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Transvaginal Mesh – Does it Degrade? Defense Day One Hinges on Science

U.S. District Court, Charleston, WV

U.S. District Court, Charleston, WV

This coverage is provided in conjunction with We Are Mesh Survivors, a coalition of synthetic vaginal mesh implant survivors united to demand justice for those who have suffered and to demand that existing products be pulled from the market until their safety can be demonstrated.

This is the first day for the defense in Huskey v. Ethicon the second bellwether trial in this federal court in Charleston, West Virginia.

After a Labor Day break, the lawyers working for Johnson & Johnson ( Ethicon)  must present their case.  The jury must decide if the Johnson & Johnson TVT-O, a polypropylene mesh sling is defective. Last April, the device was found to be defective in its design by a jury in Dallas.

Dave Thomas

Dave Thomas

The case for the defense this first day of their case, will hinge on science as they try to prove to the jury, Prolene, J&J’s brand name for polypropylene (PP) does not degrade in the body. That will be important to counter the plaintiffs’ case that degrading PP causes shrinkage, folding and hardening of the mesh which entraps nerves and causes chronic pain.

The jury pool is now down to eight as one woman had a “tragic loss” over the Labor Day weekend, according to Judge Joseph Goodwin who is overseeing this and 22,000 other similar cases filed against Ethicon, a division of J&J.

Dr. Shelby Thames, P.h.D polymer scientist

Dr. Shelby Thames, P.h.D polymer scientist

Dr. Shelby Thames was first to the stand. The PhD is retired from teaching at the University of Southern Mississippi, from the Palmer Science Research Center. It is also named after him, the Shelby Freeland Thames Polymer Research Science Center. Throughout the morning he would tell the jury about the science and chemistry of polymer science. It was established he is being paid $375 an hour.

Dave Thomas, an attorney for J&J, asked what does a polymer scientist do?

Poly means ‘many’, mer is ‘one’ says Dr. Thames. Polymers have unique characteristics they have huge molecules, you can make them strong, tough or soft if you understand the chemistry behind it.

“It’s all in the chemistry, so you have to know the chemistry,” he says in a folksy way.

Once you design a polymer on a piece of paper, then you then make it. You execute it in the lab and achieve a product. To determine if you created it properly you use an analytical tool, then test it to see if it has the properties you want. His specialty is in coatings with pigments, it has to adhere. It has to have physical properties to give it longevity in a multitude of environments. “It’s an awful lot of fun to study,” he says.

Dr. Thames has done no research with polypropylene (PP). He’s studied proteins, vegetable oils, biological materials from agriculture, hydrocarbon material and acrylic polymers cover the gamut in his $25 million facility.

That begged the question, had he ever received research dollars from Ethicon? No, he said.

Thomas: Are there things that can disrupt the polymer?

Yes, said the scientist. Heat can destroy them thermally, acid or base can cause PH changes, UV light can excite the molecules and degrade the polymer and by water. Some polymers have the tenacity to attract water. Dr. Thames added there is nothing in chemistry that is inert.

Ethicon’s Proprietary Prolene

Ethicon’s formula for its brand of Prolene is different from other manufacturers because of the selected additives.

They include:

Calcium stearate – a lubricant

DL TDP- added as an antioxidant to improve long time storage of the resin and to reduce potential oxidative reaction.

Santinox R- antioxidant promotes stability during extruding of fiber from the extruder.

Procol LA 10- another lubricant

CPC pigment- a copper-based colorant to provide enhanced visibility to the TVT device which is blue.

 

How is Polymer Made?

Dr. Thames explained you mix the polypropylene with these additives and then put them in an extruder until you get good distribution of the materials. There is a barrel at the end of the extruder that has the diameter of the fiber you want to extrude, like hamburger meat coming out of a grinder. The PP comes out in small strings, the fibers are extruded that way. That is now Prolene.

Does it leave marks on the material? Yes sir, there are extruder lines.

One study showed as an exhibit (Def. Exhibit #30884) was a study by Timothy Liebert and published in the Journal of Biomaterial Research in 1976. It showed Prolene was stabilized with the addition of antioxidants.

The important things that indicate change are tensile strength, molecular weight, toughness and elongation. Dr. Thames says in his analysis of explanted PP mesh there is no reduction in these qualities.

