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Docs Still Support Mid-Urethral Slings

Grimm fairy tale, 1852, Snow White, WikiCommons

Mesh Medical Device News Desk, September 22, 2017 ~ Many doctors cling to the assessment of their medical societies that mid-urethral slings, also known as polypropylene “tape” or “hammocks,” are the Gold Standard for the treatment of incontinence.  

The only thing that seems to be changing a bit is the realization that there needs to be true informed consent.  

This is the latest in a series of articles on Informed Consent, the process by which a patient is brought into the decision-making about her treatment plan.

While mesh-injured women continue to fight “slings” or polypropylene “hammocks” as the gold standard, citing life-altering catastrophic harm, many doctors continue to fight the realization of real-life patient harm. It’s a standoff that has gone on for far too long.

Last year when I attended the AUGS (American Urogynecology Society) annual meeting, I was taken aback to hear the then-president of the society call the mesh-injured community names such as the “Anti-Mesh Movement.”  Doctors voiced the opinion that women were urged by their lawyers to seek a “payday” hoping to cash in on their mesh injuries.

This newly published article in the International Urogynecology Journal (IUJ), Informed Consent checklists for midurethral slings: a common-sense approach, at least suggests there should be a pre-operative checklist to supplement the standard informed consent form.

The realization may come as much from a practical need to cover one’s behind when implanting a controversial medical device subject of thousands of defective product lawsuits.

Sling The Mesh rally at Parliament, July 18, 2017, CambTimes

 

UNREASONABLE ADVERSE ATTENTION

The authors of this IUJ article recognize a lot of, “new-found, unreasonable amount of adverse attention to the current gold standard for treating stress urinary incontinence, namely, the polypropylene mid-urethral sling.

They then go on to name all of the medical societies, many populated a led by Key Opinion Leaders (KOL) who do double duty as consultants to industry.  They “have all issued statements supporting the use of mid-urethral slings as the preferred first-line surgical management for SUI.”

Complications are low with an erosion/extrusion rate of around 2%, the authors write with post-operative groin pain at 1.3 to 6.4% with ”most reports noting resolution of groin pain within weeks of surgery.”

(Readers: Is this your experience?)


SHOULD WE EVEN INFORM PATIENTS? 

Allesandro Digesu, Urogyn, London

The authors ask considering all of the unresolved questions and debate, “Whether it is clinically appropriate or sensible to inform patients during the informed consent process? Should we discuss ad nauseum all of the possible rare complications associated with any kind of surgery (including death or permanent disabilities) at the time of counselling?”

Complications include permanent disabilities, untreatable chronic pain, sexual dysfunction, loss of ability to have sexual intercourse, or even death… if patients learn of this, “We might end up not treating any patients, leaving them to deal with their urinary incontinence,” conclude the authors.

Even if patients decide to proceed with surgery, this strategy will extend counselling sessions to possibly hours, providing an overwhelming amount of information that will only confuse our patients.”

So should one assume the implication is the paternalistic model of “Doctor knows best” is a better alternative than informed consent?

 

BOLAM TEST in the UK

Doctors, WikiCommons, Olga

The authors cite the Bolam standard to explain the court’ reaction to patient informed consent.

In 1957, Mr. Bolam was a patient at a mental health institution in UK. He underwent electroconvulsive therapy but was not given muscle relaxants. His body was not restrained during the procedure. He suffered serious injuries when he flailed violently during the procedure and suffered a fracture.  He sued the hospital because his doctors did not issue relaxants, did not restrain him, or inform him about the risks involved.

The majority of medical opinion at the time was opposed to using relaxants and restraints and it was common practice not to warn patients of the risk of treatment, when it is small.  Therefore, the doctor acted in accordance with responsible medical opinion and was not negligent, the courts decided.  There was no breach of standard of care if others in the profession agree. The treating doctor just needed to find experts to testify on his behalf.

It became the standard of professional negligence.

This reasoning totally negates the right of the patient to informed consent opting for the paternalistic “Doctor Knows Best” reasoning. It also overlooks the fact that medical opinion changes and doctors are sometimes the last to adopt the changes. Consider that medicine once encouraged smoking because it “relaxed the patient.”

Eventually that opinion caught up with the fact that smoking causes cancer.

