March 18, 2013, by Jane Akre ~ Recently a doctor commented about mesh-injured women by saying “These are angry women.”

I was taken aback. You trust your doctor. The doctor sells you on a minimally invasive procedure that will “fix you right up.”  Some women were told nothing – no consultation, no discussion on complications, the lack of long-term studies or the impossibility of removing mesh after it’s implanted in your deepest place.

“These are angry women.”

Many doctors turn their back on women saying they’ve “never seen this before,” or they offer some antidepressants because the problem, after all, must be in your head.  Of course these women are angry. Anyone with a remote sense of justice would be and a doctor who deals with these women everyday should have some understanding of that, one would hope.

His words sparked this dialogue from a few “angry women.“

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Ah, the anger stories. Mine stems from the very doctors who installed my mesh who refused to believe or admit it was causing the problems. It seems like that’s where many of us had the most frustration. Every time I think I’ve got a handle on the anger, something will stir the pot again. Like most I’m a work in progress.”“I will never trust or believe any doctor without researching it myself online. I am still amazed that doctors lie. If they don’t know, they should refer it out.”

 ≈

“I think mesh injured people go through Elizabeth Kubler-Ross’s “Stages of Death and Dying”, like others with cancer or other serious chronic illnesses.  It’s a loss of health, womanhood, sex and intimacy for some, active lifestyle, jobs and insurance, etc and development of pain and other uncomfortable symptoms.  It’s normal to vacillate between grief, anger, bargaining with God, depression, and finally, hopefully, acceptance.

As one of my mesh friends says, “Find peace in the place you are in.”

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“We joke that we are a small village of women who do this.  It takes a village and thank God we’ve established one. We need our own zip code. We do need a convalescent place for women to stay and have a little counseling.  Counseling would actually be simple.  They just need love and validation.  Most of us were able to fly home soon and xx had a son near there, but even she had to stay for awhile because some of these surgeries, including hers are very serious.  We could work with the surgeons who know who needs to stay longer.   I know L.A. is expensive, but we need it near there so that women do not make that long flight home too soon, nor too long a drive when they get out of hospital.   I know it is only a dream but it needs to happen.”

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One woman writes after being sick and losing her job:

“Needless to say, I was completely, totally, and absolutely in shock and I’m certain that it contributed to the “clinical depression and PTSD- both health and work related” diagnosis that I ended up with…..So that’s my thoughts on anger at the medical system….  The anger used to ooze from my every pore but I realized that I was only hurting myself more by letting that happen.  Yoga (and being/living in the “here and now”) helps A LOT!”

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“Walking is my salvation. I also just came off a 5-day water fast which helped not only my anal fissure but my mind set. I plan on doing a 20-day juice cleanse this summer. For me it not only clears my body but also my mind.”

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“Yes, I guess we ARE angry women. When I was in my worst pain and could barely walk I was crossing in a crosswalk while a car impatiently waited. I faced the car with arms opened and yelled “Go ahead make my day!” At that point I would have welcomed a speedy demise. I don’t know what the driver thought, but that sticks in my mind as one of my lowest points.”

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“Yes, the anger was affecting my marriage too b/c I was constantly taking it out on my poor husband…  In a weird way, I was trying to push him away b/c I no longer felt “worthy” as a wife, woman, mother, partner….That’s when I started seeing xx, a licensed mental health counselor (LMHC), also a nurse before going into mental health.  I just needed someone, not family, that I could cry, ventilate with, get all my feelings sorted through…  Betrayal, anger, sadness, loss of self, job, activity level, sex life, peers at work, anxiety…She helped me SO much!  Without the drugs that I didn’t want.”

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“I agree with you- that’s one of the biggest things that mesh-harmed ladies (and men) need is to talk, talk, talk, be heard (after being denied again and again by medical professionals and even their own families), talk more, and know that someone is listening, believing them, and that they are being heard.”

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“I agree xx…I was angry at my doctor, for letting me suffer for months, denying it was the mesh, then the first surgeon who agreed it was the mesh and couldn’t find it, when I asked her for a referral to UCLA, emailed me back that was nothing more she could do for me physically! This was after I told her the infectious disease doctor told me I could DIE….what happened to the oath, “Do no harm”? I sent her the angriest email I have ever written.”

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“But it is all about the money/insurance…a life is last consideration, if any at all. I thought I had released this anger against Doctors, till I wrote this email. I am still angry, healthy and healed, but angry that there are still hurt women that can’t get help.”

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“My husband bottled it all up. He was more panicky than angry, trying to get my meds, being there to support me, etc.  I don’t think he felt the anger, because he didn’t feel the pain. For example, your friend can have cancer, but you really can’t relate, because you have never had cancer. You can be there for her as a support, but you feel more like crying for her than anger.”

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“Much of my extreme anger at my doctors, hospital, anesthesia group, peers that I thought were “friends” that weren’t there for me after I was no longer working, healthcare in general, and later on the FDA and Big Pharma, ended up inadvertently being taken out on my husband.  I was literally oozing anger to the point where it made me mad to see other people smiling and “happy”.  I’d NEVER been that way my whole life- how very sad!”

“I kept (consciously and subconsciously) trying to drive my husband away because I felt like he was too good of a man to be saddled with a “ruined” wife like I had become, physically and emotionally.  I thank God every day that my husband didn’t give up on me or our marriage like I wanted him to.  A testament to a wonderful man!”

“I try to NOT think back on what I went through at all, because it definitely makes me angry.  When I think of everything I and others have endured…  And for what?  So some stupid big company can line it’s pockets with money from the pain and tears and suffering of so many women!  When I think of my Internet mesh nurse friend who didn’t make it through her mesh insertion and removal complications, it makes me sad and very angry.  That’s why I’m still around.  My anger pushes me to help others out of their horrific situations.  All I have to do is remember how I felt when I was in so much pain, so alone, being tortured, nobody understanding, and it propels me to action to get others out of that same, awful situation.”

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“I was reading all your anger stories this morning and yes we could all write a book about anger.  You could say I have keyboard anger.  I used my keyboard with the doctor who put it in me and then said “I was the only one”.  However, xx met a woman out in the waiting room while she waited for me each week to try to pee for two hours.  That lady gave me my first clue that it wasn’t just me and we are still friends.  She almost died the end of 2010 when she had partial removal in Houston and he clipped a vein.  Eight hours later and the loss of 70% of the blood in her body and she barely lived.”

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“If you were to put us four into a room together it would be an explosion of anger.  Dr Phil ain’t heard nothing yet!  It’s a bit crazy but most of my anger is now at the injustice of what happens to all the women out there who cannot get help at all and they suffer in bed.  Their kids don’t give a shit about them.  The stuff I know could fill volumes of what is wrong with the world today.

“So yes I have a lot of anger issues which I suppress and actually switch to other women’s pain.  Gotta do something with it.”

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“i AM DOING NOTHING BUT GETTING WEAKER . i HAVE NO CONTROL OVER BOWELS OR BLADDER AT ALL ANY MORE, SO GETTING THINGS HAVE GOOTEN WORSE SINCE NOVEMBER AFTER SURGERY. LAST YEAR.”

