Dec. 1, 2016 — San Diego, CA — A new study by researchers at Weill Cornell Medicine suggests the more transvaginal mesh product a surgeon uses in pelvic organ prolapse (POP) and stress urinary incontinence (SUI) surgeries the more likely a woman is to suffer complications and need revision surgery.
The study, published Nov. 30 in the journal JAMA Surgery, analyzed the outcomes of more than 41,000 women who underwent either POP or SUI between 2008 and 2012. The main outcome of the study was to see how many women suffered from mesh complications, particularly mesh erosion, or needed repeat surgeries within one year of their initial surgery.
Researchers used data from the New York Statewide Planning and Research Cooperative System, which collects patient data on all hospital discharges, outpatient surgeries, and emergency department admissions, and divided patients into one of four groups:
- Transvaginal POP repair surgery with mesh and sling (vaginal mesh plus sling group)
- Transvaginal POP repair surgery with mesh only (vaginal mesh group)
- Transvaginal POP repair surgery without mesh but with sling for SUI (POP sling group)
- Surgery for SUI with sling only (SUI sling group)
Researchers conducted a one-year follow-up on all women who underwent one of the four surgeries and found those in the vaginal mesh plus sling group had the highest risk for erosion, while those in the SUI sling group had the lowest. Researchers also found that women in the vaginal mesh plus sling group were at increased risk for repeat surgeries compared with those in the SUI sling group, who had the lowest risk.
A number of women in each of the four groups suffered from mesh erosion or needed repeat surgeries within a year. The study’s lead authors said in a news release issued by Weill Cornell Medicine Nov. 30 that the study’s results suggest no amount of mesh is completely safe. They said the results also suggest there is a “dose-dependent” relationship, meaning the more mesh is used, the more erosions or complications occur.
The first mesh used for the surgical treatment of incontinence was approved in 1996 and the products have since come under scrutiny from federal regulators. In 2008, the U.S. Food and Drug Administration warned of “serious complications” associated with the mesh products, including erosion, infection, pain, urinary problems, and recurrence of the prolapse. In 2011, the agency said it was unclear whether transvaginal POP repair with mesh was more effective than tradition non-mesh repair, and suggested the mesh may actually pose greater risks to patients.
In the United States, about 1 in 5 women will undergo surgery for POP or SUI by age 80. Researchers in the Weill Cornell Medicine study said if the risks they found were extrapolated to the U.S. general population, more than 20,000 erosions and about 14,000 repeat surgeries would have occurred among women in the U.S. during the study’s 5-year period.
Transvaginal Mesh Lawsuits
Women who were treated for POP or SUI with a transvaginal mesh product and suffered complications as a result have begun filing lawsuits against the many manufacturers of the surgical products. Manufacturers include C.R. Bard Inc., American Medical Systems Inc., Boston Scientific Corp., Ethicon Inc., Coloplast Corp., Cook Medical, and Neomedic.
- C.R. Bard Inc.
- American Medical Systems Inc.
- Boston Scientific Corp.
- Ethicon Inc.
- Coloplast Corp.
- Cook Medical
Federally filed Transvaginal Mesh Lawsuits against these manufacturers were consolidated into multidistrict litigation several years ago and have been moving through the court system ever since.
Most recently, C.R. Bard Inc. agreed to settle seven transvaginal mesh suits for undisclosed amounts, and another 17 are slated for settlement by February 2017.
If you or someone you love was implanted with a transvaginal mesh product for the treatment of pelvic organ prolapse (POP) or stress urinary incontinence (SUI), you may be entitled to compensation. Lawsuits against the manufacturers of these mesh products are beginning to settle out of court so it is imperative you act now to file your Transvaginal Mesh Lawsuit. To see if your case qualifies, call 1-800-214-1010 for a free case evaluation and to speak with a member of the Hood National Law Group legal team. Or use the form on the right-hand side of your screen.