Have you ever found a decrease in molecular weight in explanted PP? “No. If there is no decrease in molecular weight there is no degradation of PP.

“Ethicon’s polymer is both strong and tough,” said the professor.

 

Ethicon’s 7-year Dog Study

Next the jury was shown the 7-year study on dogs implanted with Prolene sutures. Ethicon concluded that study in 1992 and it was part of the evidence reviewed by Dr. Thames (PL Exhibit # 23228) which was previously presented by the plaintiffs. In it dogs would be sacrificed at interval and the suture evaluated using infrared spectroscopy for molecular weight, tensile strength and elongation.

Scanning electron microscopy has an electron beam and a mirror and can produce an image up to 7-thousand times its actual size. If there is degrading suture you would find a loss of degradation, molecular weight and tensile function would be changed.

(*Editors Note- a mesh implant whether a tape to treat incontinence or a mesh for the pelvic floor to treat pelvic organ prolapse, involves much more mesh than is contained in a suture. As Dr. Tom Margolis, an expert in many plaintiff cases has testified, “The more mesh, the more mess.”)

An analysis showed there was a degradation in the Prolene and PVDF (another polymer) and a few cracks were found.

IR Microspectroscopy looked at fine pints under a microscope in a report by Ethicon dated October 15, 1992. It showed a possible evidence of slight oxidation.

“My feeling is we are looking at something that is not Prolene. It may be an acid solvent. Protein is in flesh and when they take the explants out and they don’t clean them you would expect to see protein from the flesh.”

Dr. Thames concludes after looking at the explanted suture from the dogs, the Prolene came out well.

The stiffness of the explanted material was reduced about 5 psi slight reduction in strength required for breakage of Prolene sample. As far as elongation, the sample elongated twice its original length. “It means not only did the Prolene not undergo elongation but it improved the elongation, so it was a tougher strand of Prolene then when it was implanted in the dog.

“Overall the properties were enhanced during the 7 year implantation.”

Dr. Thames explained the mesh was improved by being able to be plasticized.

“You implant this in an animal and the triglycerides in the body can plasticize and make more pliable a molecule like Prolene. Like hand lotion, you put a plasticizer on the hand to provide elasticity and lubricity when it is chapped. That’s what’s happening now. You are improving the PP implant.”

Thomas: “Comparing data from 7-year dog study and Exhibit 2026 which allows you to draw any reliable conclusions? Does polypropylene degrade?

“In my opinion, it does not.”#

 

What’s Left Out

These cases are as remarkable for what is left out that the jury cannot hear as what is allowed in. Most of that results from Motions in Limine where the scope of what is being tried will be determined Jurors cannot hear, for example, that in this very court there are in excess of 66,000 lawsuits filed against seven manufacturers. 21,754 name Ethicon, the division of Johnson & Johnson that makes the TVT-O mid urethral sling.

The fact that another jury already found the TVT-O to be defective will not be heard in this trial.

The fact that Johnson &Johnson destroyed tens if not hundreds of thousands of court documents that were on a litigation hold in these transvaginal mesh injury cases will not be introduced in this courtroom.

The systemic or autoimmune issues erupting among many women who have the polypropylene implants will not be introduced. This case is being tried on pain and dyspareunia (painful sex). The science is not there yet to back up the systemic issues but anecdotally the majority of women appear to be reporting such affects.

21 Comments

  1. Tambrea says:

    Why can they leave out the facts that mesh has caused autoimmune issues and the distuction of evidence ?

  2. wow…..he needs to personally test the explanted meshes from women who had FBR and implant failure…not read research on dogs….. what bugs me most is that all research is not published, the failures for research to prove what the popular consensus is never published when the research is paid for by invested parties in the product being researched …… all research should be published, to advance human knowledge , learn from past mistakes so we can piggy back on steps in the right direction with research ….. he really needs to study about 1000 explanted mesh samples form men and women …. on that basis, I would discredit his testimony, but it may favorable have this person as the Ethicon expert ….. as a skilled lawyer should be able to discredit his expertise based on personal experience with human sourced explanted mesh studies

    • msm says:

      I agree, Nonie. Plus, he is testifying about sutures. Judge Goodwin already dismissed an pre-trial motion by Ethicon stating that while the materials are the same, a suture is not the same as mesh. I hope the jury keys on his reference to the material as “strong and tough” and that it was “able to be plasticized”. That doesn’t sound like something that should be used in a human, especially in the form of mesh. If it becomes ” a tougher strand of Prolene then when it was implanted “, couldn’t that cause damage to organs that are constantly moving. Especially if it is anchored to bone or has fused itself to an organ? What damage did it cause in the animals?

