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Plaintiffs’ $27 Mill Boston Scientific Mesh Verdict Upheld!

Mesh Medical Device News Desk, October 21, 2017 ~ The trial of four women, implanted with Boston Scientific’s Pinnacle mesh, was held in a Miami court November 2014 before Judge Goodwin, displaced temporarily from his Charleston, WV court, while another mesh trial took place there.

Each of the four women was awarded compensatory damages in excess of $6 million.

Last week, the mesh trial jury verdict of $27 million against Boston Scientific (BSC) was upheld by the Eleventh Circuit Court of Appeals from the Southern District of Florida.

The case was Eghnayem, Dortes, Nunez and Betancourt, (Eghnayem v Boston Scientific 2:13-cv-07965). All four women had been implanted with the Pinnacle pelvic mesh, used to treat pelvic organ prolapse (POP). All four women had complications including pain, infection, mesh erosion, dyspareunia and mesh shrinkage.

Ms. Eghnayem, art by Akre

Originally filed in the Southern District of West Virginia in multidistrict (MDL) litigation, the case consolidating the plaintiffs and was transferred to the Southern District of Florida for trial.

On November 13, 2014, after an eight-day trial, the jury found for each of the plaintiffs on four claims, deciding that the Pinnacle Pelvic Mesh Repair Kit was defectively designed, that its instructions to physicians were also defective, that the company was negligent, and failed to warn patients about the dangers of the Pinnacle.

The plaintiffs were awarded different amounts of compensation ranging from $6.5 million to $6.8 million each.

Boston Scientific immediately filed to overturn the judgment, which was denied, then to appeal the verdict.

See Mesh New Desk coverage here and here.

 

THE APPEAL

Boston Scientific claimed there were errors in the verdict, that the four women should not have been tried together, that the exclusion of the Food and Drug Administration’s clearance of Pinnacle through the 510(k) was omitted from the evidence, and that Eghnayem did not prove her claims.

Initially, Boston Scientific appealed the judgment in all four of the plaintiffs but later focused solely on the case of Amal Eghnayem, dismissing the three others.

Publishing the U.S. District Court decision October 19, 2017, Judge Judge Stanley Marcus wrote:

“After thorough review, and having had the benefit of oral argument, we can discern no error in the district court’s rulings, and accordingly we affirm the judgment.”

In upholding the jury verdict, the 11th Circuit supported the decision of Judge Joseph Goodwin, of the Southern District of West Virginia to allow the jury verdict and to deny the company’s request for a judgment in its favor. Judge Goodwin heads the federal court in Charleston, WV where the multidistrict pelvic mesh litigation is centered and more than 104,000 cases have been filed.

Boston Scientific had tried to sever the four cases claiming they were different.

A district court may consolidate multiple actions that involve a “common question of law or fact,” wrote Marcus, and that decision is “purely discretionary.”  The different jury awards showed that jurors considered each plaintiff individually, says the decision.

BSC wanted jurors to hear that the FDA cleared its Pinnacle mesh, hoping some form of an FDA acknowledgement might influence the jurors, but the appellate panel said the 510(k) is “not a safety regulation, approval under that process cannot show that BSC performed sufficient testing or complied with applicable safety regulations.”

Besides, this is not a case about federal regulatory compliance and other courts have also rejected including the 510(k) evidence under Rule 403 (Bard 4th Circuit 2016).

The long and short of it is that the district court properly exercised its broad discretion in consolidating these actions and refusing to admit FDA evidence, and the contested fact questions were properly presented to the jury,” Marcus concluded.

Rebecca Mercier Vargas

The warnings in the IFU (Instructions for Use) do not “even remotely suggest that removal might be impossible,” wrote Marcus, referring to a failure to warn.

Daniel Rogers of Shook Hardy & Bacon in Miami spoke for Boston Scientific at oral arguments in May. Rebecca Vargas of Kreusler-Walsh Compiani & Vargas in West Palm Beach argued for the women, including her client Amal Eghnayem.

Rogers has filed a notice that Boston Scientific has reached a tentative settlement with the last of the four women.

THE 2014 MIAMI TRIAL

Dr. Vladimir Iakovlov, Pathologist

During the eight-day trial, the four women claimed painful intercourse, pain, incontinence, infections and mesh exposure after being implanted with the Boston Scientific polypropylene plastic mesh used to treat pelvic organ prolapse (POP).

Dr. Dennis Miller, was presented on videotape.  As the inventor of the Pinnacle, he benefited as a Boston Scientific consultant and preceptor and trained other doctors on the Pinnacle.

Dr. Dennis Miller, urogynecologist

In all, 25 witnesses were called for the plaintiffs to testify about the Pinnacle design, its chemical characteristics and potential dangers.

Pathologist, Dr. Vladimir Iakovlov, (see MND story here)  brought his microscope into the courtroom to show slides of what happens to the polypropylene material as it undergoes oxidative degradation and mesh erosion.  He explained the foreign body response, incited by the presence of mesh, causes inflammation.

What results is scar tissue that encapsulates the mesh as the body tries to distance itself from the invader. See a study he authored in 2013: Mesh is Not Inert.

Scar tissue, also called fibroblasts, move into the mesh holes and cement it into place, making treatment very difficult, said expert, Dr. Tom Margolis.

Ultimately, the jury heard that while Boston Scientific studied different waves, weights and pore size of polypropylene mesh, those 2002 studies did not address the Marlex that would eventually be used in the Pinnacle, and did not involve human trials but rather the implantation in the abdomen of rabbits.

The rabbits were sacrificed at two weeks, six weeks and 12 weeks, so there was no assessment of the long-term effect on the rabbits.

BOSTON SCIENTIFIC

Obtryx II

Meanwhile, during the same November 2014 time period, the trial of four other women was underway in Charleston, West Virginia.

Jacqueline Tyree, and the others, claimed their Boston Scientific Obtryx Mid-Urethral sling used to treat stress urinary incontinence, was defective.

They were awarded more than $18 million by the Charleston jury.

Boston Scientific is one of seven mesh manufacturers facing product liability cases filed over their proprietary mesh products. As of today, there are 25,274 cases pending in the MDL court with 15,811 listed as closed, which may mean they are in the process of being settled.
Last May, BSC announced it would settle 37,000 of its outstanding cases. See MND story here.

