AUGS Stands by its use of Polypropylene Mesh Implants

//AUGS Stands by its use of Polypropylene Mesh Implants

AUGS Stands by its use of Polypropylene Mesh Implants

Mesh Medical Device News Desk (MND), October 22, 2018 ~ AUGS, the American Urogynecologic Society concluded its annual members meeting this month. 

Women injured by polypropylene (PP) mesh implants, which the society promotes, met with some leadership of AUGS.  See MND story here. 

Still AUGS stands by its promotion of PP mesh.   

MND checked in to see if the current thinking of AUGS regarding the use of polypropylene transvaginal mesh medical devices has evolved over the years since more reports of injury are reaching the mainstream medicine and there are approximately 150,000 defective lawsuits facing the mesh manufacturers in the U.S. alone.

This is a 4 minute read but important information to know for anyone who has a discussion about a mesh implant with her doctor.

MND has a request in to do a Q and A with the current president of AUGS. He prefers your editor send in written questions which is underway.

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MND Q: What is the current thinking by AUGS membership on the use of SUI (stress urinary incontinence) and POP (pelvic organ prolapse) mesh?

CONTEXT:   Since 2012, mesh injuries in the U.S. consolidated into more than 104,000 product liability cases filed in one federal court including injuries ranging from mesh-in-place, to life-altering severe complications, to death.  Increasingly, experts at trial are blaming polypropylene as an unstable product in the body which shrinks, leads to scar plate formation that encases nerves and hosts antibiotic resistant infections. Chronic pain and infection result with little remedy other than medication.

POP mesh, generally larger to cover the pelvic floor and support sagging organs, has been reclassified as highest risk by the FDA, Class III but manufacturers were given 30 months to remove it from the market OR prove safety and efficacy via clinical trials. AUGS indicates it is still being used, which will merit further questions.

Some doctors have changed their association with mesh. For example, former mesh user, Dr. Shlomo Raz (here) of UCLA, has reversed his thinking and now will not use PP mesh because he is seeing complications a decade later.

The SUI / AUGS Position Statements:

  • https://www.augs.org/assets/1/6/AUGS-SUFU_MUS_Position_Statement.pdf
    AUGS and SUFU Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction  support the use of the midurethral sling to treat incontinence, stress urinary incontinence specifically which is urine leakage associated with coughing, laughing or sneezing.  Blaming lawyers and the media the joint statement says, “We are concerned that the multimedia attention has resulted in confusion, fear, and an unbalanced negative perception regarding the midurethral sling as a treatment for SUI.”  it goes on to say that perception is not shared by the international medical community or women who are satisfied with their midurethral slings.
  • https://www.augs.org/assets/1/6/Provider_FAQs_MUS_for_posting.pdf
    This paper answers common questions asked about slings and polypropylene including safety and polypropylene, cancer and recalls.
  • https://www.augs.org/assets/1/6/Patient_FAQs_MUS_for_posting.pdf
    These are talking points a doctor might answer to his patients. Includes responding to the FDA that complications are “not rare,”  about autoimmune disease, about incidents of cancer, assuring readers polypropylene is safe and effective.


The POP/ AUGS  Position Statements:

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MND Q: As thinking evolves, are there any directives on who should or who should not place transvaginal mesh?

In the OR, Source: The Doctors

CONTEXT:  Discovery from trial has shown that Johnson & Johnson, for example, trained a doctors with a range of skills, not all up to the task of learning this blind procedure and assuring patient safety.

J&J discovery has shown that lower tier doctors were not learning as fast as top tier doctors (here). Often doctors blame mesh injuries on less experienced surgeons. The fact is that weekend cadaver clinics have, in some cases, sufficed for clinical surgical training.

AUGS feels that mesh should be placed by providers who:

  • Undergo specialized training in the procedures involved
  • Discuss and/or offer a non-mesh procedure, in addition to the mesh procedure
  • Provide sufficient information about risks and benefits to guide a patient through the informed consent process, helping a patient make her own decision about final treatment plans

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MND Q: Is mesh still recommended as a first line treatment, or is there any backing away from that?

CONTEXT: Many women who MND has interviewed wish they had had received true informed consent so that they would have known the full range of possible outcomes and complications from their mesh implant.

See MND ,What you should ask your surgeon (here).

Alternative surgeries are available and always have been including a Burch procedure (sutures) or using one’s own ligaments to fashion a sling, as an alternative to a polypropylene implant. Many readers state they wish they had known enough to ask for those alternatives first.

AUGS says, “First line treatment should always consist of nonsurgical approaches, including behavioral and physical therapy.  For patients who do not find relief from nonsurgical options, there are multiple surgical options.

“AUGS continues to feel that women are better served when their preferences and values are honored through a range of treatment options for SUI and POP, including the option for transvaginally placed polypropylene mesh when appropriate.”

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MND Q: What are members using for pelvic floor repair now that POP mesh cannot be marketed?

CONTEXT:  When the U.S. Food and Drug Administration reclassified the larger polypropylene mesh used for pelvic organ prolapse into Class III, highest risk, it gave industry 30 months to remove it from the market OR show it is safe and effective through clinical trials.  POP mesh otherwise must go through a higher level of FDA scrutiny, specifically premarket approval (PMA) before it can be sold.

See MND story here.

AUGS says,  “This is not the case in the U.S.”

This answer does not completely put into context the fact that POP mesh is supposed to have undergone a PMA or clinical trials before it is marketed, therefore leaving few choices for POP mesh still one the market   MND will follow up.

