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Day Six: Cavness v. Ethicon Mesh Critic Blasts Polypropylene Pelvic Mesh

Dr. Michael Carley, Baylor urogynecologist

Dr. Michael Carley, Baylor urogynecologist

Thanks to Courtroom View Network for access to a live feed in this Dallas courtroom of Judge Ken Molberg.  Carol Canvess v. Kowalczyk et al. #DC-14-04220.

MND, September 28, 2015 ~ Dr. Michael Carley, affiliated with Baylor-Health Texas, (here) first saw Carol Cavness June 14, 2012, two months after she had a Prosima pelvic mesh implanted to treat a prolapsing pelvic floor.

Her complaint was pain.  She was concerned her job as an airline mechanic would be further compromised if she could not resolve the pain soon.  Since her pain had not responded to conservative measures, she elected for a removal which Dr. Carley performed on July 9, 2012. It would be his first of two mesh excisions (removals)on the Plaintiff.

Dr. Carley removed several fragments of pink-red soft tissue adhered to synthetic material consistent with vaginal mesh.  In aggregate, the specimen came out in fragments that measured collectively  4.3 x 2.5 x .6 cm. The pieces were removed transvaginally from the posterior wall of the vagina.

A second removal yielded calcified nodules ranging in size from 0.1 to 0.3 cm in greatest dimension.

Unfortunately, that did not resolve the pain.  By August, Ms. Cavness reported stabbing pain. Conservative treatments such as pelvic floor exercises, steroids, anti-inflammatories, Celebrex or hydrocodone did not resolve the pain either.

Earlier the Defense suggested the removal surgeries and scar tissue formation from that may have caused her pain.  No, it did not, said the doctor.

By January, 2015 she still has pain and vaginal discharge and she was referred to pain management. Dr. Carley concluded,

There is a palpable foreign body in the patient’s right apex…”   He identified “several bead-like foreign bodies, unclear whether these represent synthetic mesh or not.”

 

DR MARGOLIS  – CRITIC OF POLYPROPYLENE MESH

Dr. M. Tom Margolis, urogynecologist

Dr. M. Tom Margolis, urogynecologist

There was nothing unclear about the testimony in the courtroom of Dr. Michael Margolis, a urogynecologist from the San Francisco bay area (here).  Double board certified in Ob-Gyn and Urogynecology, Dr. Margolis says he’s done more than 25,000 surgical procedures in his career including 5,000 to 6,000 for stress urinary incontinence and the rest- 14,000 or so were POP (pelvic organ prolapse) -related.

He does upward of  dozen surgeries a week with almost half mesh removals.  He made it very clear he, “Does not or ever has implanted transvaginal synthetic systems into any human being because of the well know and well established irreversible and magnificently bad complications associated with transvaginal polypropylene mesh systems, which is well described in the literature.”  

Likening it to trying to remove rebar from the sidewalk, he insisted passionately to the jury that the risks of Prosima substantially outweighed the potential benefits to any patient, including Ms. Cavness.  Her injuires are permanent and irreversible because of the design defect of the Prosima; the heavy weight of the Prosima and its Prolene PS mesh; the shrinkage capacity of Prosima (around 30 percent); the degradation of Prosima; the chronic foreign body reaction of Prosima.

He left no doubt to the Plaintiffs’ claims of a defective product grabbing a sheet of paper and crumbling it up in his hand to illustrate how mesh contracts, folds and shrinks.

“It distorts the normal anatomy and it causes new prolapse where there wasn’t prolapse before. It’s impossible to safely remove it all. Foreign body reaction causes it to scar into place.” he said, and that scar essentially locks the mesh in place. “You’re stuck with it for life.” he said.

Dr. David Robinson- Ethicon former Med. Dir.

Dr. David Robinson- Ethicon former Med. Dir.

Ethicon knew it had a faulty product an inner office email show. David Robinson, MD, the worldwide medical director said in February 2008, “Clinically there may be an impact of increased rigidity with any given mesh as it may increase vaginal stiffness postop with the potential to impair sexual function.  Suffice it to say, however, that all meshes we are working on for future use will be less rigid than our current Gynemesh PS.

