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Ethicon Abbrevo – A TVT Family Member- Day Two of Pelvic Mesh Trial

film on abbrevo The TVT-Abbrevo, one of Ethicon’s “Family of TVT” meshes to treat for stress urinary incontinence is the focus of the Perry v. Ethicon product liability trial.  

Thanks to Courtroom View Network for access to the proceedings in Kern Co. 

Coleen Perry of Bakersfield, California, and her husband Patrick, have sued Johnson & Johnson and its subsidiary, Ethicon Inc., claiming the company makes a defective product that led to her permanent injuries.

Judge Lorna Brumfield

Judge Lorna Brumfield

This is the first time Abbrevo has been the subject of product liability litigation.  Judge Lorna Brumfield is presiding.  

Abbrevo

Abbrevo

Abbrevo 

Abbrevo is made by Johnson & Johnson (J&J), the world’s largest medical device company, headquartered in New Brunswick, New Jersey. Ethicon, Inc. is a subsidiary of J&J.  Abbrevo is considered a mini-sling used to treat incontinence.

It is shorter than a TVT-O or a TVT measuring 1.1 cm x 12 cm and is made of polypropylene mesh. It’s known as the “Mini TVT-O.”

It claims “84% less mesh is placed in adductor muscles and 38% less mesh overall.”  It is placed through the obturator internus, obturator membrane and obturator externus.

Abbrevo passed through 510(k) clearance in July 2010.  The TVT-O was named as the predicate device under its 510(k) approval  (#K 100936). 

Called one of the “TVT Family” of meshes, its lineage is less than pristine. Among the TVT family members are:

  • TVT (Retropubic);
  • TVT-Obturator System (found defective twice in legal proceedings – Huskey, Batiste);
  • TVT-Secur (taken of the market in 2012);
  • TVT-Exact ( still on the market)
  • TVT-Abbrevo (still on the market)

What’s known is that there have never been any long-term studies with safety as an end point on Prolene mesh (polypropylene) used in the TVT family of meshes.

Thomas Cartmell, Wagstaff, Cartmell

Thomas Cartmell, Wagstaff, Cartmell

Familiar Faces

Some familiar faces are appearing at this Abbrevo trial in Bakersfield.  

Tom Cartmell is the lead attorney for the Perrys. He will present witnesses including, Dr. Stephen Guelcher (Huskey case); Dr. Peggy Pence (Linda Gross, Enghayem, Carolyn Lewis, Batiste cases); Dr. Bruce Rosenzweig (Huskey case); and M. Tom Margolis MD. 

For the defense, William Gage of Butler Snow is asking questions of witnesses.

 

Legal Theories

The defense must show that the company did due diligence in bringing the Abbrevo polypropylene mesh to market and/or that it went beyond what was required by the Food and Drug Administration. They must also show that adequate warnings were contained in the IFU (instructions for use) for the doctor and in the patient brochure so the woman could have true informed consent.

Laser v Machine cut mesh

Laser v Machine cut mesh

Laser v. Machine Cut Mesh 

The defense has told jurors there is no clinical difference between laser cut or machine (mechanically) cut mesh. The TVT Abbrevo uses laser cut mesh.

Attorney Kim Schmid told jurors on day one of trial that the Abbrevo is superior because it does not require any large abdominal incisions, any hospitalization, and is made of polypropylene so there is no foreign animal or human cadaver tissue foreign body reaction. It is less painful for the patient and all of this ends up with a shorter recovery period for women, she told jurors.  

It is very effective, she said, because women are still dry after treatment. 

Dr. Peggy Pence, Linda Gross trial Feb. 2013

Dr. Peggy Pence, Linda Gross trial Feb. 2013

On the stand in day two of Perry v. Ethicon, Dr. Peggy Pence appeared for the plaintiffs. An expert in regulatory requirements, Dr. Pence has appeared at many pelvic mesh trials as an expert. Always poised, she appears to hold her own even under difficult and sometimes aggressive questioning.  Even in just asking if she can elaborate on her answer, she sends a subtle message to the jury she differs with the characterization by, in this case, defense attorney William Gage.

William Gage, attorney for Ethicon

William Gage, attorney for Ethicon

As is customary, Mr. Gage asks about her compensation rate to be in the courtroom and to prepare as an expert.  At roughly $500 an hour and with about 200 hours in this case, she’s charged the client about $100,000. She is pleasant and polite in answering his questions.

Problems with Laser Cut

TVT-O started out as mechanically or machine cut mesh, said Dr. Pence, but in 2006, the company made it available in either laser or machine cut.  The laser cut didn’t catch on. Scandinavian countries refused to use it. They wanted mechanically cut mesh. Why?

