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Urogyn Society AUGS: Plaintiffs, Defense and Dissent

Lisa Rinna for Depend, Youtube 2012

Lisa Rinna for Depend, Youtube 2012

Mesh Medical Device News Desk, October 10, 2016 ~ It was a Wednesday afternoon course developed to meet the need for clarification among members of AUGS, the American Urogynecologic Society.   The setting was its 37th annual conference held in Denver last week.

Current Status and Future Potential for the Use of Mesh and Slings in Pelvic Reconstructive Surgery,” would be the only session that directly addressed the topic of how defective product lawsuits and trials have directly impacted urogynecologists in their treatment of patients, something we didn’t know at the time.

Dennis Miller, MD

Dennis Miller, MD

Dr. Dennis Miller, a urogynecologist from Milwaukee, moderated. Dr. Miller has been identified as the father of the Pinnacle pelvic mesh, now off the market, which he developed with Boston Scientific (BSC).

Janna S. Nugent, a defense attorney with Greenberg Traurig was on the panel, along with Derek Potts, of the Potts Law Firm, which represents injured women.

Geoffrey Cundiff, MD, an OB-Gyn Professor at the University of British Columbia was another panelist.

Charlie Khamis was scheduled to be there to provide “Industry Views,” but Charlie was a no-show.  Khamis was with American Medical Systems as a project manager is now with Boston Scientific as the Director of Clinical Strategy, according to LinkedIn.charlie-khamis

At the last minute he decided it was “not in their best interest to participate today,” said moderator Miller.


THE HYPE CYCLE

Dr. Miller blamed the 2010 “Hype Cycle” on a sudden increase in the number of complications with transvaginal mesh.  The rush to litigation began when the FDA issued two warnings about mesh and its complications, first in 2008, then again in 2011, when the FDA said complications were “not rare.”

The best outcome of the multidistrict litigation (MDL) is that mesh overuse has been curbed, Miller suggested, the worst outcome of the MDL is that a more substantial number of women are suffering and living with symptoms of prolapse and incontinence. To illustrate his point, he showed a videotaped clip of a 2012 Depend commercial with spokesperson, Lisa Rinna.

What was unclear was how the size 00 celebrity, corseted into a bandage dress, relates to any mesh-injured plaintiffs. See video here.

Derek Potts, Potts Law firm

Derek Potts, Potts Law firm

Miller suggested if you “force people together there is probably more agreement than you think.”

That was not to be the case.

THE PLAINTIFFS

pottsPotts began the session.  He wore a crisp, grey suit and Carolina blue tie and looked like he was about to launch into an opening before a jury.

Potts told the crowd of approximately 20 doctors that he represents women who have been divorced or committed suicide due to complications from their mesh implants.

“That’s why I’m here today, I took an oath, like you took an oath, to protect our patients and clients above all else.”

Despite the sudden voluntary withdrawal of many pelvic meshes from the market, many remain and are still in use today, he said.

Still marketed pelvic mesh

Still marketed pelvic mesh

Potts shows a slide of what’s left:

Coloplast still has Altis, Aris, Axis, Restorelle, Supris and Suspend.

Bard has Ajust, Align, Alyte, Pelvilace.

Ethicon has Gynemesh, Prolene Soft Mesh, TVT-Exact, TVT Abbrevo, TVT, TVT-O.

Boston Scientific has Advantage, Lynx, Obtryx, Repliform, Solyx, and Uphold Lite.

American Medical Systems has shuttered its operation and no longer makes pelvic mesh.

The pelvic mesh trials center on product defects and are not focused on the action of the physicians, he assured the doctors present.

In fact, plaintiffs’ attorneys often have to defend physicians when manufacturers throw them under the bus, blaming the surgeon for complications with the allegedly faulty product. “He did it wrong,” is what manufacturers say in defense of their mesh product while it is the plaintiffs’ attorney whose expert will tell the jury the doctor did the procedure correctly, it was the product that was defective.

But the defense of doctors seemed to be lost on this crowd.

Potts shows a full screen on a study, Host response to synthetic mesh in women with mesh complications August 2016, American J Obstet Gynecol, a study into the macrophage, a key cell type that mediates foreign body response, in patients who undergo mesh excision surgery for pain after an implant.  In some women with mesh complications, mesh induces a proinflammatory response that persists years after implantation.pam-moalli-u-of-pittsburgh-urogyn

Dr. Moalli, the lead investigator was sitting in the crowd. She corrected Potts; the study was about tissue degradation not mesh degrading, she said in a Woody Allen-Marshall McLuhan-like moment from the movie, Annie Hall.

