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AUGS: Mesh Procedures Left After Litigation

Woman in stirrups in demo booth

Woman in stirrups in demo booth

Mesh Medical Device News Desk, October 4, 2016 ~ The American Urogynecologic Society’s 2016 PFDWeek (pelvic floor disorders) featured pre-conference workshops about the procedures still on the market to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), but the undercurrent of pelvic mesh litigation was still on the minds of many.  

Kevin Stepp MD, Carolinas Healthcare System

Kevin Stepp MD, Carolinas Healthcare System

The ethical considerations behind exploring new technology in minimally invasive surgery brought my husband and I to a Tuesday morning session, September 27,  Advances in Laparoscopy and Robotic Reconstructive Pelvic Surgery. The course faculty was Kevin J. Stepp, MD, of the Carolinas Healthcare System in Charlotte, Andrew Sokol, MD of George Washington University Hospital and John Miklos, an Atlanta area urogynecologist were on the panel.

Andrew Sokol, MD, George Washington University Hospital

Andrew Sokol, MD, George Washington University Hospital

Up for discussion was abdominal sacral colpopexy (ASC), considered the Gold Standard of pelvic surgery, now that most of the major pelvic organ prolapse (POP) meshes have been taken off the market.

Does robotic surgery offer a novel improvement to traditional surgery? What are the responsible and ethical consideration for exploring a new technologies in minimally invasive surgery, especially considering 100,000 lawsuits that have been filed against polypropylene pelvic mesh?

Sacral Colpopexy, IUGA

Sacral Colpopexy, IUGA

A sacral colpopexy is prolapse of the top of the vagina downward, not uncommon after a hysterectomy.  The procedure can use mesh, porcine (pig), cadaver fascia or tissue from the patient. The goal of the abdominal surgery, which can be done laparoscopically, is to replicate the natural anatomic support normally presented by the uterosacral and cardinal ligaments.

The panelists agreed –  they are getting more requests to do the procedure without mesh but biologic products, the data shows, doesn’t work as well, said one.

Then there is the concern about intestinal and urinary tract injuries from trocars,  used during the procedure, as seen in the Baggish report, said another.

The sacrospinous ligament fixation is surgery that restores the uterus or vaginal vault to its natural position in a woman who has had a hysterectomy.  The stitches can be permanent or absorbed over time.

An estimated 11 percent of women will require one of these surgeries in her lifetime says the IUGA, International Urogynecological Association.

John Miklos, MD, Atlanta

John Miklos, MD, Atlanta

EARLY ADAPTERS

Robotics promise the latest and greatest technology that some doctors will turn to but each machine costs roughly $2 million plus annual maintenance. Many will jump on the technology bandwagon like driverless cars, but even with robotics, not everyone is of the same skill set, warned Dr. Miklos.

In a power point presentation, Miklos said early adapters are driven by image, ego, the institutional culture, a risk taker personality and the promise of financial gain. Later adapters are generally more conservative, risk adverse, and have less financial reason to adopt a new process or product.

Dr. Miklos was an early adapter and the first to bring the TVT (tension-free vaginal tape) to the U.S. from Sweden. Even though today he has misgivings, he still supports the use of TVT mesh for incontinence, but many who followed were challenged by the steep learning curve.

It’s important you identify your forte and extrapolate and utilize to the best of your ability to meet the needs of your patients.” Patient first and your reputation follows, he said.

Fluro on the cycle of a mass tort

Fluro on the cycle of a mass tort

Lisa Floro, Coloplast counsel, formerly with Bayer

Lisa Floro, Coloplast counsel, formerly with Bayer

He reminded the urogynecologists present that surgeons and industry have a responsibility to patients to recognize and understand the complications associated with such a device so a patient can be treated in a more timely fashion and minimize needless suffering.

Later in the day another discussion, Mesh Graft Use in Pelvic Reconstructive Surgery, led by Drs. Lucente and Cassidenti, was supposed to focus on surgical options.

Instead, a defense lawyer was present. Lisa Floro is the Associate General Counsel for Urology Care for Coloplast, a manufacturer based in Denmark that makes healthcare products and is one of seven mesh manufacturers facing 2,550 product liability lawsuits in federal court in Charleston, WV.

