The New England Journal of Medicine published a study on June 20 by John Wei, MD, a researcher and professor of urology at the University of Michigan in Ann Arbor.
“What we found is that by putting in a sling, the risk of having leakage is halved,” he said in a news release.
He is referring to stress urinary incontinence (SUI) which will plague about half of women in some form or another during their lifetime. But given all of the complications that lawyers at Searcy Denney hear from our clients every day and the thousands of lawsuits filed by women who claim life-altering problems after being implanted with synthetic mesh to treat incontinence and pelvic organ prolapse (POP), you’d think doctors would be running in the opposite direction.
According to the report in Bloomberg, the Gynecare TVT vaginal sling used to treat incontinence is considered the “gold standard” and was used in this study conducted at eight centers, all members of the Pelvic Floor Disorders Network.
In Dr. Wei’s study, the sling was implanted vaginally at the time the woman underwent prolapse surgery to correct the condition where weak muscles and tissues have allowed organs to prolapse or fall into the vagina. Dr. Wei says adding the smaller piece of mesh sling to lift the bladder in a prophylactic or preventive way, even though the woman may not be suffering the inconvenience of incontinence, showed success in preventing the condition.
In the study, Dr. Wei involved 337 women who were scheduled for prolapse surgery. Half were treated with the Gynecare TVT sling, made by Ethicon, a division of Johnson & Johnson (J&J). After a three month time period, 23.6 percent of the sling recipients had developed incontinence while 49.4 percent without the sling had urinary incontinence.
Despite the fact that these are women who may never have developed incontinence in their lifetime, Dr. Wei believes the findings could be “practice changing” for doctors and their patients.
Remember to follow the money trail. There is not exactly a clear path here. Dr. Wei lists no conflict-of-interest and Ethicon did not supply the medical devices for the OPUS Trial as it’s known. The study was funded by the U.S. National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health and coordinated by the Pelvic Floor Disorders Network (PFDN).
PFDN is made of us doctors from eight medical centers across the United States to “work together to develop and perform research studies related to women with pelvic floor disorders. In this way, studies can be done more quickly than if the medical centers were working alone. Doctors, nurses, other health care workers, and support staff all play important roles.”
“The PFDN team wants to learn more about how to help women with pelvic floor problems. Treatments are available, but there are still questions about how best to take care of women with pelvic floor problems. The PFDN was started to study pelvic floor problems and come up with answers to these questions.”
Many members of the PFDN steering committee are practitioners who are still using synthetic vaginal mesh on their patients.
Vaginal slings are smaller forms of mesh than those used to treat pelvic floor prolapse. The FDA has ordered postmarket studies for transvaginal mesh, but not for mid-urethral slings as the strap-like mesh is called. The complication rate from slings is not known but we hear from women who are also suffering symptoms from a sling implant including pain, bleeding, erosion, nerve entrapment and a return of incontinence, among other complications.
Since this study only lasted one year it cannot be considered definitive as complications can develop over years and are often attributed to the woman “getting older.”
The study was not entirely good news for the “gold standard.” Seven percent of women implanted with a sling had bladder perforations and 31 percent suffered urinary tract infections compared to 18.3 percent without the sling.
Clearly, the study shows a urethral sling is not without risk and should provide a red flag for any patient and practitioner thinking they may want to put one in “just in case.”