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Witnesses in Philadelphia Mesh Trial Tell Tale of Prolift Mesh Marketing

Prolift on eBay July 2013

Prolift on eBay July 2013

 

While Mesh News Desk (MND) is not in the courtroom in Philadelphia for the Hammons v. Ethicon pelvic mesh trial (Case No. 130503913, Court of Common Pleas), reports  are that two of the witnesses who have appeared on the stand in Philadelphia have appeared for plaintiffs during previous Prolift pelvic mesh trials.

Their stories tell a tale of how the Ethicon Prolift mesh kit mesh made it to market, blowing through any stop signs of safety and efficacy.

Ms Hammons received a Prolift pelvic mesh implant in 2009 to treat prolapse. She contends mesh particles had become implanted in her bladder, she has pain, infection, urinary and sexual dysfunction.

Ethicon is a division of Johnson & Johnson, the company facing in excess of 30,000 pelvic mesh product liability lawsuits, more than any of the other six manufacturers.

scott ciaroccaWITNESS SCOTT CIAROCCA

Ethicon engineer, Scott Ciarocca was on the stand and questioned by Adam Slater (Mazie Slater) in the Hammons case as was Dr. Anne Weber.

Both also appeared in the Budke Prolift case in Missouri in January, 2015.   See MND on the Budke trial here.

Scott Ciarocca  still works as an engineer for Ethicon Inc of Sommerville, NJ, the medical device division of Johnson & Johnson. Ciarocca started in research and development with the company in 1997. By June 2002, with just a bachelor’s degree in electrical engineering, he would became the head of the unit that would bring the Prolift to market.prolift kit from dangerous medicines

Prolift is no longer marketed in the U.S. as a medical device to shore up sagging pelvic organs. It is one of the largest meshes ever produced and came in a box sent to doctors who had been trained on its use by other doctors/ consultants known as ‘preceptors.’  The company launched Prolift in March 2005, despite warnings from doctors inside the company. 

Ciarocca would rely on the medical expertise of the Worldwide Medical Director Dr. Charlotte Owens, plucked from obscurity from a Florida women’s clinic and just four years out of her residency.  The gynecologist would be in charge of signing off on documents presented to her to launch the Prolift.

A french team of doctors worked for Ethicon as consultants help  bring Prolift to market. Among them was Professor Bernard Jacquetin, who led the group and held the patent on Prolift. Eventually he would sell his invention to the  company.  

In the Budke trial, Slater asked Ciarocca if a six-month study would provide enough assurance the product was safe.

“We did have extensive experience with suture mesh and Gynemesh PS” answered Ciarocca in the Budke case, comparing suture thread and flat hernia mesh with the Prolift.

The group performed more than 200 transvaginal mesh (TVM) implants with no slippage. But mesh erosion wand retraction was a problem and the European clinical study failed the grade.  The failure rate at six months was 12.6 percent but when the confidence interval was applied it went to 20.1 percent.  At the same time, the clinical strategy recurrence rate needed to be under 20 percent.

Ciarocca said he was not familiar with what was going on with the TVM group in Paris, he didn’t know if the design evaluation was flawed. However, in the Budke case, Slater affirmed Ciarocca was the principal developer of Prolift and in a position to know.

Two months before the March 2015 launch of Prolift, a member of the French team, Dr. Axel Arnaud, wanted to add a warning to the Instructions for Use (IFU) about a vaginal placement of mesh and the potential for complications but Ciarocca’s said the IFU stock was already printed. They would have to wait until the next revision.

On March 4, 2005 Prolift received the product release authorization to sell the Prolift.  No studies had been done on the marketed kit, just on the tools (trocars) but not on the pre-cut mesh that would be the Prolift.

Law 360 reports here  Ciarrocca testified in the Hammons case, the company had concluded Prolift pelvic mesh was safe and effective before it was sold. Adding to his testimony in the Budke case he explained the 20.1 percent failure rate was only revealed after the device was on the market.  Prior studies had shown lower rates, he told jurors.

During testimony in the Hammons trial, Ciarocca he told jurors that safety concerns over Prolift had been answered and the conclusion was it was safe and effective.

 

Anne Weber on the stand

Anne Weber, MD on the stand

ANNE WEBER, MD

Anne Weber has appeared as an expert witness for the plaintiffs in at least three pelvic mesh trials concerning Ethicon. (See the Linda Gross trial here.  See the Budke trial here.  During the Budke trial, defense told jurors she is no longer a licensed urogynecologist and has never implanted a Prolift.  She has made hundreds of thousands of dollars as an expert.