It was her job to describe the “Cycle of a Mass Tort” to the doctors present. There were no plaintiffs’ attorneys to lend balance to her claims.  And the two doctors on the panel are currently consultants to Coloplast, among other mesh makers.

As an observer who understands the plaintiffs side after reporting on nine pelvic mesh trials, the lack of the other side of the story appeared to be a tangible example of how bias seeps into industry-supported instruction.

In the changing litigation landscape, both panelists had lost lucrative consulting dollars. According to trial testimony, Dr. Lucente was a preceptor for many doctors in training, including Ethicon, maker of the Prolift mesh for POP which is no longer on the market.

Drs. Cassidenti and Lucente, Donors of the Year

Drs. Cassidenti and Lucente, Donors of the Year

Dr. Cassidenti was working with American Medical Systems as a consultant and trial expert, but AMS was sold to ENDO International, which decided to close down its mesh division, Astora Women’s Health and with it, his preceptorship.  See a background story here.

coloplast-two

AUGS Exhibit Floor

On more than one occasion, Dr. Cassidenti blamed pressure from plaintiffs’ attorneys for closing AMS.

“What can we do to keep products that are very helpful to our patients?” he asked. Currently only Restorelle by Coloplast and Uphold by Boston Scientific remain on the market as a treatment for POP.

“He is loose on his rulings,” said Coloplast’s Floro, referring to federal Judge Joseph Goodwin who is overseeing the MDL in West Virginia.  She was referring to some rulings that had gone in the favor of the defense, and some that had not. Of the 20 trials so far over pelvic mesh, defense has won six after juries looked at both sides.

Cheryl B. Iglesia M.D.

Cheryl B. Iglesia M.D.

Dr. Cheryl Iglesia from Washington D.C., said she is getting questions from her patients who want to sue and ask who to go to. “What do I say to that patient?” she asked Ms. Floro. “I don’t know what to say.  I didn’t know if there was a website that was reputable,” she asked.

Another women in the audience chimed in, “Are any reputable?”

“We do see a decrease in advertising in pelvic mesh litigation. The plaintiffs’ bar has move on to other litigation, Xarelto, talc, Volkswagen,” said Floro, who cynically compared pelvic mesh litigation to consumer fraud class action lawsuits filed over products such as Nutella where claimants can get a coupon for $5 for their trouble since the product was falsely marketed as healthy.

One doctor suggested women were “looking for a payout,” as a reason for the 100,000 plus lawsuits against seven mesh manufacturers.   Another doctor said women are coming into her office proudly displaying a check they were awarded as part of mesh litigation.

Andrew Cassidenti, MD

Andrew Cassidenti, M.D.

Cassidenti asked “Do you think when the industry gravy train is over, will they come after the physicians?”

Women who fly across the country to have their mesh removed return to their primary physician and that is a problem, opined another urogynecologist. AUGS is working on removal guidelines so that women no longer have to seek removal experts who live long distance.

Dr. Donald Ostergard

Dr. Donald Ostergard

Dr. Lucente suggested a woman came to him with pain after a cross country mesh removal odyssey, only to receive a shot and then she was okay.

Dr. Donald Ostergard, one of the founders of AUGS, who was first to suggest to the early adapters that “mesh is not inert,”stood up and asked if anyone know about Boston Scientific and allegations it smuggled counterfeit mesh resin into the U.S. from China when it could no longer buy resin domestically.

The doctors hadn’t hear anything.

“Tell us about it, Don.”

Dr. Ostergard suggested that Boston Science mesh made after 2012 might contain a substandard mesh and that Scotland had stopped selling it, all of it.

“Emotion, Fear and an alarming reaction gets way in front of the facts of science,” suggested Dr. Lucente, comparing mesh to the morcellator medical device that grinds up the uterus and sometimes fibroids masking deadly and aggressive uterine cancers. ###

 

32 Comments

  1. Mary Pat says:

    Jane, I have long respected you for your intellect, your integrity and your warrior heart that advocates for the injured. I now revere you for your unbelievable self control. Had I been there listening to what you heard I am certain I would have unleashed the wrath of God on the imbeciles and their heartless ignorant comments! How did you manage to sit there and listen to this knowing what you know? You are utterly amazing. You have my absolute respect.