Pence pointed to a study that found laser cut mesh in the TVT Secur had seven times as many erosions when compared to TVT-O and all of those erosions required surgical repair. The TVT Secur was made with laser cut mesh.   

In the patient brochure were there any warnings about laser cut mesh?  No, she answered. Was there anything about it being more stiff or dangerous once placed in the patient? Again the answer was no. Additionally, developers within Ethicon had expressed concerns, among them, Dan Smith a lead engineer and Abbrevo inventor Dr. Jean de Leval.

Asking Dr. Pence about a study published in March 2011 on the TVT Secur (laser cut mesh) outcomes after 12 months on 1,000 women concluded the erosion rate was 2.4%, pointed out Mr. Gage. And besides, he added, there is no requirement by the Food and Drug Administration that a patient even be provided a patient brochure.

Dr. Hung Luu appeared on the stand in the afternoon.  

 

Learn More:

See Patient Profile – Hope Pagano who developed Lupus three weeks after her Abbrevo implant.

Here is the 510(k) approval from the FDA dated received April 5, 2010 but with a stamped date of September 28, 2012.

Here is a MAUDE Adverse Event Report on the Gynecare TVTO Abbrevo Kit Continence System Mesh Sling Vaginal Tape. MAUDE represents adverse events called into the FDA.

Here is the FDA Summary of Safety and Effectiveness, July 1, 2010 – Gynecare TVT Abbrevo Continence System,  the Gynecare TVT Obturator System was the predicate [which has been found to be defective]

 

21 Comments

  1. David says:

    Great job with the story Jane. The links are very informative –with the correlation to the 510(k) pre-market clearance pathway. I especially like the link to the legal theories presented by the Transvaginal Mesh Working Group. These theories help to give another dimensional layer to your coverage, of not only past, but future trials. It is a real “eye-opener” into how the fraudulent marketing of “substantially equivalent” surgical mesh devices, by these different mesh manufacturer defendants, has been allowed to go on for as long as it has. They all seem to predictably being operating out of the same playbook.

    I believe the evolving transparency, being shed by these trials, will both change how implantable devices will be marketed to future patients and fundamentally how medicine is practiced. It will no longer be manufacturer/surgeon inflicted, but a legally informed patient collective will tell an industry how it will practice medicine. Medical schools with consequently have to train future surgeons (and retrain current surgeons) to put a patient’s needs before a surgeon’s own regressive, industry indoctrinated training needs.

    • Jane Akre says:

      David- the words “Gold Standard” become even more difficult to understand in face of the mounting evidence that there is very little substance behind that claim.

      • David says:

        Jane, fundamentally, I think “the gold standard” is one of perspective:

        What real benefit value is there to a “treatment,” when an industry’s self-promoted “gold standard of care” (with intent to indoctrinate the surgeons’ device efficacy fixation -to- self-gratification), is void of the patient’s effectiveness understanding?

        As stated on page 18 of the Institute of Medicine’s (IOM) July 2011, FDA sponsored report, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years: “[The IOM’s Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process] believes that the device should provide results that are not just clinically significant but beneficial to patients.’…‘Effectiveness must be differentiated from efficacy, which AHRQ [Agency for Healthcare Research and Quality] bases on ‘whether a drug or other treatment works under the best possible conditions [‘for example, a clinical trial’].’ It should be noted, therefore, that premarket clinical trials actually measure efficacy, whereas data derived from postmarketing surveillance (for example, in registries) measure effectiveness. A mandate to ensure effectiveness must by definition measure utility in a ‘real-world’ environment.”

        Specific to SUI, can any device…can the TVT-Abbrevo device in particular, be “very effective,” as Attorney Kim Schmid told the jury “…because women are still dry after treatment”? Who benefited from destroying a woman’s quality of life? Certainly not Coleen Perry: the patient! Effectiveness is from the patient’s perspective and the patient’s perspective alone (not derivable from the Defendant’s perspective). Ms. Schmid appears to have confused (on the Defendant’s behalf) the manufacturers/surgeon’s efficacy with the patient’s lack of effectiveness –the reason, I believe, for the Plaintiff Coleen Perry’s lawsuit against the Defendant.

        • David says:

          …Since the TVT-Abbrevo device was 510(k) cleared to market – there was no pre-market clinical trial. Therefore, as stated above by The IOM’s Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process “A mandate to ensure effectiveness must […] measure utility in a ‘real-world’ environment” alone (as their was no FDA safety and patient effectiveness consideration before the TVT-Abbrevo device was marketed by the Defendant”*). A “utility” (“the state of being useful, profitable, or beneficial”**) which is problematic for any non-inert polypropylene mesh’s subsequent, very foreseeable, “real-world” injurious in vivo performance predictability.

