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

Jun 21st, 2012 | By | Category: Medical News

Dr. John Wei, U of Mi. Urology

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)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)


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6 Comments to “Using Vaginal Mesh as a Preventative? Study Says it’s Okay”

  1. Ruth says:

    One of the (many) things that bothers me about this trial is that any “cost-effectiveness analysis” fails to factor in the incalculable human cost in terms of human suffering and destroyed lives which often develop much much later than the 12 month follow-up period of this study.

  2. InAz says:

    Sure, you will be continent with the mesh usuage but the pain from the mesh is horrendous. The doctors should inform the patient…yes, you will most likely be dry but you may suffer from pain and other health problems for the rest of your life.

    • Amy G says:

      You might be continent with mesh surgeries- nearly 1/4 of the women with slings still developed incontinence.
      Doesn’t seem worth the risk for essentially only 1/4 of the women saw any benefit from the device. Slightly less than 1/2 of the women went on to develop incontinence in the non-sling arm-meaning this is a fairly weak argument in support of prophylactic slings.

      A 25% chance it will be of any benefit does not seem like a worthwhile risk for taking on a device that could prohibit any sexual relations and result in crippling pain, urethral obstruction and multiple re-operations (just to name a few risks)

  3. peggy day says:

    I still rue the day, 5 years ago that I let a gynecologist talk me into an unnecessary sling to prevent “future incontinence”. The sling was placed wrong and I had to suffer through 4 months of excruciating, debilitating pain, incomplete evacuation of my bladder, and difficulties urinating at all. I endured the most painful proceedures as several doctors tried to sort out what the problem was. I was reduced to assuming humiliating positions to accomplish the dreaded task of urination and it remains that way to this day.
    I suffered through another surgery for a partial removal of the superfluous sling. I was left with a painful neuroma from one of the surgeries, still have the difficulties urinating and the constant pain. It sure has made be give up on doctors completely — and I’m a retired nurse. I’d rather die a natural death than allow them to humiliate, harm me, hurt me or just plain kill me outright.

  4. Caitlyn says:

    Why not put mesh tape in for women having any other pelvic surgery as a prophylactic measure to prevent prolapse later on? Where do you stop?

    This is already standard practice for women who have prolapse and very mild SUI symptoms – they are told that they may develop much worse stress incontinence after proplapse surgery because the urethra will be straightened out once the bladder is put back in its proper place. The prolapse is ‘kinking’ the urethra and providing a kind of artificial resistance and so, in effect, the TVT puts the ‘kink’ back in when the urethra is under increased pressure. If they opt to have it done at the same time of prolapse surgery, these women will never know if they actually needed the TVT tape or not. The study only showed half the women having problems out of those who didn’t have the TVT at the same time, so that means half of these women didn’t need it!

    Some enlightened surgeons prefer to deal with the prolapse first and to treat each condition separately – a very wise decision in my view.

  5. Jane Akre says:

    I’ll be sure to pose your questions to Dr. Wei– they are good. Any more?

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.