But the improvements were never incorporated into a new mesh for Prosima. Under Texas law, the plaintiffs must show there was a safer alternative. Though he is no fan of polypropylene mesh, Dr. Margolis said the UltraPro was lighter using about 38% less mesh than the Prosima and was half the weight. It was softer, more elastic and partially absorbable.  Even Ethicon said in an internal report, “Without any negative side effects when compared to traditional heavyweight meshes!”  

UltraPro was available at the time the Prosima was launched in January 2010.

Under questioning, Dr. Margolis and Cavness’ attorney established Ethicon knew full well that it had a problem with the heavier Prosima. Did it tell the FDA or Cavness’ implanting physician in letters, in an Instruction for Use (product label)?  No, they didn’t said the doctor.

The jury was shown a July 2012 article Pain complications of mesh surgery by Lisa Rogo-Gupta and Shlomo Raz, MD,  the father of mesh complications.  It said mesh shrinks 30 to 60 percent and mesh degradation begins immediately following insertion.”Mesh placed in vaginal surgery is not inert,” said the article (here).

Inert means, the immune system doesn’t know it’s there.

Dr. Shlomo Raz UCLA

Dr. Shlomo Raz, UCLA Urology

Otherwise, Margolis explained, the bacterial contamination and subsequent inflammatory response releases noxious degradation products, enzymes and macrophages that attack the invader foreign body, the mesh.

Did Ethicon put any of this information in its IFU? No, in fact they call the inflammatory reaction “transitory,” and that the mesh remained “soft and pliable.”  “It’s 180 degrees opposite. Its not true,” said Dr. Margolis in disgust.

MESH REMAINS BEHIND 

Despite a third mesh removal attempt by Dr. Philippe Zimmern of Dallas, Dr. Margolis insisted all of the mesh cannot be removed, based on his 17 years experience “trying to dig this stuff out.”

“She has dysfunction of the bowel, the bladder, scarring, contraction of vagina, erosion, dyspareunia. She’s suffered prolapse to new areas. She’s suffered three attempted explant surgeries and all the pain and suffering associated with them and the stuff is still there. It has not been removed,” he said of Ms. Cavness today.

She received absolutely no benefit and all of the risk, he insisted.

Cavness attorney reminded the jury of the words of Dr. Martin Weisberg of Ethicon. Seven years before Ms. Cavness 2012 implant he asked in an inner-office memo,  “Why would anyone spend any money on a device and take what they consider a risk of using a graft when they could get the same results for free with a native tissue?  If we are not confident that this will be better than what our marketing has been claiming is inadequate (native tissue repair) why bother pursuing? ”

Did the company follow his instructions?  No, they did not.

“This is exactly what happened to Carol. It breaks your heart.”

Dr. Margolis told the jury her native tissue repair done by Dr. Carney worked and is holding “perfect. She didn’t need the mesh.” he concluded.

LIFE CARE PLAN

Helen Kathryn Downs, Butler Snow, attny. for Ethicon

Helen Kathryn Downs, Butler Snow, attny. for Ethicon

What will the cost be to make life easier for the Plaintiff?  Registered nurse and life care planner, Leigh Anne Levy, told the jurors the Plaintiff will need outpatient and therapeutic care, long-term care, medications, diagnostic services for the rest of her life for her disability.

The total lifetime costs are $570,383.50, and these she considers conservative numbers.

On cross examination, Helen Kathryn Downs of Butler Snow, asked if Ms. Levy was offering any opinion whether the injuries were caused by the mesh?  No, said the RN, they make the plan based on the medical records and on her present disability.

Dr. Margolis, who examined the Plaintiff as recently as two days ago, has said Ms. Cavness likely will need two more surgeries in her lifetime. #

BACKGROUND

Prosima prototype

Prosima prototype

This is the first trial for Ethicon’s Prosima pelvic mesh used to shore up the pelvic floor from a prolapse.  The plaintiff, Carol Cavness, 60, is in the courtroom listening to the proceedings.

