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MYTH BUSTERS- What Women Are Told Today About Pelvic Mesh

Pen drawing, Wellcome Trust, WikiCommons

Pen drawing, Wellcome Trust, WikiCommons

Mesh Medical Device News Desk,  June 30, 2016 ~ PART ONE, MYTH BUSTERS- What Women Are Told Today About Pelvic Mesh

This is part one of a multi-part series uncovering common myths related to pelvic mesh. Myth Busters Part Two can be found here while Myth Busters Part Three can be found here.  

One of the problems with pelvic mesh, and there are many, is that patients never receive true informed consent.  What would informed consent look like?

Your doctor may say, this mesh is made of polypropylene, a polymer plastic, we anchor deep into your body. It can’t come out. We have no idea which individuals will have complications which that may include pelvic and chronic pain, ongoing infections, dyspareunia or painful sex, nerve damage, a return of incontinence or prolapse.  We don’t know if you will be one that falls into the 30% complication rate.  You will likely need additional surgery or surgeries to correct the problems or to remove the mesh.

How does that sound?  Ready to schedule your appointment for surgery?  In case you need more convincing, just catch a YouTube video of the procedure. That is more than most people can take.

So what ARE doctors saying to patients?

We’ve heard many things from women newly implanted with pelvic mesh of them are untrue. So if you have been told you need surgery to treat stress urinary incontinence (SUI) or pelvic organ prolapse (POP) and mesh is the answer, let’s bust some of the myths circulating about the procedures.

pants on fire

Myth #1- Don’t Worry- Pelvic Mesh is a lot of Lawyer Hype 

To presume this is true would be to believe that more than 100,000 women in the U.S. have filed lawsuits because their lawyers are looking for a legal “payday” and the women are unwitting pawns in the scheme.  Really?  How disparaging of women and the legal profession.  Fact: The women have filed lawsuits because there is indisputable evidence that the mesh manufacturers – Boston Scientific, Johnson & Johnson, AMS, CR Bard and the others – knew in advance that their mesh would have problems and they did nothing to stop the fast-track train to marketing. They trained anyone and everyone with an MD after their name who was looking for a payday – a greater return on medical procedures.  At trials, doctors have admitted they were expecting a huge jump in income by using pelvic mesh implants that everyone else was using.  Even the FDA is on record saying that pelvic mesh complications are “not rare” so shame on those doctors who are blaming lawyers and women.

edited mesh poster leaving out kathyMyth #2That Mesh Has Been Recalled

The Fact: Few meshes have been recalled although a few have been quietly removed from the market for “business reasons,” according to the manufacturer.   The ProteGen sling, made by Boston Scientific, is an exception. Introduced in 1996, three years later, ProteGen was recalled because of “a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.”  In other words, defective.

But removal from the market does not mean forgotten. To market a new medical device one needs to name a predicate and ProteGen is the predicate for at least 60 other meshes that were marketed after it. Sort of like saying our car is similar to the exploding Pinto, but don’t worry! BTW- There is no mechanism within the FDA to review meshes based on a defective predicate.

In January 2012, after the FDA required manufactures to do postmarket surveillance studies, some mesh makers quietly removed theirs from the market.  Gynecare Prolift Kit and ProliftM+ by Ethicon (Johnson & Johnson) Gynecare Prosima and Gynecare TVT Secur. The Ethicon/Gynecare/Johnson & Johnson pelvic meshes quietly went away but were not formally recalled.

 

Myth #3- Pelvic mesh is FDA approved!FDA 202

This is scary and untrue. Fact: The FDA does not approve mesh based on safety or efficacy.  The FDA approves most medical devices for sale. Classified as Class II or moderate risk, the permanent implant is not required to undergo clinical trials (human testing) which would most likely have shown the complications such as mesh erosion, infection, mesh shrinkage, nerve entrapment, etc.  The FDA’s own 510(k) approval process allows manufacturers to take the “least burdensome” route to approval, regardless of the fact that the “burden” then rests on the poor patient who discoverers after the fact that their device was marketed based on assurances from the manufacturer who has the most to gain by its marketing.

