Free Case Evaluation
Connect
With Us

Huskey v. Ethicon – Industry Rep Denies Mesh Has Problems

aaron kirkemoDay six of Husky v. Ethicon had the defense putting forth its best case.

After Dr. Thames, the polypropylene expert,  was dismissed from the morning session it was time for the taped deposition of Dr. Aaron Kirkemo, MD, a urologist and assistant  Medical Director for Ethicon, a division of Johnson & Johnson. Dr. Kirkemo had a urology practice with about 60 percent female patients until he was recruited by J&J to join the ranks of the healthcare giant where he worked from August of 2008 to July 2012.

Dr. Kirkemo is now the Medical Director at Urology and Women’s Health for Boston Scientific, see his LinkedIn here.

Ulf Ulmsten, founder of TVT

Ulf Ulmsten, founder of TVT

The first perk came as an all-expense paid trip to Sweden to visit with Dr. Ulf  Ulmsten the inventor of the TVT (transvaginal tape) who eventually sold his patent to J&J for $25 million, as has been revealed in the Lewis trial, the first trial naming J&J in this court.  Kirkemo learned the TVT method directly from Dr. Ulmsten which he described as an “epiphany” moment.

Dr Ulmsted had figured out that putting a sling in the middle of the urethra (mid-urethral) was more effective than at the neck of the bladder.  He innovated the TVT  which was launched in 1997 in Europe and in 1998 in the U.S.

The TVT-O, the type implanted in plaintiff Jo Husky, was invented in France and brought to the U.S. in 2002.

Under direct examination on videotape it was established that Dr. Kirkemo had been a favorite spokesmen and consultant to a number of medical device companies where he received honorariums to speak, including – AdvaMed, Sheraton Laboratories, AMS (American Medical Systems), Beecham, Merck, Eli Lilly, Glaxo, Pharmacia, Upjohn –  Yes, he said to all.

Dr. Kirkemo was even an early adaptor of the ProteGen, a Boston Scientific mesh sling that was taken off the market in 1999 for being defective. As stated in the FDA’s enforcement report of March 17, 1999,  “Use of ProteGen in the treatment of female urinary incontinence is associated with a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.” See background story here.

 

IFU WARNINGS

Ethicon had failed to warn about dyspareunia (painful sex)  or pelvic pain in its instruction for use (IFU), one element of a defective product claim. Dr. Kirkemo was asked why not warn about dyspareunia to surgeons, the end users?

“I don’t think I’ve ever seen a patient have dyspareunia from a retropublic sling,” he testified under oath.

Later he added “dyapareunia is part of all surgical procedures.”

He was asked if he remembered a meeting with Dr. Meng Chen.  Dr. Chen was an Ethicon employee responsible for the daily reports coming in from women who felt they were injured by the defective products. Painful sex and chronic pain,  chronic infections were among the many complaints coming into her New Jersey office. Dr. Chen asked for a meeting of her superiors to suggest expanding the IFU to include the real-life complaints she was hearing.

Dr. Kirkemo said he didn’t recall the conversation or the meeting.

 

HATES TVT-O

The plaintiff presented documents that Dr. Kirkemo was on record as hating the TVT-O. Under questioning he blamed that on the difficulty of the operation and the fact that women had to be in an extremely flexed position to have the device implanted.

“Patients with arthritis did not like it they woke up with hip pain,” he said.

 

MESH DOES NOT ERODE

The plaintiffs contend that polypropylene mesh erodes in the human body as well as shrinks and contracts, leaving the patient in chronic pain.  Does mesh erode?  It does not, said the doctor and when facing evidence presented from Professor Klosterhalfen, who had worked for Ethicon trying to develop a better mesh. Dr. Klosterhalfen was an Ethicon consultant who was introduced during the Lewis case.

Dr. Bernd Kloserhalfen

Dr. Bernd Kloserhalfen

degradingFrom the Lewis case:  The TVT mesh is the worst, said Dr. Klosterhalfen as he referred to images that showed enlarged microscopic images of cracking and degrading mesh. As the mesh degrades in the body small particles of polypropylene have been found in a woman’s vagina causing irritation and infection as the body tries to rid itself of the foreign invader. Nerves coming into contact with this mesh mess create the chronic pain seen in many women suffering transvaginal mesh complications.

