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Documentary: J&J Knew Risks of Prolift

Mesh News Desk, February 22, 2017 ~  A news magazine in The Netherlands has just aired a documentary that says Ethicon/ Johnson & Johnson was well aware problems would happen with the Prolift transvaginal mesh and marketed it anyway.  

The documentary shown on the show RADAR in mid-February.  #radartv

Prolift was the most used pelvic mesh in that country, according to government officials.

 

Prolift is a larger mesh used to cradle falling pelvic organs. It is implanted through the vagina, hence the name transvaginal mesh. Prolift is no longer on the market in the U.S. 

See the Radar program  here.

Adam Slater on Radar

 

New Jersey trial attorney Adam Slater is featured, in the program as well as two women implanted with Ethicon’s mesh – Maria and Dora.

Maria & Dora watch, Prolift implanted

 

In the 35 minute program,  Ethicon’s Worldwide Medical Director, Piet Hinoul told Slater in a videotaped deposition, he knew mesh retraction, dyspareunia and pain would occur.

“Those bastards,” says Maria. 

Offering commentary is  gynecologist, Dr. Heinrik Cammu who comments, “At some point you have to say ‘We’re not doing it'”.

But Ethicon never reached that point. 

 

Slater and Lucente

DR. LUCENTE

Dr. Vince Lucente in the U.S. helped bring Prolift to market as a consultant and teacher to other doctors on its use. TVM mesh was the prototype of Prolift.  

While it was launched on the market in March of 2015, the FDA was never alerted and there was no clearance obtained for Prolift. In fact, the FDA was not even aware it was being sold until Ethicon applied for the next generation of POP mesh, Prolift M+ and cited Prolift as its predicate device.

Slater requested raw data from Dr. Lucente in preparation for his trials in the U.S.

“The reported data has under 20% complications but our expert found there were failures that hadn’t been counted.  More erosions, more recurrences, these were the key points for safety and efficacy and the reports were worse than what Ethicon was telling people.  This great doctor had a 49.7% failure with Prolift,” said Slater referring to Lucente.  

Dr. Lucente admits in his videotaped interview that he collected $1,709,291 in compensation from Ethicon over ten years.

“Ethicon knew he wasn’t telling the truth,” says Slater.

 

INSTRUCTIONS FOR USE 

Two months before the launch of Prolift, Ethicon employees in medical affairs said doctors should be told Prolift may present significant risks for sexually active women. That warning was not in the IFU (instructions for use). Instead of revising the IFU,  the concerned doctors were told that the instructions had already been printed.

They would get to the revision next time. That never happened.

Dr. Axel Arnaud

Dr. Axel Arnaud, a French consultant to Ethicon, explains that any competent gynecologist would understand the risk, attempting to explain away the omission. Slater says they didn’t want to scare doctors away from using Prolift.

If that warning had been in the IFU, along with the true erosion rate, the risk of dyspareunia, a return of prolapse and a risk of another surgery, no doctor would be interested in the product. 

Professor Bernt Klosterhafen, who collects explanted hernia mesh, is a leading expert on removed mesh. Over time, he says, mesh becomes tough and has no function. He has a database of 600 meshes and they all have the potential to produce complications. He believes we are at the beginning of a process and will see an increasing number of complications. 

Host of Radar

In 2008 and again in 2011, the Food and Drug Administration (FDA) issued Safety advisories about transvaginal mesh. Those warnings never made it to The Netherlands until 2013. 

In January 2012, the FDA alerted Ethicon it would have to provide a higher assurance of safety for Prolift. That day Ethicon employees talked among themselves. If we pull the product off the market, we may avoid having to do those studies.

Ultimately a deal was made with the FDA, Prolift was pulled off the market in June 2012. Ethicon didn’t have to do its safety study. 

Ethicon said it discontinued marketing Prolift (and three other meshes) for commercial reasons.

A European study, published in December 2015, concluded that meshes are not effective or safe in the long term.  See See Scientific Committee on Emerging and Newly Identified Health Risks (here).