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MND Q: What lessons have we learned from the use of transvaginal mesh?

CONTEXT:  Since mesh implants and corresponding problems have been noted, at least anecdotally, since the late 90’s. MND wonders what, if anything, is the take away lesson.

AUGS answers, “Medicine in general is always seeking to improve itself, as the status quo is often suboptimal.  New technologies often provide answers to some questions, while bringing up new ones.

“Understanding the details of the relative benefits and risks for the individual patient in front of you is the goal of the physician; it is unlikely that new technologies are the right answer for every patient, but it is also the case that having an array of options to learn about and choose from is an advantage for every patient. The key is to have a clear understanding of the benefits and potential risks of new technologies before they are marketed, and that is the role of research.

“As the leader in Female Pelvic Floor Medicine and Reconstructive Surgery, AUGS strives to provide a culture of practice where new technologies can be introduced, evaluated, and deployed, and continuously re-evaluated, in an evidence-based and systematic manner.”

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MND Q: What is current science teaching us about foreign body reaction and autoimmune reaction associated with a permanent polypropylene mesh placement?

Macrophages at work, Stonybrook Medical

CONTEXT:  There is no doubt that, anecdotally, the incidents of chronic infection is observed in the mesh injured population. Without following up and studying these complications, there is no way to understand whether the polypropylene is a host or biofilms, infection, or foreign body reaction is causing the body to go on high alert sparking autoimmune reaction.

AUGS says, “There is good population-based science that there is no association between polypropylene mesh pelvic implantation and development of cancer.  There is also good science that shows some features of implants (density, pore size, architecture) may reduce undesired reactions in vivo.  There is no compelling data suggesting that there is a statistically realistic relationship between mesh implantation and systemic autoimmune responses.

Relevant Research includes:

By | 2018-11-01T13:47:49+00:00 October 22nd, 2018|News|29 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

29 Comments

  1. Advocate October 22, 2018 at 1:03 pm - Reply

    There are only two things that can end the use of Polypropylene in a mesh implant. Either the FDA takes it away from the market place, not likely, or women and men (hernia mesh) stop accepting the implants.

    • Anonymous October 30, 2018 at 5:40 am - Reply

      Have one implanted, still pee my pants. They do not do what they are implanted for. Nobody talks about this.

  2. Lorna October 22, 2018 at 3:33 pm - Reply

    I have been injured by mesh. Even after scraping it out of my bones during removal, I am left with permanent damage. I now have an autoimmune disorder. I would do an6thing to regain my premesh health. Now the US government has decided to crack down on pain and sleeping meds, I look forward to dying! Appears that’s the only way to get beyond what has been done to me.

  3. V October 22, 2018 at 6:02 pm - Reply

    An endorsement from the world’s most skilled Urogynecologist couldn’t convince a well informed consenting patient that mesh is safe. The product is defective/deadly. The more skilled surgeons (somewhat) assures a better implant…not the product. The genuine surgeons that really care about the health and welfare of their patients do not to use mesh.

  4. Still Standing October 23, 2018 at 12:09 am - Reply

    Lorna, my heart breaks for your pain.. It is just such a tragic trail of suffering for all of us. I want you to know that you deserve to have your pain and sleep issues addressed. That doesn’t mean that you have the right to have the prescriptions you want, but your doctor has an ethical responsibility to address your pain and your sleep and come up with a therapy or combination of therapies that work. Lack of sleep is directly related to more pain in study after study. You need to go to your doctor and ask for a patient-centered plan of care that addresses your pain+sleep problems with you as an active participant. Be open to different ways to reduce your pain. This may seem counterintuitive, but walking every day, even short distances can release natural endorphins in the brain that reduce pain. Mindful abdominal breathing is also beneficial. When we hurt, we brace our muscles. They become shorter and then more painful and a vicious cycle ensues. Just lying on the floor or even the bed with your arms stretched out helps open up the diaphragm and those pelvic muscles. I try to do this for 30 minutes every day. Figure out if these or other things you do to reduce your pain. I have had to come to terms with the fact that I will always have pain. I have told my doctors I can live with a level 6 pain, but anything above that limits my quality of life. Have this conversation with your doctor, telling him or her what steps you are actively taking and ask for help to get where you need to be. Insist on it. I haven’t used narcotics for pain management except right after surgery. I have found that gabapentin works well in combination with muscle relaxers and sometimes amitriptyline. I also have a prescription for sleep medication. These things keep me functioning. I was helped a lot with pelvic floor therapy at different times. I have been at Mayo since August and had a ten hour surgery on September 20th that took my vagina,part of my colon, my rectum and my anus, all because of the posterior and anterior mesh implant I had in 2008 for prolapse. The mesh had cemented around my rectum and colon and was eroded into it. The same with my vagina. My doctor told me it was one of the top 5 most tragic cases she had ever worked on. I have a permanent colostomy. My life has drastically changed and I cant ever go back to the old me. It is an emotional struggle every day. But, I will go home the middle of November and will be able to wrap my arms around my two granddaughters and be thankful for that . It will be enough to make all of this worth it. There was a period of time this summer that I wanted to die. Im so glad my attempt did not succeed.

    That said, coming from my 10 year battle with mesh, I don’t think returning to your pre-mesh health is realistic. We all get stuck thinking about that time. However, at some point, we have to move from what happened to thinking what happens now. This is more a change in how we think, the things we say to ourself, and setting up realistic expectations for friends and family. We wear ourselves out trying to ‘be strong” and pretending we are ok so our family doesn’t know how bad things are. I was the number 1great pretender for almost 10 years. My silent pretending, however, really didn’t help at all because there was not honest communication between us which increased stress and dysfunction.