“ i do not understand , no doc. has even talked to me at all. but a self examination, the mesh is still protruding out , and infections still going on. . I AM DYING ANY WAY SO WHY WON’T THEY SHOW MERCY AND LET ME BE PUT TO SLEEP. STOP MY HEART, . I do not want to die alone here. I TOLD MY DAUGHTER SINCE i was used as a guinea pig, and will be as long as I LIVE, WHEN i DIE, GIVE MEDICAL RESEARCH MY BODY , SINCE THEY DESTROYED MY LIFE  WITH THIS IMPLANT AND DOCS LIED.

“THE YOUNGER WOMEN MIGHT BE STRONGER THAN i AM, THAT ARE GOING THROUGH THIS , MAYBE THEY HAVE GOT HELP.”

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“All I could think about is that I did not want you to give up and die.  I did not want you to die alone in a world that has been cruel to you.  I had to do something but I was not sure what to do.  As I lay there I remembered another young woman who is suffering from mesh. When I spoke to her over the phone, she was a compassionate and caring young woman even as she deals with her own health issues.  I knew she would try to help you.

“At this point I am not sure what she can do to get the ball rolling but I spoke to her this morning and she is going to work on it.  You see, we are all women helping women.  You are right when you told me that the world does not care about mesh issues.  You are right when you spoke of the cruelty of doctors who do not seen compassionate for women like us.  But regardless of your anger, you must accept the care and help you are given.  You need someone to care about you and you cannot continue to be alone at this time.

“We, the small village of women who do this care very deeply about what happens to other women in this situation.”

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“The problem with anger is that we do need treatment.  xx admits she needs mental health but they have no insurance and no money.  So how do you find the money when you have to keep a roof over your family’s head and raise children?  Women have been so screwed up physically and mentally that they back away from the medical profession altogether, even when they are seriously injured and dying.  The anger really gets in the way and we no longer trust anyone.  We probably do need Dr. Phil and yet we would be hostile even to him.  He is a man.  How could he possibly understand the destruction of our organs and genitals?  We are all defined by sexuality and it is a very sensitive issue, regardless of age.”

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“When I spoke to xx yesterday, the woman is so filled with anger because she told me when she reached to find out what was done in the partial removal surgery, she said she no longer feels like a woman because something is missing.  She said she has a hollow area from where she was once a woman.  I have heard that many times before.  It isn’t that she is wanting sex.  It isn’t that she is washed up either.  It is because she feels they mutilated her body and never explained why.

“She said she exploded one time in the doctor’s office.  That explosion of course has put her on the crazy list.  We know what the explosion was about.  They lie and betray us, then ignore us.  She said they told her they were going to remove it all.  Then afterwards she said they told her it was impossible to remove it all.  It is since that surgery that the infections took over.  She said up until that point, she could still do things.”

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“I am cussin and swearing!!!! over 30 years ago the put threads of PP into rats to test rates of degradation!!! could they not see the value of putting a filament into a prospective implant patient to test biocompatibility? bastards @#$%^&^%#!!! Subcutaneous implants of polypropylene fi… [J Biomed Mater Res. 1976] – PubMed – NCBI,   http://www.ncbi.nlm.nih.gov/pubmed/993229”

Please Share your stories of anger here!  Thank you.

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Matt Hermes PhD

~March 1, 2013

I helped Adam Slater as an expert with what became Gross v Ethicon from early in 2009. My job was to help Mr. Slater make sure Ethicon had produced all its relevant documents. I have the qualifications to do that because I am a veteran researcher and have run product development for other medical device companies, not Ethicon. I’m not going to write about those documents, or Ethicon. I can’t. You perhaps read some of their production through the Gross v Ethicon trial and have your own opinions.

I have two points to make about product design and development:

First, responsible inquiry is a zero-based effort. It is unfailingly shortsighted to base today’s product solely on the last one. For implant devices, at the least, consideration of the biocompatibility of ALL materials in ALL potential end uses gives the researcher clues as to where he/she can’t go in their work.

I remember in 1992 my group was considering a particular material as a surgical suture candidate. But one of my scientists found an obscure reference that plates made of this material inserted under the eye to repair bone had swollen over the years and needed to be removed. I stopped the project. Another major device company soon introduced a suture like the one I avoided. That product was removed from the market after many instances of long-term foreign body reactions were reported.

Let’s think about meshes.

What is the true surgeon’s nightmare? It’s leaving a gauze pad behind after surgery, wouldn’t you say?

Gauzes are open weave cotton meshes; they remind you of, well, polypropylene implants.  A left behind sponge is often benign. But maybe 25% of the time it results in a persistent shrinkage and walling off into a troublesome massive foreign body. Sound familiar?

When I think of all the materials from which implant meshes have been made; polypropylene, polyester, Teflon®, polylactide, all seem to have triggered serious complications in patients. No one and I mean no one has shown that any of these synthetics would be expected to act any differently than that nightmare cotton gauze. Designers fail to do their job, in my opinion, if they give short shrift to the entire history of implants before bringing the next one forward.

Actually hernia meshes result in fewer adverse effects than the transvaginal mesh products that have generated more than 15,000 product liability plaintiffs. Why? Have designers really ignored the mechanics of a relatively unrestrained vaginal mesh as it flexes, distorts and undergoes the shrinkage forced of fibrous capsule formation resulting in mesh movement, nerve capture, erosion and pain?

I suspect that flexible implants are a separate class of biomaterial, behaving relatively independent of composition and require much more intense design efforts attended to by scientists of many disciplines.

My second point is we scientists fail to heed the powerful voices of the affected. Listen as Hope Pagano says, “We need a patch test so that we can detect an individual’s allergic response to mesh.” Nonie Wideman writes that we should test for an individual’s susceptibility to excessive response to polypropylene. Smack on, ladies.

This is individualized medicine, focused on preventing harm. It’s not obvious how one would carry out these studies but I know this: If one of these women was my boss at a device company and gave me this order I sure would figure out how to get it done!

Matthew E Hermes

hermes@clemson.edu
March 1, 2013

Dr. Hermes has a PhD in Chemistry from the University of Maryland 1959. He worked as a research scientist at DuPont (20 years), Celanese (4 years) and US Surgical, now Covidien (13 years), where he developed and introduced synthetic implant devices such as sutures, clips and staples. Dr. Hermes was the inventor and holds 32 US Patents. For the past decade he has worked as a consultant and expert in devices particularly intellectual property and products liability on absorbable and non absorbable fibers, films, meshes and devices.

He has a Masters in Literature from Wesleyan U. (Middletown, CT), and authored “Enough for One Lifetime”, biography of DuPont’s inventor of nylon, Wallace Carothers whose suicide at 41 ended an extraordinary creative career of scientific genius. He lives near Greenville, SC, and is a Research Associate Professor, Bioengineering at Clemson University.

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Linda Gross

February 28, 2013 ~ After a 31 day trial, jurors in the Linda Gross v. Ethicon case awarded $7.76 million in punitive damages to Linda and Jeff Gross for the injuries she suffered from a Johnson & Johnson product, the Prolift transvaginal mesh.

