What Should Informed Consent Look Like?

Jane Akre
August 15, 2016
Grimm fairy tale, 1852, Snow White, WikiCommons
Grimm fairy tale, 1852, Snow White, WikiCommons

Mesh Medical Device News Desk, August 12, 2016 ~ What is informed consent? If you had to advise others, what should true "informed consent" look like prior to transvaginal or hernia mesh surgery?  

What have you learned after the fact?

Informed Consent. You may have heard the term in a medical context.

Informed Consent is an acknowledgement of understanding by the patient prior to a healthcare intervention.  The doctor, clinician, nurse or health care provider asks the patient to consent to receive treatment with the understanding that that patient has been fully informed about the upsides and downsides of the treatment, whether it is a surgery, a drug, a clinical trial or a medical device implant.

In order to give informed consent the patient must have adequate reasoning faculties AND receive all of the relevant facts.

An exception is if a child needs the treatment, the parent may give informed consent or the legal guardian of a patient may give informed consent when the patient cannot.

History of Informed Consent

The term is traced back to 1957 where it was first used in a medical malpractice case by attorney P.G. Gebhard in a legal proceeding.  It establishes a doctor has a professional duty to provide care to the patient. To fail to provide that care is professional negligence that breaches the "duty of care."

Unethical medical research on humans, specifically during the Holocaust, led to the Nuremberg Code which in 1947 set an international standard for ethics in medical research.  Today an ethics committee is supposed to oversee the informed consent process. Patients should be informed if they are being entered into a clinical trial.

The World Health Organization provides informed consent templates here.

Desara mesh by Caldera Medical
Desara mesh by Caldera Medical

Conflicts of Interest - When Money Meddles

The ideals of informed consent can be compromised by the interference of financial conflicts of interest provided by profit-driven medicine and industry.

When NuVasive, a medical device maker, paid doctors at the UCLA orthopedic surgery department to use its spinal screw, it was revealed through litigation that a surgeon had not disclosed that payment and the problem was system-wide. Many doctors were receiving financial incentives and the department chair had reportedly advised them not to disclose that to the university.

The patient, who was unaware of payments to her doctor by industry, was injured by the spinal screw. She sued and received nearly $2 million.

Those on the receiving end can justify payments as preceptors or consultants by arguing that innovation must be initiated by those in the front lines, that is, doctors who are actually prescribing the drugs or implanting the medical devices. They are most qualified to advance medical innovation and the medical device or drug manufacturers are only too happy to reinforce the physician's perceived importance in the dynamic. It’s a win-win for doctors and the medical industries they co-mingle with, often at the cost of a patient.

Does money from drug companies or medical device manufacturers change doctors’ behavior?  Why would companies spend the money if it didn’t?

Many universities require doctors to reveal their financial conflicts with industry but fail to reinforce their own policies. Consider Johnson & Johnson’s relationship with UCLA. The dean of the UCLA medical school sat on the J&J board in 2014 and received $261,000 in return.

While it may not matter to some patients, the knowledge whether or not their doctor has financial ties to industry is part of true informed consent.

The trend to full disclosure of conflicts of interest is becoming more consumer-friendly. Patients can now search databases to find out whether their doctor is on the receiving end of industry dollars. See Mesh News Story here.

Pinnacle mesh
Pinnacle mesh, Boston Scientific
And that is the crux of the transvaginal mesh debacle – many women had no idea they were agreeing to an experimental procedure that had bypassed any Food and Drug Administration assurances of safety. The agency never required clinical trials.  Instead, patients were being assured the polypropylene implant was safe and effective though there was no proof of that statement. In some cases, women were not even informed they would be implanted with a medical device.  All too often, the mesh manufacturers had a conflicted financial arrangement with the doctor who failed to disclose that to his patient. It was a complete and total failure of any presumed safety nets to protect a women who trusted her doctor with her most intimate problems.

So What Should True Informed Consent look Like?