Klosterhalfen is on record as saying mesh erodes. One can see that in microscopic photos of cracked surfaces of polypropylene mesh. But Dr. Kirkemo disagreed with Klosterhalfen.

Q: Did Professor Klosterhalfen get it wrong?

“He misinterpreted it” said Kirkemo. “He didn’t prove  it with the  next step.” The doctor said the erosion was actually protein serums that had coated the mesh and accounted for the image of the dried up mud.

Did Dr. Kirkemo ever reach the conclusion that the mesh was defective, he was asked.

“I mostly found it was the physicians’ fault,” he said in explanation of the adverse events.

For his part, Dr. Kirkemo said he’d only seen two mesh exposures in patients. He had excised portion of the mesh.

“Is it difficult?

“No, its like any other place.

Aren’t there nerves in the vagina? For example, per square inch when compared to my leg, are there more or less in the vagina?

“I can’t tell you that.”

 

ABBREVO INNOVATIONAbbrevo image

Within any medical device company, innovation is the key.

A product change means the marketing department can sell the latest and greatest innovation. Ethicon had other meshes in the production line that were never launched. The Scion was one innovation.

Documents presented to Dr. Kirkemo showed he was a big fan of the Scion. It was “beautifully designed” he wrote and would solve the problems of the leg and nerve pain caused by the TVT-O where large needles pass through the obturator muscle potentially damaging nerves and muscles and causing permanent pain.

“You write, positioning can produce both orthopedic and neurologic injury and bone and nerve injuries you describe? “Yes. If done incorrectly, you can still have leg pain, groin pain, hip pain… you can have pain.”

Then came the Abbrevo, which in documents he called a “game changer.”  Why? It contained less mesh, 32 percent less mesh and the traditional thought, “less mesh is less mess,” Kirkemo agreed less mesh was a benefit that would produce less foreign body response.

Interestingly, the IFU for the Abbrevo mesh, which was eventually marketed, shows how to position a patient on the table, something Dr. Kirkemo admitted is missing from today’s TVT-O instructions for use. “It incorporates updates I thought were important,” he said referring to Abrevo IFU.

 

BENEFITS EXCEED RISK

Dr. Kirkemo insisted in testimony that the adverse event section of the TVT-O IFU contained a comprehensive list of adverse events or complications.

How frequently does leg pain occur with TVTO? – “One to two percent.”

Fortunately, those are very “rare” he added. As it says in the IFU, chronic groin pain can be managed with mild analgesics.  “It says after the operation you’re going to have sore thighs.”

Q: “Do you believe benefits of TVT-O outweigh the risks?

A: “Yes I do there are tremendous amt of physicians in love with TVT-O and  in their hands they have success with low morbidity. If  you have something working well for you you stick with it.”

 

Learn More:

IFU for TVT-O, here

IFU for Abbrevo, IFU here

Doctors Divide- Mesh News Desk, here – The growing dissent within the medical community about mesh-injuries.

Mesh News Desk, What Jurors Never Saw in Lewis v. Ethicon, March 2014, here

Background on Ulf Ulmsten, here.

Mesh News Desk – Ethicon Defends Questionable TVT Tape Science, Feb.11, 2014 here. (includes background on Dr. Klosterhalfen)

 

 

9 Comments

  1. Dawn says:

    1-2 % leg pain ……

    Where and how do they get this data ??? I never had a follow up call asking how my mesh was doing…

    So sick of these people that do not have MESH in their bodies, trying to tell us how and why we feel the way we do !

    WE ARE IN PAIN !!!!!! And this mesh degrades !! How else would we be pulling it out of our abdomens through our skin ? Or peeing it out ? Or poohing it out as well ??

    So sick

  2. msm says:

    “he’d only seen two mesh exposures in patients”

    How many patients did he see?

    “If you have something working well for you you stick with it.”

    Who is it “working well” for? Manufacturers? Docs?

    ” there are tremendous amt of physicians in love with TVT-O and in their hands they have success”

    It is amazing that the manufacturers do not have a standard for training. If there was genuine concern for the correct use of their product and patients’ well-being, they would establish a certification.

    “physicians in love”

    Just because they “love” it doesn’t mean it is a safe treatment. Are they “in love” because it is quick, easy, and profitable?