Cavness is represented by Tim Goss and Richard  Freese of Freese & Goss PLLC, Bill Blankenship of William F. Blankenship III PC, Richard Capshaw of Capshaw & Associates, Kevin Edwards and Peter de la Cerda of Edwards & de la Cerda PLLC, and Julie Rhoades and David Matthews of Matthews & Associates.

Ethicon is represented by William Massie Gage and Helen Kathryn Downs of Butler Snow LLP and Kathleen Gallagher of Beck Redden LLP. ##

36 Comments

  1. stopmeshimplants says:

    Thank goodness for Dr. Margolis! Promising testimony for Ms. Cavness. Thank you Jane for

    your excellent reports!

  2. Hal Lewis says:

    No way that J&J doesn’t settle this case before the jury comes back.

    • Jane Akre says:

      My thoughts as well…..

    • addison says:

      Good morning, Hal. You’ve mentioned that settling prior to jury/verdict, while beneficial for the injured and plaintiff attorneys, negatively affects this process by not allowing juries to voice defective design (and/or inappropriate warnings) or place value on injuries. Legally, is there a limit on the number of times this can be done, and if there isn’t, how long do you think this will continue? Also, how many verdicts per product are typically necessary within the Bellwether process? Thank you!

  3. kitty says:

    What an excellent team for the plaintiff–top cream of the crop Drs’ luv u Margolis And Raz

  4. It is very reassuring to see that at each trial new information is added to the dialogue. It validates the claims of thousands of women that mesh hurts in many ways. It hurts where it is located. It hurts our immune systems. It damages delicate nerve systems. It damages our mental health with chronic pain and depression. It ages women rapidly. Doctors have no reliable cost effective way to test to see which women will benefit from mesh and which women will be harmed by mesh. When the complications are as devastating and catastrophic as we know them to be for a significant percentage of the women implanted with polypropylene (PP) mesh the reckless regard of J&J, Ethicon to aggressively PP mesh products is in my mind indefensible. I hope the jury finds it indefensible also, as have other juries.

    • Jane Akre says:

      So well put Nonie…. you are right… Dr Margolis summarized the devastating damage very well and with great passion. The jury heard!

    • clarification ……the sentence “when the complications are as devastating and catastrophic…….. is missing the word market…sorry readers…. “aggressively market PP mesh products” is what I wished to say…. I could easily add unethically into that sentence. hoping Jane can add the missing word as the moderator …. may all meshies take heart that we are seeing progress, slow as it is, that research that was ignored that proves PP mesh is not inert, that FBR is not transitory nor mild is seeing the light of day in dark time for women’s pelvic health ….manufacturers of mesh have single handidly marginalized the health of a whole generation of women……..

    • Dawn says:

      Great post Nonie .. My thought exactly

  5. Stopmeshimplants says:

    And the fact that this woman has remaining mesh that cannot be removed is even more devastating. There are no words to describe the daily worry of what that remaining mesh will do to our bodies. It is agonizing to think of additional harm that may come as a result of this horrendous mesh. No one deserves this in our lifetime! Prayers coming for Ms. Cavness, her family, her legal team and all those who are supporting her during this mesh ordeal.

  6. anna says:

    Financial compensation is one thing, but just being able to live one day with no pain is another. The burning, and throbbing in my pelvic, groin, and leg area is enough to drive me crazy. There is nothing that will bring back mine, or any other mesh victims routine lifestyle. Nerve block only helps a little while, we’ll see what radiofrequentcy oblations do to me. Everything is scaring me especially the thought of one day ending up in a wheelchair. The numbness in my legs makes me feel like one day I wouldn’t be able to stand.