      Thanks for a great report Jane.

  3. Maria Garcia says:

    This line of testimony is exactly what I am concerned about. The plaintiff lawyers have to focus on the nerve damage caused by the “DESIGN” of the mesh device by installation. It’s like raising a tent and the corner and mid loops dictate where the stakes go and that is by design. What do the mesh devices attach to and why can they not be removed when there are complications? They attach to ligaments and cause nerve damage that is irreversible. They were counting on FBR and they got it which makes the device impossible to completely remove from the ligaments near nerves without causing more nerve damage. It doesn’t matter what Dr. Thames says because….

    Dr. Thames has done no research with polypropylene (PP). He’s studied proteins, vegetable oils, biological materials from agriculture, hydrocarbon material and acrylic polymers cover the gamut in his $25 million facility.

    Ethicon is talking about dogs and sutures not slings with anchors connecting to ligaments and causing nerve damage that is irreversible. There has been too much information about polypropylene in all cases and brands to discount the experts that deal with this everyday. If the MDL is all about sharing information from trial to trial then how can Ethicon get away with all this distraction? They can because the Plaintiff lawyers need a gotcha “CHECK MATE” maneuver and the only way they are going to get it is with focusing on the mounting positions of the mesh in relation to the nerves which there are many. Then they need to focus on the fact that these anchor points ARE causing the on going pain and suffering because “BY DESIGN” they cannot be removed. What is the common denominator in all the cases in all the brands? Polypropylene Mesh? Yes BUT… what is still bothering me is the fact that most ex-plant patients have chronic pain months later? What’s left behind is the nerve damage the anchors have caused. It’s clear to me that Judge Goodwin wants the Plaintiff attorneys to come up with a “CHECK MATE” but it’s not going to happen if they don’t focus on the ongoing chronic pain source of the problem and that is the ANCHORS! The Plaintiff experts are actually being discounted by Dr. Thames who has NEVER work with and has done no research with polypropylene (PP). Is that not comparing Apples to Oranges. Too many of us have physical proof through ex-plant surgery of what Ethicon has done and that cannot be explained away. The nerve pain cannot be fixed or EXPLAINED AWAY. It is a defective design because of the anchors and where the surgeons are instructed to place them. That should be easy enough to prove because the anchors never get removed. Physical nerve tests can be performed exposing a defective design with the mesh material failures further supporting this fact.

  4. Pam says:

    This is so sickening to my stomach!! They have 22 hr old records of dog research, but have no records of Human Studies regarding Mesh in Humans? Defense can can use the suture study on dogs, admit they have 22 yr old records, but Huskey Attorney cannot mention that ALL records regarding the studies of Mesh & FDA records cannot be mentioned??

    Wow!! I’m so disgusted & they are making this case out to be as if she HURTS because of SEX!!! I am appalled at how they can get away with this!! I’ve lost all trust in doctors, laws, & our Justice system!! I’m suffering with thousands of others daily, & surely SEX isn’t anyone of these suffering women’s 1st chief complaint!! That is mainly a complaint due to our marital/relationship connection& how DESTRUCTIVE the MESH is! It starts with your life by destroying who you love, & lastly destroys the last bit of love for yourself!!

    Why is it not mentioned that PP isn’t even safe to store food? All the other studies of how BS buying another company to hide what they were buying Polypropylene for? They can bring a witness in that has never studied PP to try and discredit any complaints as if it’s a better material, but we can’t tell the WHOLE TRUTH!!!

    Judge is a SHAM & PAID OFF!!!