Maria Cardenas,  August 18, 2014

Boston Scientific Trials So Far

The Eghnayem Miami trial was the first federal bellwether for Boston Scientific, designed to gauge how juries would respond to the evidence and the relative value of the cases.

Boston Scientific had two successful outcomes earlier in 2014 in a Massachusetts courtroom.

In the trial of Maria Cardenas, the jury decided that BCS provided adequate warnings about its Obtryx product.  The jurors were not allowed to see the Material Safety Data Sheet during the proceedings, which carried a warning the raw polypropylene plastic material was not to be used to make medical devices. Background here.

In July 2014, Boston Scientific was successful in its Pinnacle Pelvic Floor Repair Kit trial filed by Diane Albright and heard in Middlesex Co. in Massachusetts, where Boston Scientific is headquartered. See background story here.  

An unprecedented $73.5 million jury award in the Martha Salazar v. Boston Scientific  broke the Boston Scientific winning streak last September 2014 in a Dallas courtroom. That jury award has since been reduced by half due to caps on awards in Texas.

Salazar v Boston Scientific (DC 12 14349)Martha (Rodriguez) Salazar et al (Feliz Salazar, husband)  v Jorge Lopez, MD et al (Boston Scientific) filed over the Obtryx® Transobturator Mid-Urethral Sling (MUS) System story here  and here.

Pinnacle Mesh

Pinnacle Pelvic Floor Kit

The Pinnacle Pelvic Floor Repair Kit, cleared by the FDA 510(k) process to market in 2007, is no longer on the market in the U.S.

The polypropylene mesh implant was cleared based on it being “substantially equivalent” to another device already on the market.

On May 10, 2011, Boston Scientific sent an “URGENT MEDICAL DEVICE RECALL-IMMEDIATE ACTION REQUIRED” letter to all affected customers concerning its Class 2 recall for the Pinnacle Pelvic Floor Repair Kit because ‘the device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.”

Boston Scientific still sells a number of mid-urethral slings for the treatment of incontinence including:

Advantage Fit (transvaginal mid-urethral sling)

Lynx – transvaginal mid-urethral sling

Obtryx II (transobturator mid-urethral sling)

Solyx (single-incision sling system).

Boston Scientific’s ProteGen was the first mesh sling to be manufactured by any mesh maker but it was pulled from the market in 1999 after problems.  That did not stop other companies from naming it as a “predicate device” upon which to base their own mesh products. ###

69 Comments

  1. Stopmeshimplants says:

    I am noticing a pattern with these
    appeals and it is finally some good for the victims. Some day all of this mesh mess will come out and the manufacturers will be known for their greed. Physicians will be exposed for their secrecy, ignoring the complaints of women and the denial of symptoms of their patients. I cannot wait for this to happen. So, so happy for these women, their loved ones and the legal teams that represented these and courageous women.

    • Jane Akre says:

      I would love to tell that story. But there are so many!! Where to begin and what to leave out!

      • Lori says:

        I had pinnacle, debating on settling. Why couldn’t my case go there? Lifetime injuries to deal with, pudendal neuralgia.

        • Jane Akre says:

          Lori- The POP meshes are larger and potentially do the most damage ( not to minimize SUI mesh implant patients)…. I’m sorry. Did you ever get your Pinnacle removed? I wonder what Dennis Miller thinks about his invention today? These women were from Miami so it made sense to group them.

          • Kitty says:

            Dennis Miller is an arrogant man. Years at the. NURSES’ genuflected when he came into the OR. Besides the Royalties from various manufacturers. He received fine gifts from the women who adored him…fine wines and spirits

          • Jane Akre says:

            Kitty- were you treated by Dr. Miller. I met him at AUGS…. he was quite a strange duck… very accusatory when I asked him a question… something line “You’re one of them!?””” huh? I explained who I was and was not trying to do anything but have a conversation.

      • Bejah Blue says:

        I feel this coming too. I pray for it. I know the power of prayer. When my mom died it was very hard for me. My church, then the Episcopal Church in Palm Desert, CA….a large congregation, prayed for me. I swear I could feel it, it was like I was cocooned in this loving sort of circle. It was extraordinary. Let us now pray for this matter to open up, for us all to find solace and comfort, and some kind of compensation. For some of us there may never be monetary compensation. Life, God knows, is not fair but GOD knows what is happening, what has happened and I promise HE will address the inequities in HIS way, in HIS time. We must trust in this. We must have faith. Love, Bejah

  2. DebC says:

    This is good news! It’s amazing how they keep dragging this all out, but this is another great step in the right direction. These products are defective and high risk. They need to quit making excuses and trying to blame the doctor, or the patient, etc. It’s the MESH.

    Thanks for covering this.

    • Jane Akre says:

      You are welcome. Slowly, one by one,. the verdicts are being finalized…. a good three years after the fact!

      • Bejah Blue says:

        Jane. please tell me and for the benefit of us all, with regard to appeal, how many times and for how long can these cases be appealed by the defendant corporations? I was beginning to think it was indefinitely but now I think I may have been wrong. Can you enlighten us? Also I need to know where my case was filed…I think it must have been W. VA where I think MDL is based. Am I wrong. I forget where and how to check. Thanks for any guidance.

        Bejah

        • Jane Akre says:

          I’m not a lawyer… (she says time and time again) .. but you can appeal first to the judge, citing procedural errors or some such thing. Generally the judge will not agree. You can ask the judge for a directed verdict,, in other words, set aside what the jury said. Again, not too comment but it did happen in the Carolyn Lewis case in J&J ‘s favor. you can appeal to the District Appellate court… usuallky a three judge panel. They will agree or disagree. If you don’t like that, you can try to get into the state Supreme Court for consideration. My understanding is unless there have been some conflicting rulings in the lower court, the Supreme Court will not waste its time. Generally that’s it. Unless you try another bite of the high court apple. Again, denied for the same reasons. Then you are through! May take 3 years. Lawyers- please correct me or clarify if needed.

