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Drs Raz and Ackerman: Risks and Benefits Lacking for Slings

Dr. Shlomo Raz, UCLA Urology

Mesh Medical Device News Desk, November 7, 2017 ~ This well thought out opinion piece is voiced by two leaders who are well acquainted with the devastating injuries resulting from women implanted with mesh, “slings” and transvaginal mesh, used to treat incontinence and prolapse.  

Writing in the International Brazilian Journal of Urology, in July-August 2016 is an Opinion Piece (here) by Dr. A. Lenore Ackerman and Shlomo Raz MD.

The authors, from Cedars-Sinai in Los Angeles and UCLA, say about half of all women will have some component of stress urinary incontinence in their lifetime and about 10% will undergo a surgical treatment.

A. Lenore Ackerman, MD PhD

As opposed to years past when the Burch colposuspension or autologous fascial pubovaginal sling was the norm, augmented polypropylene (PP) products  have been adapted for medical use to become the preferred synthetic midurethral slings (SMUS) for the treatment of stress urinary incontinence (SUI).

By 2010, the SMUS was the standard of care worldwide because of the reported equivalent outcomes with Burch and fascial slings, their ease of use, faster recovery time and reduced cost.

PP mesh used for pelvic organ prolapse (POP) then followed, however, soon severe complications came to light and the first black box warning was issued by the FDA in 2008.

The more serious warning followed in 2011 (“complications are not rare”), and in January 2016 the FDA upgraded the alert on POP mesh moving it from a moderate risk class II to a high risk, class III.

At the same time, SUI mesh remains in class II or moderate risk even as more than half of the hundreds of thousands of lawsuits have been filed against SUI mesh alleging its defective.

At UCLA, of the nearly one-thousand patients seen over the past five years for TVM (transvaginal mesh) complications, 77% were related to the mid-urethral sling.

More than half of the adverse event reports filed with the FDA (MAUDE database) are associated with SUI repairs.

The FDA said it “continues to evaluate the effects of using surgical mesh for the treatment of SUI and will report abut that usage at a later date.”

While true patient informed consent involves understanding the benefits, safety and efficacy, as well as risks and severity, “Both of these are lacking for SMUS”, say the authors.

Pain by Jade R

CHRONIC PAIN

There are limitations in any dialogue regarding mid-urethral sling complications – dyspareunia, urethral and bladder perforation, vaginal scarring and stenosis, mesh extrusion, vaginal bleeding- have been discussed in the literature, but here the authors focus on chronic pain.

Chronic pain may not just be found in the groin area and reports of pain elsewhere often are not included in a risk/benefit analysis. Neither does chronic, debilitating pain that develops a year or more after implantation. There are no treatment plans for this type of pain.

Often women turn to a full or partial mesh removal but even with excision “approximately one-quarter of these patients will not improve or will even worsen, living with constant debilitating pain.”

 

 

FAILURE RATE

Almost everyone agrees that complications from synthetic mid-urethral slings are under-reported, but by how much?

Dr. J G Blavais estimates 15.3% will experience serious adverse event or a surgical failure. That number jumps to 25% or higher from a five-year trial of transobturator tape slings.

Transobturator mesh, from Scottish Pelvic Floor Network

Quality of life (QOL) issues such as cystitis, voiding dysfunction and neurologic symptoms are often dismissed in long-term assessments. Shame, hopelessness, regret, anxiety,and frustration, can result impacting personal relationships and creating self-image problems.

Failures may not be felt by the patient until years after an implant yet a recent Cochrane Review only addressed four outcomes after one year among 84 clinical trials. That means most of the data is short-term with limited clinical relevance.

The authors do not seek a ban on mid-urethral slings but only to highlight that little is known about the risks of mesh-augmented procedures in SUI management. Are the risks justified? Is there that much to gain by using synthetic mesh over a Burch colosuspension and autologous fascial sling?

Advocating SMUS as a quick fix for everyone may be growing the divide between patients and physicians and add to the emotional devastating of the injured patient.

“As a community we must take this public outcry seriously, acknowledge our lack of insight into these complications, and pursue a deeper understanding of the pathophysiology of poor outcomes after SMUS.”