    This time, I had to have a very honest talk with my son and daughter, both in their 40s. It was hard to say the words vagina, rectum, anus to them, but I had to let them know everything that was going to happen. My husband as well. I was surprised by how they responded and showed up for me physically and emotionally during this time. My daughter helped the nurse change my colostomy wafer and bag. This would have never happened before. I had to become as vulnerable as I have ever been and because of this, I felt as supported as I have ever been during 9 mesh surgeries.

    So, dear woman, do what you must to reduce your suffering. Sometimes we CAN change how we experience pain even though we still have pain. You deserve to have this happen. Bring together everything you can to get there.

  5. Wren October 23, 2018 at 4:51 pm - Reply

    To Still Standing. You are my hero. I have next to nothing in comparison to what you have endured. Thank you for sharing your painful details and still spreading hope and strength to those around you. I pray for a great recovery for you and that your family will continue supporting all the mountains you will continue to climb. Keep being strong

  6. Still Standing October 23, 2018 at 11:06 pm - Reply

    Wren, thank you for your kind words. I’m no hero, though. I have certainly had my less than days. What I have done is more from desperation than heroic attributes. Here is what I want you to take away. Your pain is your pain. Dont try to measure what you are experiencing in the context of comparing what you are dealing with to someone you think has it worse. Your experience has a profound impact on your life. Honor yourself by acknowledging that. Then figure out how to balance things out. It can take effort to do that, but you are worth it. One of my dear college friends says none of us get out of here alive. We all face deeply physically and emotionally painful challenges as we go through this world. We also experience great joy and powerful moments. These are uniquely personal. My hope is that you can put up more days of joy than days of pain as you nevigate through your own mesh story. My prayers are with you. I truly believe it is possible.

  7. David October 25, 2018 at 9:09 am - Reply

    When a surgeon indiscriminately abuses surgical mesh they are guilty of committing medical malpractice.

    I would challenge any surgeon indiscriminately abuse mesh, who believes they are not guilty of medical malpractice, to debate me openly, in this forum, that their conduct is acceptable.

    • Jane Akre October 25, 2018 at 12:49 pm - Reply

      David, I welcome your submissions, essays on hernia mesh injuries. I know you have lived it! I’m sorry.

      • David October 25, 2018 at 6:44 pm - Reply

        Thank you Jane.

  8. Still Standing October 25, 2018 at 11:56 pm - Reply

    Dave, Im no friend of mesh because it has done such destructive damage to me, but I also know that surgical mesh has been a life saver for many people who have big hernias, women who feel that they got their life back after having prolapse and bladder mesh surgery. Important variables that have not been determined and need more research should look for factors that may predispose certain individuals to have severe reactions to the mesh. Do genetics play a role? Do environmental factors such a smoking status, other medical conditions, physical,fitness levels , etc have a role in mesh failure. Many studies have found that surgeon skill and experience does have an impact but that is true in any surgery. Are there pre and post operative patient care issues that need to be addressed? Of course, just in the last decade, the composition of the mesh, the pore sizes, and other polypropylene mesh properties have been studied. If polypropylene mesh does remain on the market, there has to be a validated screening tool to help patients and physicians make a determination of potential adverse events based on the unique attributes of the individual. Without a minimum of that decision making tool, patients are engaged in a crap shoot with their own health and life on the line. Until those at risk are screened out, no one should be offered the polypropylene mesh option. Until then, the lucky ones will have dodged a bullet, and the unlucky ones, well, here we are.

    • David October 27, 2018 at 12:28 am - Reply

      Still Standing, thank you for responding to my post. I welcome the dialogue. Would you agree that every patient would want the least risky device responsibly used?

  9. Still Standing October 30, 2018 at 5:16 pm - Reply

    Well, I cant speakf for every patient but some where along the line, that needs to be a physician-patient conversation. That is an important discuusion. Sometmes the least risky device also has greater failure rate and requires additional surgeries. For example, in pelvic repaiirs, autologous grafts harvested from he womans fascia is less risky in terms of compatibility of the tissue, but there are risks involved with that these grafts. There is a much higher recurance of incontinence and of increased pain, of hernia formation at the harvesting site, increased operative time. Also , the womans skin integrity also needs to be considered. For older women, skin has lost elasticity and is less hydrated, making the use off their tissue less than ideal. They would run the risk of needing a reopertion in 5-10 years. That becomes more dangerou as we age. Other considerattions have to factor in as well. Smokng status, other cormorbid diseases such as diabetes, cardiac,and pulmonary disease, lifestyle habits such as nutrition, exercise, and weight have an enormous role in surgical outcomes. If quite a few of these conditions are present it raises the stakes.

    Allografts from human cadavers are another possibility, but there are risks there, too with a risk of disease transmission. Also, they are in limited supply and are expensive, so of course, insurance isnt keen to pay for these as a first option.

    A lot more could and should be said about this topic. I am still Mayo but hope to be given the ok to head home mid-November. Some friends came out and there were six of us having a conversation about mesh. Two women in 60s, four 72-78. Every single one of them has had mesh bladder sling placement. Not one regretted having it except me and that was a posterior and anterior prolpse repair. So, what a conundrum. I cant say that they should be denied this surgery if they feel that the benefits outweigh the risks. I certainly would not and I tell every woman I meet to not have mesh. Every single Mayo staff heard my story and words of caution.