          • Bejah Blue says:

            That is very helpful Jane, thanks so much. Now what I am wondering is if the courts and the system tend to favor corporations in this less than fair world. I wonder what stats are kept on such things and by whom.

            So maybe the Universe is suggesting you go to law school….ha! I heard that.

            Bejah

    • Bejah Blue says:

      Absolutely, it is the material that is the problem, not the weave, not the method of implant, and not the issue being addressed medically. The material should not EVER be used in the human body. If there are people who do not complain of harm then it must either be some mystery related to their physiology that medical science has not yet discovered or it is that they have not yet made the connection or it may be that they have yet to be symptomatic. We must remember that the burden of proof is on the plantiff. This is made very difficult when we are dealing with defendants that destroy evidence (the destroyed files), when they are able to prevent expert witnesses from testifying, and when they are able to pay off judges, witnesses, law firms, and who knows who else. God help us. Bejah

    • Bejah Blue says:

      Bullies are essentially weak and needy at their core and that is why organizations that fit this profile try to blame others, accept no responsibility and feel no remorse, I expect. They are soul-less and inhumane because that is how they learned to survive. For them survival is about two things: Wealth and power. Outside of these impulses they are empty. Bejah

      • Disgusted says:

        I agree Bejah, the material, polypropylene is the problem. It causes foreign body reaction (I know about this personally). It is not inert as has been said in literature.
        We can add that the way of manufacturing it causes additional issues, whether mechanically cut or laser cut, etc. The weave also changes things some. But the fact that it is not inert is the bottom line. It took my body about 2 years to react to it. I’ve heard of some women going up to 15 years before problems. It also can shrink, which is what caused my first issue. It worked great for about 18 months and then became so tight that it was within cells of my urethra. Went home with a catheter for 2 weeks to prevent damage to my urethra. The “tape” was just cut, so it gave the monster tape a chance to get into both sides of my urethra. Which doctor Raz removed and my urethra is “very damaged” which are his words.

        I was reading about slings online and found some literature that this was actually invented in 1907. So it wasn’t a new idea. They just didn’t have the material they needed to make it work. It was abandoned. Mechanically speaking, the idea works. If they take away that we are biological beings, it makes sense. But we are biological, live tissue with nerves, etc. So much more than a mechanical machine. The inventors forgot about humanity. We are paying for it.

  3. Lordhelpus says:

    God is in control, just leave room for him…

  4. Anna says:

    Dear Jane,
    I am now just wondering if my case will ever come to closure…
    Been told several times the tvt-mesh nightmare case is in closing phases, but now it seems like it could be months ahead before it closes…
    guess i need to just wait and be patient, what else can I do…
    Just needed to releas my inner fears and tension…
    thanks for listening
    Anna

    • Bejah Blue says:

      Anna, Better months than years. It will go by more quickly than you imagine. Look at how quickly the last six months passed. Keep the faith! Bejah

  5. Bejah Blue says:

    I was just revisiting some of Noni Widemans writings on foreign body response as it relates to polypropelene mesh and I have included a quote from her on this. I have a question for myself, for us all…why is it that I have a teflon implant in my brain and I have NEVER had a foreign body response to it? I have a surgical steel hip replacement (I fell breaking up a dog fight) and I have NEVER had a foreign body response to it. Why? Some of us (not me) have breast implants but most have no foreign body response to those…why? Why do we supposedly have a foreign body response to polypropelene and even then, according to what the manufacturer’s who are making billions….that is less than 2% of the implanted population. Could they be lying? Could the real number be much higher? Some have said it is closer to at least 20% of those who have made the connection between illnesses and implant. Could it be that this is a toxic material that should NEVER be used in the human body as the refiners claimed? Even with hernia implants…could the complications be due to foreign body response? What are the stats on those implants (Mostly men?) and why do we not hear much about them? Food for thought? Now there is a shift and these corporations are taking there devices to third world nations I hear….we can not, must not allow that to happen. It is time to approach the World Health Organiztion, the United Nations, NGO’s in general and warn them to not allow this. Bejah

    Researching patients found they were not alone with their questions or symptoms. Patients like me discovered they could be considered by the medical community as high responders to medical mesh. In other words we are all the population of patients experiencing chronic foreign body reaction to synthetic mesh implants. These synthetic meshes mentioned are predominately constructed of polypropylene or similar polymeric constructs. To break it down in simpler terms we all found that hypersensitivity to foreign body implants was, and is, the common denominator among us. You might say for simplicity‘s sake we high responders are all “allergic” to the materials doctors implanted in us.

    • Kitty says:

      The INFLAMMATORY response is complicated. Some mesh came from toxic material…and from toxins in China. As SS stated from her research
      ..there has been no solid evidence that mesh causes autoimmune. She believes some women may have pre existing condition or propensity for select conditions..ie..rheumatoid. MS. Diabetes, et al. Corneal dystrophy etc etc . I say B.S.How does a high funtioning woman’s body break down over a 10 year period to the point of crippled?

      • Bejah Blue says:

        I agree Kitty. She must be conflicted about all of this at some level. She is exceptionally bright. I will want to know where she finally lands on these issues and why. Bejah

        • Still Standing says:

          Bejah, I wanted to respond to you about your comment about me being terribly conflicted because your are a nice person and you deserve an answer. I am not conflicted and let me tell you why.

