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Day 16: Linda Gross v. Ethicon Scientist Knew Prolift Transvaginal Mesh Was Defective

Dr. U. Klinge, mesh researcher

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

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.

D16  Ethicon had no pore s ize specificity  email in 2009

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

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.

D16 emails need to be improved shrinkage of the mesh   2

 

 

 

 

 

 

 

 

 

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 distince pore size

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.

D16  pulled it out of our existing bag od tricks  ethicon  using hernia mesh for prolift

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

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

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 D16   pore size folo to dr muhl work

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.

D16  article may 2009 on pore size published look it up muhl and dr klinge

Other Images from the Day:

D16  the vagai8na is not the abdomen

D16  comparison between abdominal mesh and pelvic mesh

 

5 Comments

  1. Melynda says:

    Every day of this trial leaves me even more flabbergasted than the day before. Thank you for reporting this, Jane.

  2. Lana Keeton says:

    The Three Stooges would be better at repairing pelvic organ prolapse than this collective group of idiots at Ethicon.

  3. AnnMarie says:

    As a someone who has been assaulted and battered by the prolift, I wonder if we can also file criminal charges? The criminal act on me occurred in 2009 and I still am unable to work due to having repeated surgeries, removal and failed repairs, sex is history and depression is the norm now, sitting is painful, etc. Mesh complications takes your soul as a woman. Ethicon is just a bunch of arrogant idiots who managed to find dumb and dumber doctors to be their accomplices. I have a science degree and where the heck was the science behind these PERMANENT torture devices? I was not told of these complications and no brochure was given. I am sure Dr Mengele, the Nazi doctor, would loved to have had the Prolift to torture women prisoners with. We all just continue to be Ethicon’s experiments. Praying justice will prevail. Also, where is the mainstream media with this attack on women? Jane thank you for your coverage and support!

  4. Patty Brush says:

    My night mare began Dec 2009!! I was lied to but didn’t know it until it was all over. First of all the morning of surgery the doctor didn’t show up they had to call around and find him. They found him on the goff course playing goff. He came in and the surgery was suppose to take about 1 and a half hours but he called my husband when he started and was exactly twenty minutes he call my husband and said he was finished. Well I ended up staying two nights and it was suppose to had been out patient. The doctor call the first night and said they were going to give me two pints of blood he accidentally nick me a little and I lost two pints of blood. Well this is only the beginning of my night mare. It goes on for 6 years of different surgeries and pain and surffering. This is 2014 and I’m still hurt and I am seeing a doctor in Nashville , Tn and he is trying to fix me. But I don’t know if I will ever be without pain!!

  5. Suri says:

    Wrote a lengthy comment on this site about my mesh surgery in 1997. I lost my whole life and everything I ever worked for and my pain is to this day is horrible. When can I get justice in court and get some M_O_N_E_Y to help ease my pain and put me back in a clean bed of my own home. I can not eat right due to not enough money and i don’t get food stamps. $720 a month is not enough money to live on when I need a caregiver. I was 40 yrs old when I got the surgery. Worst mistake of my life, hands down. I so wish I could work, have sex, have love again, have my own home, a car, and afford my medicine and go out to eat with my family without feeling so indigent and pathetic. I can’t pay so all my family and friends quit asking me to go anywhere. I never feel good enough to dress anyway and Im sure as hell not going to bum off everybody like a homeless pig. Yea, I had dreams. I was going to be married with a couple grandkids, living in FL, become a famous self help–beauty arthor, and play tennis and travel the world. Now, look which way my life went … and I didn’t even have a say. I never did anything to go to prison. I was a good, honest, hard working hair salon owner who worked 12 hour days 7 days a week for the first three years of my first hair salon. I just bought my first home months before this surgery. I lost everything. I could have gotten it all back if only I could stay out of pain and work. I’m so jealous of people who have their health and work. So jealous. And what is crazy is some people are jealous of me because they can not see the pain inside my body. I try to blend in but my sparkle is gone. I think about death everyday and I know the clock is ticking and I wonder if I did get my settlement before I died if I could move to a new town and get a few comfortable years financially and afford a nice clean environment and keep my bad health a secret from the world and blend in and …just laugh because something was funny. That never happens to me anymore and my family and friends just don’t get it. They think I can get up and go get it all back and be happy and have sex. That is a lie. I can not get up on a regular schedule. I missed four doctor apps last month and couldn’t buy all my medicine. I was hungry many days. I don’t get food stamps. If I applied, I would get $16 a month. Im too tired ans sick to go get that $16. I have good dreams sometimes but then I have to wake up to my pain. My pain never sleeps. I just learned to live with it…on pain ans sleeping meds. My heart hurts and flutters, and my kidney is now joining the badder pain. My lower back hurts so bad, I can’t wash dishes. So i have to use throw away everything. Very expensive to be disabled. Living in my car for three winters. Showering at the Gym. I kept telling them my plumbing was being worked on. Yea, right, they saw my car parked in the parking lot day after day. I never worked out because it was too painful. I was always afraid I was going to be killed, robbed, or the police would make me go to a public shelter. Life is not fair. The people that did that to me and thousands of oher women need life in prison. I never gave my consent to be experimented on. I had goals. I had a fun life. My whole family is affected by what happend to me. I used to be the one with the money helping everybody out…crazy how things change and they can not help me at all. Now after I die, and J&J finally gets around to paying my family…Im sure they will feel so guilty for not helping me more. I forgive my family but I do not forgive the FDA or Johnson & Johnson. Go to hell.

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