    So, back to your question. I think it depends on the person and what they value. I was given two options for this past surgery. One was aa less risky surgery up front, but there would be several more surgeries in store over the next two years. The other one was more brutal with higher surgical risks.i was fully informed by all three surgeons who sat down with me at one time. They did not try to talk me out of it. Initially, I chose the first option, but as I carefully researched both, I began to change my mind. When I went in to have my stoma sites marked, the nurse said my surgeon wanted me marked in several places because they were uncertain what they would find. When I met with the surgeons two days before my surgery, I told them I had changed my mind and would go for what was behind door number 2. My surgeons told me I had made a wise and mature decision. They asked me what precipitated my decision change. I explained what I found scientifically and on websites like WebMd, Mayo Clinic and other trusted medical information websites. My surgery was over 10 hours, I needed blood transfusions and had an ICU stay and an emergency room admission a week after discharge. Recovery has been difficult. But, i dont regret doing it at all. I lost body parts and now have a colostomy, but the worst part is over. The thought of having numerous additional surgeries and recoveries ahead makes me shudder. I didnt want to go through that and more importantly I didnt want my family to have to endure it, either. When I laid it all out, the risk was worth it. No one could make that call except me. That is why I think patients have a responsibility to ask an abundance of questions and the medical community has a responsibility to provide detailed and accurate information. In the end, we dont have a magic ball to see into the future. We just have to go with what we have on one given day. I think that is what has been so egregious about the mesh. There were risks emerging but no one was interested in explaining them to patients. They were blown off as just rare events. Janes story about the payout to the man who invented the mesh to produce good outcomes was chilling. Sorry the man is dead, he should have been tried as any common criminal along with J&J and left to,rot beneath all the excised mesh pieces removed from our bodies.

    Sometimes we spend more time deciding what car to buy, or even what to have for dinner than we do really becoming involved in the medical decisions that are made about us. It is time that buyer beware becomes part of the patient experience and we make fully informed decisions. This includes second and third opinions if needed.

    • David October 31, 2018 at 2:36 pm - Reply

      Still Standing, I am very sorry to hear about what you have and continue to go through. Although our lives will never be the same, I truly believe, together we can all make a difference for those future patients targeted for exploitation by the global medical device industry. You want to bring this industry to its knees, interrupt its ability to preyed upon patients. So obvious is the path to this end, but so difficult it will be. Fighting these lawsuits is just of cost of doing business for them and is not really getting this issue anywhere. Property framed, there is an arena that this issue MUST be drawn into.

      What responsible use of any long-term, permanently implantable medical device means to me is to take a historical account of the efficacy from non-device surgical (and non-surgical) treatments for a condition. And, which safety and effectiveness comes as a benefit to patients, without unwarranted, highten device risks.

      A surgeon’s responsible use of any implantable medical device first recognizes the following: “the primary purpose of a classification for any disease is to stratify for severity so that reasonable comparisons can be made between various treatment strategies.” (Fitzgibbons RF Jr.) For example, if a patient had stage 1 cancer and he/she was subjected to the unwarranted risk of a stage 4 treatment regime, did the surgeon act in their patient’s best interest? On the opposite side of the spectrum, what if that patient had stage 4 cancer and the surgeon approached it with a stage 1 treatment regime and the patient died, did the surgeon act in their patient’s best interest? Industry and their leading physician commingled social propagation of the standard of the care insulates the “surgeon foot soldier,” acting out in clinical practice, from State recognized legal accountability to reoffended.

      What happened to the efficacy of device predecessor native tissue repairs? The sad reality today is that the severity of a patient’s condition no longer matters. A patient’s choice is no treatment or the industry inflicted “treatment” of indiscriminate device abuse. Is it a progressive society that allows the physician and manufacturer social mob to restricts medicine, with intent to exploit an opportunity in an unsuspecting patient’s body? I think not!

      As it would relate to the current success rate of the Shouldice hernia repair (the gold standard native hernia tissue repair before heavy industry marketing in the mid 80s), the Shouldice Hospital states on their website: “More than 98% of [its] cases are performed […]…without the use of mesh.” And, “mesh should never be used because it’s easier, faster, cheaper or due to lack of familiarity with, or expertise in, the use of natural-tissue techniques!”

      Industry’s destructive influence in the medical schools corrupts the impressionable physician mindset into thinking that its heighten efficacy need, restricted to indiscriminate device abuse, comes before the safety and long-term effectiveness of a surgical procedure for their patients. It does not! What the Shouldice Hospital example indicates is that with proper surgeon training mesh should, and can be, still used as a last not first resort. Responsible use patient safety guidelines could be set in place which would recognize the use/abuse threshold for an implantable medical device. These safety guidelines could be threshold set in recognition of disease severity and patient demographic nuances. That is the ethical advancement of medicine which will benefit world societies.

      While the obvious reason why mesh is currently being indiscriminately abused, as the standard of care, is the money. There is also another, more narcissistic layer to the immediacy of this surgeons’ heighten device efficacy infliction. I believe, mesh functions as an “ego buffer” for the industry compromised surgeon. In that, if the repair fails they came blame the mesh…or patient response. But, hypothetically speaking, if they even had the proficiency to attempt to perform a tissue repair and the repair failed, it would place the failure on their ego. So the sickness in the physician mindset is, to use excessive force (indiscriminate mesh abuse), to self-gratify oneself.