          Kitty states that my reasoning is BS , but in an effort to put some academic light on this discussion , here is my reply. It is recognized in the scientific realm that people experience illness and disease that is determined by nature and nurture. There is an entire science called Epigenetics that sheds light on this and there is not enough space to explain it all here. Look it up. There is strong evidence that parts of genes (alleles)(our nature) can be turned off or on because of nurture ( social and emotional influence). While you have DNA that that sets certain characteristics such as sex, eye color, ..you remember 7th grade science. However, other part of our DNA are more complicated. they may never get expressed unless there is a precipitating factor. For example, African Americans have a high rate of type 2 diabetes. While there is a genetic leaning toward that, those who watch their weight, exercise daily, and have other healthy lifestyles may never have Type II diabetes. Others may do all the right things and still develop it. Middle Easteners have a disproportionally high prevalence of Bechets disease, an autoimmune disorder. However, It is not expressed in every person of Middle Eastern heritage. There is genetic tendency for high cholestrol, yet lifestyle choices can determine if you will in fact have high cholesterol that needs to be treated. My parents both had autoimmune disorders, different ones that killed both of them before the age of 70. However, I had no evidence of autoimmune disease until my 60s, about a year after the mesh implant. My doctors think the mesh caused the expression of my immune disorder. It is a terrible one, very rare that causes horrible ulcerations of all areas where I have mucous membranes. Mouth, vagina, vulva, esophagus, eyes….you get the picture. Im certainly a believer in the hypothesis that mesh causes autoimmune response, but I can’t say for sure without further scientific evidence. My sister is in her 70 s and does not have autoimmune disease. If it was a slam dunk, she would most certainly have developed a disorder based on our parents don’t you think? Women in my mothers side of the family have osteoporosis. Yet, even with all I have been through, I do not. Yet my sister does. I think the difference for me is that I have always had a healthy diet and an active lifestyle. My sister smokes and is sedentary. Did that contribute to her having it and me not having it? Science says that it does. You just can’t make conclusions without looking at a bigger picture, not just at the people who are in a particular cohort. ( women who have mesh complications)

          You posted some interesting information about redheads. Two first look conflicting studies about redheads are that (1) redheads need more drugs to be sedated, and (2) red heads need less opioids for pain. So, do you want your doctor to cut your opioids in half because a research study said you should need less pain medication just because of your hair color? Of course not. Maybe other scientists will continue the research, but until then, you don’t want your doctor to oversedate you for surgery or under medicate you for pain just because you are a redhead and a few studies suggested some unique characteristics of redheads.

          It amazes me that so many readers here excoriate the FDA and drug companies for failing to do SCIENTIFIC studies, as well they should be, then dismiss other science because they don’t agree with the outcome. One can’t have it both ways. It is a fact at the present that there is not enough science to determine if polypropylene causes autoimmune disease. It appears to be fact on this site, but I imagine women who have never had mesh complications don’t read here. Women with mesh complications comment and it is easy to read a hundred people’s stories and assume it is hard evidence. Yet, if you put me in a room with 12 of my friends who have had bladder slings and have NEVER had complications even though they are in their 70s, you would have to assume that mesh is a good thing and causes no problems for most people based on the 13 people in the room. That is why science is different, it makes assumptions then sets out to disprove those assumptions. If there is a preponderance of evidence, then scientific conclusions can be made.

          Here is what science is showing: doctors who had less experience implanting mesh have higher rates of complications, women who had pelvic floor disorder have higher rates of complications, having both anterior and posterior mesh increases expected complications, women who smoke have higher complication rates……mesh is being robustly studied and there is much more to learn. Women with mesh complications need the medical community to figure this out. Plumbers aren’t going to compel the science. Doctors are. To call them names and say they are all greedy and inhumane is not right. How do we feel when all women with mesh complications are labeled as money hungry drug seekers? Once again, women with complications are the ones who post here because of theirpoor medical advice and care. That does not mean that all doctors in AUGS are horrible people. The blatant generalizations are cruel on both sides.

          Ditto for all attorneys and judges. Where is the evidence that they are getting under the table payoffs, that they are all crooked? That is an unkind way to generalize people who have taken out loans to represent mesh women. Are there crooked attorneys? Yes. Are there unscrupulous legal referral companies? Absolutely. Are there dedicated attorneys who are doing the best they can? Certainly. Should the judges called out and be accused of criminal behavior without hard evidence? Only you guys can answer that. Hopefully, readers will consider giving them the same respect that they want from attorneys.

          This is why I quit posting here and won’t post again. It makes me sick to read the horrible things people post about others they don’t know. It is sometimes like a flash mob of hate that doesn’t end. I know it comes from a source of deep pain, but It is possible to have meaningful and deep conversations without dragging other people though the mesh mud. Saying unfounded things about others will not make you feel better. Negative thinking breeds more negative thinking, which is not the path toward emotional strength to get through your day. Actually, there is pretty good scientific evidence about negative thinking and its impact on our wellbeing. Even without it, though, it goes back to basic Bible teachings, the ” do unto others as you would have others do unto you.” I read Gods name invoked often here and I believe he is at work in all our lives because His love is boundless and forgiving.” It is impossible to claim that truth , though, if we are not willing to try to ” do unto others”.

          This is a long post, but I’m done now. I encourage all readers here to do whatever it takes to be as well as possible. I tried over the times I have posted here to give accurate, well researched information and encouraging words. Guard against slander and heresay and conspiracy theories. They do nothing to move any of us toward healing physically and emotionally.

          • Jane Akre says:

            Thank you for adding your intelligence here SS. As an editor, there is certainly a lot of back and forth but I ask it not be directed at each other….. on the other hand, if someone knows/feels/senses their doctor or the medical establishment or their lawyer has done them wrong,…I don’t think its my job to edit them. I prefer they have evidence as well…Outrageous statements that slander are not welcome here. If you have evidence, state it! I personally always welcomed your thoughtful and intelligent comments so I hope you stay. I will keep a better eye for things that should be challenged factually. Emotionally, I hope people feel they can share their feelings here….unless it is cruelly directed at an individual. Thank you for understanding.

          • Kitty says:

            Just to set the record straight ..i said 2 esteemed AUGS members were terrible. The one male is highly esteemed by collegues…but received scathing reports from many of Jane’s followers. The female rhat i mentioned is an esteemed AUGS member who gathets scientific information and writes reports for AUGs. SHE treated me shabbily. She brought in psychologists and neurology. Refused a translabial ultrasound ….sent me to psychiatry and then neurologist wanted me to go on
            Psychotropics and get off hydrocodone. THEY BELIEVED MY PAIN WAS PSYCHSOMATIC. Today I have waxing and waning deep pelvic ache….negative for UTI…terrible urine retention. Mayo clinic Dr wanted me to cath…but I get too many bacterial infactiions with that. I’d rather pee 5 times in the morning and dribble with over flow during the day. The love of $ is the root of all evil. INFLAMMATORY EROSIVE ARTHRITIS…TUMOR ON ADRENAL GLAND. PRE DISBETiC….. FOOT DROP CORNEAL DYSTROPHY…ALL DIANOSED THIS PAST 10 YEARS. OH DID I MENTION

          • Jane Akre says:

            Kitty- I certainly hope you have added your voice to the UCLA autoimmune registry which will conclude tomorrow Tuesday!

