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In the Beginning: Suffering in Silence

sunflowerI recently was asked how I started with mesh as a topic for reporting.

I’m not mesh-injured myself. The reader wanted to know if I had a family member or friend who had mesh. No, I said, but when working as the National News Editor for InjuryBoard people started calling me. This was back in 2009. They told me stories about their mesh injuries and the doctors who turned their backs. I could not believe this was happening…. then I did the research and found everything they said was true.

I was and continue to be amazed at the huge divides between the devastating injuries and the safety nets that are supposed to be there to protect Americans.   They’ve fallen away and the women are falling through the cracks.    So I thought it might be time to revisit what we knew and uncovered back in 2009 compared to what is happening today.

Unfortunately not much has changed.   Here is the first in a four-part series, Suffering in Silence.  I hope you enjoy reading all four parts. ~ Jane Akre, Editor, Mesh News Desk, formerly with Injuryboard

http://news.legalexaminer.com/suffering-in-silence–medical-device-surgical-mesh.aspx?googleid=260038#ixzz1Tk4Lg1VQ

19 Comments

  1. Jane says:

    This is an amazing story and I hope it gets a lot of exposure because this has to stop. I’m afraid for unsuspecting women out there that don’t know about this and may have the surgery. Because of all the issues I have from my surgery I no longer have any faith in the medical profession. I live my life in fear that any day I will get an infection and have to have surgery. I live in fear to drive because I get random stabbing pains in my groin area that doctors do not know what causes it. I have nerve damage in my leg and lymphedema in both legs from this surgery.

    I was just declined disability after a 2 year process because the doctors will not admit that my issues stem from the surgery. There are many days that I cannot function as a normal person. I had a job with endless sick days because I worked there so many years but moved to another state in 2011. I’ve been trying to work, tried working from home free lance. I can’t sit or stand for any period of time due to back spasms and leg pain. I’m currently going for therapy but it’s a slow process to help with the pain I now have. It took me from 2008 to March of 2014 to get a diagnosis of the pain I have which is Myofascial pain. This pain started within 36 hours after the surgery. I have mesh erosion that fortunately has not become infected. My uro gyn is monitoring it for now because surgery would involve possibly making the leg pain worse. I’ve lost 3 years of wages now, reapplying for disability is my only hope. Wouldn’t wish this feeling on my worst enemy.

    • msm says:

      JANE ! That’s nearly identical to my story! (ith the one unfortunate exception that I’ve had 3 surgeries and am still dealing with infection). I was basically “conned” into Tension-free Vaginal Tape with the promise of “simple”, “fast”, “best long-term solution”, etc. Before the procedure, I searched and found that TVT was “clinically proven safe and effective” on the manufacturer’s site. I had problems very shortly after the procedure and was told I should expect a “little discomfort” since it is a synthetic material and I should be pleased with the results because the incontinence was mostly under control. I never expected the degree of pain, the persistent infection, the extrusion and erosion, the loss of a decent quality of life, the financial, physical, and emotional cost that would result. Finding a urogynecologist with guts enough to go against his “colleagues” and make a proper diagnosis, was hard to find. It was distressing to learn that not all of the mesh could be removed and that the remainder could migrate and do further damage.

      So here I am along with thousands of others, who are left to suffer with the pain, recurring infection, and fear of more surgery. Then to hear “professional” organizations continue to declare it as the “gold standard” and how it helps thousands of women increasing in number every year, makes me wonder about the connection of these “professionals” to the manufacturers of these products. New and “improved” versions of TVT are continuing to be “cleared” without testing and this will only serve to confound future studies. With more and more women being implanted with different versions of TVT, it will take years and even decades to determine the full extent of the damage done to the female population as a whole.

      Case in point:

      In the 1960’s, over 50% of men and 30% of women smoked and we saw no problems with it. It was advertised as relaxing, sexy, grownup, and cool. Even when the detrimental effects began to come to light, it took years for the medical community and the Attorney General to issue warnings about the health risks, remove advertisement from TV, and educate the public on the dangers. So many lives were lost and ruined as a result of this lag between discovery and action. Did tobacco companies perpetuate the delay? Absolutely.

      TVT studies:

      Doctors boast that TVT mid-urethral slings are helping more and more women everyday. What will be the result 3-5 years from now? Many of the “studies” showing that the TVT mesh is safe, tend to use vague baselines, and admit that there are no control groups and further study is needed. The primary measures used for determining a “successful” result are usually sexual satisfaction and function inventories and/or subjective reports of pain during sexual intercourse. These pain levels will vary greatly based on the patients’ general pain history, (i.e. 1 to 10 scale is different for someone who has experienced childbirth than for someone who has not). The act of intercourse itself and the partners involved introduces so many variables that there cannot be a true objective measurement. One study started with over 150 subjects but when they got to the final results, fewer than 40 subjects remained. Others were “eliminated” during the study for various reasons (i.e., were no longer in a relationship, developed other unrelated illness/injury, died, dropped out).