      The reality has always been, since the majority of hernia repairs are preformed by the general surgeon. The issue for the general practicing surgeon is “the jack of all the master of none”. Very simply put, patients are being force to compromise their life-time of safety due to a surgeon’s lack of competency to act in their patient’s best interest. The answer is a structure of medicine issue: there should, as the Shouldice Hospital also demonstrates, be centers of excellence specifically for hernia, POP and SUI repair. These centers would classify disease severity, relational to patient demographic nuances, to mitigate the unwarranted, heightened risk from indiscriminate surgeon mesh abuse. And, only then, at the threshold of use/abuse, responsibly use the understood least risky mesh devices, situationally appropriate to each patient.

      The mesh industry and their physician collaborators come-up with the rationalized away excuse that harm resulting from the surgeon limited to indiscriminately abuse mesh is justified. It is NOT! It is NOT about the number of patients who recognize the outcome of harm. It was first about the unwarranted, heighten level of device (and aggressive surgical dissection) risk needed to implant the device, subjected to all patients without just cause. Patients are purported to have a legal right to weigh the risks and benefits before the surgery. Patients need to ask themselves the question if they are willing to sacrifice their life-time of safety due to a surgeon’s lack of competence. A surgeon’s excessive use of force: unwarranted device implantation, is medical malpractice…as it was their failure to first act in their patient’s best interest!

  10. Frustrated October 31, 2018 at 10:00 am - Reply

    Even a complication rate of 3% with 100,000 slings implanted means statistically 3,000 (three thousand) women will be maimed, will suffer severe complications just so 97% can be glad and not pee their pants a little when they cough or sneeze! How is this acceptable to anyone?

    3000 women statistically HAVE to suffer complications, no one knows why or who it will be but these women will suffer terribly for the rest of their lives just so you don’t pee your pants a little. In what alternate universe is this acceptable. It would be different if this was a life saving procedure, if it allowed someone to walk, breath, or to avoid certain death. It is to keep you from peeing your pants a little!!!

    No woman should be happy that she didn’t have complications because it comes at the expense of their sisters who do suffer. Be grateful you dodged a bullet…so far! Long term complications means for the rest of your life you are at risk of being the chosen 3%.

    • Jane Akre October 31, 2018 at 10:07 am - Reply

      You sound like me….. Let’s say ten planes take off from your airport today but we know one, two or 3 of them will not make it to their destination…..(representing a 10, 20 or 30% complication rate)… Do we continue to send those planes up? Of course not. The airport would be shut down and the feds called in to investigate. So what are we doing? AND how is even 3% (it’s much more) acceptable? We know a simple mesh erosion can lead to much more devastation, mangled urethras, removed urethras or colon, sepsis…. Alternative universe indeed….head in the sand, certainly. Reckless disregard for life? Absolutely. Just my opinion of course. Thank you Frustrated,,,, I am too and I’m not even mesh injured. Can imagine how violated you all must feel.

  11. Frustrated October 31, 2018 at 3:06 pm - Reply

    You are required to have a counseling session with a pharmacist for certain types of drugs because of the possible consequences of taking that drug.

    The FDA/insurance companies should be funding a resource center dedicated to all mesh where patients are required to complete a 15 minute counseling session before the procedure can be authorized. The nurse/counselor would be unbiased and unmotivated by financial incentives. Patients would get real and accurate information about all their alternatives!

    Patients would no longer choose mesh if they had all the info, looked at pictures of it, understood the devastation it can cause and were required to watch a removal surgery. mesh would fall out of favor, the market for mesh would shrink and manufacturers would stop selling them! This is the nature of our system, they will pull the device if its no longer profitable, they aren’t going to pull it just because some women have an “adverse” reaction to it!!! Lives and families destroyed mean nothing to them!!!

    • Jane Akre October 31, 2018 at 3:39 pm - Reply

      You have hit on a solution… now to get insurance to get onboard! But not impossible.

      • Advocate November 2, 2018 at 3:32 pm - Reply

        Wait Jane, there’s a second side to the coin, that must be considered. Let’s start with a couple of assumptions, that I personally think, lends to the opening problems.

        We believe, that a government agency like the FDA, somehow has the expertise, time and money to do the job it was set up to do in 1906. This agency is woefully inadequate for today’s world. I know they would say that’s not true, but going into drugs and devices without running 3rd party, non vested interested testing, and subsequently approving the submissions based on self reporting documentation, is just asking for trouble. It’s akin to asking the fox to guard the hen house. The temptation is just too great and frankly, counter intuitive.

        Secondly, the argument about the time and cost to get to market needed medical discoveries, that could enhance the quality of life or even save lives, would be a disincentive for the private sector to even embark on these sciences. So there would need to be some sort of financial assistance to make the work a worthwhile venture. These companies are obviously about making money, not humanitarian ventures.

        To go at the issues being discussed, I have two comments or concerns. The first is an emotional pull. Having lost my father a few years back to cancer, I remember how he went into research programs in his fight. The opportunity to use experimental drugs, was based on the number of slots in a research project that might be available at that stage of his fight. So with issues of life or death weight, I say throw out the concerns of FDA approval. But to Frustrated’s point, is it necessary to be so quick to get to market, when talking about one’s wetting of the pants? I have to ask a question at this stage, do we really think medicine can achieve a 100% safe set for all of the population, in every drug and device? Absolutely not.