          * First half of IOM report Conclusion 7-1: “The 510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices with some exceptions.”

          ** https://www.google.com/?gws_rd=ssl#q=utility+definition

        • Kitty says:

          “Gold Standard” should not be used until the research is completed and that would be dogs, cats rats what ever they use for testing. So many people complain about testing being done on animals —–well unfortunately that is the way it has to be. I do not value animals above humans. The animal must have the device in for equal to—or over 10 years to do adequate test for antoimmune et al problems. If folks don’t like animal testing then the human being must be the test sample. Also people that complain that all we do is post on Jane’s site

          –they too are not getting the picture. The more we chat with each other–the more informaton we glean. This helps us to write intelligent questions to our government. If we never had the opportunity to discuss this on Janes site—we wouln’t be so enlightened.

          • Jane Akre says:

            Kitty- thank you but I really consider this a site for everyone,,, not mine. I’m not mesh injured. It’s really more your site and I thank everyone who contributes their comments and thoughts. Together we are stronger and smarter.

  2. Jane Akre says:

    March 2014 from Matthews and Associates on similar issues from the Batiste trial.

    http://www.dmlawfirm.com/j-j-mesh-trial-dallas-day-2

  3. Bejah says:

    Jane, Sorry for off topic comment but what happened to the articles on the Joan Budke trial????? Isn’t it possible that people may still want to comment on that…the fact that there was a settlement, speculation about how much it may be and how settlements work? Am I missing something? Thanks. I suppose I could have gone to this trial in Bakersfield but my car can not be driven until I have some work done so would need to ride share with someone in LA or San Diego area. Any idea how long this one may go on…is average a week or so? How are the judges selected? The one in the Joan Budke trial looked very foolish…I kept seeing him in a court jester costume in my minds eye. Assuming he is not very bright or perhaps suffering from Dementia, might that be why the defense attempted to secure a directed verdict re the Linda Gross trial? Can they do that? How revolting. As long as I am ranting anyway has anyone noticed that the counsel for the defense, the infamous Cristy whats her name….she looks increasingly evil and monsterous…as if her body is deforming with every evil thing she does. This is IMHO a very real phenomenon, for example when I adopted my beautiful Belgian Tervurean puppy she was traumatized and in quarantine. Her eyes were small and set deep in her head. A year later she had large brown watery eyes…so beautiful. It was as if she had been buried deep within herself. If you look at photos of former prisoners-of-war and compare the images with present day ones you can see this phenomenon. I will pray for a good outcome for the plantiff in this case in Bakersfield and would be happy to go there with others if that is workable and makes sense. I would suggest that we ask Jane’s thoughts on attending a trial, so that, at the very least she knows we will be present. If any of you go to the trials perhaps you can file a report so we can all read of your experience and observations. I wish Jane would post the trials on her site if she has not so that it is not necessary to link to another site for that data…keep it in our faces! Remind us. Thank you.

    • kitty says:

      Thank u for bringing us back to topic Jane—-and love your reporting

      • Bejah says:

        Kitty, If you are referring to me I am very sorry to have offended or irritated you. I will be more careful from now on and try to refrain from commenting at all. Clearly I should have just sent Jane a private email if I was confused about something on her site.

        • Kitty says:

          Bejah—how did you offend me? I enjoyed your post. I guess i’m the one that should stop writing. I think you are a terrific writer.

          Kitty

          • Bejah says:

            Kitty, I guess I am too sensitive (Gee, I wonder why!?!?!?) and misinterpreted your post. I am so relieved I did not upset you. Thanks for your kind words. Take care…

    • kitty says:

      U are too funny–”-but love your humor

      G-D knows we need it. Sorry I can’t see u j

      U in court—-in surgery.

    • Jane Akre says:

      Please go to News,,, the faint title… click on that and below will reveal all the recent stories done. I wish it was clearer but it isn’t. thank you…

  4. Jane Akre says:

    The Budke trial settled my friend for some undisclosed amount of $$$… It was very stressful on the family.. Unfortunately the jury did not get to declare the Prolift is defectively designed, which is pretty obvious to all by this time. The Arms Cannot Be Removed! How is that safe and effective? The patient has no quality of life but hey, she is continent?? Here is the conclusion of the trial. Mr. Budke got a flood of comments, which I believe he may appreciate.

    http://meshmedicaldevicenewsdesk.com/budke-v-ethicon-pelvic-mesh-death-case-settles

  5. sandy says:

    gold standard of care of my tushy. I’m so sick and tired of hearing those words. I’m laying in the hospital with post-surgical infection all which started because of a mesh implant 3 years ago. they don’t even know yet how to fix this for sure still waitigng to see which of antibiotics will take care of the MRSA infection that I have. going on day 3 in the hospital so explain to me again about gold standard of care and all of the wonderful things that I can expect from having mesh implanted in me really!!! how many victims would say this is a gold standard of care. you can call horse poop candy but it still horse poop. and meshes fall into the category of horse poop I still can’t believe they’re trying to defend these things after how many of thousands and thousands of people have suffered. in my personal opinion I think these people are delusional.

