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Some Thoughts on Mesh: Product Design & Development

Matt Hermes PhD

Matt Hermes PhD

~March 1, 2013

I helped Adam Slater as an expert with what became Gross v Ethicon from early in 2009. My job was to help Mr. Slater make sure Ethicon had produced all its relevant documents. I have the qualifications to do that because I am a veteran researcher and have run product development for other medical device companies, not Ethicon. I’m not going to write about those documents, or Ethicon. I can’t. You perhaps read some of their production through the Gross v Ethicon trial and have your own opinions.

I have two points to make about product design and development:

First, responsible inquiry is a zero-based effort. It is unfailingly shortsighted to base today’s product solely on the last one. For implant devices, at the least, consideration of the biocompatibility of ALL materials in ALL potential end uses gives the researcher clues as to where he/she can’t go in their work.

I remember in 1992 my group was considering a particular material as a surgical suture candidate. But one of my scientists found an obscure reference that plates made of this material inserted under the eye to repair bone had swollen over the years and needed to be removed. I stopped the project. Another major device company soon introduced a suture like the one I avoided. That product was removed from the market after many instances of long-term foreign body reactions were reported.

Let’s think about meshes.

What is the true surgeon’s nightmare? It’s leaving a gauze pad behind after surgery, wouldn’t you say?

Gauzes are open weave cotton meshes; they remind you of, well, polypropylene implants.  A left behind sponge is often benign. But maybe 25% of the time it results in a persistent shrinkage and walling off into a troublesome massive foreign body. Sound familiar?

When I think of all the materials from which implant meshes have been made; polypropylene, polyester, Teflon®, polylactide, all seem to have triggered serious complications in patients. No one and I mean no one has shown that any of these synthetics would be expected to act any differently than that nightmare cotton gauze. Designers fail to do their job, in my opinion, if they give short shrift to the entire history of implants before bringing the next one forward.

Actually hernia meshes result in fewer adverse effects than the transvaginal mesh products that have generated more than 15,000 product liability plaintiffs. Why? Have designers really ignored the mechanics of a relatively unrestrained vaginal mesh as it flexes, distorts and undergoes the shrinkage forced of fibrous capsule formation resulting in mesh movement, nerve capture, erosion and pain?

I suspect that flexible implants are a separate class of biomaterial, behaving relatively independent of composition and require much more intense design efforts attended to by scientists of many disciplines.

My second point is we scientists fail to heed the powerful voices of the affected. Listen as Hope Pagano says, “We need a patch test so that we can detect an individual’s allergic response to mesh.” Nonie Wideman writes that we should test for an individual’s susceptibility to excessive response to polypropylene. Smack on, ladies.

This is individualized medicine, focused on preventing harm. It’s not obvious how one would carry out these studies but I know this: If one of these women was my boss at a device company and gave me this order I sure would figure out how to get it done!

Matthew E Hermes

hermes@clemson.edu

March 1, 2013

Dr. Hermes has a PhD in Chemistry from the University of Maryland 1959. He worked as a research scientist at DuPont (20 years), Celanese (4 years) and US Surgical, now Covidien (13 years), where he developed and introduced synthetic implant devices such as sutures, clips and staples. Dr. Hermes was the inventor and holds 32 US Patents. For the past decade he has worked as a consultant and expert in devices particularly intellectual property and products liability on absorbable and non absorbable fibers, films, meshes and devices.

He has a Masters in Literature from Wesleyan U. (Middletown, CT), and authored “Enough for One Lifetime”, biography of DuPont’s inventor of nylon, Wallace Carothers whose suicide at 41 ended an extraordinary creative career of scientific genius. He lives near Greenville, SC, and is a Research Associate Professor, Bioengineering at Clemson University.

20 Comments

  1. Kathleen says:

    I have a question about granulomas. I noticed in one of the reports it stated that there were 77 of 683 who had complications from mesh who had late onset complications. Is there anyway to stop the granulomas from forming? Thank you for your work supporting the plaintiffs and for your article.

    • Matt Hermes says:

      Kathleen, I am not sure I can do much with your question. Ms Akre has been kind to publish my research thoughts as a seasoned scientist based on my PhD and (long) experience. But I am not a physician so anything I might say is based on my reading of the literature.