          • Disgusted says:

            Hi Still Standing,

            I hope you do not leave this site. I know many of us are angry and bitter. What has happened is devastating. I understand your scientific view point. I think your writings are very helpful to us as women. I agree, if you read just this site, you would have a much different viewpoint of mesh then if you read many others. And yes, there may be some predisposition’s to cause auto immune disease. My cousin developed lupus after breast implants. Her father had lupus. There is some medical evidence that the polypropylene covering the breast implant can cause an auto immune disorder.

            You are very good at being objective and scientific. It’s awesome how you furthered your education after being hurt by mesh. I think we need your balancing statements here. Reminders to stay balanced.

            I will state, we were not protected by the FDA in the way we should have been. For a minor issue of incontinence we have suffered unspeakable humiliation, pain, and hardships. I agree that we need to be careful and not use “all or nothing” thinking. It isn’t useful. Not all doctors are out to get us. Clearly true. However, it is often hard to see the truth when you are the one stuck in it. “you can’t see the forest for the trees”. I think many of us are stuck there. It’s too up close and personal. Even if you help just one woman with your comments, she is worth that. Thank you for what you’ve previously added to this site. I for one, will miss your research terribly.

          • Bejah Blue says:

            SS, I am happy to see you post here again and I am deeply hurt that you say you will not again. We need you. You know that. This population is severely wounded by any definition. People lash out when they are wounded. It is human nature. Yes, I am familiar with epigenetics. All of that aside, we are still left with the realities that exist and the truth that there are serious problems with polypropelene mesh implants on many levels and if it is 2% or 20% or more, it is too much, too high a percentage, there are too many problems with this material to continue its use. We need to start over with other materials and go about it the right way. I am certain there are many others who are having problems who have not made the connection with the mesh implant. I did only after seeing adverts on TV put up by law firms representing victims. Then I began to make the connection. It may take years, even decades for many to began to make the connections and/or suffer undeniable effects. Why do you think the processor of the refined product said it should never be used in the human body? I could go on. If you are saying that beyond our not having evidence of the causal link(s) beyond a reasonable doubt then let us continue with that process. Show us that is being done. If you are saying there is probably not a causal link then I feel you are wrong. I can not prove it this night but I will endeavor to prove it. I believe it is undeniable. Call it women’s intuition or whatever spooky thing you wish. I say also that the molecules in our bodies carry emotion and our bodies speak to us in this way and they never mislead us. We are not hysterical, we are not psychosomatic dolts, and when we have not had a period for seven years and should be, when our urinary tracts and bladders are malfunctioning there is a reason and it is unlikely that it is because of some issue with our DNA or some cells that turn on or off due to some maladaptive inherited genetic trait. Also, I must add that I feel very hurt that you retreat from us when we need you the most because of the kind of reasoning you have articulated. There is so much at stake here and there is so much good you can do. I am very sad. Bejah

          • Jane Akre says:

            Thank you Bejah. SS should stay. I told her I would be more mindful of any hurtful comments. A reminder- Please don’t level any comments AT each other… unless they are very kind. This should be a safe place. Thank you.

  6. Disgusted says:

    Thank you Jane, your dedication to our plight is admirable. So much information.

    I just saw a “Dr.” urologist. I have frequent UTI’s. I have been told I need my bladder out by one of several urologists. I have on average an infection every 1 1/2 months. I don’t think they ever really clear. Now I’m on a different prophylactic antibiotic. Hopefully it will make a difference infection wise. However, I have developed a terrible problem with thrush. I also have 2 4mm kidney stones, first time ever had one.

    That was the state of affairs when I went into her office. She asked “why are you here?” I answered because I need a urologist, I need to get these infections under control and I went septic in 2014 and never want to go there again! She looked at my husband and myself and told us “this was to be expected” considering my history. Nothing can be done. You just have to live with all this damage.
    I was crying in her office, I almost died. I was in a coma for 4 days. Coming out of it was hard, I acted like a small child for a few months. My family all flew down to see me, because the doctors didn’t know if I would live.

    She then told us that she puts it in and takes it out. My husband asked “don’t you see complications?” She answered, indignantly “of course I do, I take it out. That is a complication.” I was crying too hard to be coherent, my husband decided this conversation was over. She acts like it’s just part of the deal. Some need it removed and she does it. Nothing about the fact that it is extremely hard to remove.

    I’ve had 2 mesh removal operations. Dr. Raz did the second one. He knows what he is doing, and I say he’s the best in the industry for removing mesh. This was in 2010.
    Fast forward to 2017. I had a translabial ultrasound done. I still have a 4″ piece of mesh in me, on the right side. Odd thing being, I’ve told my friend for years that it felt like mesh was still on the right side. I believe Dr. Raz was telling me what he thought was the truth. He is conscientious. It is that hard to find!!
    We were both shocked, and expected the film to be mesh free. Though it did explain a lot of things. After the second removal doctor Raz did, I had another 8 hour surgery to remove mesh. The doctor could not find any.
    So to calmly say “I put it in, and when I need to, I take it out” Is such crap!! I wish I could write to someone about this, that would make a difference. It is just so maddening.
    I do believe in God. I wouldn’t be alive without Him. I pray for us all.
    I am going to a urologist that is 7 hours away. I have a pelvic pain doctor that is 13 hours away. I am fortunate my husband supports me and takes me to these appointments. I know I’m blessed. However, it doesn’t take the suffering away! We need a reprieve from pain!
    I will continue to pray for us all!

    • Jane Akre says:

      That’s an incredible story. I wonder if Dr. Raz would take another pass at it…. perhaps this is the evidence that mesh does move. Put it in and take it out….. right. How many people do NOT go back to their doc after complications, so the doc can say “I never see complications…” d-Mannose, Superior Labs, you can get on Amazon and it might be what will help alleviate your UTI. It prevents the bacteria from taking hold is my understanding. Seems to work for many. I apologize if you have already tried this but really if you have not, please try. You have been through so much. I’m sorry.