Potts continued to explain that why, in 14 of the 20 trials so far, the juries have sided with plaintiffs:

The product was poorly designed because of its small pore size; there was little or no study before it was released; manufacturers misrepresented safety and efficacy; there was insufficient warning of the risk; manufacturers concealed knowledge of the potential of injuries from the FDA and other doctors; manufacturers knowingly used polypropylene resin mesh which is not intended for implantation according to its Materials Safety Data Sheet.

He said the polypropylene grade polypropylene is industrial grade, “used as carpet backing.”

Subpoenas have been issued by the Department of Justice, there is a grand jury gathered in Charleston, WV. and more than 96,000 lawsuits filed – all of that could have been prevented if there had been any clinical trials. But that was not the business model, he said.

How many meshes have been implanted in the US? While nobody knows for use there have been at least 3.5 to 4 million slings. In 2010 there were 100,000 meshes for prolapse implanted in a year.   In all, more than five to six million women have been implanted with polypropylene mesh for incontinence or prolapse, according to Potts.

Potts warned physicians not to use the standard conflict of interest one-page forms. It’s too risky,” he said.  Avoid conflicts of interest because juries love to hear that. “It makes their mouths water.”

“It’s just not the case the plaintiffs’ bar wants to remove all mesh. I don’t know anyone trying to shut down the manufacturers,” he assured the doctors whose society still supports the use of mid-urethral slings for incontinence.~ Derek Potts

THE DISSENT

Andrew Cassidenti, MD

Andrew Cassidenti, MD

Dr. Cassidenti asked why 60% of the lawsuits name slings as being defective. Because the vast majority of implants are slings for incontinence, Potts tried to explain.

“You have no credibility” shouted Cassidenti, now raising his voice and his very large presence in the room. Even though he was three rows back, his vehemence changed the tone of the conversation.  

“It impedes progress” he continued.

Potts did not engage.

Dr. Miller appeared nervous. We are all trying to learn from each other, he said. “Try not to win the argument,” this is not a debate, he said encouraging kumbaya among those present. But that was not to be.

Geoff Cundiff, MD, U of British Columbia

Geoff Cundiff, MD, U of British Columbia

Cassidenti raised his voice again.  “How many women are leaking urine because you terrorized them?”

Offering a brief respite was Dr. Geoffrey Cundiff, MD, from British Columbia.   There was an explosion of new mesh kits that entered the market from 2000-2005, he said. “Everyone was in a rush to be on board.”

He had asked for safety and efficacy results on the new kits.  Cundiff says he learned early not to put a mesh through the vagina. He did fascia slings.

If prolapse shows up early in a woman’s lifetime, it must be more serious and will likely need mesh, he concluded as a reason to keep mesh on the market.

Janna Nugent, Greenberg Traurig

Janna Nugent, Greenberg Traurig

THE DEFENSE

Attorney Janet Nugent who represents C.R. Bard in transvaginal mesh litigation was dressed in a feminine red flowered dress. The mother of three came out strong.

“My stomach turns to see manufacturers pull their products from the market. I want the doctor and patient to make a choice and not a group of plaintiffs’ attorneys. That’s the bias I have,” she stated emphatically.

Nugent assured the group that the 510(k) clearance process is a “proven process” that works, and not a rubber stamp. Mesh has undergone biocompatibility testing and if the FDA is satisfied, the product is cleared for market. As far as the warning about not to implant polypropylene that comes with a MSDS?msds-bard

(A Material Safety Data Sheet, that accompanies polypropylene resin. It’s Medical Application Caution states it’s not to be use for implantable medical devices. See one here on the right and below.)

msds-med-app-three“The chemicals used have been tested and proven safe and effective,” she said.

Of the $1 billion paid out so far for mesh settlements, they are “not an admission of liability. It’s a business decision.”

When asked if there was more litigation ahead that would name doctors with medical malpractice, she stated erroneously that the statute of limitations will “limit lawsuits.”

(Actually, tolling agreements in the mesh litigation have largely set aside statutes.)

Nugent said she’s heard certain language is put in an operative report for the benefit of a larger settlement at the behest of a woman’s law firm. Her law firm has taken depositions of medical funding companies and is trying to find out the source of the late night phone calls to women soliciting new cases.

As far as Boston Scientific and claims of counterfeit resin the company smuggled in from China, Nugent said she is “not aware of any health effects of the allegedly counterfeit resin.”  And the FDA said don’t remove BSC mesh made after 2012, she reminded the group.

A doctor offered that pain isn’t always due to mesh; the patient may have had bs-logopain before the mesh, besides, mesh removals can cause pain. Even facing that reality, women are running out and getting removals, said another doctor in the group.