In 2015, the Bolam test was overturned by an appeals court in England and fell out of favor and these authors conclude, in order to avoid the risk of a lawsuit for medical negligence, their duty needs to be to provide all possible information to help patients make decision and to respect their final decision.

 

SO WHAT IS ENOUGH INFORMATION?  

The authors conclude, clinicians should adopt a guidance checklist, but that is difficult at best because there is so much opinion concerning transvaginal and hernia mesh.  What are the potential outcomes and risks? What is the chance of a procedure going wrong?  Can it be removed?  Are there satisfactory options if I want a non-mesh repair?

There has not been a procedure specific checklist in other gynecologic surgeries such as hysterectomy or tubal ligation.  However doctors are keenly aware they are entering a potentially litigious arena in regard to polypropylene mesh in vaginal surgery.

“It could be argued that one downside to employing an informed consent checklist is that we appear to be defensive and trying to justify performing the current gold standard procedure for correcting SUI. Instead of using it a means of trying to avoid/reduce the risk of lawsuits, we should use it to promote an open discussion with our patients about risks and benefits of the midurethral sling.”

 

 

SO WHAT SHOULD PATIENTS BE TOLD?

The authors do suggest that only experienced and skilled surgeons implant permanent mid-urethral slings and manage complications related to them.  They characterize competence as doctors who have received appropriate training in the management of SUI and work within a multidisciplinary team and regularly carry out anti-incontinence surgery in women with a sufficient workload per year to maintain a high skill level.

The authors conclude it is time to rethink the informed consent process and use this as an opportunity to promote better understanding “by our patients.”

“Ideally women should be able to access public records, audit data, and registries of national and international professional scientific societies to better understand the published success, failure, improvement and other complication rates associated with mid-urethral slings.”


Your Editor asks
–  Does that include patient-centered websites?  Let’s settle on some realistic numbers for the rate of erosion, need for mesh excision, complication rate. Let’s tell patients that it is very difficult, if not impossible to remove a mesh implant in the delicate pelvic area and that there is a potential for pudendal nerve injury and entrapment of the nerve, as well as damage from the trocars or needles used to place mesh.

Let’s tell prospective patients that the mesh may shrink, may cause chronic infection, may spark an autoimmune reaction, may cause dyspareunia, or painful sex. Let’s come to some agreement on the actual rate of erosion, complications, mesh removal. And let’s tell patients that after jurors have listened to evidence from both sides at trial, they have concluded many of the pelvic meshes still on the market, are defectively designed.

That might be a good way to start the informed consent process.

Note* Conflict of interest disclosures for the authors of this report include –  G. Alessandro Digesu (Dept of Urogynaecology, St. Mary’s Hospital, London, UK)  – consultant to AMS, Astellas, Medtronic, Dompe, Standard Innovation Corporation, a speaker for industry and trial participant. Steven E. Swift (Department of Ob Gyn, Medical University of South Carolina) has done research for Astellas and Cook.

Lawyer Victoria Handley (Handley Law Limited, Liverpool, England) reports no conflict of interest.

LEARN MORE:

Informed Consent, What We Are Learning, August 2017
https://www.meshmedicaldevicenewsdesk.com/informed-consent-learning/

What Should Informed Consent Look Like, August 2016
https://www.meshmedicaldevicenewsdesk.com/informed-consent-look-like/

Dr. V on Informed Consent, December 2013
https://www.meshmedicaldevicenewsdesk.com/dr-veronikis-informed-consent/

AUGS Informed Consent Toolkit, March 2013
https://www.meshmedicaldevicenewsdesk.com/highlights-from-augs-informed-consent-toolkit/

10 Comments

  1. Kitty says:

    Mid evil urethral slings ha

  2. Danie S says:

    Meshe or sling do not support organs, rather it degrade in the body eroding to tissue and near by organs. DOCTOR WITH LACK OF SKILLS , WANTING TO MAKE MONEY FAST AND ARE ACTUALLY DRIVEN BY GREED.

  3. Stopmeshimplants says:

    I can tell you if my doctor had shared any of those possible outcomes I would have not continued with the surgery. Not one was mentioned at any time during any of my consult visits or pre-op visits. Still fuming 12 years later. At the very least women should be given ALL of the information and then they can make a decision. This is and will be the biggest regret of my life.