      • Disgusted says:

        Thank you Jane. I have tried D-Mannose. I still get infections. I went septic while I was on Cipro, D-Mannose and cranberry tablets. I knew something was wrong, called the doctor and was told to give time for the antibiotic to work. I was non-responsive 3 days later. That was in 2014.
        Before the infection I was on macrobid to prevent it.
        I will say that I have a low white count, was put on IVIG which did solve the low level, but did not stop infections. The hematologist said my count is low because my body is fighting too much and can’t catch up. He felt the IVIG wasn’t making any difference and took me off of it.

        I am going to see Dr. Peters in MI. He did my interstim and knocked the pain down by over 50%. He is going to do a work up and see what is going on. I told him about the idiot Dr. at UW. She is just a mesh machine, in – out.

        On another note, I think we should all gather together at a mesh convention for doctors. To see us all, how could they deny it?

        • Jane Akre says:

          Any referrals to competent doctors are more than welcome…. if you want to send me his first name and location, I’d appreciate it.

          I understand cranberry is very acidic and not what you want when you ave an active infection….Still Standing has written about that…. Try this d-mannose:

          https://www.amazon.com/Superior-Labs-D-Mannose-Supplement-Vegetable/product-reviews/B00V5K9L4K

          • Disgusted says:

            Jane . . . His name is Dr. Kenneth Peters. He works at Beaumont Hospital in MI. He is a urologist. I found him by reading one of his papers on the interstim. He had found that when the interstim was planted into the S2-S4 and the pudendal nerve the response from his study was always the pudendal nerve was better. So he stopped going to the SI joints. I thought he’d done a through job and went to him. I had 3 doctors telling me it was my only option for reduced pain. I did not want to have another implant because of the mesh implant. After much coaxing from my doctors I did the trial and had great results. My pain has been reduced by over 50% overall. My good friend, also mesh injured, pudendal and obturator neuralgia followed in my footsteps. She is much better. Neither one of us could sit for more than 15 mins without severe pain. Now we can sit through dinner at a restaurant, with a pillow of course. But, big change.

            He is a very caring doctor. He is straight forward and tells the truth. For instance I asked him how it works and he told us “they don’t know”, just that it does. It has something to do with the brain. They tried it on paraplegics and no help at all. The cord to the brain was disconnected. There is much more research going on here.

          • Jane Akre says:

            Thank you so much for the referral….. Many will benefit. Perhaps we should do an interview! Thanks again. I’m so happy you found some degree of relief from your pain…. that is very good news.

          • Disgusted says:

            I have ordered this D-Mannose. I hope it helps. Always worth a try. I’ve spent a lot of money on supplements trying to find something that would work for me. But that is my state of affairs at this time.

          • Jane Akre says:

            You deserve a good turn…. a MASSIVE good turn…I too hope it helps.

        • bejah blue says:

          Sign me up! Bejah

      • Bejah Blue says:

        BTW has anyone received a thank you from UCLA for participating in their survey or been told what they intend to do with the data…any response at all from them? Just wondering now that it is November. Bejah

        • Jane Akre says:

          Bejah- It just closed yesterday. The researcher wanted 500 folks and I believe she got that… just from our efforts so THANK YOU to all who participated. I will bug her about any information that is forthcoming from the research… it is truly needed.

          • Bejah Blue says:

            Thanks Jane for tracking all of this for us. Such a comfort to have you there…a voice of reason and compassion.

            Bejah

    • Bejah Blue says:

      So you went to a female Urologist and she spoke to you that way????!!!! What a monster. You should have told her off and walked out young lady. I also feel you should report her to the medical board of the state you live in for gross failure to adhere to her oath as a physician and even the most basic human decency. I am so sorry that happened to you. There is no excuse for such wretched conduct. Please never go back there and never accept such treatment from any physician again. You have been through such horrors. Please do not take seriously her suggestion that you have your bladder removed. Please do not do that. Bejah

  7. Bejah Blue says:

    Dear people, Are we aware of this? This I pulled from NIH this afternoon. Could this help some of us? Bejah

    Collagen scaffold: a treatment for large mesh exposure following vaginal prolapse repair
    Marianna Alperin corresponding author

    The publisher’s final edited version of this article is available at Int Urogynecol J

    Abstract: Transvaginal repair with mesh of pelvic organ prolapse (POP) provides women with the durability of a synthetic graft using the less-invasive route of vaginal surgery. However, morbidities such as mesh exposures are common and challenging to manage. Small intestinal submucosa (SIS) is a naturally occurring collagen matrix derived from porcine intestine. It contains growth factors and cytokines that promote healing of damaged tissue. This case report describes a large vaginal mesh exposure due to necrosis of the full thickness of the anterior vaginal wall. A remarkable and rapid regeneration of vaginal tissue over the exposed mesh was achieved with SIS placement after failure of treatment with vaginal estrogen for >6 months. Collagen scaffold is an effective, rapid, and minimally invasive treatment for large vaginal mesh exposures.

  8. Bejah Blue says:

    Dear people…Something we should be aware of perhaps…note differing mesh products and methodologies I was not aware of. Hope this is useful and not redundant. Sometimes it is hard to keep track of what we have and have not discussed! Take care all, Bejah (See excerpt below and path to primary article).