Weber helped develop the sub-specialty of urogynecology and has authored numerous articles on the field.  She testified during the Budke trial that the ACOG (American College of Obstetrics and Gynecology) bulletin she authored had described the the mesh placement practice as “experimental.” That was later edited to remove the word “experimental” after numerous preceptors (industry consultant/ doctors) complained to ACOG. Weber testified doctors were concerned that insurance would not pay for an ‘experimental’ procedure.

She told jurors in the Budke case that Ethicon doctors/ developers were unhappy about the long-term complications for the Prolift mesh and wanted to replace it.  It failed to fulfill expectations, Dr. Weber said.

Lawyers for defense include Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP.  Adam Slater of Mazie Slater and Shain Specter of Kline & Specter.  The trial is expected to take two weeks.  #

 

LEARN MORE

Philly.com coverage of Day One

http://articles.philly.com/2015-12-03/business/68716727_1_mesh-ethicon-prolift

 

 

42 Comments

  1. Toni says:

    Don’t forget to mention the pro lift was never submitted to the FDA till 2 yrs after they implanted the crap in my body . How does that even happen wow they are so concerned with making money they forget to do their jobs .

    • Emmie says:

      Hi Toni:

      What year did you have the Prolift implant? I had my Prolift implant in November 2006 and also had TVT-S which was never discussed with my doctor. I found this info when I rquested my surgery notes. The doctor’s notes show he only implanted the Prolift yet the hospital surgery report notes implants of Prolift and TVT-S.

      2006 implants failed to correct my prolapse and incontinence. My doctor than decided to implant the TVT-O in 2007. This implant failed to correct my issues. I live in chronic pain from the 3 implants.

      Just recently learned from Philadephia trial that the Prolift mesh implant equals the width of 2 and 1/2 football fields . My doctor never explained the amount of mesh nor did he tell me I would have 8 anchor hooks in my groin.

      I have suffer now and for years with pain ,contractions, and spasms. My groin, hips, and legs hurt so much. I lost a great paying job I loved due to my implants. I applied for SSD and luckily was approved on my first try. I lost over 75% of my income.

      I am sorry you had the Prolift implant. It is the mother of all mesh. Wish we could go back in time and know what we know now. I lost trust in doctors and pharmaceutical companies.

      My life is one of pain and depression. One doctor told me if I live long enough, I will eventually be confined to a wheelchair.

      Trusted my doctor and I am so sorry for that decision.

      .I

      • Bejah Blue says:

        Emmie, Prolift was implanted in me in 2010. I also have muscle spasms in my legs, my stomach and even under right arm. It is frightening. I thought it was probably from my spine but you make me wonder if these things may also be polypropelene mesh related. May I ask if you have any spine issues that are out of the ordinary aging category? Thanks. BTW I take Tizadine for the spasms and I do massages with green minty alcohol and that helps as does heat.

        Bejah

    • Jane Akre says:

      You are so right… …. We learned from the Linda Gross case that Ethicon did not submit it to the FDA for any review.. It was not until they wanted to market the Prolift M+ that the FDA even knew Prolift was on the market!! Sanctions? Not at all. Thanks for the reminder.

  2. Toni says:

    Even worse is FDA did nothing to them for not submitting it till two yrs after they had implanted it in numerous 100 or 1000’s of women

  3. Linda says:

    Ladies,

    we have to ban together to get Jane to these trials. We have to fund the site. They need to know the site won’t be closed out. Jane if we can fund will you go? Even if it is the closing days. I think rhey need to see her there!!! It’s up to us.

    • Jane Akre says:

      I do not want funding from anyone who is broke… but thank you. That’s been the dilemma, you all are not exactly in a good shape financially for the most part. I”m not either but I’m still working jobs to pay the bills… Still working through the judicial channels to keep up coverage. This will not be the last Bard and Boston Trial.. I will see them now or later.

    • Bejah Blue says:

      Thanks for your comments and energy Linda, Love to read of our continuing piss and vinegar regarding this horrific issue.

      I wanted to just add a footnote. Remember when Jane said that what the defendants really objected to, really did not want to see was….not Jane in the courtroom, but a gallery full of victims, (especially if there were protesters outside the courtroom with banners and posters as that could draw media attention, hope springs eternal on that last note!). In another earlier writing Jane noted again that the defendants were quite uncomfortable when victims attended trials. Sooooo, maybe if we could get victims who live in the vicinity of the court…maybe a 3-4 hour drive, we could carpool and fill the courtroom as best we can with victims, rather than with Jane, and then we can report to Jane with notes and drawings and take photos outside or where we can and submit all of that.