    • Angry says:

      Anna I totally understand where you are at. My growing older years have me so concerned as I am sure yours does too, how could it not . I am and have been to a point that I just cant stand the pain and medication only keeps me from going over the edge. Day after day, month after month and year after year is just too long to keep trying to be strong. The body can not withstand this level of relentless pain. Add to it the mental toll it takes, the anger just trying to grasp how and why did this happen to us, and the domino effect that follows as most of us are well aware of. I hope to God that this trial goes to the jury and not a side bar settlement, if so it adds another slap across all are faces. Each slap gets a little harder to accept and makes the emotional punishment deeper. We have been put in a real bad position in life. If a settlement is offered to all, based on tiers , it will never be near enough. Just counting the cost to date of the medication I had to pay for and out of pocket doctor bills ect is massive. On the other side of the fence, trials for all, I was told that IF that was to happen it would take YEARS and possibly over ten. Hell at the rate I am going and what my entire body has been dealing with , knowing how I feel I wont be here in ten damn years. How many of us are concerned of what toll it takes on our bodies having to swallow a cocktail of medication just to be able to try and act normal. I have always considered myself a strong women, but things are changing fast. How dare these companies just rip so many peoples lives apart and have brass ones to continue doing it. Jane I do not think I could contain myself in one of these trials, good chance I would be the one locked up like a criminal. To all of the ladies and men out there living the same nightmare remember one thing. GOD does not like ugly and we may or may not see this to the end but one day each and everyone of these SOBs will have their day. Ok, I feel better letting out a little steam. God Bless and pray !

      • Jane Akre says:

        Wouldnt that be interesting to have the mesh injured hauled away to court. Defense made a comment during the last trial (Budke) asking ‘are you going to bring them in by busloads’ referring to the two mesh injured women in the courtroom. She, Christy Jones, didn’t like it at al that they were there!

        • Angry says:

          Jane maybe then someone might talk to us. Sad but true

        • Bejah Blue says:

          Jane, A crude bunch aren’t they? They (the defense) refer to the plaintiffs as “Them” meaning the human beings they have damaged so severely”. They speak of us as if we were not even human. We have been dehumanized, dismissed by the doctors who implanted us, and told by judges in courts of law to “Get lost” and stop (whining) about “mesh”. Yes, let’s bring in busloads of “Them”. Please let’s do that, with canes, and crutches and wheelchairs and diapers and kleenex boxes and pain medication. Let the juries see who is crude and what humanity looks like.

          Bejah

  7. Emmie says:

    Wish the juries could see the busloads of all the mesh victims who live with the monster pain of our implants

    Ethicon will most likely settle without a jury verdict. Another win for the victim, but not for us thousands waiting for our day in court. All the money in the world will not bring a pain free existence to Carol. I pray and hope a doctor will find a cure for us mesh victims.

    Spoke to Doctor/Lawyer Vigna today. I learned there are eight hooks in my groin from the Prolift and two TVT implants. My pain has been off the scales the past few days. All I want is my life back. J&J///Ethicon robbed me; they need to accept the consequences of their mesh Implant marketing scheme to the victims and public.

    I highly recommend Mr. Vigna to anyone suffering from pudendal nerve injury. He shows much concern and offers his advice freely. If you do not yet have a lawyer, please talk to him before you commit to another lawyer.

    • Bejah Blue says:

      Emmie,

      Remember that every settlement in favor of a plaintiff is good news for all of us, not just that person, in some important ways. Since trials result in an endless and rather embarassing for the courts (I would think) parade of defendant appeals we must view settlements as good news or relatively good news for us all because it represents a loss for the oh so guilty defendant(s). So in a way this is good news for you too, of course, although we all understand what you mean.

      Do not lose touch with what the FATHER would ask you to believe. Remember also that the great adversary wants you to be angry, disoriented and deny its existence. Let us not turn on each other but stand together with reason, objectivity, integrity and faith guiding us. Do not indulge in resentment, or excess anger, or the feeling that your settlement is more important than your sister’s or brother’s settlement although this is a perfectly normal and human reaction. All are to be celebrated, all are a “win” for all of us, and all give us hope.

      Thanks for the feedback regarding your hopeful encounter with Dr. Vigna.

