Dangerous Products Guide: Vaginal Mesh Side Effects
Thousands of women across the United States suffer from Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) as a result of pelvic muscle weakness. Now, many of these same women are suffering from complications and side effects from surgically implanted vaginal mesh, pelvic mesh and bladder sling products, approved medical treatments for these common disorders. Greensboro, N.C.-based Ward Black Law is aggressively pursuing injury claims related to these products, and has provided a must-read guide below to keep you informed about product alerts, risks and recalls.
Originally designed to treat hernias, the mesh/surgical sling transitioned into the women’s health market in the 1990s to treat and solve Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI):
- POP, when the pelvic organs literally sag into the vagina, occurs as a result of the stretching and weakening of muscles in the pelvic region and is typically found in older women who have had children, who have been through menopause and who have had hysterectomies.
- SUI is most often associated with muscle weakness due to childbirth or pregnancy.
Under the FDA’s 510k fast-track approval process, the transvaginal mesh/sling was approved without extensive testing for vaginal repairs. Since approval, the FDA has issued three consumer alerts/notifications:
- a 2008 safety alert about “rare” complications associated with the use of mesh products,
- a 2009 safety alert due to the high number of complaints associated with the product, and
- a July 13, 2011 alert update to report that complications were no longer considered “rare.”
On January 4, 2012, the FDA issued another update, requiring vaginal mesh/sling manufacturers to conduct thorough studies of risks, complications and side effects associated with the products. According to the FDA announcement, “The manufacturers will be required to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh devices for POP and single-incision mini-sling devices for SUI. Data from the studies will enable the agency to better understand the safety and effectiveness profiles of these devices.” It is important to note that these safety studies do not include mesh/slings inserted through the abdomen.
Complications, Risks and Side Effects
Complications include everything from erosion of vaginal tissue to infection, organ perforation, and even recurrence of POP and SUI. For some women, the treatment has resulted in unbearable pain during sexual intercourse, profound scarring and even death.
In October 2005, safety reviewers with the Journal of Obstetrics and Gynecology studied the cases of 19 women implanted with the vaginal mesh and found that nine of them experienced “intractable mesh erosions and infection: vaginal mesh erosions not responding to antibiotics and oversewing (performed elsewhere up to 4 times), purulent vaginal discharge and bleeding, recurrent urinary tract infections, and severe pain.” Also according to the report, “All women with a posterior intravaginal sling reported buttock/rectal pain aggravated by sitting, defecation, or sexual intercourse.”
Lawyers and Settlements.com, a legal news source reporting on dangerous drugs and products and associated litigation, reports the following list of claims being made for vaginal mesh/sling:
- mesh erosion into the vagina, bladder, intestines and uterus
- pelvic pain,
- urinary problems, including recurrence of prolapse and/or incontinence,
- development of urinary retention
- bowel, bladder, and blood vessel perforation during insertion,
- vaginal scarring,
- dyspareunia (pain with sexual relations),
- fistulas and recurrence of prolapsed organs
- neuropathic pain
For more information about the health effects of the transvaginal mesh/sling, visit WebMD.com.
Recalls and Lawsuits
Concern over serious health issues in women is increasing as the number of reported incidents of women suffering from painful complications and side effects associated with these surgically implanted vaginal mesh/sling products continues to mount. Lawsuits are being filed across the United States against product manufacturers like Johnson & Johnson and Bard/Avaulta.
According to a June 5, 2012, article in the NYTimes.com, Johnson & Johnson has agreed to stop selling four of its vaginal mesh products, distributed by its Ethicon division, including the following:
- Gynecare TVT Secur
- Gynecare Prosima
- Gynecare Prolift
- Gynecare Prolift+M
This is the latest in a long line of product difficulties for Johnson & Johnson, although the company reports that their decision to stop selling the mesh/sling was not for safety reasons but because of market viability. The company also avers that this is not a product recall.
Boston Scientific, another manufacturer of vaginal mesh products, issued a Class II recall for both its anterior and posterior Pinnacle Pelvic Floor Repair Kits, not as a result of patient complications, but because of design flaws that caused the product to detach during implantation.
A lawsuit against C.R. Bard, manufacturer of the Avaulta mesh product, was settled in July 2012 for $5.5 million. Bloomberg News reports that, “Jurors in state court in Bakersfield, California, concluded July 20  that Christine Scott and her husband deserved the damage award because of injuries caused by Bard’s Avaulta Plus vaginal implant.” The details of the case cite a total of nine surgeries the plaintiff, Scott, underwent to correct the complications caused by the Avaulta Plus vaginal implant.
If you’ve had a transvaginal mesh/sling implant and have experienced complications like the ones described above, you may have a case. The Greensboro attorneys at Ward Black Law have extensive experience in such cases and can help women across North Carolina understand their rights. We also provide a powerful voice for our clients, representing them before some of the largest pharmaceutical and health product manufacturers in the nation.
Please call our office at 800-531-9191 or 336-333-2244 or contact us via email to discuss your potential case.