        So what percentage of risk is acceptable? Your airplane analogy doesn’t work because it’s to high. Nobody believes 3 of 10 planes not reaching the destination is a good thing. But that’s travel not health. To make the point a bit stronger…in baseball, 70% failure as a batter, will get you into the Hall of Fame. ( I know you don’t do sports) So what percentage do “we” live with as a baseline. I like the way Still Standing goes about it. It must be a personal decision on a patient by patient basis. Some personalities are riverboat gamblers and yet others require a 100% guarantee or they won’t budge. This creates the bigger issue in today’s world of medicine. Frustrated asks, why do 3,000 have to suffer for the betterment of 97,000? I say, there is always sacrifice of the few, for the many. An old conundrum comes to mind, a mother is stuck on a fallen branch stretched over a rapidly rising flood water. In her harms are two children. If she continues to hold both, the water is sure to sweep them all away to their deaths. If she let’s one go, she might then save the other. I have no answer on how that plays out because it’s just too personal.

        Unfortunately, the mindset of many people is, “bad stuff happens to other people, it’ll never happen to me.” That’s why there will be 3,000 sacrifices. Those 3,000 believed they were part of the 97,000 going in. So the idea of counseling, as suggested by Frustrated, is a fine idea and should happen. The challenge is this, what information should the independent 3rd party be discussing, and where do they obtain that information. I know the assumption was, it’s all about the “bad” effects of the drug, device or procedure, and to quote “Patients would no longer choose mesh,” supports that. What if, after showing all those nasty and very realistic potential side effects, the counselor then showed women running and dancing, picking up children and grandchildren? Would Patients choose mesh? Perhaps, but the point is, to do the proper service of counseling, both side must be presented. That means ALL side effects must be disclosed, as they are known at that time. And that’s the legal question, did the manufacturer disclose all they knew or should have known? We are now back, full circle, to who oversees the original information and then verifies it to the best of science, at that moment in time. Nothing changes, until we as a public, demand a change in how and who is looking out for the best interests of the consumer.
        Just my opinion…

        • Jane Akre November 5, 2018 at 11:02 am - Reply

          Wow- a lot to consider. But I’m stuck on your point- there are alternatives to incontinence with fewer or no side effects. They are the tried and true methods. Do they work forever? I can’t tell you how many times I’ve heard, My grandmother had a bladder tack and it lasted her whole life..” That’s the old way until “innovation” (profits) interjected itself. Personally i do not think we will ever have mesh off the market …there are too many people who are Obese, smoke, do not take care of themselves- for them it’s a last resort. (Part of my thinking is evolving that patients have to do their part to stay healthy and not to gain weight and definitely NOT to smoke). But it should be a very last resort… very very last, my opinion only.

  12. Pleasebekind November 6, 2018 at 10:54 am - Reply

    Can we please make sure we are not SUI shaming women who are already having issues dealing with the embarrassment of SUI? It is not a fat smoking women’s condition. The primary cause of SUI is Vaginal Delivery during childbirth, damaged tissue or nerves from surgery, age and the weakening of muscles… According to Mayo the first contributing factor that may worsen stress incontinence is illnesses that cause chronic coughing or sneezing, allergies has the same impact and can do the same damage. “The pelvic floor supports the bladder and urethra. If this area gets stretched, weakened or damaged, then SUI can happen. Pregnancy and childbirth can cause this. Chronic coughing or nerve injuries to the lower back or pelvic surgery (like surgery for prostate cancer) can also weaken the muscles”. Chronic Constipation is an important factor as is intense orgasms and genetically inherited factors. Risks factors for SUI include race, age, obesity, menopause, COPD, smoking, hysterectomy, lifting heavy objects constantly, high impact exercising causes SUI and the fact that a woman starts leaking urine while running, jumping on a trampoline, laughing and having an orgasm are very common reasons that women seek treatment.

    We should focus on impacts that can really make a difference…If the primary cause of SUI is childbirth/pregnancy then we should be pushing for Bladder health training as a part of any birth. We do counseling on breastfeeding for women when they give birth and its completed before they leave the hospital. We should have a program that teaches women about SUI and Prolapse that occurs after pregnancy and teaches them how to do Kegel Exercises correctly. Women need to be taught early in life why putting excess pressure on their pelvic muscles should always be avoided/minimized or protected against such as how to contract the pelvic floor prior to sneezing, coughing, lifting, high impact exercising, etc…

    We absolutely can not stigmatize SUI as an obese smokers problem. We need to talk about it earlier in life before it becomes a problem. Yes obesity and chronic cough can be a contributing factor but focusing on those two factors is insulting to all the women who got SUI from exercising, lifting, jumping, having allergies, giving birth, weightlifting, etc.. All the women who are generally healthy and still get SUI shouldn’t feel embarrassed because we wrap SUI up in such a negative blanket.

    • Still Standing November 6, 2018 at 6:06 pm - Reply

      You are absolutely right about early education about not just bladder health, but about the pelvic floor muscles and how to keep,them healthy. I had a hysterectomy in my 30s, then prolapse at 58.i do not remember one medical person talking to me about possible prolapse. . Women are encouraged to have mammograms and breast checks. No one talks about their bladder and vagina over coffee. I truly believe that every woman who plans abdominal,surgery should be evaluated for pelvic floor dysfunction. Hypertonic pelvic muscles that are impacted by surgery can become even more dysfunctional. In some European countries, every woman who has abdominal surgery has pelvic floor therapy post surgery, it should be reimbursed fully by Medicare, Medicaid, and private insurance. How we care for our body in our younger years certainly impacts what we experience as we age. It is shameful how in the dark women have been, but we can change that.

