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/