    • Kitty says:

      I was given a “comic type book by Krames publishing. It suggested a very beautiful outcome. The only precaution was not to lift for 6 weeks or so. I did not lift for 3 months…but when I did lift after 3 months…. It was very very bad. I never thought it was the mesh..because the KRAMES booklet was my bible . How could something so perfect even cross my mind that this glorified surgery went very wrong.
      Devastating lies lies lies. I wish so much i would have saved that booklet.

  4. Disgusted says:

    This “gold standard” device has stolen my life. Sex is excruciating. I have pudendal neuralgia and obturator neuralgia. I am getting by with opiods, muscle relaxants, botox shots (which are exceedingly painful) and a pudendal interstim. I have extremes of retention where cathing is so painful to extreme incontinence when my bladder decides to dump. I have foreign body reaction to the mesh which created a granuloma that is very painful. I have difficulty wearing underware let alone pads. Might as well be in bed full time with them, as the pain is unbearable. So I live my life as best I can. Because my bladder signals are non-existent (neurogenic bladder), I have no idea the status of my bladder. We were recently driving on a trip and had normal life complications – a tire on the trailer blew out. It was a harried ride and my husband was nervous. He waited a little longer to stop. I got out of the truck and immediately started to leak. Barely made it to the bathroom and didn’t have time to mess with the lock on the door that didn’t work. No choice I had to sit down. Yes, as luck would have it a woman opened the door and I was apologizing profusely trying to explain the lock didn’t work. She was so embarrassed and missed most of my words. Just when I thought it couldn’t get worse (I thought I was done) I got up and leaked all over the floor. Now I had a big mess to clean up as well. I did the best I could using paper towels. I rinsed out my underware and put them in a plastic baggie and shoved them in my purse. The bottom of my skirt was wet, so I stood at the sink and rinsed it out like I stained it. I got out to the truck and was going through my suitcase. My husband asked what I was doing. I informed him I was looking for my underware. He asked why would you need that? My look gave him all the information he needed. He apologized and said I guess I waited a little too long to stop. I guess so. I had mild incontinence to begin with. No cystocele. I cannot understand why they are holding onto to this product and calling it the gold standard. When it goes bad, it goes very bad. Not worth any risk. We’re not talking temporary issues.

    • Jane Akre says:

      Disgusted, I’m getting a visual of your situation…. it’s heartbreaking. I’m so sorry. I only with some from Ethicon would put themselves in your place just for a moment if not a lifetime.

      • MsD says:

        Kris…
        I am moved beyond words after reading your story. My Mother had at least 2 mesh devices implanted, 1 in 2001, at age 57, and another in 2006-that I have records for. My sister and I would take Mother places and we knew to stop every 20-30 minutes. She graduated from panty liners, to pads, Depends, self cathing, interstim…
        And the last 5 years of her life, a foley. The embarrassment and shame she felt was one of the saddest experiences I ever felt in my life, and my heart goes out to you, with hugs and understanding. My Mother died last year. I pray you will find a good Dr, and have it all removed somehow.
        With ♥️Mary

    • Kitty says:

      I appreciate your humiliation. I have experienced the nightmare as well. The thing is….i just threw my underwear in the trash. I have thrown dozens of expensive vanity Fair and Jockey wear away.

  5. Kris says:

    Dearest Jane, I understand how this must be very overwhelming to you. I try to call my lawyer for answers yet he never gives me any about the tvm implant or should I say I have all 3 that were recalled. I recently found out after being very insistent on a umbilical hernia repair, and now I have the same mesh right above my navel. I have so much pain I just cry for I will never have resolution nor can it be removed. I am grateful to be alive, but no one wants me anymore and I am just a bit over 52 years old. Being that a severe car accident caused the tvm to be used for my pelvic cavity was completely detached on the left side. Since it was my 8th total car accident, none of which I caused left me disabled, another story. With that said why don’t they settle? Not that material things matter but when you have literally nothing left, no furniture, no clothing that fits due to constant malnutrition, so much I could say. My husband of 24 years left me. I feel so hopeless. If they really knew what happens to us maybe they would care! If one or the other doesn’t happen soon for me I face a very bleak situation. I hope if anything else that they may not feel as alone as myself. I pray for a miracle, it is the only thing that will save me. Thank you Jane for all you do.

    • Jane Akre says:

      Kris- It sound like you need to connect with supportive folks in your area. Could you tell us where you are located? Do you have a law firm? A good doc? Are you referring to hernia mesh alone? I’m sorry about your husband…..

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