Using Vaginal Mesh as a Preventative? Study Says it's Okay

June 20, 2012 ~ With all of the bad news about vaginal mesh (see Patient Profiles) and the thousands of lawsuits that have been filed by women who claim life-altering complications, a story like this is a glaring departure and deserves a closer look.

Bloomberg reports on a newly published study that says the Johnson & Johnson vaginal sling, the “gold standard” cuts in half a women’s risk of developing incontinence down the road.

Published June 20, 2012 in the New England Journal of Medicine, the study was conducted 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 says.

The sling is inserted vaginally at the time of prolapse surgery to correct the condition where weak muscles and tissues have allowed organs to prolapse or fall into the vagina. At the time of the surgery, Dr. Wei says adding the smaller piece of mesh sling to lift the bladder in a prophylactic or preventive measure prevents incontinence in one-quarter to half of all women after the surgery.

Reminder - these are women who may never have developed incontinence in their lifetime!

“There have been two schools of thought: put in a sling as a preventive measure when we put the bladder back up, or wait until there is a problem and then fix it,” often with surgery, said Wei. “What we found is that by putting in a sling, the risk of having leakage is halved.”

The Study

In the study 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% of the sling recipients had developed incontinence while 49.4% without the sling had urinary incontinence or as Bloomberg reports “were treated for the condition.”

The benefits lasted for the full year the women were followed and they will outweigh the risks for most patients, Wei said in a telephone interview with Bloomberg. On the flip side, 7% of the women with the sling had a bladder perforation while 31% of the women with slings had urinary tract infections compared to 18.3 % of those without the sling.

Many women tell MDND that their mesh complications occurred more than one year after placement of the mesh.

Where Did the Funding Come From?

It is always a good idea to look at who sponsors any study, especially when it goes against the grain of what is being uncovered with thousands of lawsuits filed against Ethicon over damages they experienced from vaginal mesh. In this case, 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.

Bloomberg reports J& J was not involved in the study by providing funding or the devices used.

An accompanying editorial supporting the safety of slings was written by Cheryl Iglesia, M.D. who voiced support for vaginal slings at the September 2011 gathering of the FDA expert panel on vaginal mesh.

Dr. Wei in 2011

The prophylactic placement of a mid-urethral sling in women undergoing vaginal prolapse repair who do not have stress incontinence was introduced by Dr. Wei at the American Urogynecologic Society (AUGS) 32nd Annual Scientific Meeting last September.

Dr. Wei told the crowd that tension-free vaginal tape (TVT) had resulted in superior continence rates at 3 and 12 months and he predicted the study could be "practice changing" for other doctors and their patients.

Risks of Slings

But there was a downside, admitted the doctor, such as a higher rate of bladder perforations - 6.7 % - with TVT, and zero with placebo, major bleeding or vascular complications, and incomplete bladder emptying.

During that gathering, Dr. Mikio Nihira of the Oklahoma College of Medicine told Medscape Medical News that the use of a sling when there is no incontinence is not without risk.

"The OPUS trial results (name of the observational study) are very interesting and certainly compelling, but my personal worry about doing a sling in somebody who doesn’t have symptomatic incontinence beforehand is the very small but concerning risk of that person developing a bladder perforation, and they had a few of those."

Dr. Nihira was not part of the study.

"I did Burch's before we did the urethral sling. That was an open abdominal procedure, it was a big deal compared with a urethral sling which is an outpatient procedure. So it might be tempting to do these procedures, yet they are not without risk, as the study shows," Dr. Nihira cautioned.

Learn More:

NEJM article

http://www.nejm.org/doi/full/10.1056/NEJMoa1111967

Clinicial Trials

http://clinicaltrials.gov/show/NCT00460434

OPUS Trial, published in Clinical Trials 2009

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2878478/?tool=pubmed

Truth in Medicine - My Experience with TVT Surgery

http://truthinmedicine-lor.blogspot.com/

Sponsors and Collaborators:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Office of Research on Women's Health (ORWH)