  13. Jane Akre November 6, 2018 at 11:44 am - Reply

    I hope my comments were not taken as SUI shaming. From the industry’s point of view, they will never let go of PP mesh for those instances of obese smokers with poor tissue quality and a lot of vaginal births. I’ve heard that many times from doctors…of course there are other reasons for incontinence. I’m sorry if my comments appeared to be negative. Thank you for pointing that out! ja

  14. Frustrated November 8, 2018 at 12:52 am - Reply

    So we shouldn’t use transportation as an example for comparison. How about the following? You do the math on what percentage of injury is acceptable before all these companies acted responsibly and voluntarily recalled their products.

    The United States Consumer Product Safety Commission – some of the recalls just in the LAST MONTH:

    recalls 641,000 hammer drills because there were eleven reports of the little plastic handles breaking or slipping with one report of a torn rotator cuff.

    Recalls 22,500 slap bracelets werde recalled because of 4 reports of minor cuts to hands or wrists.

    Recalls 17,600 men’s bicycles due to fall hazard 37 reports of cracks resulting in one injury of cuts and abrasions.

    Recalls 164,000 Brookstone wireless speakers due to fire hazard 12 reports of speakers overheating and catching fire resulting in 5 reports of property damage totaling $2,000.

    Recalls 1,400,000 Flushmate pressure assist flush system due to laceration and impact hazards 1,446 reports bursting resulting in $710,000 in property damage 23 injury reports with one having foot surgery.

    Recalls 350,000 solar powered battery lights due to fire hazard with seven reports of fixtures overheating and property damage, no injuries reported.

    Recalls 12,400 yoga backless chairs for fall hazard as a bar can break, 3 reports of chairs remaking with one injury.

    Recalls 246,000 Walmart camp axes due to injury hazard as the axe head detaches from the handle due to 2 reports of axe head detaching with minor injury.

    FDA Recalls in the last month:

    Dog food was recalled because of elevated levels of vitamin D

    Birth control pills recalled because the instructions for the veridate were missing.

    Medicines, popcorn, pistachios, undeclared milk in chocolate, hot curry powder, spices, all just within the last two weeks.

    The FDA should mandate a recall on the POP devices (each device by name and by manufacturer), force the manufacturers to locate every device they sold, notify the end user ( the patient, not the dr) about what symptoms to be aware of especially as it relates to rectal and colon pain, erosion, rupture, sepsis. All primary care, family and general practitioners should be warned about new onset symptoms and how to refer. Colorectal surgeons, gastroenterologist, endoscopy facilities and general surgeons as well as all emergency services departments must be made aware that Urogynecologic implants can rupture organs and cause life threatening sepsis.

    It is absolutely unacceptable that you can get 641,000 hammer drills recalled from the market because of 11 adverse events reports and ONE injury and mesh victims are still being implanted every day. There are literally thousands of adverse event reports and destroyed vaginas and muscles and bladders and rectums, destroyed livelihoods, destroyed families and marriages, destroyed dreams, destroyed women!

    How can this be? Where is the outrage for all these victims of an outrageous scam?

  15. Anon November 8, 2018 at 11:04 am - Reply

    One word Frustrated…Money! Greed! Unethical! Bribes! Crooks!

  16. Frustrated November 8, 2018 at 12:20 pm - Reply

    Advocate stated that counseling should include both sides of the coin, the good and the bad. I think that makes no sense, the Dr has already told the patient the good, it is up to the counselor to present the bad. This is what pharmacists do with medications; they make sure you understand possible side effects and interactions with other drugs and the potentials negatives of the medication so you can make an informed decision.

    To address the statement that there is always sacrifices of the few for the many and what percentage is acceptable I think you could look at the side effects of common procedures for that answer.

    WHO Classification of side effects:

    Very Common – more than one in 10 people are likely to have the side effect
    Common – between one in 10 and one in 100 people are affected
    Uncommon – between one in 100 and one in 1,000 people are affected
    Rare – between one in 1,000 and one in 10,000 people are affected
    Very Rare – fewer than one in 10,000 people are affected

    Most common side effects of drugs are mild and can be inconvenient or upsetting but are not harmful to health.
    Whether marketed drugs that are later found to cause severe, rare side effects continue to be prescribed depends on the nature and severity of the disease and the availability of other treatments.

    Drugs with side effects can be licensed but the beneficial effects must outweigh the risks of harms. The decision takes into account the following:
    The type of illness being treated
    The improvement offered by the drug
    The intensity of side effects
    The likelihood of serious side effects and
    The possibility of predicting who is most likely to experience serious side-effects.

    SUI is neither an illness nor a disease, the improvement offered can be obtained through other means, the intensity of the side effects can be devastating causing severe physical harm, the likelihood of serious side effects is Common (according to the WHO Classification) and its impossible to predict who is most likely to experience serious side-effects.
    3% risk of SEVERE side effects is unacceptable in any treatment unless it is a lifesaving procedure/medicine/device. How in our medically and technologically advanced society can anyone think this is acceptable? If this were a drug, it would have never been approved because yes, the manufacturers knew of the severe consequences and life altering injuries women would suffer before they put it on the market.

    Put it in perspective:
    The risk of a healthy child dying from general anesthetic is around 1 in 100,000 very rare
    The risk of a healthy person dying from anesthetic for non-emergency surgery is 1 in 100,000 very rare
    The risk of an anesthetist making a mistake is 1 in every 185,000 very rare
    But everyone is warned about this risk prior to surgery because you have to accept the fact that this might happen, we typically find this an acceptable risk because it is very rare. Women were not warned about the severe life altering devastating side effects of mesh nor were they told that it is common, or in the case with mesh for Pelvic Organ Prolapse the devastating, life altering severe side effects are very common.

