesh. Lawsuits have been filed in Georgia and New Jersey against manufacturers of the vaginal mesh devices, and others are sure to follow. The FDA is requesting that women injured by these devices report incidents to the agency and include the manufacturer and other identifying information. In addition, many women have promised to show up together at the agency to voice their concerns.

If you or a loved one has been injured due to vaginal mesh problems, contact a vaginal mesh lawyer at Chaffin Luhana LLP at 888-480-1123 immediately for a free and confidential case review today. You may be entitled to compensation, and the lawyers at Chaffin Luhana can help.