    • Jane Akre says:

      I had to hold my hand down…….grrrrr… it was best for me to be a fly on the wall… not confrontational. I am a member of AUGS now so I hope to listen and learn.I do believe they just need information. This is a prime example of how industry infiltrates and influences. With information people can take care of what needs to be done but first the information…. that is my goal.

  2. Nameless says:

    Tell us about it Don, because we are either too damn stupid or illiterate that we still don’t have information that the Scots have already acted on. Even those women who are running after all that non existent money know more than we do. So let’s see how many implant have I got scheduled for next week. Cash or charge.

  3. Kitty says:

    Why weren’t women sent to PT…immediately …6 weeks after surgery? “Go to PT…go directly to PT..do not pass GO!” This should be A STANDARD of Care!

    • Six weeks is when pelvic floor therapy, internal and external, shouldn’t start for six to eight weeks after surgery, depending on how you are healing. But you are right, PT should be part of the standard of care. Actually, many doctors require pelvic floor therapy before surgery now ( mine does). Operating in the pelvic area where there are hypertonic muscles or other pelvic floor issues will increase post operative pain,which can lead to a chronic pain condition.

      • Bobbie says:

        Just a comment regards to Pelvic Floor therapy.It was recommended to go to Pelvic Floor therapy.In Canada Alberta it’s cost well over 60 .00 a visit and then I was to now it’s recommended to go to yoga 2 times a week build my core and to take meds .To hope minimize my pain.also if they take out my TVT it will be 100 percent I still have pain.There for not going take my TVT out.

  4. Sue says:

    I had a revision surgery done in may of 2013 which basically i was reconstructed all my parts. I can send that copy to you.
    i have a recalled mesh, I had a portion Of it removed and they couldn’t locate the remainder..six months later i started having sever pain my lower back which led me to a pain specialist. That dr said he needs documentation that this is and could be related to the mesh. So i need documentation for that. If you can provide any information on that would be of great value

    NOW i have a cyst on my spine that I need to try and prove can and is caused by the mesh not removed. It was very corroded and totally unable to remove! Dr tried to remove it vaginally instead it had to be removed with a c section procedure!
    having pain injections in my back..then a year later I ended up with MRSA in my stomach. I continued with several injections once a month then recently had a MRI that shows a cyst between the lower lumbar L4& L5 pressing on nerves.
    My attorneys office says that it has to be stated in the documents that this is from the mesh!

  5. Sue says:

    A year after the mesh removed I got
    MRSA. I stated to the drs doing the ER and surgeon and we all concluded that it came from the corroded mesh. NOT
    ONE Dr documentated it. I have been
    in the lawyers system for three years. each time the paperwork moved I was
    told by each employee that it was all document!!! Last individual told me
    that it strictly has to say that is caused by the mesh. It is already been filed
    but now I have to have it documented. my pain dr wants information and he possible will sign off.
    Three yeaRS AND OF COURSE I CAN GO TO ANOTHER ATTORNEY CAUSE HE WILL GET 40% NO MATTER WHAT

    • Jane Akre says:

      Lana Keeton had a bad case of MRSA during her stay in the hospital… unfortunately hospital acquired infections can happen during any procedure….

  6. stopmeshimplants says:

    The ignorance of this professional group of physicians is simply astonishing. Thank you, Jane, for your report. I would have lost it in that audience. How they choose to bury their head and not acknowledge our pain is just wrong!