The nine-person jury awarded the South Dakota couple $3.35 million in compensatory damages Monday, February 25, making the award total $11.1 million.

Jurors were encouraged to punish the company with total assets of $121.3 billion and make them feel the award.

“They intended to deceive,” said Adam Slater, attorney for Ms. Gross of Mazie, Slater Katz & Freeman.

Adam Slater

“Teach them, teach them. Deter and discourage J&J and Ethicon from similar wrongful conduct in the future,” he said.

FRAUD

Jurors found that J&J and its Ethicon unit failed to properly warn of the risks of the transvaginal mesh implant, the Prolift and the company made fraudulent misrepresentations to Ms. Gross, a nurse who sued due to her injuries.

Linda Gross

She has endured nine mesh removal and 18 surgeries altogether. Testimony in the case shows she lives with chronic pain, is on multiple medications and cannot sit for more than 20 minutes.

The jurors did not find the Prolift mesh was defective.

David Mazie pointed out to the jury that the original $3.35 million verdict represented just 45 minutes of the $57 million per day advertising budget for J&J in 2012.

Mazie told the jurors, “There is a culture at Ethicon and J&J, it wasn’t one person or one isolated event. It was person after person after person. They have a culture there clearly from the evidence and that culture does not care. They care about one thing, the almighty dollars. Hit them right in the pocketbook.”

Christy Jones, who represented Ethicon in court clasped her hands together and leaned forward to the jury during the punitive phase saying,

Christy Jones

“I’m begging you to think about what was done and why.  I understand your verdict. I understand you have said we have fallen short but I ask you to think about the fact that is completely different from saying we should be punished because we deliberately acted or failed to act with reckless indifference of the consequences.”

WILLFUL AND WANTON

To find a punitive award jurors must have concluded there was willful or wanton disregard of Linda Gross’s rights through a deliberate act or omission; done with the knowledge there was a high degree of probability of harm and done with reckless indifference to the consequences of the act. The evidence must be clear and convincing with no doubt or substantial doubt.  That is a tougher standard than the preponderance of the evidence standard used at trial.

Jurors had the option to award no punitive damages. The six men and three women declined to comment after the trial concluded, reports Bloomberg.

Ethicon announced it would appeal both monetary awards according to Sheri Woodruff, a company spokesperson in an email to Bloomberg.

“The punitive damage award is unsupported by the evidence presented at trial. Ethicon acted appropriately in the research, development and marketing of the Prolift,” she said.

PROLIFT BYPASSED FDA APPROVAL

Last June the company announced it would remove from the market Prolift and three other vaginal meshes for financial not safety reasons.

Prolift kit

Johnson & Johnson began marketing Prolift, a polypropylene mesh, in March 2005 bypassing any Food and Drug Administration clearance. When the FDA discovered that action it approved Prolift for market in 2008 without imposing any sanctions.

There are currently 2,182 cases against Ethicon filed in New Jersey Superior Court before Judge Carol Higbee as well as 3,988 cases filed naming Ethicon consolidated in the Southern District of West Virginia.

Other mesh manufacturers product liability cases filed in West Virginia multidistrict litigation include C.R. Bard (2,080 cases as of Feb. 25); American Medical Systems (4,208); Boston Scientific (2,394) and Coloplast (203).

The many lawsuits filed in individual state courts naming polypropylene mesh used in prolapse repair are expected to top 20,000 and run into the billions of dollars.

Last July, Christine Scott won a $5.5 million verdict against C.R. Bard in a California state court. See the story here.  These are the first two actions putting the petroleum-based mesh on trial.

Hernia repair patients implanted with the same polypropylene mesh often report the similar symptoms of mesh migration, erosion, infection and nerve damage.  #

Follow all 30 other days of coverage on MDND Legal Desk as well as the day-to-day proceedings on the MDND Facebook page including graphics shown to the jury.

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February 26, 2013~ An attorney for Johnson & Johnson begged the jury today not to award punitive damages in the Linda Gross v. Ethicon trial that could amount to $20 million.

Judge Carol Higbee reminded the nine jurors who returned for this final phase of the 29 day trial that the standard must be clear and convincing evidence that the harm suffered by Linda Gross was the result of acts or omissions by the healthcare giant accompanied by a wanton and willful disregard  of the patient.  The company would have had to know the acts or omissions had a high probability of harm but showed reckless indifference to the consequences.

A punitive award is intended to discourage egregious behavior in the future. Jurors also have the option not to award punitive damages when they reconvene Wednesday morning.

Linda Gross

Jurors on Monday awarded Linda and Jeff Gross $3.35 million in compensatory damages for the harm she suffered after being implanted with the Prolift transvaginal mesh. Specifically, the jurors found Ethicon, a division of J&J, failed to properly warn of the risks of vaginal mesh and made fraudulent misrepresentation to Ms. Gross, 47, a South Dakota nurse, who sued the company.

Christy Jones, the attorney for Ethicon asked the jury not to further punish the company beyond yesterday’s award.

Jones spoke softly with many pauses when she told jurors the company cared about women’s health and did not act with wanton and willful disregard of the consequences, a higher standard to prove then the preponderance of the evidence standard for compensatory damages.

“I’m asking you, I’m begging you to think about what was done and why” she said pleading and bending forward to the jurors.

“I understand you have said we have fallen short but I ask you to think about the fact, that is completely different from saying we should be punished because we deliberately acted or failed to act with reckless indifference of the consequences,” she said.

WORTH OF THE COMPANY

Evidence was presented by both sides about the value of Johnson & Johnson and its various healthcare divisions.

Frank Tinari PhD, Economist

Economist Dr. Frank Tinari was brought back to the stand where he showed the total assets of J&J and its 250 divisions at $121.3 billion with a net worth in 2012 of $64.8 billion.

“Take one-thousand million and that’s one billion,” he said trying to put it in perspective.

J&J averaged $11.5 billion every year in profit since 2009 with expenditures of $57 million every day in marketing and advertising.

Attorney David Mazie asked “Every 45 minutes of every single day, J&J spends the amount the jury awarded yesterday?”
“That’s correct,” said Dr. Tinari.

On cross exam, Ethicon attorney William Gage reminded jurors that was the relative worth of all of the subsidiaries, not just women’s health division.

Mark Schneider, financial manager, J&J

The defense brought Mark Schneider to the stand, a senior manager of financial reporting at J&J.  Looking uncomfortable at times, Schneider broke down the numbers for Prolift profits concluding that the net income from the sale of the Prolift vaginal mesh after taxes in South Dakota was $24,498 and in New Jersey was $122,413.

Mazie asked if he had a dollar-for-dollar amount for Prolift sales, which Schneider did not.

Mazie: “Are you aware that for the first half of 2008 the total sales for Prolift were $55 million? Schneider answered that might have been a peak period.

Mazie: “You are telling us under oath that J&J made $24, 498 in profit in South Dakota? That’s what you’re telling them?

Schneider: “Yes.”

Mazie: “The profit in New Jersey for seven years was $46,647?”

