Transvaginal Mesh Law
Transvaginal mesh is a medical device used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) in women. Thousands of women have been injured by this defective product.
Complications transvaginal mesh can include:
Erosion, bleeding, erosion through the vagina, perforation of the organ, infection, pain, bleeding, and painful sexual intercourse (dyspareunia), recurring prolapse or incontinence, neuro-muscular problems, scarring or shrinkage, and emotional problems. Some of these symptoms required hospitalization and additional revision surgery, sometimes even to remove the mesh.
In 1996, the FDA cleared the first surgical mesh product for use in SUI procedures. And in 2002, it cleared the first for POP procedures. When used in transvaginal POP repair, mesh is inserted through small stitches made in the vaginal wall (also known as “transvaginal”) to reinforce the weakened vaginal wall and support bulging organs. For SUI repair, the mesh is used as a sling to support the urethra.
The FDA reported in 2010 that approximately 300,000 women underwent surgical procedures in the United States to repair POP – an additional 260,000 women underwent SUI repair procedures. One out three POP surgeries used mesh, and 75% of the mesh POP procedures were done transvaginally. For SUI surgeries, 80% were done with transvaginal mesh.
In 2008, and in 2011, the FDA warned of the possible adverse side effects of surgically implanted transvaginal mesh. To date, the FDA has received over 3,874 reports of injury, death and malfunction occurring after transvaginal mesh procedures.
In 2008, the FDA stated nine manufacturers were mentioned in the reports of post-surgical transvaginal mesh complications. The majority of adverse events have been noted among products made by:
* American Medical Systems, MDL No. 2325<http://www.wvsd.uscourts.gov/MDL/amsinc/index.html>
* C.R. Bard, MDL No. 2187<http://www.wvsd.uscourts.gov/MDL/2187/index.html>
* Boston Scientific, MDL No. 2326<http://www.wvsd.uscourts.gov/MDL/boston/index.html>
* Johnson & Johnson, Ethicon, MDL No.2327
* Mentor Corp. ObTape Transobturator Sling, MDL No. 2004<http://www.gamd.uscourts.gov/divisions/mdl_cases.htm>
The FDA Warnings:
October 20, 2008 – The FDA releases a Public Health Notification warning patients and doctors of over 1,000 reports of complications associated with transvaginal placement of surgical mesh in repair of POP and SUI.
At the time, the FDA stated that the complications were reported in rare cases. The most commonly reported side effect was erosion through the vaginal wall, but other complications included pain, urinary problems, recurrence, organ perforation and vaginal scarring. The report further stated that cases of vaginal scarring and erosion caused a decrease in patient quality of life and pain, including dyspareunia.
July 13, 2011 – The FDA updated its 2008 Public Health Notification with a Safety Communication. The FDA reported that complications were not rare, contrary the FDA’s previous statement. Additionally, the complications may be life-altering.
On top of the 1,000 reports of complications received prior to its 2008 notification, the FDA received an additional 2,874 reports of injury, death and malfunction. 1,503 were associated with POP repairs, while the SUI cases totaled 1,371.
Additionally, the FDA reported patients who received a transvaginal mesh procedure were at greater risk of complications over patients who received traditional non-mesh procedures. Synthetic mesh vaginal procedures introduced risks not present in other non-mesh surgeries. The FDA also suggested transvaginal POP repair does not appear to provide any benefit compared to traditional surgeries without mesh – it does not improve quality of life.
If you or a loved one has been injured by transvaginal mesh, you should contact us immediately for a free consultation.