  7. Karla says:

    I am confused. Why not advocate for the injured while you had a chance. What good is being a member of AUGS if all you can do is listen to what all mesh injured already know. We know they deny the risks and injuries, we know they keep doctors in the dark. We know we need a public advocate. We know we need to be heard somewhere. We need doctors to know how horrifically injured we are. We are thousands of injured women who would have loved to be able to be at this convention, with the opportunity to disagree with those statements. Everything in this article we already knew. How is AUGS going to help us if they only hear the manufacturers side of this nightmare ? Please enlighten me as to how being a fly on the wall helps Mesh victims. Are you not allowed to speak ? How would it have been detrimental ? I like many others appreciate all you do but kind of feel like the opportunity to educate these doctors, advocate for the injured, was lost. What is the advantage of being a member of AUGS? I personally don’t care about all the lies they continue to spew, I am more concerned about how to get the truth out to them. Is there something I don’t know about. What is the strategy? Maybe I was just hoping to hear that all of us victims had a verbal advocate able to give a voice to the absolutely, without a doubt, truly injured mesh victims.
    Thanks for the report.

    • Jane Akre says:

      Hi Karla- You make a good point and I thought about it,,, but decided to go the route of helping forge understanding and relationships. That is based on the assumption that doctors may be curious about what is happening in the real world outside of what they are told in societies. For example, one doctor is in charge of coming up with guidelines for AUGS for the treatment of mesh injured patients. I sought him out and we had a a discussion during which he said but no one is improving after their explant! I said talk to a doctor in Seattle, she is seeing improvements after mesh removal. Then I told her about him. She planned to contact him. A small thing, but hopefully it made a difference on some level. You all are welcome to camp outside the next meeting in Providence in 2017 … but I think I will try this approach first. Hope you understand. Stay well.

    • Tommy says:

      Because it is all lies untill we can find some one to really stand up we are out of any truth here god help us all

  8. Janis Urban says:

    My explant Doctor a Urogynecologist with a Speciality in Pelvic Floor Reconstruction. Tells my Husband “I’m skeptical that the Mesh is causing all my issues” This after he removed my Mesh. My First follow-up Appt. following a 5 day stay in Hospital with a surgical open wound infection. Then,10-weeks of open wound care. Last wound care visit Dr. tells me I was his first mesh removal!? I have had 5 other of his Patients since tell me otherwise! Mesh Horrors. One close friend, Mesh Injured also, said Dr’s comment ” Oh Yes! Poor Jan, she thinks it’s the Mesh that is causing all her Health Issues. I have had many open discussions with this Doctor about Mesh and the Complications. He has always listened. He puts in 80 to 100 Implants yearly??? He strictly uses Boston Scientific Devices but has used other Mesh Devices in the Past. I brought him information regarding the Alleged Counterfeit Material Boston Scientific has been charged with and other information regarding the materials used in devices in the early years of BS devices. He was taken back! I said to him this could all fall back on you, Doctor. I’d watch your back! I’m not sure if he has got all the mesh out. Now I have Doubts! How do you trust him? He is Head of the Urogynecology Department at this large Healthcare System. I had requested to have a panel of Doctors sit down with me and other mesh Injured to discuss a Standard of Care Policy for Mesh Complications. After my compassionate zealous emails to the Director of Women’s Healthcare, I was notified by Risk Management that the Healthcare System had no resources and were not interested, that my emails could be considered threatening and not to discuss this with any of their Doctors. My Doctor asked why I did not come to him, first? I’ve bitten my tongue so many times so as to keep implanting advocacy for the mesh injured. They have since changed their Web Page and now include Mesh Complications. It is hard to find any help for the complications of Mesh! It’s Wrong! Each Day I tell myself to believe, that healing is on its way! Healing Wishes to All! Janis Urban xo

  9. Disgusted says:

    Awesome Jane that you are a member of AUGS. Thank you so much. Your self control is amazing. I am so sick of all this. Just reading about trocars it’s absolutely unbelievable that more women aren’t injured. I would think that this would be a much studied issue by now. Apparently not. That they are still supporting SUI mesh is evil.