    Surgical department of the technical University, Aachen, Germany.
    Samples of 17 non-absorbable meshes (1 polyester, 10 polypropylene, 2 reduced polypropylene, and 4 polytetrafluorethylene, PTFE) and 1 absorbable mesh (polyglactin 910) that had been implanted for repair of abdominal wall defects.
    INTERVENTIONS: Light and transmission electron microscopy, immunohistochemistry, and histological examination.
    MAIN OUTCOME MEASURES:
    Signs of inflammatory response.
    RESULTS: Light microscopy showed chronic inflammatory tissue reaction, even after years, with pronounced differences among materials. Partial volume of inflammatory cells (%) varied from 32 in polypropylene, to 12 in expanded PTFE, 8 in polyester, and 7 in reduced polypropylene. Formation of connective tissue correlated significantly with the extent of the inflammatory reaction (p<0.01). In meshes implanted for long periods there were still numerous macrophages (a large cell that is present in blood, lymph, and connective tissues, removing waste products, harmful microorganisms, and foreign material from the bloodstream ) at the interface between tissue and polypropylene (45%), polyester (45%), expanded PTFE (25%), and reduced polypropylene (22%). There was no difference in time dependent tissue reactions (p = 0.19).
    CONCLUSION: Inflammation around alloplastic materials used to repair defects in the abdominal wall persists for many years. There was evidence of long term wound complications as a result of persistent foreign body reactions. Further studies are required to evaluate the long term tissue response to these materials.
    PMID:10452261
    DOI:10.1080/11024159950189726
    [Indexed for MEDLINE]

    • Kitty says:

      Bejah…The report is interesting; however, It cannot conclude if MESH Is or IS NOT RESPONSIBLE FOR AUTOIMMUNE. It is interesting in theory. The facts are in…some women developed autoimmune disease after implant. I am not sure of the older lady that passed away after she developed some horrible autoimmune. The family won millions in court.

      • Bejah Blue says:

        Hi Kitty, everyone…I am going to be posting something about auto immune soon. I just finished reading most of a book about Multiple Sclerosis which is an auto immune disease I guess. The book is Brain Disorders Sourcebook by Roger Cicala, M.D. He is medical Dir. of the Methodist Contemporary Pain Inst. and former Professor of Medicine and Chief Resident at U. Tenn. Seems like a good guy. I am interested in MS because of the demyelination in my L7+8 cranial nerves and why that happened (This was pre-mesh by a year or so). I am naturally concerned and in this kind of situation I naturally suspect a possible genetic link. Naturally it is a source of concern. Scientific inquiry is the best way to address that concern, hard for an empathic poetic and intuitive soul like me but I try when it makes sense. Dr. Cicala is immensely readable and covers a lot of ground. I also appreciate his extensive indexing, etc. I am also reading Larry Dossey’s Healing Words at present. It is a lush and beautiful book, much more my cup of tea…very comforting, It is, if we must say something, about prayer. It is good medicine. Not a “new” read but that does not matter, esp. with something like this. I believe books come to us when it is time to read them much of the time. So I venture into my retreat (No SAT TV, no internet, no phone…for a time. Also reading Deepak Chopra’s book on Merlin and the symbolism of the Grail and King Arthur myths. Also very beautiful. One must feed the soul with books, not just the mind. It is turning cold now. Time to curl up with a good book and in my case a mug of warm milk and rum. Love to all, B

        • Bejah Blue says:

          BTW people, especially those who use artificial sweetener PLEASE know that it can contribute to demyelination of the nerves. This is VERY serious. Please stop using it. Use something else. Ok, I am off now. See ya.

          Bejah

  9. Bejah Blue says:

    I do not understand the reasoning that there is not sufficient evidence to link autoimmune to polypropylene mesh. I read the factual stories here about the damage, the suffering, the permanent life altering injuries that are medically documented, all of which occurred post implant. I consider what we do know about this material and the subterfuge associated with its development, marketing and use. I read about the profit for the corporations marketing it and the physicians implanting it, the deception, the lack of proper explanation on the part of physicians to their patients, the deliberate failure of highly regarded medical centers to retain tags and identifying data on implanted devices, I consider the foot dragging of the FDA, the taking down of links on this matter, the deliberate destruction of documents on the part of the defendant corporations, the blatant effort of these entities, which is also well documented, to prevent the testimony of expert witnesses, the effort to dismiss valid cases based on jurisdiction or some technicality…all of this and more and I cannot accept that there is not enough scientific evidence to establish a well defined causal link between autoimmune issues and polypropylenee mesh implants. Show me the science that is ongoing…point to the legitimate research that is NOT funded by the defendant corporations, and tell me that the intuitive sense of the women whose lives have been destroyed is misplaced…that we are all psychosomatic as a medical professional Kitty saw attempted to claim? Yes, we should refrain from besmirching others even if they are guilty, but I cut these woman a lot of slack. Their lives have been ruined. As I said to Jane the other day, they have a right to be pissed off and they need a place to vent. I say, let them do it here, this is their safe place. If the world does not like it then F**K the world. Bejah

  10. Bejah Blue says:

    With regard to polypropelene mesh and establishing a causal link, I ask that we all review the following fm Pelvicmeshownersguide website: Bejah

    What we know about polypropylene:

    What we know about PP is that contrary to popular belief PP does not remain inert in the human body when subjected to a chronic oxidation process in foreign body reaction (FBR) ( 6 ). We know that FBR in the cohort of patients with mesh complications has not been transitory as surgeons and manufacturers had claimed it would be ( 8 ).We know that during the degradation process of PP in the human body the leachates of the degradation of PP are free radicals, and depending on the residues of the manufacturing and sterilization processes adsorption of toxic residues into the human body can occur (9). We also know biofilms can form on mesh implants and harbour bacteria that becomes a source of chronic infection. Bacteria are implicated in the hastening of polypropylene degradation ( 10 ). We know that polypropylene can have an adjuvant effect in the human body (11). It has long been understood that adjuvants help elict strong immune responses.

    Surgical polypropylene (PP) mesh is not inert according to peer reviewed published research ( 2 ). The foreign body response uses an oxidation process to degrade the mesh filaments, so phagocytes can attempt to dispose of the foreign body which in this case is mesh (3). The oxidation process makes surgical mesh stiff and brittle in a flexible weight bearing part of the body. The painful mechanical and chemical irritation of degrading mesh is well documented with over 60 thousand lawsuits against mesh manufacturers(12).