      What I take away from your posts is that we all need to not just read Jane’s reports but get out there where the news is like junior journalists and take a more active role.

      I had a funny dream last night that I went to the White House and demanded that Johnson & Johnson be dismantled (And I mean that in the nicest way, of course). I do not recall the rest of the dream but I felt I was taken seriously.

      Bejah

      • Barb says:

        BEJAH BLUE So wonderful to hear from you!! I hoe you are doing the best you can along with all other mesh injured people. I’m not sure what is going on again with me!!! Started bleeding heavily just out of he blue, making me nervous! The last time thats when they discovered mesh erosion, calling the Doctor tomorrow either more erosion or something else! Does anyone know if you bleed when having organ prolapse?? So she said if I have any symptons like before she would try to remove more mesh or hysterectomy!!! Infections galore, painful then before, hard time walking! Will there ever be any kind of relief?? If the surgeon does a hysterectomy would they be able to remove any or all the mesh? My prolapse is almost grade 3 so that is going to be another surgery within a year as well!! Feeling hopeless just like the rest, however through the pain still have a sense of humor much harder to smile. On a personal note my son got called back to base 4 days early, not liking the reason very emotional but I know between my prayers and I hope we all can just say a prayer for not only us but for him as well!! I have never been able to tell him the whole ordeal all us mesh victums are going through including myself!! Dear God in heaven please watch over all my mesh sisters and brothers for being able to have some type of relief from our every day struggles and also please keep my son and all armed forces safe from harm, AMEN

  4. Bejah Blue says:

    I was thinking last night about the allegation that the defendants and/or their agents/counsel protesting the commentary on MMND and I was a little surprised that they would harbor the concern they seem to but I suppose it comes down to concern about public opinion, more importantly public perception and the probability that a ground swell may be possible at some point if this “problem” of freedom of speech were not controlled. I think they are right to be concerned and I thank GOD we have this resource and that the people of the world have such a resource. It is damage control in advance of a great flood that may be more likely than any of us realize. I am reminded again of this expression, “The truth shall reveal itself in the end”.

    I woke at 3:00am in pain and sorrow and turned on the television and warmed some milk. There was a lecture on PBS and I want to share with you one little thing the speaker, whose name I have forgotten I am sorry to say, shared with us. I thought it might be helpful.

    I was also reminded of a disagreement in the last day or two in our midst concerning comparisons between Nazi death camps and the horror of these polypropelene implants. Such comparisons can be highly emotionally charged and sometimes inappropriate but we must remember INTENTION. Was it the intention of the person making the analogy to err in any aspect of her comparison or was she just reaching for the most horrific thing she could think of from within her own pain.

    The fact that on some level comparisons are meaningful illustrates the depth of the horror of what has been done to us. With this in mind I share this with you and it is not lost on me that things do happen for a reason, at least sometimes, and perhaps I was meant to wake and hear these words this morning in the dark and cold of early December and share them with you:

    Victor Frankel was a contemporary of Freud and Jung and others whose names escape me in this moment but who represented the great minds of that era. Victor Frankel was hauled off to a death camp one day along with his whole family including his pregnant wife. All perished but Victor. He wrote a book afterward that took him only nine days to write. I think we should all read it. It is a seminal work in the field of psychiatry I think it is safe to say.

    He wrote that no matter where you are, how horrific the circumstances, how unbearable your pain, how bleak your tomorrows seem, you still can make the choice to do good in your life, to make right choices that will please your soul and ease your burden. You can give another a hug, you can share a crust of bread, you can give someone a smile, you can dream, you can choose to survive until that is no longer possible.

    I think this is an important lesson for us and it leads me into thoughts of gratitude and that is a good place to be. Perhaps such thinking helped Victor to survive. As I recall he weighed about 80 pounds at liberation. There will be no liberation for most of us but we can find the courage to live the best most honorable life we can until that is no longer possible. Let’s try and allow that to illuminate the rest of our days.