    • Actually, pelvic mesh is being studied robustly. Below is a link to current
      scientific literature on pelvic mesh. There are over 2300 scientific journal articles listic on Pub Med, a search engine for scientific literature. The research comes from all over the world, not just the U.S. It takes time and lots of money to conduct scientific research. Mesh is especially hard to study because there are so many variables to tease out…type of mesh, physical condition of the woman, experience of the physician, implant method, existing pelvic floor disorder ( vaginal birth increases probability of mesh complications), etc. This is what guides medicine and in instances like mesh complications, it takes a while to catch up. Here is the link if you are interested in seeing what is being studied.

      https://www.ncbi.nlm.nih.gov/pubmed

      • Well, the link did not go to all of the articles. So, go to this link, then type in pelvic mesh in the search box, then it will bring up all the research articles. You can click on them individually and can get an idea of their conclusions by reading the abstract. Some of the full articles are available in PDF, but many have to be purchased unless you have access through a university system.

        Now, Jane, are you in Matthew’s path? I know you live in Florida, but not shure where. Stay safe. It looks very ominous.

        • Jane Akre says:

          Yes directly in the path but we have chosen to stay. We have a pretty safe building. I hope. It is very stressful though. Excuse the break in coverage but I’ve been focused on getting ready. Should be past us by Sunday!!! Thank you for asking!!!

          • Mary Pat says:

            Dear Jane, I am praying for you. Us mesh injured people are good at praying. Some days, it is all we can do! God keep you safe !

          • Jane Akre says:

            Thank you Mary Pat, the storm has passed and we don’t have power, but that’s okay…..now my daughter in Charleston, I can’t wait till she’s safe too.thx????

  10. DebC says:

    Pay day? What a joke. Like many, I haven’t seen a penny. Like many, I paid out of pocket for much of my health care. I had help from family and friends… Even though I had insurance, it was expensive to travel.. deductibles… loss of work… etc.. But, at least I had insurance and help. How many do not? How many wind up taking out loans at high interest rates from lending companies to cover their treatments – to pay doctors that don’t even wind up helping/fixing their problems? How many women are winding up further in debt, even if they DO get a check? Not to mention still dealing with life-long health issues? How many families are now dealing with a chronically ill mom… wife… etc., and all that goes with that? Even the few that have collected $ – was it worth it?? Are they all better and living a care-free life of luxury?? I HIGHLY doubt it.
    These doctors are freaking clueless! Or, heartless! Or BOTH!!!

  11. Kitty says:

    Jane is correct…we should all be at AUGS convention….come with our w\c diapers canes walker’s et al. WHERE IS Dr Miller? He and the Dutchman…

  12. Marcie says:

    First And always thank you Jane for all you do. You have helped bring light, education, awareness, and reporting to a subject no other was willing to pick up. You have helped countless patients find doctors that can provide a safe way of removing mesh fully. I just wanted to chime in on my personal mesh experience with the above so called gold standard. I was implanted with the lateral vault and it went scarily wrong. Also this is a very difficult mesh to remove as it is in fact attached to your spine. Since this surgery I have also had sever complications and damage done to my spine back bone. I have MRI imagining from when the mesh was placed and there was no seen damage to post mesh removal where I have I herniated discs, bulging discs, arthritis and a slew of other complications. My bowel was also compensated. The mesh was actually stuck to my bowel and double looped around my intestines. Colaplast’s defense was told by the company that there were no problems. The women were in fact making all the allegations up. When the medical records were turned over to them they thought each women would be turning over a small file that could be quickly gone over. Instead they found out they were way understaffed and the women had huge complications that would take a great amount of time to sort through. From what I have been told there is a quit a large devide between what the companies are telling even their own legal teams and what is really happening with the mesh injured. There is no amount of money that will right what they have done to us. We would all gladly take our health back and go back to living.

    • Kitty says:

      Hello Marcie—Yesterday on our way home we were stuck in traffic because of an event in our town. People had to park blocks away from the entrance. I noted many older women with their families walking many blocks from the parking lot thru the darkness to the gates. It hit me so hard— I dont think that this reality ever hit as hard as it did last night as I watched women my age walking with their children and grandchildren. Because we were stuck in backup of traffic it was even more painful to watch. “I sat and watched the people play” I cannot walk with my family any longer.”

  13. K says:

    Karma!!! I hope all of these panelists lose their practices and left with nothing!

  14. anon says:

    “Another doctor said women are coming into her office proudly displaying a check they were awarded as part of mesh litigation”

    ?????????????????????????????????????

    Where do these “Barneys” come from?