There’s only one person to protect you and that’s you, concludes the presenter## 

 

 

28 Comments

  1. Doreen D says:

    I had a vaginal prolapse repair with mesh in 2007 which has ruined my life because my body rejected the mesh straight after the operation but the surgeon refused to remove it until 6 months later by which time my body had grown over the mesh so the surgeon was only able to remove a small amount as he did not have the experience to remove it and I have been left with chronic pain ever since. This mesh should have never been used on humans. It’s disgraceful that J&J only care about making money and have no concerns of the devistation they have caused to innocent human beings.

  2. Anon says:

    This is clearly CRIMINAL BEHAVIOR…….
    When is our Criminal Justice Department going to step in?

  3. Sandy says:

    You know I don’t understand why it’s taking Boston scientific so long to make settlement offers I believe the law firms has a lot to do with it like my attorney tells me oh Boston scientific has deep pockets all of this is in benefit for the law firm all these other firms are settling but mostyn law firm when you call they never have anything to tell you.

    • Jane Akre says:

      They can’t FORCE a company to settle!! At lest you get to talk to someone. There is a Boston Sci case coming up March 13 in Philadelphia…. another July in Los Angeles.

  4. Sandy says:

    I’m so frustrated with this nonsense Boston scientific knows there product was faulty but yet they still want to dispute all findings judge Goodwin needs to push for this company to pay and stop beating around the bush with the nonsense but you know ladies it’s all about Money Money Money the big wigs don’t care about the ones who have been injured they only care about how there bank account will grow from all of us being ruined for life

    • Anon says:

      Does anyone else find this documentary disturbing? In light of all of this evidence……. Why is our Criminal Justice System not criminally holding JJ Ethicon and Dr. Vince Lucente responsible for our mesh injuries.

      • UpsetwithEthicon/JnJ says:

        Why do we need to be on gag order? Are we suppose to pretend that we don’t see the youtube videos and the truth they tell? Google and see how many are out there. Definitely more than 5 years ago.

  5. Linda Dodson says:

    The FDA should be held liable for the devastating harm that these medical mesh devices have caused. The FDA should have never approved these devices for placement in a woman’s pelvic floor area. Until the FDA stops allowing companies to fast track these devices, the harm will continue. The manufacturers are crooked and very greedy. The women who have lawsuits are now being harmed by some attorneys that do not put their clients best interest first.

  6. Mart says:

    Well Jane your right they can’t force a company to settle but there’s things that can be done to get these cases moving along its all about the money for the big wigs

  7. Mart says:

    Also Jane I’m not worried about other Boston scientific cases I’m worried about my own case thank you

  8. Mart says:

    There’s a lot of criminal things going on here but I gaurantee these companies are paying off the big wigs to avoid prosecution money talks and bullshit walks let’s keep this thing honest here I’m not sugar coating nothing these companies should be held liable and they should be made to pay and be fully prosecuted to the fullest extent of the law

  9. Mart says:

    Anyone out there waiting to here about settlement talks for Boston scientific

  10. Mart says:

    My doctor said that my mesh removal was the most difficult case he’s seen yet I had to have my urethra reconstructed and I had to wear a piss bag for 2weeks afterwards how humiliating that was for me my sex life is ruined nothing but pain now I’ve been diagnosed with all these different kind of illnesses

  11. Anon says:

    There are absolutely No more legal questions left for this court, judge, or juries to weigh……. Dr. Vince Lucente and Ethicon’s Worldwide Medical Director, Piet Hinoul they admitted (under oath) on this documentary that they knew that Gynecare Prolift would injure some women, specifically mesh retraction, dyspareunia, and that pain would occur. I was one of the thousand (mesh victims) that was implanted with Gynecare Prolift before Ethicon got FDA approval.