Dr. Vincent Lucente suggest patients are seeing this an opportunity. Three quarters of those patients requiring records had no measurable complaints that he could find.

Dr. Cundiff said until the litigation is concluded, “I can’t make them better.”

How many of the cases filed are legitimate? someone asked aloud.

“One hundred percent,” said Potts. ###

38 Comments

  1. D g says:

    Their ‘business decision’ has altered my life. Having two surgeries in a 12 month period, suffering with illnesses I did not have prior to mesh, and to even suggest as though we’re doing this on purpose to ourself is demeaning. Obviously they cannot see past their greed. Maybe if one of their wives or daughters get to go through this hell with mesh they might sing a different tune? Amazing, highly educated , yet dumb as hell.

  2. Patient Advocate says:

    Excellent article. Thank you.

  3. Mary Pat says:

    Wow! They treated Potts with the same disrespect and rudeness that we encounter! Thank you, Jane, for the great reveal. I wish it was on video for all the world to see how some doctors abuse the mesh injured with their arrogant, greedy uncaring attitudes.

  4. Barbara says:

    I would rather live with a diaper then this pain and I barely dribbled if coughing or laughing hard !
    It’s the same now except awful pelvic burning contracture nerve pain! That is a huge torture to live with.
    Kill the 510-k corrupt law making Angels before there time!
    Twitter @melling_lynn Sign petition
    Save lives!

  5. Linda says:

    My Life is horrible due to Caldera device! Multiple surgeries, only partial removal! YEARS of pain and today GI issues! Shame on anyone defending ANY of these devices! You haven’t a clue how we Suffer! Caldera sellout settlement is a slap in the face!

  6. Kitty says:

    JANE…I WANT TO THANK U FOR THIS REPORT…I need to study this ….
    Read and re read several times before I comment. Again…….excellent that u were actually there
    ..Bravo

  7. Cheryll says:

    Great article thank you Jane 2004 mentor corporation, lupus from mesh and aquiredhemopheliafactorvlll, it ruined our lives

  8. SHALINI says:

    So sure, we all are crazy in our heads, not knowing who we all are and from where we all are from, but we all feel the same pain so suppose now you can call it a mesh disease
    Because it’s not the failure of that ridiculous mesh you made , it’s just a diseases going around that we all feel the same
    Seriously make sense to me
    I truly demand an answer from the these people
    Let’s take one of them, fir an experience. Put some mesh in and rip them out from their tissue, let the mesh pinch and poke through their butts.
    Then take a statement

  9. SHALINI says:

    Yes we went inside our bodies and pull out meshes in our tissue. All the woman around the world
    Yes we had a network
    Saying how to go in and pull the mesh out so it started eroding in pieces
    Shameful creature
    Disgust me thinking you guys are counted in human

  10. PM Spouse says:

    My wife next week will go under for the 11th time necause of the Gold Standard. It is shameful what she has had to endure. She cannot walk more than 20 yards, her quality of life is gone for ever. The pain has not gone away after 10 surgeries and is not expected to. The manufactures are not in any hurry to move forward with settlememts, it appears they want the suffers to die. Where is the media attention that talcum powder gets. Mesh victims have suffered far longer than powder victims and in larger numbers. Even the congressional reps I have contacted do not care. What a shame.

  11. Janis Urban says:

    Where are the Biocompatibility Studies and Toxicity Studies? Who, What and How many were tested? Reality Check! It’s just not the Pelvic Damage! The Foreign Body Response, Inflammation, Biofilms are Killing me! Doctors can only test for what they know? Is what they find mimicking diseases? I’ve been diagnosed with some pretty rare disorders? I don’t have most of the systems in any of these disorders? Only what they find in the lab? I believe this MDL has destroyed any chance of me becoming well. I am a Liability to treat. High Risk! All because of a piece of plastic implanted in me without my informed consent? Congress and the FDA protecting Industry, the Medical Comunity and the #2 Plastic Industry, Polypropylene! Commerce! It is not a coincidence! Mad Science meets Quackery! The Perfect Lie(s)! Life over!

  12. Chell says:

    Thanks for this article Jane. I have to say that I am quite disappointed that when asked about the legitimacy of the lawsuits Mr. Potts didn’t get more detailed about how pain isn’t the only effect of this mesh. I wish the mention of the injuries women have suffered was more evident in his statements. Yes pain is definitely one of the issues but the injuries from erosion of the mesh should have been mentioned as well. I had a Caldera sling that eroded into my urethra and have had several surgeries to repair all the damage from the fistula that was a result if the erosion and many severe infections that destroyed my tissue. I still have some of the mesh in my body and am still suffering daily and facing more surgeries. My life will never be near the quality that it was before this “simple procedure” for urinary incontinence was performed on my body. The FDA allowing the mesh to remain on the market is a travesty of justice for all the women injured and lives forever changed by this product and the greed of the manufacturers still producing it.