Continue, PART TWO, PART THREE

8 Comments

  1. Kitty says:

    Thanks for refresher course Jane
    Lest we forget why we are so depressed with years of disability

  2. AP says:

    The product implanted in me was clearly labeled “Not for Use” per FDA regulations. The doctor who performed the Ethicon implant won’t even speak to me now. I am still in physical therapy over 2 years later, having back to back UTI’s and trying my best to walk without hurting. This is life as I know it now. God bless you Jane for you being an advocate for the hurting, hopeless victims.

    • Jane Akre says:

      For doctors to stop associating with their injured patients is beyond belief. Unfortunately it is the norm. The only doctor I’ve seen who stuck with his patient through thick and thin is Linda Gross’ doc from South Dakota….. he just stayed with her trying to get her help! I guess he really cared about his patient.

    • AP, Im so sorry for your pain and that you have been abandoned by your physician. Who is ordering your physical therapy? Is it pelvic floor therapy, or therapy to help you walk without pain? Seek out a referral to pelvic floor therapy if you are not receiving that. It could help. So, who is coordinating your care? There has to be someone who is looking at all the working parts and overseeing your medical interventions. This mesh related pelvic pain generates pain in many ways and each one has to be diagnosed and treated individually.

      UTIs are problemmatic for all of us. I have had many dozens of them since 2008. I never had one before the mesh The surgery can shorten your urethra, which leads to increased succeptibility to UTI. I am now taking D-Manosse, an OTC supplement that was recommended by my integrative health physician. It has truly been a wonderful miracle for me. You can order it online. It is a complex sugar that prevents bacteria from adhering to the bladder wall. Take one or two a day for maintenence and more if you feel that you are getting a UTI. This does not supplant antibiotic treatment, but I have been on the D-Manosse since January of this year, and have not had a UTI. which is a record for me. Just an important note, be sure you are getting a cathed urine sample for UTI diagnosis. Some physicians just prescribe them based on your description, when it could be that you are experiencing muscle pain. Pelvic pain can cause many types of bladder dysfunction. Bracing from the pain tenses up our muscles and the bladder and rectum. This can cause incomplete emptying of the bladder and that is when the bacteria have a chance to multiply, leading to UTI. Also, constipation can keep all the muscles tight , which can also impact your bladder function. Do what you can to have a bowel movement every day. I found that Natural Calm + Calcium plus Miralax plus Benefiber daily keep me going. There are so many things that we need to get working in order to manage our pain. Even small steps we take to improve bladder and digestive health can reduce our suffering, and that can change our day in a positive way. I hope you can move toward that hope of less painful days.

      • Jane Akre says:

        Thank you so much Still Standing…. You are very much appreciated!

      • AP says:

        Jane, in response to your concern regarding who/what direction was given after my former doctor wouldn’t speak to me after I complained to her about the problems/issues I was having following the mesh implant. Well, sad
        to say, I had to do the foot work myself with the help of my family doctor who has helped me out more than anyone. He directed me to all the doctors I am under the care of. To be noted; the OBGYN doctor that I was treated by is the doctor who told me that 97% percent of all women have underwent a UTI by the age of 65. She noted that I was a rare case in not having my first UTI until I was 76 years old. As said in my previous comment; now I have them back to back and my immune system has dropped because of it. Again, thank you for all you are doing in an attempt to help those of us who are scarred or sustained permanent nerve damage due to the Ethicon mesh. There is a reason for everything and I will state again; Ethicon, J & J will have their day to face and it won’t be a piece of cake.

      • AP says:

        I just realized that I did not answer your question as asked, I continue with this in hopes I don’t miss anything else. As you indicated, we all need and should help one another. The orthopedic surgeon that ordered my therapy specified both the pelvic floor therapy as well as therapy for walking without pain. My family doctor who I have been going to since 1987 is coordinating my care. Further the following specialists are overseeing my progress. I am seen and given a report from the Neurology, Orthopedic, Gynecologist,allergest, opthamologist, dermatologist, cardiologist and an ENT specialist. as stated in a previous desk comment; compared t the way I used to be this is my life as I know it now. The UTI’s and walking on my right leg are on the top of the list. I have other issues which I deem minor, that said, it comes down to the fact I am seeing a doctor about 3 days every week. Sorry I missed all this in the first comment. TP

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