Schneider: “That’s based on the profits and loss that I had.”

Mazie: “No further questions,” he ended abruptly.

CLEAR AND CONVINCING EVIDENCE

Adam Slater

In the afternoon, Ms. Gross attorney, Adam Slater reminded jurors of the importance of the  civil justice system.

“You have Linda and Jeff coming from South Dakota, coming to a courtroom against Johnson & Johnson, one of the biggest companies in the world and they get nine people from Atlantic County to decide what’s right and wrong. It doesn’t get any better than that,” he said.

Slater said the burden for jurors now is to consider clear and convincing evidence of reckless indifference which he said jurors had already found in concluding J&J fraudulently misrepresented  the dangers of Prolift and failed to warn about the risks of Prolift.

He reminded jurors of the words of Medical Director, Dr. Charlotte Owens who confirmed there would be some women who would experience chronic inflammatory reaction some at a significant level, though the company never explored removal options.

Dr. Axel Arnaud, Ethicon

Dr. Axel Arnaud’s testimony was replayed in which he said manufacturers don’t have a “crystal ball” to know what complications will arise and that a 5-15% complication rate is”a good wording,” even though the patient brochure called the complication rate “rare.”

Slater asked jurors to “deter and discourage” the corporate behavior and “send a message and make that number count and make sure it’s heard.”

Punitive damages in New Jersey are capped at five times the compensatory amount or in this case $16.75 million, a fact jurors have not been told.

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Day 28 Verdict Day!

February 25, 2013 ~ Jurors in the Linda Gross v. Ethicon trial awarded the 47-year old woman from South Dakota and her husband $3.35 million today in an Atlantic City, New Jersey Courtroom.

Jurors have been deliberating 5 days now in the product liability trial.

Jurors decided the Prolift was not defectively designed by a 9-0 vote.

By a 7-2 vote the jurors decided there was a failure to provide adequate warning to Dr. Benson the implanting surgeon.

By a 7-2 vote jurors decided the Prolift was the proximate cause of injury to Ms. Gross.

By a 7-2 vote jurors decided there was no fraudulent misrepresentation to Dr. Benson, her implanting surgeon.

By a 7-2 vote plaintiffs proved a fraudulent misrepresentation was made to Ms. Gross and that was the proximate cause of injury to Linda Gross.

Linda Gross

MONETARY AMOUNTS

What amount  of money compensates Linda Gross from her past pain and future pain of suffering, disability loss of enjoyment of life  $1.1 million.

For her past wages- $180,000.

For her future wages $500,000.

For the reasonable value of past medical services  $385,000.

For the reasonable cost of future medical treatment and household services $1 million.

Compensation to Jeff Gross $185,000 for loss of the companionship of his wife.

Punitive damages will now be considered by the court which could be five times compensatory damage or $350,000, which ever is greater.

The $3.35 million was awarded because Ethicon failed to properly warn of the risks of the vaginal mesh to Linda Gross and made fraudulent misrepresentations. The plaintiff did not prove the mesh had a defective design.

Linda Gross as jury verdict was read

Late add here* Jurors were instructed by Judge Carol Higbee to call in at 4pm EST to see if the case was over or if they should return back tomorrow morning to decide punitive damages. Interestingly,  when the jury was polled, Juror #7 said he didn’t think the pain and suffering awarded ($1.1 million) was a “fair amount.”

Late Late Add* 4:15 pm- Judge Higbee has called the jurors back to the courtroom at 9:30 tomorrow morning (Tues, Feb 26) to discuss punitive damages.

Linda Gross and her attorneys say Ethicon, a division of Johnson & Johnson, produced a defective Prolift transvaginal mesh used to treat prolapsed organs, and failed to tell doctors about the dangers. The plaintiffs also claimed Ethicon used deceit and fraudulent misrepresentation to promote Prolift.

Attorney Adam Slater looks back at Linda Gross

BACKGROUND

The Prolift Pelvic Floor system was an innovative new transvaginal mesh that for the first time would be sold pre-cut in a kit with hook like trocars of metal implanting devices.

Made by Ethicon, the medical device division of Johnson & Johnson, Prolift would use the Gynemesh soft prolene (PS) used for hernia repair.

During the trial jurors saw that the marketing team always worked closely with Research & Development and Regulatory Affairs with a targeted March 2005 launch date.  The date was important. Ethicon wanted to take advantage of the market and beat out the upcoming competition and charge a “premium price” for the Prolift, according to internal company records.

But as late as January 2005 the launch team was hearing from its French scientists who developed the TVM procedure (how to use new tools to place the mesh).  Evidence was presented that showed they suggested a different type of mesh be used to replace the Gynemesh because early indications on cadaver and animal testing showed a 21 percent and higher complication rate with Gynemesh placed in the pelvis.

Prolift kit

Gynemesh was called the “worst of a bad lot” of meshes and some inside the company thought it caused too many complications.

Ms. Gross who had worked as a hospice nurse, is now unable to sit any more than 20 minutes. She has to self-catheterize in order to urinate and has chronic pain in her legs and pelvis. She has undergone 9 mesh removal operations and over “400 medical encounters” since the Prolift was implanted in July 2006.

Her story painted a sympathetic picture of a woman who does not resemble her former self.

Linda

What was not introduced before the jury was the fact that Ethicon decided to bypass any approval by the FDA and instead just began marketing and selling Prolift, under the radar.

On the stand, the head of Regulatory Affairs Sean O’Bryan said the company thought the mesh was similar enough to the Gynemesh used for hernia repair, even though the technical implantation was entirely different and the area of the body it would be placed was a new applications.

Ethicon did not run any human clinical trials and did not study how best to remove the mesh if there were complications.  Despite the red flags before launch, Prolift met its March 2005 date.

The case show how different “tiers” of doctors were chosen to be trained in Prolift. Some were “preceptors” used to teach other doctors on the new product. Often there was compensation for the doctors and large dinners and events to promote the product to new doctors. Within the company, the upper “tier” of doctors feared the lower “tiers” or less skilled doctors were not understanding how to implant the mesh in the “blind” procedure practiced during weekend cadaver teaching sessions.

An expert witness for Ethicon said Ms. Gross multiple removal surgeries caused her pelvic muscle to spasm and she never gave her body enough time to recover between surgeries.

Last year, Ethicon decided to remove Prolift and three other transvaginal meshes from the market in a phased stages over 18 months. An investigation by MDND recently found it can be purchased on eBay and is still sold overseas.

Last June, a California jury awarded $5.5 million to a woman injured by the C.R. Bard Avaulta mesh, another pelvic organ prolapse mesh that comes precut in a kit. That ruling is on appeal. (Story here)

As of February 25, there were 2,182 cases against Ethicon filed in New Jersey Superior Court and 3,887 consolidated in federal court in the Southern District of West Virginia.

Other cases naming Ethicon are filed in various state courts around the country. #

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Linda Gross

Thanks again to Courtroom View Network for access to this trial!

February 21, 2013 ~ On this Day 26 of the Linda Gross v. Ethicon trial, the jury took this second full day of deliberations to ask the court to re-read Ms. Gross’s testimony from her court appearance.