    “they have success”

    How does he measure “success” ? Doing well a month post-op? A year? 10 years?

    “He had excised portion of the mesh.” “Is it difficult? ” “No, its like any other place.”

    From where else has he removed mesh?

    If he needed treatment for incontinence after prostate surgery, would he choose to have mesh implanted?

  3. PLC says:

    ……and to think the jury is never going to be able to hear the real truth in this court room…..ugh. 🙁

  4. Laura says:

    Does the Plantiffs lawyers get to cross examine the defense’s arguments? I sure hope so. This witness is clearly bought and paid for. To get on a witness stand a make these sort of unreliable statements is sickening. Way to go Johnson & Johnson, throw the doctor’s under the bus for your eroding defective product. If you don’t believe it’s defective, read the medical records of thousands of women and start basing your research on the injuries (adverse effects) it has caused. That is where the truth lies! Injured women across this country are your samples for research. We are the “standard” you should measure. As far as dyspareunia being part of any surgical procedure? You forgot to mention with your product it was a lifetime sentence. You can also sample that in thousands of women’s households across this country. You take your “gold standard” product and implant it in your loved ones. Then let’s see what you have to say about your ” gold standard” product!

  5. sandy says:

    Documents presented to Dr. Kirkemo showed he was a big fan of the Scion. It was “beautifully designed” he wrote and would solve the problems of the leg and nerve pain caused by the TVT-O where large needles pass through the obturator muscle potentially damaging nerves and muscles and causing permanent pain.

    OK FOR US WHO HAVE HAD LARGE NEEDLES PASS THROUGH THE OBTURATOR MUSCLE THAT DID CAUSE DAMAGE TO OUR MUSCLE AND NERVES HOW DOES HE ADDRESS THAT??? HE JUST ADMITTED WHEN A SLING IS PLACED IN THIS MANNER IT DOES CAUSE DAMAGE. SO THEN THE DESIGN AS TO HOW THIS IS TO BE PLACED DOES CAUSE DAMAGE RIGHT AND WOULD BE DEFECTIVE RIGHT! I just see a lot of contradictions in what he is saying. In one sentence he says it does not cause problems then turns around and says it could. I just want the truth to come out in these trials. I never knew I had to call AMS after my surgery to report I was having problems. I wonder how many doctors will stand by these companies once they know that the companies are blaming the doctors. ALL I KNOW IS I WAS FINE BEFORE THE MESH AND NOW I HAVE LOST EVERYTHING EXCEPT THE PAIN I CONFRONT EVERY DAY!!!!

    • msm says:

      Sandy, you are so right. WHEN WILL THE DOCS REALIZE THEY ARE BEING THROWN UNDER THE BUS by these manufacturers. Most of these cases are still within the statute of limitation. The plaintiffs can turn around and sue the doc. Ethicon “experts” have tesitfied that any injury is due to the surgeons techniques. A verdict for the defendant, opens the door for malpractice suits. While some techniques may be better than others, the product should not be so unstable that a millimeter in positioning can make the difference between a positive result of a life-altering injury. This is a part of the body that has tremendous movement, changing pressures, and friction with even the slightest change in position. There must be allowance for movement without injury. There must especially be allowance for some amount of shifting immediately after the procedure. This is an un-anchored “tension-free” tape that relies on tissue integration over weeks to find its final resting place. DOCS KNOW THIS ! Why are they allowing mesh manufacturers to drag them through the mud (not that those staunch supporters of TVT don’t deserve it).

  6. Tambrea says:

    What a liar!!!! Not only is intercource painfull for the woman but also her partner! He should be ashamed of himself. I hope he can not sleep at night!

  7. Lana Keeton says:

    For the record…Dr. Thames is not a polymer engineer and consequently not a “polypropylene expert” as Ethicon is trying to portray him. His comments on the stand that triglycerides plasticize polypropylene and improve it are junk science. Ethicon is grasping at new straws. Lana Keeton

  8. jade says:

    Lana- You are 100% correct. Dr. Thomes is a PAINT CHEMIST- coatings and additives – he’s NOT a PP expert or an expert in anyway with PP! This is a travesty!

Post a Comment

Your email is never published nor shared. Required fields are marked *

*
*

© 2016 - 2017 Mesh Newsdesk. All rights reserved.
This is a Sundown Legal Marketing law firm website.