    • Jane Akre says:

      not to mention criminal……

    • Bejah says:

      Sandy, I had a MRSA infection in 2007 long before my mesh implant. It was injected right into my blood in the ER of a local hospital where I had gone with a suspected TIA. They kept me overnight and then I went home. Six days later I woke at 4am with a swollen and painful arm and the site of the IV was hot and inflamed. My 24 nurse hotline told me to go back to that ER immediately and I did. I was admitted and put in isolation where I remained for 19 days. They had to remove a large vein in my left arm. They pumped blood thinner in my stomach using a needle every few hours and I was on a Zyvoxx drip for the duration. I survived but I worry now about my immune system. You must be very vigalent if you have an infection. Be sure you are being treated by expert physicians. How long have you been on the antibiotic and if I may ask what is it? Also start eating like your life depended on it, that is high quality slow food. I recommend also taking supplements to strengthen your immune system. These might include Colostrum by Jastrow (Not all are made the same), Platimum Performance Immune Formula for Humans (They also make products for horses and dogs) and a high quality multi vitiman. I swear that Vitiman B Complex helps my Depression and I also take 5000 units of B12 as well and Vit D twice a day. Having this infection is very serious. Please let us know how you are doing. Try to be positive because your body knows what you are thinking and will respond accordingly.

  6. Kitty says:

    inflammation can cause autoimmune with thyroid Jan said she has problems with weight gain—— diabetes. Did you have your thyroid checked.

  7. sandy says:

    Amen Jane — as are the settlement amounts they are offering

  8. Sandy says:

    Beulah after 3 days in the hospital I was sent home with Sulfamethoxazole/Trimethoprim. They want to try this for 2 weeks and see how I am doing. In the hospital I was on 3 different antibiotics. I was given lots of other drugs which I am not even sure what they were. I came home early because my other half was afraid of missing work and I had no one to take care of my pets. When I told him they were all I had he got mad so I really had no choice but to get out and come home. I am very tired and really not hungry but I ate good yesterday. At least to me. I don’t know how long I will have to fight this infection and I am mad and depressed all at the same time. If I had not had mesh surgery I would never gotten this infection. If Dr. Hibner had not had to do pudendal nerve surgery — no infection. But then if I would never had the mesh surgery there would not have been nerve damage so no infection.

    I am so fed up! I heard that there were women in Canada that received settlements from AMS. I wonder how much they settled for. I have heard nothing from AMS, I have a good attorney who I have to believe will not let me get screwed. I know I keep saying we have to believe we have to have hope. But mine is gone again. I am so sick of being hurt and in pain. I want to wake up and feel good again.

    AMS TOOK MY LIFE. THEY TOOK THE OLD ME AWAY ONE DAY WHILE IN SURGERY THEY TOOK ME AWAY. THEY DIDN’T CARE THAT I HAD A NAME. THEY DIDN’T CARE THAT I HAD A GGOD JOB WITH GOOD PAY, THAT I HAD A FAMILY. THAT I HAD DREAMS AND A FUTURE! THEY ONLY SAW ME AS A TARGET TO MAKE MONEY OFF OF. THEY HAVEN’T SEEN THE PAIN AND SICKNESS I HAVE HAD TO GO THROUGH. THEY DON’T CARE. IF I DIED TOMORROW I WOULD JUST BE ANOTHER NUMBER-NOT A PERSON

    I am not afraid to go to court. I have good documentation of when and how I was hurt. My doctors agree mesh did this to me. My life has spun out of control since then. I need to change my circumstances as soon as I can but now I am trapped. Incarcerated in my house every day. When is it my turn to have hope of a future? When is it my turn to have AMS look at my case and say oh shit look at what we did to this woman. I had no clue what was going to happen to me. I was never told about mesh and what it is made of.

    Sorry for the rant,, I am just depressed and have no hope. People say hang on your day will come. But then I am told that settlements are low. AMS took 15 years of salary away from me, they took my joy, happiness and physical abilities away from me. The pain and suffering fresh at my door has been caused by them. I deserve to be paid for all of this AMS. you know you did wrong or you would not be making settlements!!!! I have had no promises made to me. I have been told very little except just wait. That would be fine if I had dreams to hang on.

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