The jury received the case after closing arguments on Friday, February 15, and jury instructions when they returned on Tuesday, February 19.

Dr. Kevin Benson

The jury must decide whether the Prolift product made by Ethicon, a division of Johnson & Johnson, was defective and whether her physician, Dr. Kevin Benson, was adequately warned about the potential for complications. The physician is the end user of any medical device, not the patient, and the failure-to-warn would apply to the doctor.

The third charge for the jury is to determine whether or not Ethicon made misrepresentations to Ms. Gross, 47, or Dr. Benson about the safety and risks of Prolift.

Ms. Gross had the Prolift surgery in July 2006 to correct a prolapse of her rectum into her vagina.

She says the surgery changed her life.

Court reporter reads testimony

“Who you see standing here now is not who I was,” she said. Gross is on 20 different medications and has had 19 operations and 400 “medical encounters” since July 2006. She called them “painful and humiliating.”

Ms. Gross is unable to work and says she cannot sit longer than 20 minutes.

Readers can revisit her testimony during Day 14 of the trial here. And see more excerpts as they happened on the MDND Facebook page here.

In the rather dry reading of the court reporter, the nine jurors, six women and three men, missed the emotion that Linda Gross brought to the stand such as her emotional outburst at Ethicon attorney Christy Jones.

Christy Jones

Linda Gross

“Why did I need to keep researching. You are trying to blame it on me ~ it’s not right!’ she became emotional during trial.

Linda was told by Dr. Benson she should expect a two to three week recovery following one night in the hospital. She did not receive a patient brochure so she went home and printed out one on the Ethicon website.

Ms. Gross said Dr. Benson was very enthusiastic about the new Prolift System. During courtroom testimony it was revealed he was one of the many Ethicon consultants who was  training doctors on the novel use of a mesh kit and implantation tools that would be called Prolift.

Prolift was sold by Ethicon with no FDA notice, a fact that was not allowed to be considered by jurors in this case.

Ms. Gross said she expected the brochure would have told her everything she needed to know because she trusted a worldwide company such as Johnson & Johnson.

Patient brochure

Since she had to manually help herself defecate she said, “I had hope I was willing to take a chance I might get better.”

Ms. Gross said she developed urinary problems since Prolift and has had to self-catheterize to urinate four times a day since her surgery.

Jurors were reminded by the defense that Gross, a nurse, had seen a hernia mesh protruding through a patient’s stomach during her job.

Adam Slater

During trial plaintiff attorney Adam Slater showed jurors internal company emails that J&J was told by French scientists the Prolift mesh (Gynemesh used in hernia repair) should be substituted with another mesh less likely to cause problems.

Despite many red flags from scientists, the company and its marketing arm continued the product to its launch date of March 2005.

AWARD

If jurors determine Prolift was defectively designed and J&J failed to provide adequate warnings or misrepresented the dangers to Ms. Gross and that was the proximate cause of her injuries, the jury can then consider damages.

If compulsory damages are awarded, Judge Carol Higbee can determine whether the plaintiff can also seek punitive damages which are capped at five times compensatory damages or $350,000 whichever is higher.

The jury returns for deliberations Friday morning.

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Dr. David Spellberg, urologist

By David Spellberg, MD

As a Urologist, I have read about horrible complications such as bleeding, abdominal pain, perforated organs, and sexual dysfunction associated with certain types of mesh products and some of the terrible suffering of mesh patients.

The Food and Drug Administration issued two warnings, one in October of 2008 and another in July 2011, alerting physicians and manufacturers of the risks of synthetic transvaginal mesh, including extrusion through the vaginal wall or into organs, chronic pain, infections, scarring, shrinkage, and neuromuscular problems. It also mentioned that a return of incontinence, prolapse, multiple surgeries, and other complications were “not rare”.

Unfortunately, those warnings were not heeded and now there are significant numbers of patients with lifelong problems. Many require multiple surgical procedures; oftentimes with worsening results as in many instances the mesh cannot be completely removed.

The need for transvaginal mesh occurs for women in those cases where the vaginal lining or epithelium becomes so thin and weak that they develop pelvic organ prolapse. This means the bladder, rectum, uterus and occasionally the entire vaginal canal can drop, which requires surgery to fix.

Prior to the use of mesh, many women would have their own muscle tissue from their abdominal wall or thigh used to support the fallen organs. This was a more complicated procedure with a more painful recovery and mesh was developed as a way to address those issues. Mesh was used to reinforce the weakened muscle and tissue, but it appears there were many unforeseen problems with certain types of mesh.

Now when there is a problem with the implanted  mesh and it needs to be removed, it is a more complicated procedure and many times the mesh itself has adhered to other tissue and is not able to be seen or completely removed.

One of the big problems has been the difficulty in visualizing mesh after it has been placed, especially if removal is needed due to complications. Unfortunately, current imaging techniques such as CT scans, MRI, and high definition ultrasound have not always been as effective as needed. Sometimes these imaging modalities are not able to actually see the mesh, making it impossible to know what needs to be removed.

In fact, many patients are just given pain medications, an anti-inflammatory  and even antidepressant medications because a complete diagnosis has not been made. It is unfortunate that many patients are being dismissed by their doctors as they are told “there is nothing that can be done.”

I was recently intrigued by a demonstration of the Niris 1300e OCT scanning system produced by Imalux Corporation (here).

The Niris is an OCT (Optical Coherence Technology). The OCT technology is not new, but has been around for many years. The Niris has been FDA approved for tissue surveillance, and is extensively used for cancer surveillance.

In the past few months Imalux identified and through studies showed the clinical validity of the Niris 1300e in identifying the precise location of mesh in patients. (See study here)

The capability of the Niris 1300e was dramatically superior to a typical ultrasound machine in the identification of previously placed mesh, because in addition to its being less invasive to the patient, it has the ability to scan epithelial tissue where diagnostically significant alterations in tissue structure first occur.

Also, spatial resolution of 10 – 20 microns provides a useful tool in distinguishing between inflammation, benign lesions and/or dysplasia. Niris images are acquired at a minimum of 8 frames per second making surveillance using Niris practical and efficient.

As a physician, I was extremely impressed how simple the equipment is to be trained on and even more amazed at how reproducible and consistent the results are. Where ultrasound would be influenced by the experience of the user and the quality of the machine, the Niris 1300e was able to produce the same results in the hands of different users. In the past unfortunately, many patients may have had procedures to remove vaginal mesh only to find out that a partial removal was performed due to the difficulty in knowing where all of the mesh was placed.  I believe with this new application of OCT technology physicians treating patients with mesh problems could have an easier, less invasive and more effective way to deal with their complications.

I believe this technology may also be used in the future to help identify and be used as an adjunct factor in determining whether hormonal replacement is needed in para/post-menopausal women and as a great surveillance tool for cervical cancer.

The Niris system is able to generate consistent and accurate measurements of the vaginal epithelial lining, which as explained earlier tends to thin as women age. By keeping a record of the thickness of the lining, women and their physicians may be able to follow and determine if and when hormonal treatment is needed, along with monitoring for cancer in a more effective manner.