      Where are age and cohort studies? Why not study 30-40 year olds with active lifestyles (define active), 30-40 year olds who are sedentary (define sedentary). Take into account pre-existing and co-morbid conditions before selection. Do the same for 40-50 year olds, 50-60, etc. Follow them for 10 years. Publish results at points along the way. We’ll never see these studies.

      Why not start in the lab. What are the forces generated by different movements of the human body and what pressure is exerted on the mesh and on the surrounding organs. This would need to take into account variables such as differences in anatomy and angles of placement, depth of placement and density of the tissue. If the measurement of success is sexual function, then measure forces generated during intercourse and consider all of the variables of size, weight, position, duration, etc. We’ll never see these studies, either.

      We know that the anatomy varies drastically between women and changes dramatically over time. We also know that the female pelvic anatomy varies tremendously especially with tissue density, ligamentous laxity, pelvic floor strength, presence or absence of organs and the positions and angles of those organs. It is impossible to determine if it will cause harm to any individual. For any professional to tell any patient that this is the best and the “gold standard” is unethical, uncaring, and immoral.

      Considering the FDA does not conduct its own testing of most of these products, it is no surprise that the manufacturers’ studies would show that the product is “clinically proven safe and effective”. There are as many studies published about dealing with the complications as there are showing the safety and efficacy. The FDA’s responsibilities need to be defined and limited to what it can evaluate and regulate in-house.

      Slightly off topic but it shows the absurdity of the FDA :

      The news reported recently that the FDA and the USDA are fighting over who should regulate and inspect catfish. Yes, domestic catfish! Right now, both agencies are claiming control. Now, I ask you, why is the FDA trying to regulate the fishing industry when the USDA is much better equipped. To justify funding? Probably. In the meantime, catfish is rotting and people are being harmed, even killed, by medical devices “cleared” without testing.

      Off topic but relevant:

      We’ve all heard the government speak of “tort reform” because of the plethora of medical lawsuits bogging down the court system. How many of the products in question are “cleared” by the FDA and how many are TESTED by and APPROVED by the FDA? There’s a study that could enlighten our lawmakers as to what “reform” would result on fewer lawsuits, mass torts, MDLs, class actions, etc. Then look at who really profits. Promote the Sunshine in Litigation Act. That will shine a light on what is really going on in the court systems and who is really profiting.

      • Jane Akre says:

        MSM- what women are told today about the promises of mesh is a travesty!. Even some doctors realize their colleagues are not giving true “informed consent” Until that happens, let’s do what Scotland did.

    • Carly says:

      Linda- I’m from Maryland too………..I have a wonderful urogyn in Md also have a pelvic pain Dr in Md. My uro took out all of my mesh and my pelvic pain found the nerve damage I have from a MRN.

      Please feel free to call me so we can chat……410-446-8454 Carly

  2. Dear Jane and Mesh Medical Device News Desk blog readers: it is disheartening to read that this surgical mesh scandal has lasted 5 years. The harm is horrifying and almost inconceivable to anyone that does not know a mesh-injured patient. Sadly, implanted devices made of chromium/cobalt (metal-on-metal hips), cardiovascular devices (failed electrical leads), Bayer Essure coils for birth control and surgical mesh (petroleum by-product plastic) are all cleared by the FDA usually with no human clinical trials or patient outcome registry/research. This is a very profitable scheme that is now institutionalized and legislated. It is imperative that each of us work every day to inform the public of this scandal and work toward removal of the market for these products that are unsafe and ineffective bloodsuckers on our economy and the lives of U.S. citizens. Our government and the medical community leaders have had every opportunity to correct the situation and they have failed miserably. Implanted devices that are safe and effective can prove their value by providing a warranty on product and providing patients with an independent robust and transparent registry that will contact implant patients with recall information and the opportunity to self-report adverse events. We have this on cars and appliances! Public health and our economy trump the un-earned entitlement of this for-profit industry segment.

    • Jane Akre says:

      Joleen- You are so right! Why are we not registering medical implants, and actively reporting adverse events, therefore making it more difficult for manufacturers to hide their problems and be less accountable! Consumers Union Safe Patient Project has this information available. You state it very well Joleen…I wish we had a Petitions Campaign that would go directly to the government as Scotland does…in the meantime the FDA reclassifying POP mesh is a good start. I hope everyone has weighed in. See page one of Mesh News Desk.