  13. Cynthia B says:

    my attorney is potts, so sad to see even he is treated rudely and dismissed. I also had a partial removal at mcgee’s in 2004.

  14. Anon says:

    The lack of compassion for mesh victims is so disheartening and demeaning. The attitude of some of these doctors puzzles me. Furthermore, I bet my last penny that Ms. Rinna was paid millions to represent the depends product. The video did absolutely nothing to convince me that she wears the product.

    • Jane Akre says:

      The visual of Lina Rinna was unclear to me…even being there, she didn’t look like she was upset her options of pelvic mesh have been taken away…

  15. Disgusted says:

    Thank you Jane. All this suffering going on and they’re still interested in “incontinence”. I am sick of it all. They have claimed that incontinence is a pariah. Mesh damage is the real pariah. The fact that AUGS is standing behind this is just a testimony to the fact that money is more important than people. The statement that settlements are just “business decisions” made my blood boil. We are held over a barrel and then they are free to injure many more! God help us all.

  16. Doctor Cundiff’s comment that he can’t make women better until their lawsuits are over and dealt with is offensive. I found him to be a skilled arrogant condescending doctor. Thanks to the abilities of his associate, under his guidance, my mesh was removed. He dismissed my request for a referral to a rheumatologist, offered no referral for chronic pain management, told me there were no bugs on my mesh and told me in future to avoid polypropylene. After 5 years I can finally sit without taking pain killers. No thanks to him for assisting me with recovering. He is one doctor I would like to see implanted with mesh through a clean contaminated orifice of his body. I would pray he experiences extreme foreign body response. I would feel Karma was being fair if he were to suffer for at least two years before anyone removed his mesh. I would feel empathy would be learned if he experienced impotence and nerve damage. ans if he wanted justice for having being tortured in the name of medical treatment I would hope some doctor would treat him the way he treats patients, and make snide remarks if he pursued justice. I hope Karma is a bitch.

  17. anon says:

    One of my new doctors told me that he used google to look up every new patient.

    We are treated so bad..

  18. Anon says:

    I just want to say that, “this article saddens me”, specifically the condescending remarks by the doctors. I too almost committed suicide before learning what was causing the excruciating pain in my pelvic area. I had already endured two (2) revisions, I still had no idea and if my doctor knew he was not saying a word. I had no idea what was causing my severe pelvic pain, dyspaurnia, being awakened in the middle of the night screaming because of excruciating, sharp, twisting pain in my pelvic area and so on…….. After years of this madness, going back continuously, over and over to the doctor saying something is just not right. So…… five years after my implant, two months after my second revision, still unaware of what is causing this unbearable pain I decided that there is no hope, I have cancer, I’m dying. I wrote my suicide letter, addressed both of my children, got in my bed with the pills of my choice. I was dead serious. I dialed the suicide 800 number, the person that answered knew that I was serious. She skillfully kept me on the phone until the police got to my home and knocked on my door. Eventually, I was taken to Peachford in Atlanta, Georgia for evaluation after spending a couple hours in the nearest hospital. I learned, after my short stay at Peachford, some months later, that transvaginal mesh was causing my problems. I am so honored and stoked that I am alive today… in a position to share my story with fellow mesh victims, in hopes to maybe save a life, to strengthen and to encourage to never (ever) give up. My implanting doctor recently apologized in writing for the years of pain and suffering that the mesh has caused me. We have so much to live for. Never (ever) give up. WE need each other.

    • Jane Akre says:

      I’m so sorry Anon and grateful you were not successful with your plan. Your doctor needs to know… all doctors need to know!!! I would reiterate something Dr. Daniel Elliott of Mayo clinic has suggested- write your doctor a letter and send it certified mail. Let him or her know how your life changed after your implant. Careful not to blame everything in the world on a mesh implant, but really what were the direct effects of the implant, as you experienced it. Make sure that doctor sees your letter… At least they will not be able to truthfully say that they’ve never seen anyone with a mesh complication. Anon, maybe you could help with a letter. I would publish it…. Thank you for your words…

  19. Tommy says:

    Im going to beg Alex Jones to help me invistagate this whole mesh mess its time for it lies lies and more lies im ready for the truth im living this hell some one needs to help us.

  20. anon says:

    Jane,

    When a mesh patient goes to one of the doctors who can perform the reversal surgery, or attempt to remove mesh, they don’t all lie about all of the issues women are having with mesh on their notes or to the insurance company or to the attorneys.