I believe with the use of the Niris technology, many future patients can avoid these types of problems, so hope is on the way.

[Editor's Note* Op-Ed essays are the opinion of the writer. Some Opinion pieces may be sponsored and helping to support MDND.]

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Thanks go out to Courtroom View Network for access to this trial.

February 5, 2013 ~ On this Day 17 as the Linda Gross v. Ethicon trial plaintiff presentation wraps up, the  former Medical Director for Ethicon Women’s Health and Urology (Gynecare) was brought to the stand via his videotaped presentation.

Dr. David Robinson, Ethicon Medical Director Worldwide – Nov 2005 to Dec 2010, from LinkedIn

David Robinson was involved in all aspects of the decision to sell Prolift in March 2005, the same transvaginal mesh placed in Linda Gross, 47, one year later with devastating results.

Robinson said the benefits should always exceed the risks of any device before it is sold.

And if there were complications?

“It would be my job to assess why we were seeing what  we’re seeing to make a decision what the causation was and go from there.” Robinson said.

Q:”Would a woman having to self-catheterize for a year be a serious complication?”

Robinson:”I raised it as an issue for them to discuss.”

Pore size measurement and mono filaments, Ethicon

Pre-Launch

On tape Adam Slater, attorney for Linda Gross, asked him which studies made up the decision to launch Prolift.

The French team’s TVM study looking at the implantation technique was one, a retrospective study of 687 patients, and 2.5 years of freestanding Gynemesh studies.

Gynemesh was the name of the Ethicon mesh that would be put in the Prolift “kit” containing pre-cut mesh and implantation tools – the first kit used as an innovative Prolift Pelvic Floor Repair System.

It was designed to make a grid of collagen that tissue would grow in to support pelvic organs that had prolapsed.

David Robinson, courtesy Courtroom View Network

Mesh Shrinkage

Early studies showed the mesh would shrink and contract. This complication occurring in a woman’s pelvic floor could cause chronic pain and there has already been testimony that Ethicon did not study how to remove mesh if complications occurred.

Slater:” How much contraction was understood to occur with the Prolift mesh?”

Robinson: “The exact percentage wasn’t known for sure, it would shrink or contract in the 30% range, that was my working assumption.”

 Adverse Event Reports Coming In

The French TVM study showed an erosion rate for mesh of 18.6%, a US study showed 13%.

At a meeting August 13, 2010, Ethicon execs including David Robinson discussed a study by Dr. Cheryl Iglesia that had to be halted prematurely.  The study is here.

Using the Prolift mesh, the preliminary erosion rate was found to be 15.6% higher than the 15% criteria that had been established as the uppermost limit for complications.

Slater to Robinson: “Do you think 15% is a high erosion rate?

Robinson: ” It’s a rate that fell in the range we were familiar with 10-19%  had been seen.”

Courtroom Day 17

Prolift Registry

Jonathan Meek, from LinkedIn

In an email sent from Jonathan Meek (marketing) to David Robinson, about setting up a Prolift registry in Australia, Meek asked Robinson to review it from a clinical perspective.

“Dave,” the email asked, “from a clinical point of view, is there a legal risk if someone captures complication data on it? Robinson answered, “I don’t know about a legal risk but we clearly have a world wide customer quality risk. When any adverse event is captured in a registry it has to be reported to worldwide customer quality and ultimately a decision made regarding its reportability.

“Consequently if none of our competitors are keeping registries, our complication data may appear increasingly accurate but with decreasing appeal.”

July 2006 was the same month Linda Gross was implanted with the Prolift mesh.

Replace Prolift

Discussions within the company show that Ultrapro was considered to be the replacement for the Prolift. “Their main concern is the Prolene Soft material (Gynemesh PS used in Prolift) over time contracts creating the potential for failures and/or erosions.”

“The scientific knowledge about the uses of meshes in surgery is still in its infancy” the company acknowledged in a Gynecare  report, “Characteristics of Synthetic Materials used in Prolapse and Incontinence Surgery.”

Scott Jones, Sales Ethicon

Scott Jones, Sales

Appearing briefly via his deposition was Scott Jones, Marketing at Ethicon. He testified that he was not aware that Ethicon offered training to surgeons on how to manage erosion complications. He admitted mesh removal was a “complicated procedure.”

Jones would bring a brochure to doctors in order to sell them on the new Prolift procedure but he admitted there was no long-term data to provide to prospective surgeons.

Jones: said a 10 percent complication rate was not rare. He admitted as the market became flooded with pelvic meshes his company introduced mesh to physicians with a “lower skill set.”

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Dr. U. Klinge, mesh researcher

February 4, 2013 ~On this Day 16 of Linda Gross v. Ethicon,
German mesh researcher Dr. U. Klinge appeared on the stand.  Dr. Klinge, a hernia surgeon who has performed 300 surgeries, also worked as an Ethicon consultant on new mesh material for 10 years.

He has authored more than 100 articles and worked with mesh biocompatibility in the body for more than 20 years.

As an Ethicon consultant he provided the science that brought many hernia meshes to the market. He says the science was never done on the Prolift to adapt the hernia mesh (Gynemesh PS) to a woman’s pelvic area.

Thanks extended to Courtroom View Network for access to this trial!

In July 2006, Linda Gross was implanted with the Prolift, a new procedure using the Gynemesh PS hernia mesh. It would be sold pre-cut in a kit with implantation devices, an innovative new product made by the Ethicon division of Johnson & Johnson.

Dr. Klinge

Back in 1998 Dr. U. Klinge, in his studies with Professor Klosterhalfen at The Technical University of Aachen, found that  a “modification of polypropylene (PP) meshes could be helpful to prevent major and minor complications of surgical PP-meshes” here.

Pore size measurement and mono filaments, Ethicon

Working with Ethicon at its Norderstadt, Germany facility, something called “porosity” was seen to be critical for a successful implant. Porosity is the amount of space left inside a piece of mesh in its “pores” even after it undergoes a stress like movement.

The larger the space, the less fibrotic tissue would grow across the pore. Scar tissue is inflexible that bridges the gap but also leads to mesh shrinkage and eventually pain when placed in the pelvic floor, a complication that never ends.

Ethicon had not developed any pore size specification, according to an email from Ethicon R&D engineer Scott Ciarocca to Dan Burkley, who did porosity testing for Ethicon.

When Ethicon funded a study in 2002, Dr. Klinge told the jury the company was very aware that the pore size of mesh under 1 mm would cause fibrotic bridging scarring across the pore hole have a scar plate that could lead to shrinkage and complications.

Dr. U. Klinge

Q: “Was Gynemsh PS  safe to be placed in woman’s tissue?”

A: ” It is not as safe in design and never had a chance to be.”

Q: “What is the general basis of that opinion  of the structural disadvantage of this mesh?

A: “You have rather small pores that are even made smaller by filaments across the pores. You have complete columns of pores and this together leads to an incorporation of the device into scar formation. That means by matrix of scar shrinkage and entire area of mesh is integrated into the scar plate in the area of the pelvic floor, this is disastrous.”