  3. pam says:

    Was reading back in 2009, , when I WAS BEING LIED TO AND NOT KNOWING WHAT WAS HAPPENING TO MY BODY, infections, and pains at times that would take me off my feet for 45 minutes to sometimes over an hour. I brushed off, they would go away. I STILL HAD MY STRENGTH THEN.

    the year beginning of , what I CALL HELL, DOCTORS LYING, INFECTIONS, TELLING ME NO INFECTIONS AND THEN INFECTION, my mind was being torn by lies and mind games by those I trusted.

    Where are some of the ones that posted in 2009 , today? I KKNOW DR MILLER FROM VANDERBILT SAID HE REFUSED TO PUT MESH IN ANYONE THAT SMOKED. Smoking cased mesh to move and erode and infections and pain. and they have said we were crazy??? How many women with mesh, has been through hell , with mesh cutting, causing bleeding, infections, pain, and more, that have never smoked in their life? We know how the doctors in the 50’s and 60’s pushed cigarettes , on the young back then, on tv and billboard signs, had to make some money for those that pushed mesh and lied today, for money, and the greed of it. OVER PEOPLE’S LIVES.

    KEEP QUITE, DON’T TELL, DON’T WARN, GAG, WHY,? they did not want the truth about mesh told, on news , to warn others the more no warnings went out, all investors and chemical companies would pull the wool over people’s eyes women that were being lied too, no answers, crazy? it’s not the mesh, something else, you don’t have infection, to 2 or 3 days later call comes that they say you have infection and have got to take this anti biotic. 4 and 5 months on going of infections, that anti biotic was not clearing up, pains , until it goes into severe damaged pain from mesh into nerves, moving into body parts, ,no end to the hell.

    after years , would it be wrong to tell some more off that lie about mesh, YOU WANT TO SAY IF YOU WANT TO PLAY MIND GAMES AND LIE LIKE THE DEVIL, GO PLAY WITH MINDS JUST LIKE YOURS IN THE STREET, OR IN PRISON WHERE THEY TEACH LIES AND MIND GAMES, NOT ALL , ARE INTO MIND GAMES AND LIE LIKE THE DEVIL, TO GET GREEDY MONEY. WE BELIEVE AS THE USA PROMISES CITIZENS, TRUTH AND JUSTICE WHERE GUILTY PAY, THAT WAS DONE BY CHEMICAL COMPANIES , NOT THOSE THAT TELL THE TRUTH. OUR PROOF, EXAM US! LET US TELL THE TRUTH. WE KNOW THE DIFFERENCE BETWEEN A LIE AND TRUTH. THAT EDUCATION HAS NOTHING TO DO WITH AT ALL, THE MESH CAUSED THE PAIN AND INFECTION AND TOOK OUR HEALTH DOWN, BY THOSE WE TRUSTED TO DO THEIR JOB AND DID NOT, EVEN FDA ALONG WITH CHEMICAL COMPANIES AND MORE.

    (NOT YELLING) SMILING JANE! DID NOTICE YOU USED CAPS IN POST TOO. IN 2009. I LIKE YOUR STYLE JANE. TY

    • Kitty says:

      We should plan on meeting in DC area this fall and go to Eric Holder’s office and insist on seeing Barack and Michelle Obama and ask them about J&J cover up. Lets plan the date and meet. Who ever makes it makes it. Should we charter a bus?

      • msm says:

        Might make more headway with the Secretary of Health and Human Services who is a member of the President’s Cabinet and oversees the FDA. If the government policy doesn’t change, people will continue to be injured, sickened, and even killed by defective products “cleared” by the FDA and “tested” by the manufacturers. If nothing changes, nothing changes.

        • Kitty says:

          msm—-What ever you believe to be the best to do. You have really given a lot of information and could probably get us to the right people. The problem is getting a group together. As Jane mentioned in the most recent post–the Scottish women were brave enough to go to the government. We really should go—but how to we get this thing together? What to bring et al? My daughter lives in DC area and could probably host 10 of us. We could notify media. If Pam could get her records together and someone could help her present them calmly.—I have my records and some inconsistancies or should I say down right lies in one such record. What about Sandy and Jade and all the others.?

  4. Sandy says:

    I would love to go with you I think it is necessary to get our government to listen to us. However, unfortunately I can’t travel right now. I am going to see a specialist in Phoenix in 4 weeks. I pray he can help me. He is my last hope right now. I wish so much I could be there. But right now I can’t sit for longer than 10-15 minutes. I am praying for all of us and support who ever can go. 🙁 sorry

    • Kitty says:

      Sandy I hope your MD visit goes well. Hopefully we can get something together.