  5. BS says:

    This is BS!!! I am very disappointed in the outcome of this. First J&J admit to default of the product and now they all of a sudden find the box of files missing and are claiming no default!!! I have been injured by the TVT-O and my lawyers have informed me not to talk to anyone regarding this issue but, it is clear that the Judge is on their side and doesn’t care about the patients this product has hurt in more ways they he could ever imagine! This is not fair to us women who have endured such pain due to this product. I only hope that he can sleep at night with the injustice he is doing to all of us. God Bless all of us who have to live with the pain and suffering this has caused. It’s all about the Benjamin s with these medical companies!!!!!

  6. Dean says:

    I have said this many times this needs to be on public television on the news so when a jury is chosen they might have caught a glimpse of what is really going on as it seems to be very little on the news or talk shows about this issue WHY?Think about it I asked why this was not happening and I didn’t get an answer I wrote our television net works and got no reply people just can’t depend on people to just come across this HUGE issue just on the internet it needs to be out there so the public can really see what’s going on behind closed doors

    • Kitty says:

      Hello Dean—Transvaginal mesh!!! Vaginal response—— Many people —believe it or not find this offensive—as did the Ob/GYN Docs in the days of Masters and Johnson research.(Human Sexual Response) This device is about woman’s sexuality–How shameful to have TV carry this report about the S—s and wh–es that can no longer have orgasms.

      • Dean says:

        Hi kitty it’s shameful as this product is clearly not about having orgasms as it it’s about the body rejecting a foreign body of which is the TVT O Mesh and the horrific things it’s has caused for all who are suffering from having this implant.I can tell you from seeing what my poor wife has and still is going through with here daily pain and taking high doses of medication for this pain I don’t think she really cares about an orgasm due to her pain she endures on a daily basis due to having this implant

  7. Donna hall says:

    I agree with what BS and Dean has written here….there is not enough information out there to have peoples awareness lifted so that they would be able to understand what damage this product has done to the health of so many women….it is pitiful to make an appointme nt with a dr only to have the dr explain away that they dont think the issue is the mesh that is causing the patients chronic pain…..it appears it is a conspiracy…to blame the injured women for having other issues in that area that caused this problem…not the mesh itself….People will not get involved with issues that dont seem to affect them…what these people dont know is that they probably allready know someone affected by mesh….it did seem to be an issue not spoken outloud often in the beginning but after years of pain and no resolve I think it is time to bring it up and make an awareness for everyone…….i think these doctors need to get there heads out of the sand and stand up for their patients and not be so concerned obout not getting involved with the legal side of all this…maybe we might get somewhere with finding help for our injured ladies! I want to do something for my daughter but everywhere we turn seems to be a dead end……This is not right

  8. AmyG says:

    What about the people who had their implants prior to FDA approval? I just wonder if that could hurt or help since it’s seems informed consent and FDA approval are being used against the mesh injured. Thank you for your reports Jane. I know we all appreciate being able to stay in the loop.

    • Jane Akre says:
        Technically the FDA approved the device to sell,,, not for safety and efficacy. that is the loophole with the 510(k) – no clinical trials required, just an exchange of paperwork. The jury will hear nothing about the 510(k) in this trial.
  9. PLC says:

    Was the jury allowed to hear about the 510k process in any of the other trials?

  10. Karen says:

    Come on Doctor , we are Human !!!! the year is 2014 !!!!!

  11. Nanci scherer says:

    What does FBR stand for?

    • Jane Akre says:

      FBR= Foreign Body Reaction….. what happens when the body detects a foreign body… it reacts! walls if off,forms scar tissue, which shrinks, entraps nerves…

  12. Shirley says:

    Shrinkage I may add plus the year don`t matter mine was implanted 10 yrs ago and partial extraction in 2012 due to shrinkage over time and erosion science does matter but animal testing come on we are humans there is a difference. Cannot be completely removed due to grown into the internal organs. This trial reminds me of Erin Brokenvich Movie where the defence councils tried to defend that contamination of water did not cause so many people to become ill sick and die from their waste management practices. Own up too being scientifically wrong and loosing records is a joke they destroyed evidence a known fact. WHAT A JOKE! WE ARE NOT DOGS WE ARE HUMAN BEINGS!!!!

  13. jade says:

    This Dr. Thomas doesn’t know – he’s in coatings and pigments – a “paint chemist” – UNbelievable – he’s not an expert in PP or what it does! DR. THOMAS IS A PAINT CHEMIST!

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