      Granuloma is an imprecise term and I suggest the authors of the “683 patients” studies struggled to characterize what they came to see as far too many adverse effects in their initial work, most of it in France. There was a team of docs there, about nine of them who attempted to find a better way to deal with vaginal prolapse. Were all their patients informed as to the risks? I do not know. Did they report their results adequately? I think so. Were they satisfied with the results? I know at least one of the leaders of this team (Dr Cosson) was not and found the level of granulomas and other surgical complications unacceptable though that opinion does not shine through in the paper. You can read the paper you referred to at http://onlinelibrary.wiley.com/doi/10.1111/j.1447-0756.2008.00820.x/pdf

      There have been a number of approaches in the literature suggesting changes in mesh structure to reduce persistent granulomas but, in my opinion, the critical need is for presurgical identification of those individuals who are likely to have allergic or persistent inflammatory reactions to the mesh implants. So it is my opinion developers have not been able to prevent granuloma formation.

  2. tvtinfo says:

    Thank you for your very interesting article, Dr Hermes.

    How true that scientists need to heed the powerful voices of the affected. If only they and government regulators in the UK would think like that. They seem to focus so narrowly on the published papers and ‘success rates’ rather than the harmful effects that women have been reporting for some time now.

    Regarding the testing of women for their individual responses – as you point out, this would present a challenge but, as we all know, where there is a will there is a way. I’m with Hope and Nonie. It’s just common sense that we should be tested for an adverse reaction to any material that is being considered as a permanenet implant in our bodies! You can be tested for nickel and other allergies, so why not plastic?

    tvtinfo

  3. Kathy says:

    Please continue to speak out against mesh. The women that are in constant pain and agony is a crime.

    Do you have an opinion on if the anchors cause even more pain? Thank you so much .

  4. cathy williams says:

    dr. hermes,

    i have had pain from mesh. it was put in in the year 2007. i have had continuous bladder infections and every time i have a urine specimen done, there is always a foreign body present. i have had a bloody infection once. my question to you is this: i now have a recurrence of melanoma cancer on the inside of my body (groin) and i was wanting to know if you think the mesh could have triggered my cancer?

    thank you,

    cathy

    • Matt Hermes says:

      Thank you for your response.

      I am sorry to read of your continuing illness. I am not a physician, just a materials scientist with a lot of years since my PhD. So I am afraid it would be wrong for me to make any comment relating to your medical history or melanoma and mesh. I get to read the literature and interpret what the MDs say and report, and I do not recall reading of any such relationship. I encourage you to become your own expert. I urge you to tackle the literature on your own (scholar.google.com) as so many of your friends who write on this and other websites do.

  5. MaryW says:

    Dr. Hermes,

    Thank you for having the courage and decency to speak the truth about mesh.

    Are there diagnostic tests that can determine what the implanted mesh is doing in regards to inflammation and autoimmune response? Are there treatments for both problems? If yes, what?

    Next question: What can you or others do to educate the AMA and doctors on a global scale so that they will understand mesh related health problems and learn how to treat them? There are countless heartbreaking posts on the internet by women who are either dismissed by their doctors, abused by their doctors or refused treatment by their doctors. It is shocking to see all of the posts from women who have been advised to take anti-depressants for their pain. WHY, oh WHY, don’t doctors want to realize that the mesh causes problems? I’m sure there are thousands of women (and their friends and family members) who would like to know the answer to that question.

    Mesh removal can cause lymphedema. Lymphedema is a permanent problem. It is disfiguring and painful. Please add that to your list of problems that mesh causes.

    • Matt Hermes says:

      Thank you for your comments.

      From my material science viewpoint – I am not an MD – I see nothing in the literature that can yet identify individuals who will have extreme inflammatory or autoimmune response. My associates at Clemson and Kiyatec have sought funding from NIH (rejected on the first go-round) and from one major device manufacturer to identify biomarkers in individuals that would warn away from implants for some people. We have been working on this for a year and are in agreement with the testing ideas that Ms Pagano and Ms Wideman have written about on these pages. But I can warn that no tests protocol development, even if well funded, will come quickly because of the need to correlate high response to these biomarkers with clinical response.

      I encourage women to camp out at the door of the NIH Office of Research on Womens’ Health for recognition of the problems of identifying those at risk and for how to manage revision and recovery.

      • Cindy Madrid says:

        Hello. I am researching hernia repair before i submit to mesh implantation. I think I am allergic to polypropylene. I have had a previous miserable and violent reaction to polypropylene monofilament sutures. They basically necrotized my flesh around the sutures and caused tremendous pain, inflammation and itching. They were used to close 2mm core sample wounds in a laser hair removal experiment. The holes left in my legs are on the order of 12mm 20 years later. Reaction to the sutures were immediate. I feel that an internal mesh of the same material will impart a short mean disabled life upon me.

