Informed Consent - What We Are Learning

Mesh Medical Device News Desk, August 18, 2017 ~ What are we learning about Informed Consent?  Almost all medical bodies agree informed consent, sharing information about pros and cons of a procedure to educate a patient, is important!  

But what is informed consent when it comes to pelvic and hernia mesh?  

What do people wish they had heard before the procedure?  The list is long and growing.

We hear the term “Informed consent” in the context of mesh implants. Patients, whether hernia or pelvic mesh patients, are owed an explanation of the potential downfalls of their mesh implant.

Informed consent is not only information about your treatment options, from your medical provider, but it is the pros and cons of a procedure, drug or device that helps you make an informed decision.

Ideally, the language is in a written form you can take home and study before making a decision that’s right for you, rather then when you are on a gurney ready to be wheeled into surgery.

There is a world of difference among professionals, marketers, scientists, consumers, and doctors as to what informed consent should look like. And any information based on marketing alone is hardly informed consent.

In a March 2017 report (here), it finds that two in 10 GPs didn’t understand surgery for incontinence or pelvic organ prolapse and almost half did not believe that complications could be mesh-related.

In the U.S., at the last session of the American Urogynecologic Society, those who brought to light their mesh complications were denigrated and called part of the “Anti-Mesh Movement” by the group's president.

So how can there be agreement on transvaginal or hernia informed consent when there is so much disagreement?

We can listen and we can learn from those mesh-injured about what they wish they knew before their mesh implant including:  

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.  They too can cause injuries, so much so, that they have been upgraded to a high risk status, Class III, by the FDA.  

Pelvic and hernia 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 sexual relations after their mesh implant. Many men have pain after a mesh implant. Testicle loss is a possibility.

Biofilm infections are possible, which cannot be treated with antibiotics.

Autoimmune issues have been reported including pain, aches, fibromyalgia, rheumatoid arthritis, Lupus, rashes, brain fog, dental problems, among others.

Your doctor may have been trained in a weekend cadaver clinic and may be a preceptor or consultant for the company that makes the mesh he is using. What is his/her training?

Mesh placement is a blind procedure using stainless steel trocars that resemble a hook.  They too can cause injuries, so much so, that they have been upgraded to a high risk status, Class III, by the FDA.  

Pelvic and hernia 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 sexual relations after their mesh implant. Many men have pain after a mesh implant. Testicle loss is a possibility.

‍Biofilm infections are possible, which cannot be treated with antibiotics.

Autoimmune issues have been reported including pain, aches, fibromyalgia, rheumatoid arthritis, Lupus, rashes, brain fog, dental problems, among others.

Your doctor may have been trained in a weekend cadaver clinic and may be a preceptor or consultant for the company that makes the mesh he is using. What is his/her training?

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, and pudendal nerve has been reported during pelvic mesh placement or removal surgery.

There are more than 150,000 defective product lawsuits filed against seven mesh manufacturers around the world. Hernia mesh lawsuits are consolidating in multidistrict litigation.  

Many pelvic meshes have been quietly removed from the market.

Some resin is suspected to have been smuggled into the U.S. is low-grade and adulterated polypropylene resin from China.

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; a heart-lung patient; in a patient with diabetes; in a woman who exercises regularly; in a patient with a pacemaker; or into someone who can’t undergo anesthesia.

According to the FDA in a July 2011 Safety Communication, 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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