Q: ” Was Ethicon aware before launch of Prolift in 2005 of this problems?

A:”No doubt.”

Searching for a New Mesh for Prolift

Ethicon was on an active search for a better mesh material, documents showed, a year before it launched Prolift.  In a email from French scientist working for Ethicon, Michel Cosson to Scott Ciarocca, R&D for Ethicon confirmed internally, the company felt it needed to improve the mesh.

Erosion and retraction were occurring along with the main concern, shrinkage leading to pain and dyspareunia or pain with sex.

With mesh  equal to about four football fields of suture material, in 20 years it will still be reacting.

Ethicon- No distinct pore size

“Even after 20 years, the tissue is still reacting to the mesh,” said Professor Klosterhalfen on the biological response to surgical mesh in a June 2, 2006 Ethicon Expert meeting on mesh for pelvic floor repair.

Despite claims by Ethicon that the Prolift was specifically designed for pelvic floor repair, an email shown to the jury sent internally admitted “we pulled a mesh out of our existing bag of tricks” meaning the prolene soft mesh that made up the Gynemesh used in Prolift had previously been used for hernia repair.

Dr. Klinge: ” I thought we made it clear with our experiments you need a specific design for a specific indication and a specific area therefore it is not suitable to just put mesh from one area in another.”

Q:”Based on your work with biomaterial sciences, tissue response and your work in this field for 20 years as well as the internal documents from Ethicon, do you have an opinion whether Gynemesh and Prolift is a defective product?”

A: “Yes, it was a defective product.”

Dr. U. Klinge

Q: “Was it unreasonably dangerous when it was sold in 2005?

A:”Yes, they never should have sold it.”

On Cross Examination, William Gage, an attorney for Ethicon established that 91% of all meshes sold today are polypropylene (PP). Dr. Klinge agreed it is appropriate for use on the pelvic floor if you have the correct construction of the PP, that is greater than 1 mm pore size.

Dr. Klinge has implanted hernia but not pelvic floor mesh.

William Gage, Ethicon attorney

Mr. Gage established that somewhere between 5 and 20 million people worldwide have been implanted with PP mesh.

Q: “You remember talking about foreign body reaction and chronic inflammation, fibrotic bridging where scar tissue builds around pores and causes problems for the patient? It’s well known response that all meshes call chronic and inflammatory response after implant?

A: “Yes”

Q: “You knew about that but you implanted it anyway because you know benefit exceeded the risks?”

A: “From a risk balance that can be done as I told you that is a discussion at our conferences every year.”

Q: “The reason it’s been a discussion is since 1985 is because no perfect mesh has been built yet has it?”

A:”There will never be a perfect mesh that fulfills all these requirements.”

APPLYING FORCE TO MESH

Referring back to the work of Dr. Thomas Muhl, who appeared on the stand in the trial last week, it was established when a mechanical load is placed on mesh, similar to what happens in the body especially the pelvic region, the pores will disappear.

In 2007, Dr. Muhl devised machinery to replicate human forces on mesh in the body. With a 1.65 lb- force the good pores disappear completely.

“If you place it in a place where there is movement, the good pores will disappear and a complete fibrotic bridging of the entire mesh area will occur,” said Dr. Klinge.

Good pores were referred to as those that did not cause fibrotic bridging and were larger. In this study 75% would cause fibrotic bridging, scar plate and shrinkage. Muhl proposed software to measure the pore size under various stresses.

Stress tests could have and should have been done, said Dr. Klinge.

“Yes, always when you intend to use mesh in an area you cannot rule out is tension-free, where there is some mechanical load, you have to look at what happens to pores in case this stress will appear,” he told the jury.

Was Ethicon aware of the 2007 study? An Ethicon internal email showed the jury it was.

Other Images from the Day:

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Dr. Axel Arnaud, Ethicon Med. Dir. Europe, Courtesy Courtroom View Network

February 1, 2013~ As the plaintiff’s case wraps up in the Linda Gross v. Ethicon trial, the deposition of the Medical Affairs Director of Ethicon (Johnson & Johnson) Europe appeared to jurors via his taped deposition. Dr. Axel Arnaud seemed dismissive of the questions asked by plaintiff attorney Adam Slater.

At times his thick French accent was difficult to understand and there were a few words between the men lost in translation. Otherwise his powerful testimony showed just how much Ethicon understood before and after the launch of Prolift and what little the company did in the name of patient safety. Thanks as always to Courtroom View Network. 

Linda Gross’ rectocele

Day 15 in Ms. Gross product liability lawsuit against Ethicon, a division of Johnson & Johnson, produced a mountain of documents, many generated from the European team in development both before the controversial new prolapse mesh device, Prolift was launched and after.

Dr. Axel Arnaud, the Paris-based Medical Affairs Director for Ethicon since 1992, was primarily focused on developing the Prolift, polypropylene mesh that would be delivered to doctors in a pre-cut kit. It was made of the Gynemesh PS, another Ethicon product, and now considered the leading product to market to treat women suffering from pelvic organ prolapse (POP). Not that there was any real suffering.

The company noted in a Power Point presentation that  POP is a “functional disorder not a life-threatening disease.”

Still with the proper marketing, products for the aging Baby Boomer market were forecast to be a winner. Marketing was an important ingredient. At every  product development or clinical data meeting was at least one marketing manager, either U.S.-based or European.

Plaintiff attorney Adam Slater asked Dr. Arnaud: ” We learn marketing people weigh in heavily on clinical data on what they need to successfully market the product?

Dr. Arnaud: “I want to disagree with that. The marketing did not have input. It was essentially medically driven.”

Later in their exchange, the doctor was careful to call Ophelie Berthier, the French marketing team member, the “European Product Manager in Charge of the Commercialization of Prolift.”

Slater asked, “Marketing?”  “Yes,” said Dr. Arnaud.

There Is No Gold Standard

Documents show the developers of the new mesh product knew there was no “Gold Standard” developed yet to place transvaginal mesh. Dr. Arnaud and the French team working for Ethicon wanted to develop a “simple, safe, reproducible, logical and effective method that attract non-experts,” that is surgeons who may not have the top skills.

The first meeting of Group TVM, made up of six  gynecologist  and experts in pelvic floor surgeries, was held in Nice, France on June 5, 2000. The group would work with hospital centers,universities, non-profit hospitals and private clinics to coordinate logistics in France. Later three additional experts were added with expertise in gynecology. Dr. Arnaud coordinated the group.

Group TVM  was focused on the novel procedure tools and technique. In September 2003, along with three U.S. doctors, they would conduct a study on the TVM procedure with  three month follow-up.

An earlier study showed a post-complication rate of mesh exposure of 12.3% using the TVM technique of mesh implant using trocars or hook like devices to thread the implant into the pelvis.

Prolift had a March 2005 day of launch set in company stone.

From the two people present at the meeting from marketing, “this will be sufficient data to launch the product.”

 

 

 

 

 

 

 

 

 

Manageable Complications

Adverse events that were “manageable” was the goal. Dr. Arnaud said an erosion rate of 30% would be high. Generally it was between 5 to 10%  but 20% would still be acceptable.