    Bejah

  5. kitty says:

    Jane thank you. Remember when I made the comment—“please don’t leave us” Bejah was confused by my remark. It all comes to fruition

  6. Toni says:

    Emmie I had my Pro lift and TVT in January of 06 so it had been on the market for 9 months . It seemed OK at first but was sickly but never knew it was related to implant till it started reading. Dr took a small piece out and I was immediately in con tenant he wanted to implant another but I was in constant pain so he finally did a butch procedure . It helped incontinence but he said he would not attempt to remove anymore mesh. I finally got with Dr Veronikis he removed 85% but since then I have had 9 UTI,s since July and now have to get it fixed. I live in Kansas so ST Louis is a long way to see Veronikis again. That was a long way in desperation to remove this nightmare. We’re do you live Emmie I would love to find other women close to me. Nobody understands what we are going through. That Jane and god for this site.

    • Bejah Blue says:

      Toni, It would be so wonderful if you all could form group therapy collectives in the cities and towns where you live. I think it would help so much to be able to talk about things in the comfort of the living room in someone’s home. Talk therapy can be so powerful and you do not need a facilitator, just establish some ground rules in the beginning and have someone serve as moderator (This should be a rotating post to be fair) and you will all do fine. The added benefit is that I promise you the defendants will not be comfortable with this kind of grass roots organization. At some point it may be necessary to screen for infiltrators. I hope you will all try to reach out to each other and do this. Do not be afraid. Just don’t talk about your case, talk about your body and mind issues but you can discuss the legal issue in general terms, TORTs, the MDL(s), the judges, etc. I think it would make you all feel better and it would strengthen our community. Hope you can make this happen Toni. You might want to talk with Tammy as I think she is in a group in her area.

      Bejah

  7. Linda says:

    I had the TVT and as long as it was inside me, I had UTI’s and bacterial infections. I was antibiotics for a full 18 months. If I did not stay on Antibiotics I was infected. Since I had my full removal 2 years ago, I have not had a UTI. I still have chronic nerve pain and no sex but no infections. Removal was done by Dr. Raz at UCLA, Am I cured? No but I have been infection FREE!

    • Jane Akre says:

      So glad you went to Dr. Raz. I’ve known a few people who went to him and have returned to a normal life, or almost normal… just a travesty!

    • Bejah Blue says:

      Very happy for you Linda. Did you repopulate your gut with pro biotics after the antibiotic treatment? If not you should do that. Buy good quality that is refrigerated. Personally I think we should all take it all the time. Again, so very happy for you.

      Bejah

  8. Linda says:

    Well improved yes, normal no. Before mesh I cycled 120 miles a week, went to the gym 4 days a week and was an outdoor enthusiast.! The new normal is getting through my day at work,ssplitting up house work chores to work 10-15 minutes rest 30. I can’t clean anything that requires bending such as the tub or shower and no more gardening. My primary care told me about a year ago,” Linda you need to work on acceptance.’ I have accepted a new normal and it has helped the depression. I realize if I do tooo much I have unmanageable pain and then my depression is horrific. if I moderate what I do, I get frustrated but then I remember, “Oh yeah, this is the new normal.” I used to go out dancing every weekend. Now when I get home I immediately lay down on the heating pad and rest. If I don’t, I can’t make it to work the next day. We have to make adjustments to survive.It sounds gloomy but my reality with mesh inside me was so much abdominal swelling I looked 7 months pregnant. I still have swelling but it is not as extreme. With mesh in I could not defacate and i was curled in a ball with pain. Now I don’t get infections and I am able to do a few things that are not too demanding. With the mesh in I was sooo sick I literally wanted to die. I know that is not on common as many women blog about it or thoughts of hopelessness. I am heart broken for the women that can’t get it out.. It does not cure but it definately made a positive difference. That’s why these women need their settlement to get health care. I know with my continued pain, there is a strong possibility I will be limited in mobility. I do wonder how many women will end up wheel chair dependent. I think it’s a risk for all of us. I can feel it in my back and hips. Despite improvement, sex is still not an option. I never though I would love my sex life at the age of 48. Have to accept the new normal.

  9. Linda says:

    I meant lost sex life at 48.

  10. Liz says:

    Do you have any information on the trial in Philadelphia of Oaricia Hammons. Everything seems to be quiet. No reporting of any kind. Also the Sherrer case in Mo???

    • Jane Akre says:

      Liz- I am not in Philadelphia though I understand it is going to the jury today. Sherrer we got knocked out of for no particular reason and in violation of the court’s own rules. We can appeal that to the judge but the attorney will cost thousands.

  11. Toni says:

    Any updates on the Prolift case haven’t heard anything are they keeping Jane out of that too. Jane thank you for all the news lord knows you seem to be only media link who cares what they have done destroying so many lives. Without a care what they have done to us all.