      Bejah

      Bejah

      • Emmie says:

        Bejah:

        My words were in NO way intentions NOT to cheer for Carol. I read and re-read my posting and cannot understand where you got the idea that words were written for only the good of myself. The bad thing about texts and written word is it does not show the non-verbal expressions.

        We are all in this together as “mesh sisters” and need to support and listen to a sister when she is in need of an ear or shoulder. What pharmaceutical companies have done to us with their bladder mesh slings is horrendous. They have given us a death sentence; a long painful death sentence. I personally think a bullet to my head would have been a kinder sentence.

        The idea a huge corporation can take a plaintiff through the courts for days and days and than offer an out of court settlement is an insult to us victims, our justice system, taxpayer’s money, and the jury. I think the jury should be allowed to give their verdict.

        Bejah…. I am sorry you got the wrong idea from my post.

        Please accept my apologies to all who misunderstood.

        I am shoulder to shoulder with you all…and I keep the FAITH.

        I pray to my God everyday for comfort and pain free days for all of us.

        Watch for 1111 or 111….I believe it is a reminder from God and angels for us not to give up HOPE…and a reminder to keep the FAITH. (Hebrews)

        I see it everyday and even when I heat something in my microwave, I enter my times in ones as a reminder to me to say a little pray for us mesh sisters and the crazy world we live in today. Stop filling my gas tank with 11 and also say a prayer. Might sound dumb…but it is my reminder.

        • Jane Akre says:

          Thanks for getting along everyone…..electronic communications are very imperfect!!!

        • Bejah Blue says:

          Emmie, I did’nt intend for you to think my comments were about you….we’re fine, sometimes, as you say, the written word can result in a loss of clarity and that is my fault as I wrote the post. Please accept my apologies.

          Bejah

  8. PLC says:

    Could the defence appeal if there was a court room full of us? Could they stop us?

    • Jane Akre says:

      The courts are open to the public in the US as long as there is room. You are allowed and encouraged to show up. Must follow the rules of the court and not disrupt the proceedings. The jury will see you! Juries aren’t stupid. Defense hates it when you show up….

      • Emmie says:

        Jane…

        Could you give me your email address??

      • Bejah Blue says:

        I love that juries are not stupid….sometimes I wonder.

        I love that the defense hates it when we show up….doesn’t it make you want to get on that old bus right now and head on out to the courthouse? We could all wear purple…the color of healing…we could all wear purple hats (I love hats). No one said anything about purple ribbons or wristbands so I guess that was not very popular. This is a hard army to get moving!

        Bejah

  9. Greg Vigna says:

    Thanks for the update. Simply the attorneys must do a better job making sure their clients are medically case managed to physicians with the knowledge to classify pain as primary myofascial vs. secondary myofascial. Primary is muscle pain caused by spasm/irritation from the mesh while secondary myofascial pain is caused by pudendal neuralgia. Also, pudendal neuralgia should be diagnosed if present because the future care plans are more extensive for pudendal neuralgia that primary myofascial pain. In this case it looks like there wasn’t a pointed diagnosis so the life care plan was worth only 500K. Pudenal neuralgia life care plans are work 950K to 1.6 million. Also, nurses are not able to comment on causation since they are not allowed. Simply in a Bellwether trial there must be Physician Life Care Planners. A bit disappointing for the plaintiff.

    Greg Vigna, MD, JD

    Certified Life Care Planner

    • Jane Akre says:

      Correct me if I’m wrong but I believe Linda Gross’ life care plan was funded at $1 million. Good thing she had one. She is the only one beside Cavness that I’ve heard of. Check with your attorney – it’s your case!