Slater:  “Acceptable to who?

Arnaud:  “You know 5% is great 10% is the average, 20% is the upper limit”.

Ophelie Bertier, the European marketer said in an email that shrinkage which leads to dyspareunia was an ongoing problem. Slater asked Dr. Arnaud if he thought complications could be figured out by a woman’s surgeon after the fact?

Dr. Axel Arnaud

A: “If you are a device manufacturer, it’s not necessarily your role to find a  solution for the complications of surgical complication. So if there is a retraction, what can the manufacturer do? Nothing. It’s the surgeon. What can the manufacturer say? There is nothing we can do.”

“When you design a product, are an inventor, you don’t know what will happen in 20 years, you don’t have a crystal ball.”

Slater asked, so Ethicon launched the product anyway?

Dr. Arnaud: ” Very frankly I can say erosion, we knew; retraction, we knew. I don’t think we hid anything to anyone. there are a lot who are benefiting from those procedures.”

Dr. Axel Arnaud

“Now you are telling me I’m a very bad boy I should never have done that but I do not feel bad because we offered the world a procedure; maybe things have not gone perfectly well, but  we are not hiding anything we tried to do our best; not to make money; as TVM  doctors are absolutely not interested in  the money.”

 

 

Before Prolift Launch

Working for Gynecare in the Netherlands, Wessel Van Dijk wrote to company officials in an email. “Gynemesh was over designed for the pelvic floor.” He asked for a substitute product, one that was as “light” as possible to reduce foreign body reaction to avoid the formation of scar tissue.

.

Eight months before the launch of Prolift an e-mail from Professor Jacquetin of the French TVM team knew there was still a problem with the stiffness of the Prolift material. Mesh that is stiff and had shrinkage would not be compatible in a sexually active women.

But improvements in the material would be the “next frontier.” With American Medical Systems (AMS) right on their tail with a new product launch – Launch the Prolift anyway- was the goal. On target – March 2005.

“But continue to improve and be proactive and not reactive about that.

Slater: “Did your company ever make an effort to identify how many women would experience the serious complications that would cause permanent impairment?  Did you ever make an effort to quantify that? 

Arnaud: “I don’t know.”

Slater: “Are you aware their erosion rate at the TVM study that counted all exposures of mesh into vagina was 20.7%?”

Arnaud: “I’m aware of that.”

Slater: “Is it your testimony to this jury that is acceptable?  Yes or no? 

Arnaud: “Yes.”

A couple of months before the launch of Prolift, Dr. Arnaud sent an email to Ophelie Berthier, marketing for Ethicon.  It requested to add a Warning to the Prolift IFU, (Instructions for use), the technical language that would go to doctors. 

Dr. Aaraud had just been informed by TVM group of researches about the correlation between the removal of a uterus (hysterectomy) and an increased rate of mesh erosion and retraction that can lead to anatomical distortion of the vagina. “This must be taken into consideration in a sexually active woman.”

Warning ~ Never made it to IFU

But the additional warning never made it into the IFU because the product insert had already been printed in time for the March 2005 launch and the launch team didn’t believe the data was strong enough to put the information in the IFU.

Doctors did not have the advantage of that warning in recommending Prolift mesh to women following a hysterectomy.

First Do No Harm 

At a Gynecare presentation now two months before the March 2005 launch a “Graft or No Graft” power point presentation was given about Prolift.

Primum non nocere –or First Do No Harm, those in attendance were reminded. Since pelvic organ prolapse is a functional disorder not a life threatening disease, abstaining from treatment is an option.

Slater: “You had no long-term data regarding Prolift when you launched it?

Arnaud:” No we had no long term data when you launch a product. We had long term data about the material used,” he said.

Slater:”Did you talk to doctors who were removing mesh to determine the difficulty of removing the mesh. Did you look into that issue?”

Mesh removed from a woman at Mayo Clinic

Arnaud: “We did not specifically do that.”

Showing Dr. Arnaud pieces of mesh that were removed from a woman at the Mayo Clinic, Slater asked if Ethicon knew at the time of launch that there would be complications that would require cutting the mesh out of a woman’s body.  Those complications are very rare, said Dr. Arnaud.

Slater then read his questions.

Adam Slater reads his questions

Arnaud: “We knew  implanting a mesh in the human body inguinal area, abdominal wall, vaginal wall may result in the need to remove it, I can say yes we knew because its obvious when you implant something when something goes wrong you must excise it.”

Slater: ‘You knew it would take surgical skill to remove it?”

Arnaud: “Correct.”

Slater showed Dr. Arnaud a report he authored in May 2005, two months after the launch of Prolift. It says:

“In summary, our conclusions in placing UlraPro within in pelvic floor as a direct substitute in sub for Gynecare PS is very reasonable.”

Slater: “That’s the conclusion in this document correct?”  “Yes.”

French TVM Group

The French TVM group meanwhile continued to conduct studies on the TVM procedure itself. In one study that spanned from March 2005 to August 2006 at locations around France involving 107 patients, there was 15-25% mesh shrinkage in 60% of the cases. Among women who reported symptoms of tenderness or pain as a result, there were 21 patients or 19.6%. Dr. Arnaud said that was a significant number.

Dr. Arnaud told Slater he didn’t remember if he saw this data or not.

Mesh is Not Bad

Mesh Is Not Bad

The message to prioritize for the new Prolift transvaginal mesh would be “Mesh is not Bad” though out 2007 said Ethicons Worldwide Marketing Director Allison London Brown. That message would echo through educational efforts and public announcements to “continue to drive sales of Prolift and Gynemesh PS.”

Two Years After the Launch of Prolift

In 2007, two years after Prolift was launched, some at the Ethicon TVM group were still not happy with the complications of mesh shrinkage and erosion. A pore size less than 1 mm led to excessive scar bridging and excessive fibrosis, both known to cause chronic pain and dyspareunia.

UltraPro mesh would be the solution in the next generation of Prolift, the Prolift+M. But increasingly the thought was that polypropylene mesh might be part of the problem.

“Polypropylene meshes might not be improvable in terms of shrinkage, we
may need a completely new material”
said Dr. Peter Meier, of Ethicon Women’s
Health &  Urology in an email.

Along with the conclusion by Peter Meier was
Jonathan Meek, another in the Ethicon,
Gynecare division. It was his assessment that Prolift’s Gynemesh PS was the “Best of a Bad Lot” and there was a need to develop graphs that mimicked human tissue.

Dr. Arnaud called him a “dreamer.”

“Graphs that mimic human tissue mechanical property are a dream,” he said.

Dr. Axel Arnaud

“There are two kinds of people, those who dream about an ideal material and marketers, so this is fine but these people are not in the real life regarding this,” he said.”Anyone not having knowledge in this area can dream that way.”

Slater reminded him the Michel Cosson who was a French expert in pelvic organ repair and part of the French TVM group also felt polypropylene “might not be improvable in terms of shrinkage.”   Arnaud said Cosson was an expert in POP repair, not in biomaterials.

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