  12. Toni says:

    I have had this Product TVT nightmare almost 10 yrs in January at 41 now almost 51 My youngest just turned 18 so they been through hell with me single and struggling. Not fair to my kids either. So depressed much of that time . 5 surgeries. Now have more issues with bladder kidneys infection 8 in last 6 months.

    • Jane Akre says:

      It is so unfair to children and husbands. Please have them write something for all to read. I will post it under Your Turn. They do not have to be identified. other husbands and kids will realize they are not alone.

  13. jfa says:

    Gynecare Gynemesh PS brand

    I don’t understand what Gynecare Gynemesh PS brand is and if anyone else has experience with this mesh, please educate me on what it is, the dangers and what you have experienced with it as far as sickness/medical issues and immune system problems. .

    Has this mesh been tried in court yet? Please advise. Thank you.

    Also, and I cry as I type this…As another year ends..

    Thank you and G-d bless to Judge Goodwin, all the Judges dealing with mesh in their courtrooms, to my attorneys, all of the attorneys & their staff, doctors & their staff, the consultants, experts, medical staff, and journalists, like Jane, who stand beside women in this mesh nightmare. If this site was not here, and there were not a few folks who cared so much about us women who have been injured from mesh, I can say with all honesty, the death rate rate for mesh victims would be higher. Being told it is in your head will not fly any more. Women know better now. It only took 12 years to get the word out that mesh is bad, and now we spend another 12+ years proving it.

    • Jane Akre says:

      Gynecare is a division of JOhnson & Johnson and its Ethicon medical device division. You have an Prolene mesh made of polypropylene

      • Bejah Blue says:

        AND….that polypropelene is purchased from the refiner/producer along with a written warning that it is never to be used in the human body. JnJ does it anyway and gets away with it…gets away with murder IMHO. It is my memory that JnJ set up a middleman company to handle the purchase from the producer and then bought it from them inserting a little legal insulation for itself. They continue producing these products using the same material which may be in differing weights, intensities, weaves. Hope I have this right, if not please advise. I think jfa and others who may be new to this community should know this and may not.

        Bejah

    • kitty says:

      JfA—I believe gynmesh PS is still on the msrket–but they have to put it in thru the abdomsn. PLEASE—anyone if I am wrong—correct me. My story is long with pelvic and spinal deterioration. Presently I am spinning the drain–however slowly. My believe is the mesh pulls and can cause the pelvic structure to go out of alighnment along with other possible immune problems caused by the Chevron Phillips polyprop. That was not meant for long term placement.

      • Jane Akre says:

        You are so right Kitty… instead of taking it off the market, the instructions for use changed to place it abdominally JUST IN CASE there is anything to a transvaginal placement causing bacterial colonies. Funny that is argued against at trial by defense for the manufacturers who changed their own instructions! I’m so sorry

      • Bejah Blue says:

        Abdominal placement also causes terrible problems although not as serious as vaginal placement. They should not be allowed to get away with this distinction. It is the material that is the problem, in the final analysis.

        Bejah

      • Bejah Blue says:

        Kitty, I am so sorry you are not feeling better. Maybe try doing some creative visualization and delete the drain imagery from your consciousness. I know it is hard. Saying a prayer for you.

        Bejah

  14. kitty says:

    I heard from a reliable source that J n J wants to Bankrupt attorneys

    • Bejah Blue says:

      Kitty, Don’t ya think they may want to because they are killers, but know that they will not succeed. This is another glaring example, if true, of how evil they are. If small law firms who have not rolled their cases into larger firms see that they are at risk I imagine they would drop out in some way.

      Bejah

      P.S. Almost done with the letter Kitty….also wanted to see Mr. “T” move up in the polls and be in a stronger position before submitting it to Jane for review. I did not forget.

      • kitty says:

        Democratic Debate: all agreed to radically control opoids. I guess they believe that any one that takes a narcotic for uncontrolled —sometimes chronic pain is a brainless sociopathic suicidal moron that will turn to Heroin as soon as the vicadin RX runs out.

  15. jfa says:

    Its advantages include minimal tissue reactivity and durability. Disadvantages include fragility, high plasticity, high expense, and difficulty of use compared to standard nylon sutures.

    Prolene is also used in the manufacture of artist’s water-colour paint brushes. When carefully blended with the traditional material sable hair, it produces a brush of comparable quality at a more economical price.

    Sooo..I had a cheaply made plastic paintbrush in me

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