  6. Joyce says:

    I am confused by what is best to do. I am trying to find a Doctor who understands about the problems caused by this pelvic mesh and can help me know and understand what is the best way to proceed. I have been told both, First: Leave the mesh in and just remove the areas which erode as they erode, Second: remove as much of the mesh now as possible to help control the infections, bleeding, discharge and erosion’s. Who is right?

    The problems this mesh has caused, has changed my life greatly, but at the same time from what I have been told, removing it could more than likely make things worse. It would appear that we women are/ or could be in a position of doing more harm to ourselves. Is there any answer to all this pain?

    Thank you

    • Kathy says:

      Joyce,

      I pray someday that someone will lead ALL of us in the right direction instead of us walking around for years trying to get help. The stress of it all is too much. We need medical help, now. We need to get help with our pain, our fear and our complete lack of faith in doctors to lead us to health. What other health issue have humans ever had to find their own help with such a large group of people in pain. It is insane.

  7. Dawn says:

    I hope your research on polypropylene can finally be heard. I feel my body has been destroyed by this mesh. I was 47 when implanted , 3 years later I feel like I am 90 years old. I have torn tendons in both shoulders and yet I never did anything to injure them:(. How do I prove polypropylene caused this damage? Is there a blood test? My hair is falling out, my vision is blurry, I can’t lose weight, I gained 25 lbs and yet never changed how I was eating over the last 20 years… Please fight on our behalf !!! How can so many of us have the same symptoms from all over the world? This mesh has destroyed our lives and all for greed .. Thank you

    • Lana Keeton says:

      Dear Dawn,

      I agree from my research your symptoms are all polypropylene related with one exception. The torn tendons in your shoulders are probably from Cipro, Levaquin or one of the fluoroquinolone class of antibiotics you probably have been taking for the persistent infections from the mesh. Which in reality makes the polypropylene responsible.

      Look up the complications of these antibiotics and you will find torn tendons is one of them. I took only 5 total of the Cipro over 3 days and got excruciating pain under my right shoulder blade that pain meds would not touch. It took about 5 days for the pain to subside. I will never take one of those again for any reason.

      I also know several other women who have torn tendons from these kinds of antibiotics.

      Sorry you are suffering so. Hope you are able to find some relief.

      Best, Lana

  8. Teresa says:

    To the doctors point.. “scientists fail to heed the powerful voices of the affected.” .Watching Hope Pagano advancing with her research is mind boggling! I learn from her daily of what the poisons of not only Nonylphenol is doing to us but the mixture of other chemicals involved. The mesh device makers has made the “perfect storm” with in our bodies. Almost as if there is a culling of women! The team efforts of Noni and Hope is the perfect storm to get the reality of the poisonings heard! These are two women are powerhouses and deeply respected and appreciated!

  9. Jane Akre says:

    Dr. Hermes ~ Apparently your words have meaning for many. How is it that an untested product is put in women’s pelvic regions after its been chemically treated and is itself a petroleum-based product? Thank you for speaking up. May others follow…

  10. Matt Hermes says:

    Jane – Thank you for your kind words.

    In the US the system for getting FDA approval to market “Class II” devices like meshes is broken.

    The Institute of Medicine, an arm of the National Academy of Sciences, reported in late 2011 that the existing “510k” regulatory process, does not provide assurances of safety and efficacy for the broad range of products including mesh. Device developers need only claim their new product is “substantially equivalent” to a previously approved device; a cascade of approvals has resulted, one upon another back to the date of the 1976 initiation of the regulations.

    Additionally, though testing standards have been developed for many types of devices, including meshes, they do not require clinical studies, and the test method themselves become quickly out of date as new products appear. Thoughtful scientists recognize, “You cannot develop a new product with an old test,” yet I do not believe special testing solely for a pelvic mesh was mandated.

    So US mesh products, treated or modified, go through an approval scheme that is rigorous for what it examines but is so limited that it can narrow the vision of the corporate researchers since the goal would appear to be 510k marketing approval with no required broad-based consideration of all the parameters of safety and efficacy. Further the decision to seek FDA approval for a new product rests with the developer and as Gross v Ethicon demonstrated, Ethicon for one decided that their Prolift did not require new FDA approval.

    And just a note, linking this issue to “petroleum-based products” is a red herring in my book. The material stands for itself; its origin is completely irrelevant. If terms like “petroleum-based” or “synthetic” become culturally perjorative they hinder the communication of science across that narrow gap between the scientists among us and those seeking to learn and contribute. And as you know I am all for that contribution!