    Crestor is a commonly prescribed statin, it rarely causes liver damage but most people believe that risk is outweighed by the benefits of reducing the risk of heart attack and stroke.

    Mesh is a commonly prescribed implant for Stress Urinary Incontinence that Commonly causes erosion through the vaginal wall (the risk of which is not present with any other treatment for SUI) and can cause damage to vaginal tissue and pelvic tissue when it has to be removed. Commonly is classified as up to 1 in 100. A 2% rate would be 2 out of 100 women would suffer vaginal erosion, a 3% rate would be 3 out of 100 women would suffer vaginal erosion, you get the correlation. The rate of complications with Pelvic Organ Prolapse Mesh was somewhere between 15% and 20% before it was put on the market. Women were not told that life altering, devastating, deadly complications were VERY COMMON.

    What level of risk is acceptable?
    COMMON side effects of chemotherapy are temporary fatigue, hair loss, easy brusing, infection, anemia, nausea and vomiting, appetite changes, constipation, diarrhea, mouth, tonue and throat problems, nerve and muscle problems, skin and nail changes, urine and bladder changes, weight changes, concentration and focus problems, mood changes, changes in libido and fertility problems. These complications suck but they are temporary common side effects that you choose to go through because it might save your life.
    UNCOMMON side effects of a pacemaker implant are infection at implant side, allergic reaction to the dye or anesthesia, swelling, bruising or bleeding at the site, damage to blood vessels or nerves near the pacemaker and collapsed lung, life-threatening complications of pacemaker implantation are rare. Pacemaker implant is a lifesaving procedure so you accept the UNCOMMON and RARE side effects.
    In January 2018 the FDA requested a recall of Limbrel due to RARE but serious and reversible side effects associated with Limbrel. Limbrel is a prescription medical food capsule to help with osteoarthritis pain. It was recalled because after 13 years on the market and 2 million prescriptions written to over 450,000 patients, there were 30 THIRTY adverse event reports. These RARE Serious side effects are reversible and no one had died from them. “Primus retained independent medical and former senior FDA safety experts to conduct a further investigation of these cases and the ingredients in Limbrel. It is the opinion of these experts based on a thorough review of the medical literature, adverse event reports to FDA, and FDA’s health hazard evaluation that there is no basis on which to conclude that Limbrel potentially causes life-threatening adverse effects, and that none of the reported adverse events show liver failure or respiratory failure. Nonetheless, in an effort to cooperate with FDA, Primus voluntarily ceased its promotion and distribution of Limbrel on December 21, 2017, and is now recalling Limbrel as FDA has requested.”

    COMMON side effects of surgical mesh for SUI repair, in descending order of frequency, include: pain, chronic pain, mesh erosion through the vagina (also called exposure, extrusion or protrusion), infection, urinary problems, recurrent incontinence, pain during sexual intercourse (dyspareunia) which may not resolve with treatment, bleeding, organ perforation, neuro-muscular problems and vaginal scarring. Many of these complications require additional medical intervention, and sometimes require surgical treatment and/or hospitalization and may cause permanent damage. With the exception of mesh erosion, the above complications can occur following a non-mesh surgical repair for SUI. I repeat, COMMON side effects, for a non-life threatening condition. SUI doesn’t rise to the level of illness or disease, it is a lifestyle issue. Women deserve to know the truth.

    What they don’t tell you is that mesh was advanced because of the supposed high rate of failure in traditional surgery for SUI. But failure of traditional surgery means your SUI returns, failure of mesh augmented surgery for SUI means severe dissection of normal healthy tissue to remove the mesh. There is no comparison because the failure of traditional surgery is not devastating, failure of mesh surgery is.

    WHERE IS THE OUTRAGE? FDA can force a recall on Limbrel without any proof that it causes RARE side effects, hasn’t caused anyone’s death, only had 30 adverse event reports out of 450,000 patients but out of an abundance of caution forced a recall.
    On the other hand, the FDA knows that gynecological implants (mesh) commonly causes serious adverse events up to and including death, has a high potential to destroy a woman’s life, livelihood, marriage, mental health, and cause serious health problems for the rest of her life, has thousands of adverse event reports and has done nothing but issue advisories.

    WHERE IS THE OUTRAGE

    • Jane Akre November 8, 2018 at 12:35 pm - Reply

      Outrage is partially what fuels Mesh News Desk and continues to do so. Only with information can one act!

    • Advocate November 12, 2018 at 5:36 pm - Reply

      I agree with virtually your entire post. I’m a huge believer in overhauling the FDA! I want to make one thing clear though.. If you think the doctors told the whole truth about good, well then, you give the doctor credit for knowing a lot. News flash, not surprising anyone… they don’t know as much as you and I think they should, good or bad. That’s why a third party is such a desired intermediary. But they need to give all the facts…and that is of both sides. All the facts… trust but verify.
      As to my point about about sacrifice, that’s a personal issue for me, but perhaps the real focus of that statement should have been the 3,000 that thought they were part of the 97,000. You can’t be a sacrifice when you think you’re in the safety of the majority. I think of sacrifice when you know you are walking into harms way and still do it. But again, that strays from the point, the point of a government service not serving the people to it’s fullest, putting those people in harms way without full disclosure.

  17. Anon November 8, 2018 at 4:36 pm - Reply

    Thank You Frustrated…no hidden agenda Just Facts….Just Truth

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