    • TONI says:

      Anon I was reading your post and I am curious about your statement about being 1 of a 1000 women implanted with the Prolift before FDA approval. We’re did you get that number of women implanted. I’ve never heard the number of how many are out there. I was also implanted with it prior to approval. I of coarse did not no what type or much about what was done to me other than the doctor who implanted me saying he was going to make me and my life so much better following surgery in 2006. He was so wrong. My life has been ruined my health my sex life my self confidence my relationships all gone due to that surgery. I am now unemployed uninsured and alone. Trying to hold onto my home of 21 yrs. I am to the point of giving up. Feel like my life is over. I had my Prolift 85% removed but have suffered since then. Non stop infections have taken a toll on my body. I was engaged but he left me I am sure that the fact that I did not want sex for fear of yet another painful UTI for which I was on antibiotics for over a year was a big part of him leaving. My life is over due to this hell I’ve been through. If it were not for my kids. I’d just assume be dead. And to have these people say we had surgery to get money from these company’s is just ridiculous. I would be in my carreer making great money and happy if it were not for being implanted 11 years ago and the 4 surgeries to try to fix me after the fact. Well it has not fixed me it’s simply doing whatever I can and doctors can to try to fix what shouldn’t have ever happened in the first place. The simple fact that the FDA let them get away with non approval once it was discovered tells me they are not concerned about the people they are paid to protect. Think they and the judicial system all in there pockets. How else does this continue to be done to women or men in the case of hernia mesh.

      • Anon says:

        TONI……….I meant to say one (1) of thousands. I am estimating that thousands of TMV victims were implanted between the period of time that J J Ethicon placed Gynecare Prolift on the market and the actual approval by FDA. Ethicon began marketing Gynecare Prolift in March of 2005 before FDA knew it, they got somewhat of a clearance from FDA May 15, 2008. Gynecare Prolift was taken off the market in 2012.

        • Anon says:

          sorry……….TVM victims

        • Toni says:

          Anon, yes I was implanted in Jan of 2006 so I know full well about them not having FDA approval. I was told by my doctor he was going to rebuild me after going to him for nothing more than an IUD removal as I was at my 5 yr date to remove it. That’s when he said I was prolapse. And needed a hysterectomy. Funny cause I felt just fine and he also implanted a TVT at that time as well as the Prolift. So I believed the doctor as they are the experts. Well let’s see I’ve had 5 surgeries since including a removal were the doc got 85%. Every surgery had come with a price. I’ve always been a strong woman but I am at my end. Jobless close to homeless my fiancee long gone. I am now just over 50 and have lost hope of ever doing better. Adult diapers are not really something a man finds attractive. My ex was sweet enough to say he was going to find a woman who did not pee on him during sex. All of this and these companies knew what it could do and FDA did nothing about the non submission to add insult to injury. I sure wish I had the problem of peeing a little few drops when I sneezed and or had a terrible cold that made me cough. I’d take it all back for the hell they all put me through. Oh and I wonder how my doctors wife fells about it too. As my doctor bragged on implanting her before me. Oh and it was supposed to improve my sex life not end it.

          • Anon says:

            Toni………I am Sooo Sorry ☹. Your story breaks my heart. You were actually implanted a couple of months before me in 2006. I hope you fight JJ Ethicon to get the financial support that you will need for the rest of your life.

  12. Anon says:

    In my case……..JJ Ethicon began marketing and selling Gynecare Prolift almost three years before they had FDA approval.

  13. Lana F says:

    My question is why don’t we get a chance at a trail. Why some do and some don’t? Were all damaged for life.we need to stand together and fight for criminal charges against the manufacturers.and what about the accusations against boston scientific buying from china? If it comes out to be true and we have garbage in us that’s killing us. They really have no how much damage they have done to us.

    • Anon says:

      Lana F……. I totally agree with you on all accounts. All mesh victims has been permanently damaged/harmed by these defective products.

  14. Disgusted says:

    Again, this report is basically saying that mesh for POP repair is not a good choice. They claim it is good for SUI. I received a TOT in Jan of 2008. It worked well for 14 months and then shrank. It has caused pudendal and obturator neuralgia. It was in both sides of my urethra and caused severe damage. I currently have a doctor in Nashville that says my bladdder should be removed. My urethra has lost it’s ability of self protection – the scar tissue that has replaced the mucosa offers no barrier. So I get frequent UTI’s. I have tried various preventatives, D-mannose, low dose antibiotics, cranberry supplements, etc. I still find I get infections. I have to cath periodically because of retention issues. I am frustrated. I don’t see how they can claim that slings are safe. There is a risk of losing your life to this for an inconvenience of incontinence.

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