  11. a nurse says:

    Dear Dr Hermes, My transvaginal mesh was put in 2006 and I always wondered if it could be the cause of the start of my horrible itchy rashes, new onset thyroid problems (hyper), boil-like ulcerations on my legs and pelvis, infected leg hair follicles, dilated blood vessels, fluctuating BP (90/60-145/104), generalized swelling, severe fatigue, widespread flu-like symptoms with overall muscular pain (as well as pelvic and urinary pain with mesh erosion), frequent nausea and vomiting, and headaches- all either started or severely exacerbated after the mesh was put in, worsened after it was removed, and then some of these symptoms have gradually improved over the many years since then. In 2008 or 2009 I asked my allergist/immunologist from a major university if a sensitivity to the mesh could be the cause of these symptoms. His answer was: But MESH IS SUPPOSED TO BE INERT! Many doctors think that and I just don’t understand how they do with all of the biology, microbiology, chemistry, and physics classes they probably had to take to get into med school. I then asked this doctor about sensitivity testing to mesh and he said that even a “negative” skin test would not mean that a person wouldn’t react to it internally. (Then, logically imo, how can mesh be inert?). I think when it comes to surgical mesh that “confirmation bias”, which is when a group of (usually smart) people believe findings that support what they want to see even if they actually don’t, plays a role in this happening. Dr Hermes, how do we make these “smart” doctors see and pay attention what is so (literally) painfully obvious to those who have been harmed by mesh? Thank you SO much for bringing more attention to this very serious complication of mesh.

    • Matt Hermes says:

      Thank you for your note. Your narrative of symptoms parallels so many others and I hope your improvements continue.

      Attitudes in the medical and business community change under the pressure of advocacy. The many women who have been consistent and vocal with their demands for attention do a great service. But from the medical and the science side there are few “champions”. I find a scarcity of well known leaders from the physicians organizations, from the Office of Research on Women’s Health at NIH or from the academia who are knowledgable, outspoken AND have the resources to do the research necessary to provide safe and efficacious surgical solutions.

      One story: Recall now, I am a materials scientist, not a physician. NIH recently rejected funding for research I proposed through Clemson (working with four well known and committed surgeons in the Greenville Hospital System in Greenville, SC) to try to identify those women at risk for complications from mesh implant by performing apriori blood tests. This is a speculative proposal, it might not work but we had a long list of physicians and scientists who encouraged funding.

      Among the reasons for rejection were that none of us had experience in this exact area and we had not published on this topic previously. And the underlying subtext was, we don’t know who you are. Well they are correct on the above points, I am an under the radar kind of scientist and my 32 patents are not in this field and my concepts as to how to identify those at risk will be my next patent. And of course no one has published on this. It is new.

      But this points out that there is no well known, leading scientist or group of researchers who have bitten into this challenge. There is an opportunity here for the right really smart (woman) scientist making her way through the academic ladder to make a real name for herself by saying I will be the champion, I will join to solve this problem.

      • Kathy says:

        In the meantime we are really in a daily struggle to survive. With out science behind me I feel I have been getting more symptoms fro the mesh the longer it is in my body, mine was implanted into me in 2007. since then, Menopause came and in the last few years I have had more misery from the mesh and fear that aging on the inside has caused the mesh to move and it really is painful.

        There are so many health issues with mesh falling through the cracks that it is barbaric. Let us start with the fact that when the FDA warning came out in 2008 why wouldn’t the Urologist that put this mesh into my body think that maybe it would have been a good. Idea to call and check on my health ? Why did my family doc or OBGYN not check to make sure I was ok ? The sweeping under the rug should be enough to scare everyone.

        I think the entire mesh story from the FDA, to the mesh kit being sold by a rep that keep them in their car ( creepy) to now the lack of anyone ( except Dr. Raz and Rodriquez ) helping us a crime. A crime by many, many people.

        I know the lawsuits do not blame the doctors but I blame the lack of direction on them and I do not understand how they can still be putting slings into women to this day.

  12. Matt Hermes says:

    GHDB – Have you heard of it? I just learned of it today.

    The Gynecological Health and Disease Branch is a newly established research section within the NICHD* at NIH**. Dr. Trent Mackay (301-435-6988) says it began operation in November 2012 and is trying to find its way in face of tight budgets and hiring freezes. Dr. Susan Meikle, (pronounced mee’kle) an OB/GYN is the Program Director of the Pelvic Floor Disorders Project (301-273-8541). Those of you wishing to identify a “champion” who might accelerate research on the effects and understanding of mesh might want to give Dr. Miekle a call and help add urgency to her mission.

    * NICHD – National Institute of Child Health and Human Development

    ** National Institutes of Health

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