      • Kitty says:

        I keep thinking of Dr Margolis at the Linda Batiste trial and his statements–especially about the Immune system attacking, attacking attacking the plastic in the body. Immune response, inflammation–PAIN. The hell with thre studies about placement, position of intercourse et al. Its about the PLASTIC stupid.

  5. Linda says:

    I’m in Maryland. I had the mesh implanted in June 2009 and symptoms started about 6 months later. I saw a commercial on TV for a lawyer and warning about mesh implants and I thought, “OMG, those are my symptoms.” . Can’t believe I didn’t connect it all together because I have other health problems that have worsened and some new ones and related it to my problems. I’m only 53. I also had to stop working due to pain. I have 2 bulging disks in my back and started having the hip and thigh pain and thought it was related to my back. I have had plenty of UTI’s, some urine given for testing was the color or tea. My last test, 3 weeks ago, was during a regular check up and I mention pressure but no other symptoms. My PCP sent out a urine sample, normal color, dip showed no blood, but after lab reported growth it was Strep B. I was dumbfounded. No burning, no blood, normal color and if I hadn’t brought up pressure the test would have never been done. I was prescibed penicillin and my doctor said she was in a hurry when I began asking questions she couldn’t answer. Last year I felt a little numbness on my left side, normally doesn’t cover such a large area. Was rushed to ER. Said it was probably a TIA. I saw a vascular surgeon and my left caroid artery was 95% blocked. He said it didn’t make sense that I had problems with my left side. He said if you have a blockage or clot on the left, it effects the right side of the body. He said he thought I was going to show a right side blockage when he did the dye test but the right artery was very good. DOES ANYONE KNOW IF THE MESH EFFECTS THE BRAIN, such as loss of memory, taking longer to do things, or can a very small piece, in a CT scan not show but have caused the problem. I don’t think I know as much as I should. COULD SOMEONE SHOW ME A GOOD SITE TO GO TO SO I CAN FIND OUT MORE. I think my decline in my physical and mental health may be due to the mesh. I AM CLOSE ENOUGH TO DC and I would go and could probably get a group of nice woman or families to let people stay with them, if needed. Thanks for your help.

    P.S. Lawyers office called and said that the company for the mesh I have wants to settle. They are breaking down settlements from 1 to 4. He said since I have not had any surgeries yet and a lot of my symptoms are coming from me and not doctors notes I will probably fall under category 2. Settlement $10,000. I said my uro/gyn does not take my Medical Assistance that I had to apply for because I haven’t worked since 2011. My plan had to find me one I could go to and the soonest I could get in September 11th. He said that I will get a letter with all the information and if I don’t except it they will not appeal it for me. He said they have been fighting them for so long and this will be the end of it for them. I have to wait for the letter but I think that’s crazy. These companies are rich and I can’t work and have a multitude of problems, most probably because of bladder mesh implant and I’m supposed to say “Okay, take your fee and I’m sure the balance will get through”. I’m scared and I don’t know what to do.

  6. Debbie says:

    My daughter had the mesh put in about six years ago and this past year she has suffered with major migraine headaches and symptoms like having a stroke but it is not a stroke. her body goes stiff and/or numb she couldn’t walk and she stuttered. I know that it states some of the problems are neuromuscular which seems to be major issues she is having not to mention sex extremely painful. she is basically having seizures almost every three days in fact today she had one and went to the emergency room. seizure make her arms and her legs start shaking or they become stiff she knows when they’re coming about but has no control over them. She goes to a specialist with headaches she’s had MRIs CAT scans and no one seems to know what it is and after reading some of these articles it sounds like she’s having problems throughout her body from the mesh. Please anyone out there are you experiencing the limbs shaking or stiffening like a seizure affect. She’s only 30 years old with three children a son of four years old and I am a mother that is so concerned please does anyone have any advice or suggestions also because of the problems she had to have a hysterectomy from this. Neurons muscular is what I’m asking about now if anyone has similar problems to see if this mesh should be removed because of her body reacting to it. Thanks and appreciate any help

  7. kiwi70 says:

    The same is happening here in New Zealand and it is totally disgusting that doctors are allowed to continue to implant this rubbish into women knowing full well that it is incredibly difficult if not impossible to remove the stuff when problems occur. * operations later and I still am meshed up.

    • Jane Akre says:

      Kiwi- I am wondering if the media in New Zealand is more open to this major story? What do you think? If so could you please let me know which media outlets should be approached. I believe you have the equivalent of 60 Minutes there? Any other news magazine on tv or otherwise. Our media in the U.S. is very broken I’m afraid, otherwise this would be a front-page story. Let me know Janeakre@meshnewsdesk.com

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