    When the attorneys are taking statements from the women, it is like rewinding a tape and hitting re-play over and over as they all have the same symptoms and issues to different levels.

    The cat scans and mri’s don’t lie either.

    These doctors who say women are making it up to get paid know that faking it would be impossible. Mesh gets so much worse over time.

    The material is the worse culprit. It is poison. The doctors may believe in the procedure, but the mesh compound and material is damning.

    Most doctors who implant the mesh are not mesh surgeons. They dabble, so to speak, in a little of this and a little of that and cause more damage to patients by not being an expert.

    Urologist for men should never touch females. That is insane. You work on men your whole career and one day a rep comes in and tells you to implant mesh in women and make a killing. It’s so easy they say, and risk free. They give the link to the youtube tutorial, and in less than an hour the doctor suddenly becomes a mesh expert.

    Doctors are at fault for not staying in their lane. Using patients for profit has to stop. If you are a doctor, practice medicine in the field you were trained for and stick with it. Stop crossing over.

    A dermatologist is not a plastic surgeon, but many pretend to be!

    An ENT was offering facial skin procedures at his office!

    A baby doctor OBGYM is advertising for botox and surgeries in which she has no business performing. She barely graduated med school and she was a terrible intern.

    Doctors are not that smart. They just are not smart. They read the material, memorize, pass the tests and many are so clueless. And they refuse to ever admit a patient or staff member is right, about anything.

    Research your doctors ladies. Some of you will be mortified and shocked at what you will find.

    Who has board orders, who can’t write rx, who is on probation, who has been charged with crimes, and who is on the take with big pharma. That will blow your mind how much they get paid for being a drug pusher.

    • Kitty says:

      I guess..I have to disagree about Drs’. If u ever worked in a teaching hospital..u would see the gruesome on calls and rotations and hard . work they go thru when they amazing surgeries. NURSES GENUFLECT IN THE OR. They may start taking royalties and become rich. Then years later the truth comes out and they crawl over corpses to save themselves.. “The love of money is the root of all evil”

    • Anon says:

      Good Morning Jane,
      I want to thank you for providing a haven for us to… vent…to share our pain and suffering…to encourage…to help each other to heal. This tool that you provide has been a wonderful cathartic avenue to release our wounded emotions. I think its safe to speak for the 100,000 and counting to say, “Thank You” Agape’

    • Michelle says:

      This article was wonderful. Confirming so much for me. And I agree, there is a big problem with the amount of men involved in this, from the big pharma, to the doctors who have no clue what we go through. There isn’t enough money to fix what has been done or even improve our quality of life. And sadly, they don’t even believe that.

  21. martha says:

    Do any one know about problems on these slings in south africa?

    • Jane Akre says:

      Hello Martha…. not particularly. But we’d like to know. I imagine the same manufacturers distributed their products worldwide in that we know of lawsuits over injuries are taking place in Australia, Israel, France etc…..You could email me privately if you prefer janeakre@meshnewsdesk.com thank you.

  22. Anon says:

    Good Morning Jane,
    I totally agree with you. All implanting doctors need to know how these products has adversely impacted every aspect of our lives. However, I am in litigation now so some of what I shared, with you guys, is now part of my video-taped deposition. I have to limit my sharing, for now. My doctor is now aware, in fact, the hospital that I was initially taken to by ambulance……..is the hospital where I was implanted and is where my doctor continues to practice. So my reality and issues with mesh are well documented. My ultimate goal/reason for sharing is to strengthen other mesh victims and to encourage to never allow anyone to tell you that you are not harmed by these products, we are. Our pain/struggles are real. (They know)

  23. Kitty says:

    Perhaps the reason that folks don’t have compassion for us is that they may be repulsed that we are looking for “sexual Healing:

  24. jan says:

    I guess there not getting the overall point..
    I love her as an actress
    But wearing depends at 40 & 50 should not be..
    It is embarrassing to be on a date are if you have a man in your life and there is know way you want him touching your back side and feeling a diaper. . What these manufacturers have done to us is wrong.
    I am to young to be in this situation. . My life of having that special person will never be because of Boston scientific. .I am know longer able to work and I have to live in pain and in diapers. .
    This is so wrong

  25. Anon says:

    Really!!! Sexual Healing? But…. if so, sex was a precious gift from our creator, So…..No one: no other human being, no defective product, no manufacturer has the right to take that gift away.
    Now we’re bashing each other?

  26. Dorothy C says:

    Jane I haven’t received a e/mail sense October 17. Please see what I’ve done wrong. Thanks I can’t get along without everyone.

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