    Mesh fragmentation, migration, leachates and the peroxide secretions meant to destroy the mesh, do collateral damage. Peroxide irritates and damage surrounding tissues invoking a stronger foreign body response as free radicals leach into surrounding tissues ( 4 ). However disturbing the failure of PP mesh to remain inert when it is permanency planned, the most troublesome property of polypropylene mesh may be the adjuvant effect it has in the human body. According to researchers(Bennewitz, Biomaterials, 2005) This results in a “detrimental humoral or cytotoxic response” around the implant causing an “inflammatory tissue reaction.” What do we know about adjuvants? The purpose of adjuvants in vaccines is to trigger a strong immune response. It is well documented that adjuvants in vaccines have caused autoimmune diseases in a subset of patients over exposed or hypersensitive to adjuvants (5). Can it be argued that permanently implanted devices or materials that have an adjuvant effect, over expose patients to the damaging effects of constant immune system stimulation? Can this chronic stimulation of the immune system by a surgical mesh agent that elicits an adjuvant effect, be a cause of ASIA? Can this this be identified as pathogenisis to autoimmne exacerbation and or initiation? I believe so. I believe this deserves to be researched in depth, arms length from invested parties such as manufacturers and researchers benefiting from manufacturer grants and sponsorships.

    The connection of adjuvant activity to autoimmune:

    Many patients reported symptoms that are best described by Autoimmune/inflammatory Syndrome Induced by Adjuvants, (ASIA) (13). Their complaints also fit into the description of HAD (14), Implant Syndrome (15) and SIN (16). The definition, or explanation of ASIA, is found in publications of Yehuda Shoenfeld and Nancy Agmon-Levina at the Zabludowicz Center for Autoimmune Diseases, ( 1 ) According to these leading researchers in the newly burgeoning field of autoimmunity this syndrome appears following chronic stimulation of the immune system by agents which have adjuvant characteristics.

    • Jane Akre says:

      I would love it if you could source that info…. thank you, it is good.

      • bejah blue says:

        Of course. When I get home. Remind me. First I must dawn my “Queen of the Night” costume, my purple and black tights and my long purple gloves and witchy hat and open the door for trick or treaters (So they do not boysenberry jam my screen door or toilet paper my house!). I am so bad, I have been getting into the Halloween chocolates!!! The site is the one run by the nurse/victim. Remind me if I forget. I will be busy playing Scrabble. In the morning on the first I must go stand in support of my friend in court. Busy day tomorrow. Love, Bejah

        • Kitty says:

          Bejah…Take it easy on the chocolates. I think of u every time I dig into my pomegranate…so perfectly ripe and crunchy.. Are they in season in your area?

          • Bejah Blue says:

            Kitty, You are so sweet…I am sending the chocolates to my guy’s business today for his clients, he is NOT allowed to have any! Yes, it is in the winter when the fruit comes. I have some in my refrigerator. I will use them at Thanksgiving. The color is so gorgeous. I will put some in the cranberry sauce and in the salads (edgy Waldorf and a molded gelatin salad of some sort). If I make a Rhubarb raspberry pie which I always try to do I will put some in that as well. Love ya, Bejah

          • Bejah Blue says:

            Good morning all, Just a gentle reminder about pomegranates. “The health benefits of pomegranates are innumerable and what makes them special is that apart from being healthy, they are delicious too. Pomegranates have
            anti-oxidant, anti-viral, and
            anti-tumor properties and are a good source of vitamins, especially vitamin A, C, and E, as well as folic acid.”

            I always get a bottle, even the small one, when I am at the market and just drink it there (Good medicine). The fruits are now $2 each at Von’s BTW but worth every penny. Remember people food is medicine.

            Bejah

      • Bejah Blue says:

        Jane, Did you see the source data? Do you need more from me? Let me know.

        Bejah

    • Kitty says:

      Bejah…research material is so boring…but it is so excellent that you are providing these studies for us. Not just giving general assumptions. As we all know we should not assume anything because it uses an ass out of u and me

  11. Bejah Blue says:

    One more thing before I leave for the day…please read this people and know that with regard to my implant I was told by the Head of Medical Records at UCLA that she talked to the surgical nurse in Urology about the missing implant data in my medical file and was told that the tag was thrown in the garbage. AND No info on the tag was noted in my medical file. I tell you this was deliberate. Why do you think Jnj would not want that information recorded in 2010…could it be that they knew this was wrong and wanted to cover their tracks? Read on about your tags…please. Bejah

    Pelvic Mesh: Your Device is Tracked. So Are You

    Posted on July 30, 2017 |

    The FDA requires Medical Device distributors to track your device up until and including your death—including your name, address, phone number and social security number. Title 21 of the FDA regulations require the device distributor, final distributor, or multiple distributors (devices that move from patient to patient), promptly upon purchase, provide the manufacturer the name and addresses of all distributors along its journey to you, including the lot number, the date the device was received, and the person from whom it was received.

    Tracking Devices vs. Device Tracking

    The last distributor before your implant must also provide the manufacturer with their own name and address, the unique device identifier (e.g. lot or serial number), your name, address, phone number and social security number—unless you refuse to release that information under 821.55(a).* They must also record the date of your implant, name, address, and phone of both implanting surgeon and regular physician, and the date the device was explanted.
    If a patient dies, the end point distributor must provide the date of death, name, address, and phone of treating physician, date of any explant with contact information for explanting physician, and, where applicable, and the date the device was returned to the manufacturer, retired from use or disposed of in any other way.
    * Any patient receiving a device subject to tracking may refuse permission to release their name, address, phone and social security number or any other identifying information but, the hundreds of pelvic mesh implantees who were not told they had an implant or that a tracking system exists, would have no way to refuse permission. Title 21 can override a patient’s right to privacy if the “health or safety of the patient requires that such persons have access to the information.”
    (fm same site as comment above)

  12. bejah blue says:

    Thanks Jane…I love you guys. I want to help in some way. I am still very interested in addressing the inappropriate presence of salesmen in the operating with my unconscious naked body without my knowledge or permission. This makes my blood boil and I will not stand for it. At the very least we must be asked to be notified of this, the detail of the individuals name and affiliation must be noted, and we must sign off on such a thing. If we do not approve then it should not be allowed. If the surgeon needs some salesperson in the room then they are not qualified to do the surgery IMHO!!!! This must be changed. I am certain in my case that this salesperson from Ethicon encouraged the surgical nurse to throw out my implant tag (Probably took her to some high end cafe for lunch (It does not take much to influence people). Doctors and nurses should refuse such things but they do not. There is a lot that needs to be fixed. Bejah

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