The American Congress of Obstetricians and Gynecologists (ACOG) says informed consent “should be looked on as a process rather than a signature on a form.  This process includes a mutual sharing of information over time between the clinician and the patient to facilitate the patient’s autonomy in the process of making ongoing choices.”   [Informed Consent August 2009 ACOG Committee on Ethics. No. 439]

It does not include information about whether medical practitioners should inform the patient about his financial conflicts with a device manufacturer or pharmaceutical company.

Another ACOG Committee Report No. 390,  raises the potential for a conflict of interest with a physicians' secondary interest such as a financial one.  It says “A conflict of interest is not necessarily wrong, but it creates the occasion and temptation for the physician to breach a primary obligation to the patient.”

ACOG acknowledges there is “ever-increasing intrusion into the patient-physician relationship by government and by the marketplace.  Whether a care plan, treatment protocol it may limit what a physician can provide for the patient.”  If that happens the physician should withdraw from the organization.

ACOG identifies the Paternalistic Model, a patient physician model where the physician might present only the information he thinks will lead the patient to the “right” decision. ACOG says this model is not appropriate when the patient is able to make a true informed decision but may be a good choice if the patient is ill and unable to engage in a discussion.

An Informative Model puts the physician in the role of delivering technical and objective information regarding the patient’s options with little professional input from the physician. A concern with the model is it may limit liability but may not work in the best interest of the patient who maybe eager to hear what her physician’s professional judgment.

An Interpretive Model is somewhere in between the paternalistic and informative models.  (ACOG Committee Opinion No. 395)

American Urogynecologic Society AUGS

The American Urogynecologic Society (AUGS) is a member organization of about 1,900 urogynecologists.  Concerning the question whether or not to use polypropylene pelvic meshon a woman with prolapse, AUGS provides an   Informed Consent Toolkit.

It says mesh for pelvic organ prolapse (POP) has shown good results when used in abdominal hernia repairs and mid-urethral slings. It admits there were no controlled clinical trials in human subjects because of the “substantial equivalent” standard was all that was required by the FDA.

The toolkit says mesh erosion ranges from 2 to 17 percent while infection are uncommon with modern mesh materials.   Injury of bladder or rectum occurs in 2-4% of the procedures. The true incidence of chronic pain with intercourse is not known it says, “but is suspected to be low, as they have not been reported in most of the clinical trials.”

What Should True Informed Consent Contain?

Women who have been implanted with pelvic mesh, also known as transvaginal mesh, report other outcomes. Most wish they had know about these possibilities before their surgery.  Some information that Mesh News Desk has accumulated over its five years reporting on this issue include the following:

  • Mesh is a permanent implant and may not be able to be removed
  • Mesh placement is a blind procedure using stainless steel trocars that resemble a hook
  • Pelvic mesh was never tested in humans before it was marketed
  • You have some chance of being harmed sexually, also known as dyspareunia. Many women report they can no longer have sex.
  • Biofilm formation is possible which cannot be treated with antibiotics.
  • Autoimmune issues have been reported including pain, aches, fibromyalgia, rheumatoid arthritis, Lupus, rashes, brain fog, dental decay, among others
  • Your doctor may have been trained in a weekend cadaver clinic. What is his/her training?
  •         Your doctor may be a preceptor or trainer, consultant for the company that makes the mesh he is using.
  • You may experience a return of incontinence or prolapse after your mesh surgery.  
  • You may face repeated surgeries to remove the mesh or to reconstruct your pelvic region.
  • Surgical injury to the bladder, colon, pudendal nerve have been reported during pelvic mesh placement or removal surgery.
  • There are more than 100,000 lawsuits filed against seven mesh manufacturers alleging defective product
  • Many pelvic meshes have been quietly removed from the market.
  • A number of devices still on the market have been found to be defectively designed.
  • Pelvic mesh should never be implanted in a woman who may become pregnant, who has a pre-existing condition; in a heart-lung patient; in a patient with diabetes; in a woman who exercises regularly; in a patient with a pacemaker.
  • According to the FDA in a July 2011 Safety Communication (here) the FDA reported that complications are "not rare" and that in most cases, pelvic organ prolapse (POP) can be successfully treated without pelvic mesh.  
  • FDA- Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
  • FDA - Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
  • FDA- There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
  • FDA- While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
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