    Ok, I am calling this doctor out right now. In fact, I will call her an out and out liar and I accuse her of starting rumors and gossip that are not true.

    Go ask Miklos and Moore or Dr. Raz if they believe this res gestae? Of course they don’t! That female doctor has probably never encountered a real mesh patient in her life!

    First of all, most women have not gotten paid anything yet in settlements.

    Court cases won are still on appeal?

    The women who may have received a settlement are binned by numerous enforceable CA and NDA’s.

    That doctor would/could have reported the women and they would have lost it all and would have been forced to pay back attorney fees and court costs and could be sued.

    Come on lady!!! You sound revengeful. You know you would have blew the whistle on them since you are so pro medical device.

    Tell the truth for once in your doctor life. Being a doctor does not take much these days. The pendulum will switch in the near future and doctors will be held more accountable for what they say and do where patients are concerned.

    AMA is so antiquated. they actually protect doctors like this who are so ignorant.

    When was the last time Miklos & Moore or Raz saw a woman infected with mesh get excited about anything other than removal or getting relief from all of the pain and suffering? Money is not what mesh victims want, it is what they need for survival.

    No woman has received enough money to go around bragging. If anything, they are crying, wondering how such low offers are going to affect them the rest of their lives, mostly, medically.

    AUGS will never admit that mesh kills, harms and ruins lives. I don’t know why they are so hung up on mesh. It is a bad medical device.

    But then again, so is the IUD’s that young girls and women are having installed. It almost killed my friends daughter. She was infected with Mirena. Yea, infected is the right word.

    She bled (or should I say hemorrhaged) for 12 weeks before the doctor would remove it. And then her Mother had to demand he take it out! He wanted to leave it in to see if she recovered. The device cost almost $1000, and they were self pay.

    I advised her against it before she had it inserted. She said the male doctor told her it would stop her period pain. It made it many times worse, and she suffered in pain so bad.

    Her Mother said her whole personality changed. She said she became a monster. very ill tempered, became physically sick, short tempered, moody, emotional, could not sleep, and many other side effects. She was constantly in a lot of pain. He left her in pain the whole 3 months he tried this experiment.

    Her Mother said the minute he pulled it out, her bleeding slowed some. In a few days she was almost like her self again. It took a few more days for the bleeding to stop. And the horrible smell finally went away too. Her Mother said you could smell her across the room. The device caused her body to put off a smell that could not be covered up. Nobody could live like that!

    Never again!! No more medical devices for women! The dang things don’t work.

    She said, of course the doctor was mad, and he pouted that he had to take it out, and she now has a new OBGYN.

    I can’t believe doctors really believe all women want is money over over health, happiness and life. That is the most stupid, most irresponsible, illiterate way of thinking that is out dated and worthless.

    You now ladies, there is always that one in a crowd that screams “look at me” I got something to say, even though she made it up, it made her feel special to put the idea into other doctors minds that mesh patients are fakers. What a tool..

    Jane, I know that was hard for you to listen too. Thank you for the patience it took to endure such a travesty of a conference. One sided it seems.

    Alice Cooper once said, “Only Women Bleed. ” Women have it so bad. no one cares about women like they should. Where is the respect or admiration?

    To the lady doctor bashing women, I have to ask, would you get a mesh implant if your doctor recommended it?

    • Jane Akre says:

      I got the impression she was sharing a personal experience and it sounded, if I had to guess of a mesh in place check for a small amount….. which some may have received. I cannot imagine anyone proudly waving a check as though they had put one over on the manufacturer or something even vaguely similar to what she relayed. This doctor was on Long Island, a middle aged women. I didn’t get her name. Suffolk county I believe. Agreed, for wmen to show such distain for other women who are also their patients, is especially egregious.

  15. Kitty says:

    I am surprised that AUGS doesn’t ostrisize?? (Spelling) Dr Ostergard. How could they NOT know such salient information.

    • Jane Akre says:

      I did have some higher ranked key opinion leader say Dr Ostergard was crazy. I thought that was quite insulting and I was taken aback by his comment, so if others feel that way, that is ostracizing him.

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