The physicians argue that it may be time to return to bioethics and the “first, do no harm” when it comes to treatment. For an inconvenience like incontinence, it may be better not to do something rather than risk causing more harm than good.  ###

14 Comments

  1. Sheryl T says:

    There are far too many women with permanent and life-altering injuries already, yet these procedures continue to no avail. I would much rather have lived with the stress incontinence and prolapse I had then to have sought help only to be given the life sentence that’s been handed to me! The time to “First, do no harm,” was long, long ago!!

  2. Victim Forever says:

    Seven years ago had tvt-o & pop transvaginal mesh implanted. Four years ago had to have removal surgery. Only able to explant 80% so still have 20% inside. Changed doctor who has confirmed I have an autoimmune disorder. I truly believe it’s the remaining 20% mesh now leaching into my organs.My body has been turning against itself. Probably has been all these years. Finally have a doctor who believes mesh is not inert, that it is messing with my antibodies. We will continue testing. Who knows how this ends but my lawyer will be getting this information soon.

    • Jane Akre says:

      Very soon with the information coming out about autoimmune disorders associated with mesh, that could be added to a list of recognized reactions to mesh. First science must confirm that suspicion. The longer manufacturers wait to offer you settlements, the closer that day comes.

  3. Disgusted says:

    I notice Dr. Raz was writing in the international Brazilian Journal of Urology. I wish it was in AUGS or anything US based. Probably wouldn’t be allowed. He is a kind and compassionate doctor. Hopefully someone will listen. This is pure madness. I think Jane once said that in the future this will be the decade known as the worst treatment of women, or something to that effect. She was prophetic. It will happen, I may not be alive to see it.

  4. Cynthia F says:

    All these years I have suffered. The Dr.’s all said same thing there is nothing wrong. Then my lab work ups started showing signs of infection over and over again!!! Until the antibiotics stopped even working or mating me feel worse.
    Thank God I found others who know my struggles my endless life
    altering pain!!!
    48 going on 90!

    • Jane Akre says:

      My dear, you need better doctors. Where are you located? Perhaps some will have a recommendation as to where they have found help. Thank you.

  5. Emma says:

    I’ve had get for 12 yrs -autoimmune disease after first 3mnths but took 6yrs to diagnose-r.e.m syndrome , now in wheelchair no life and UK surgeons refusing to remove. Cannot be catheterirised (when at 1 of my many hospital stays they tried but pain excruciating and leg shot off on it’s own!!) Got constant utis + can no longer weight bear hence life in a wheelchair. Unbelievable this procedure is still allowed.

  6. Teresa A says:

    I first had the tvt secure in 2011. Within 2 months I knew something was wrong. I started having vaginal discomfort, pain with sexual relations, vaginitis and discharge. Extreme pain when md examined and felt the Mesh petruding out of pubic area. Md stated he could feel fibers of the mesh and took samples of vaginal stain for testing. Set up date to have this mesh removed. After removal, waited 4 months, then Md placed Tvt O. Within 1 month started having severe pains, not able to have sexual relations due to pain, not able to walk1/8 mile. Used to run Mini/marathons before all this, I did travel nursing in the states of Ky and IN. Traveled for Hospice care and Medical Staffing. Now I’m disabled, I have finally got most of the mesh out after 5 surgeries. One more to go to try to fix me!! Pendendal blocks x2 every 3 weeks indefinitely for pain. No company should get off for ruining a life like this!!! MOST CRIMINALS GO TO JAIL FOR THESE CRIMES!!!!

    • Jane Akre says:

      Teresa- If you had problems with the first implant, why in the world would the doctor put in another!? Have you told him about your outcome? I certainly hope you and others let the doctors who implanted you know, through a certified letter, about your outcome. They can then no longer say that “you’re the only one” or “I’ve had no bad outcomes” …. the absurdity of that is amazing!

      • Monica says:

        I had the J&J mesh and complained to the doctor about the pain, UTI’s, sexual issues, etc. and I was told that it was defective but the Boston Scientific one was so much better. We’ve been lied to by the companies, our doctors, FDA, and even attorneys. When does all this stop?

  7. Frenchie says:

    Great article.
    Article should be published in United State, Coast to Coast papers.
    Does the FDA
    receive a copy.

  8. Kitty says:

    I will print and send to Dr Barbara Levy. She lives in DC.

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