    • glad to see you posting Greg. ..your advice is invaluable… I have asked my lawyer to proceed with a Life Care Plan here in Canada… mesh removal specialists are few and farther in between than in the USA… and those who understand pudendal nerve damage are rarer than hen’s teeth….. coming up to 4 years post TVT Secur Removal, still cannot sit for more than 15 minutes without pain…still feel the burn of inflammation, still have low back pain that made me cringe when I woke up in the sedative in the lithotomy position during mesh removal procedure…. the pain was excruciating before I was given general anesthesia ….. am hoping my lawyer has a Canadian version of you in his arsenal…. pudendal neuralgia was written on my medical records…

  10. Greg Vigna says:

    The life care plan goes to the cost of future care to the life expectancy of the plaintiff. In this mesh debacle, any woman with the diagnosis of pudendal neuralgia who believes they are getting a settlement that isn’t adequate for their injuries and believes they are getting UNDUE PRESSURE FROM THEIR OWN ATTORNEY to take a substandard settlement needs to do the following:

    1) Ask in writing the legal reasons why they should take the Settlement? ex: Statute of Limitations Issues, Evidence in medical record that suggest malpractice.

    Understand that crap such as bankruptcy is useless banter.

    2) Provide them documentation of your pudendal neuralgia

    If they say they won’t represent you in individual litigation without a real legal reason or the documentation of pudendal neuralgia, as a Certified Life Care Planner, I can spend one hour with you interviewing and reviewing records and provide a rough idea of future care cost going forward with the high priced treatments needed based on National Pricing.

    With this documentation I doubt an attorney will simply release a pudendal injured since ethically it would be difficult and might be a basis for malpractice in State Court against the attorney whereby they would actually be defending the mesh maker and liable for the damages. I doubt they will want to deal with that and will need to litigate or refer and give up their Quantum Merit for the fee for their underserved settlement offer.

    Greg Vigna, MD, JD

  11. Bejah Blue says:

    Thank you Dr. Vigna. So good to know you are out there in the world. I am going to discuss this with my counsel and I hope many more of us will also.

    Bejah B

  12. Bejah Blue says:

    Dear Dr. Margolis,

    It seems like so many years since I went to visit you. So much has happened in this ever expanding HELL of polypropelene mesh and I have learned so much through the passage of the years.

    You have been a heroic figure throughout this saga, standing up for the disadvantaged, the wounded, the victims. I wonder how we can ever express our thanks to you for remaining steadfast and insistent when so many have retreated.

    I was a human being when I saw you, now I have withered, I am broken, and I am certain I am dying because of the impact of this device on my body. Still I find comfort in every report I read of your testimony and thank you from the bottom of my heart for being an example of honor, of courage, of truth in the face of the most egregious evil.

    You told me that you would try taking the train to the office when I raved about it. You said you would try it. I hope you did and found it as wonderful as I have.

    Bejah Blue

  13. Kitty says:

    And Bravo to Jane checks in the mail

  14. Bejah Blue says:

    Let’s try to avoid cryptic messages and mudslinging from the sidelines lest the true motivations of some among us come into question.

    For the record I have contributed to Jane’s mission and would make more meaningful contributions if I were able to.

    Statements and questions out of left field are a little baffling and seem to have little value given our core concerns. I suggest that if people have something to say they do it in a straightforward way as other options are rather distasteful.

    I am sure we all contribute what we can when we can. I have never, and will never question the contributions of others and I venture to guess that Jane does not either. We all contribute what we can. Jane has been especially prolific of late and I hope she is adequately covered for those so much appreciated efforts. I expect that she is.

    We all know that there are many of us who can not make ends meet, are losing or have lost their homes, have to wait in line at food pantries for groceries and worry about staying warm this winter. The mention of financial support for Jane’s work in view of this will only cause these men and women to feel greater sorrow, guilt and the hopelessness and worthlessness that comes with their situations, and out of the Depression, Anxiety and even suicidal ideation that they must battle every day. IMHO out of context mention of the expectation of financial support for Jane from the sidelines seems misplaced at best and does not reflect the Jane I have come to know at all.

    Bejah

    Bejah

    • Jane Akre says:

      Thanks Bejah, though I have two advertisers, I could use more to make my bills. I’ve taken on other work which keeps me away from the mesh beat. I do appreciate the support though. Thankfully I do not know what you are referring… probably best I do not.

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