American Medical Systems’ transvaginal mesh products are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). These conditions, which become more common after childbirth, are often caused by weakened pelvic muscles. The mesh devices are supposed to strengthen the pelvis and provide some relief for their troublesome symptoms. Instead, however, many women are suing AMS alleging that these products actually caused much more harm than good. Lawsuits allege that the devices are not designed correctly and can lead to serious, sometimes permanent injuries.
AMS transvaginal mesh/sling products include:
Transvaginal and Pelvic Mesh Devices “May Expose Patients to Greater Risk,” Says FDA
On July 13, 2011, the U.S. Food and Drug Administration (FDA) said in a Safety Communication that complications associated with transvaginal mesh implants are “not rare” and that there is no conclusive evidence showing that transvaginal mesh is more effective than non-mesh repair in all patients with POP. In fact, the agency said that the mesh device “may expose patients to greater risk.”
The FDA reported that it had received 2,874 new reports of complications linked to transvaginal mesh between January 2008 and December 2010. Of these, 1,503 were associated with POP repairs and 1,371 were associated with SUI repairs. Studies reviewed by the agency show that about 10 percent of women who have transvaginal mesh experience erosion (where the mesh cuts through the tissues) within 12 months of surgery; more than half of them needed additional surgery to remove the mesh. In some cases, even multiple surgeries did not resolve complications.
AMS transvaginal mesh and pelvic mesh complications may include:
- Erosion of the mesh through the vaginal tissue
- Exposure or extrusion of mesh, which can require multiple surgeries
- Feeling a lump in the vaginal opening or something protruding from the vagina
- Painful sexual intercourse
- Perforation or puncture of the bladder, intestines and bowels, as well as blood vessels around the vaginal wall
- Recurrent Pelvic Organ Prolapse (POP)
- Recurrent Stress Urinary Incontinence (SUI)
- Urinary problems
- Vaginal bleeding
- Vaginal chronic drainage, discharge and infections
- Vaginal pain
- Vaginal scarring and shortening
Women who experience AMS transvaginal mesh and pelvic sling failures often undergo at least one additional surgical procedure to remove the device. However, it is not usual for victims of AMS surgical mesh complications to require repeated excision surgeries. Unfortunately, excision surgery does not guarantee the reversal of complications, and many women will continue to suffer with vaginal pain and an impaired quality of life.
Expert Advisory Panel Recommends TVM Reclassification Due to Safety Issues
One of the first critics of these products, and the FDA for approving them, was the watchdog group Public Citizen, founded by Ralph Nader. On August 25, 2011, the group stated that the FDA should recall transvaginal mesh products due to safety concerns and painful side effects. The FDA stated in an August 31, 2011 Executive Summary that it “believes that vaginal placement of surgical mesh for Pelvic Organ Prolapse (POP) repair inherently introduces risks of complications that are unique to the mesh itself.”
In September of that year, the FDA convened a meeting of the Obstetrics and Gynecology Medical Device advisory panel. A majority of the group agreed that the safety, effectiveness and benefits of transvaginal mesh devices in POP repair were not well established and warranted long-term follow up.
The agency proposed reclassification of mesh devices used in the repair of POP from Class 2 to Class 3. This meant that surgical mesh for POP repair could no longer take the FDA’s lax 510(k) approval route, and that manufacturers would actually have to perform clinical tests to prove their products were safe and effective.
Help for Women Suffering from Transvaginal Mesh Complications
If you or someone you know suffered painful injuries after being implanted with a transvaginal mesh device, you may have valuable legal rights. We’re here to answer any questions you may have. For a free case review, please fill out our online form to the right or call our office at 1(800)-YOURLAWYER.
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