Has the FDA Recalled Transvaginal Mesh Surgery in Kentucky? Nope!

Transvaginal mesh appeared on the scene in the 1990s as a method of permanently repairing pelvic organ prolapse (POP). Unfortunately, for many women, it only caused more problems.

The Condition and the Remedy

A condition generally found in older women after childbirth, a hysterectomy, or menopause, POP happens when a woman’s pelvic muscles become weak, allowing the organs in the pelvic area to drop into the vagina, or become prolapsed. Because organs function properly only when they are in their correct position, these women need some kind of support for the prolapsed organs.

Transvaginal mesh is a sling made from a synthetic material, such as polyester or polypropylene, that is implanted in the vagina to hold the prolapsed organs in their proper position. The mesh is similar to a mesh that has been used successfully for years in hernia operations. The mesh was never approved for vaginal use, and no testing was required for the Food and Drug Administration (FDA) to put the device through its fast-track approval, the 510(k).

The Unwanted Results

Among the complications that arise after transvaginal mesh is implanted, two stand out—first, mesh erosion, or mesh extrusion. This is a dangerous condition in which the rough edges of the mesh cut into the vaginal lining and nearby organs, causing organ perforation, infection, bleeding, pain during intercourse, and urinary problems.

A second adverse development is mesh contraction or shrinkage, which leads to vaginal shortening, tightening, and pain, as well as pain during intercourse or inability to engage in intercourse. Men may also experience pain and irritation of the penis when it comes into contact with the eroded mesh during intercourse.

Attempts to surgically remove the eroded mesh are difficult because it becomes embedded in the flesh. Several surgeries may be required to remove all pieces of the mesh.

The FDA’s Response

In 2008, the FDA acknowledged in a public health notification that dangerous complications could result from transvaginal mesh implants but that these complications were rare. In 2011, the FDA issued a revision to its earlier statement, declaring that complications were not rare after all. The FDA subsequently ordered the manufacturers of transvaginal mesh to conduct post-market safety testing.

According to Drugwatch.com, what the FDA discovered after reviewing research results published from 1996 to 2011 was disturbing:

  • Transvaginal mesh repairs introduce more risks than traditional non-mesh repairs.
  • No evidence shows that mesh repairs on the top or back wall of the vagina are more beneficial than traditional non-mesh repairs.
  • Transvaginal mesh surgery may not cure the symptoms of prolapse.

Despite the thousands of injuries and seven deaths associated with transvaginal mesh surgical prolapse repairs, despite the outcry from consumer advocates, the FDA’s Obstetrics and Gynecology Devices Advisory Committee did not order that the devices be removed from the market. They did, however, order more stringent testing of new mesh devices, and recommend reclassifying the devices as Class III, which requires premarket approval of any future mesh devices.

In January 2012, the FDA ordered transvaginal mesh manufacturers to perform three-year studies on their products, analyzing the side effects and their impact on women’s quality of life.

Kentucky transvaginal mesh complications can destroy women’s lives. If you are facing additional surgeries to remove a defective mesh, or if you are experiencing more or continuing pain post-surgery, contact the Louisville personal injury lawyers at Gray and White Law. Call 502-210-8942 or toll free at 888-450-4456 and set up a FREE, no-obligation, confidential consultation.

Matthew L. White
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Founder & Partner of Louisville Personal Injury Law Firm Gray & White Law