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J&J Federal Trial – Transvaginal Tape Risks Outweigh Benefits

Jane Akre

Jane Akre

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.

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Tuesday in the trial of Huskey v. Ethicon, the fourth jury trial over Johnson & Johnson’s controversial transvaginal meshes, Dr. Bruce Rosenzweig, an expert for the plaintiff, told jurors he had implanted 15 or 20 of the polypropylene slings.

He stopped doing them after seeing patient complications and today only does the burch procedure using sutures. Today he also treats patients with mesh complications and has seen about 1,000 patients so far, he estimated.

Dr. Rosenzweig

Dr. Rosenzweig

Transvaginal meshes were developed in the last 15 years to shore up sagging pelvic organs and the urethra as a treatment for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). They are made of J&J’s Prolene polypropylene (PP).

To a reasonable degree of medical certainty, the doctor testified that the risks of using a polypropylene TVT-O outweigh the benefits. Why? He told the jury he’s seen the complications specifically in the meshes used to treat incontinence in about 200 patients.

TOT sling, Scottish Pelvic Floor Network

TOT sling, Scottish Pelvic Floor Network

The arms of the obturator pass through about three or four muscle groups through the inner thigh, muscles that help with walking and balance. Problems include pain, trouble voiding or urinating, hardened, stiffened, shrunken and contracted mesh that degrades and leads to foreign body reaction. Upon removal the mesh “looks brittle and fragmented” he told the jury of seven.

Degrading Polypropylene

Degrading Polypropylene

The problems are particularly prevalent when the mesh is considered a heavyweight.

The greater the weight, measured in the number of grams in meters square, the more foreign body response (FBR). It’s not unlike a splinter in the body. When a portion is left behind the body tries to wall off the foreign body creating chronic foreign body reaction. In the obturator space, the obturator nerve is susceptible to the irritation caused by this reaction which results in pain.

As proof, the plaintiffs showed an article by Dr. Todd Heniford, a hernia doctor and long-time J&J “opinion leader” or consultant. Heniford had even produced a video for the company extolling the virtues of a lighter weight mesh when compared to traditional hernia mesh, but that video was not entered into evidence in this case. Even his article, “The Argument for Lightweight Polyproylene Mesh in Hernia Repair” Dr. Heniford confirmed that Prolene mesh (the proprietary name for J&J’s version of mesh) is considered heavyweight.

B. Todd Heniford, MD

B. Todd Heniford, MD

Add to that problem, said Dr. Rosenzweig, is the pelvic mesh put into Mrs. Huskey was laser cut, not mechanically cut. The doctor opined that process stiffens the mesh. An internal study presented in an exhibit compared laser cut mesh to mechanically cut mesh.

“At one inch of stretch the laser cut TVT was 3 times stiffer than machine cut mesh” further irritating nerves and muscles and furthering mesh erosion, it said.

 

INSTRUCTIONS FOR USE

Called the IFU, those are the instructions that accompany any medical device.

A physician is supposed to read and understand the IFU before advising patients on a risk-versus-benefit analysis. It is also intended to tell a physician who is a good candidate for a procedure and who is contraindicated, or not a good candidate.

Dr. Rosenzweig was provided a list of warnings that could be in the IFU – chronic pain, dyspareunia, nerve and muscle damage, the need for future surgeries, degradation and shrinkage, foreign body response, “Are these complications associated with the TVT-O?” Yes, that is correct.

But according to the doctor, none of the complications appear in the IFU for the TVT-O and he received none of these warnings when he attended training by Ethicon in Belgium a decade ago.

Instead, the doctor said the IFU downplays complications saying they can be managed in a day or so. “I’ve seen patients that have leg and groin pain and chronic pain syndrome that lasts much longer than 24 hours and are not managed with mild analgesics.”

In an email presented in court dated January 29, 2009, Meng Chen, the Associate Medical Director at Ethicon, spoke up to her colleagues about the characterization of complications as ‘transitory.’ She said in the email, “Pardon me what I see each day,  these patient experiences are not transitory at all.”

Also missing from the IFU were contraindications – warnings that the TVT-O should not be used in pregnant women, younger women who are still growing, women who might want future pregnancies and thin, active women, such as Jo Huskey.

 

ENDORSEMENTS

Jones during Linda Gross trial

Jones during Linda Gross trial, February 2013

On cross examination, Christy Jones, representing Ethicon, provided her version of glowing endorsements of the TVT products. Medical societies such as the American Urogynecologic Society (AUGS) and American Urological Association (AUA) among others, have concluded synthetic PP slings are an appropriate treatment choice for women with stress incontinence, said Jones.

In fact, Jones said two separate organizations say monofilament polypropylene mesh is the “most extensively studied in history” and there are a lot of studies on mid-urethral slings with more than 2,000 in the literature.

Some of the studies offer evidence that is “moderate,” said Rosenzweig in response.

While medical school rarely teach the burch and fascia procedures, Jones said transvaginal tape remains the current “Gold Standard” with over 3 million mid-urethral slings placed worldwide.

DEFECTIVE IN INSTRUCTIONS? 

Dr. Gretchen Byrkit, ob/gyn

Dr. Gretchen Byrkit, ob/gyn

Product liability is all about proving a product is defective – defective in design, in manufacture and/or in instructions.

The plaintiffs must prove by the preponderance of the evidence, (more likely true than not true), that one or all three occurred. Since the “end user” of the instructions is the doctor, who then advises the patient, the plaintiffs brought the implanting physician to the stand via videotape to see what she knew in advance of putting a TVT-O into Jo Husky in February 2011.

Huskey was a physical therapy assistant and was extremely active. She had lost 50 pounds and wanted to keep it off. Hiking, walking with her husband and doing 8 miles on an elliptical machine were all part of her routine. But she also had incontinence and went to see Dr. Gretchen Brykit in January of 2011.

The partner in her Illinois practice, Dr. Derin S. Rominger had trained Dr. Byrkit on how to use the TVT-O and he had received his training on its use in 2006 from a “preceptor” or doctor/consultant working for J&J.

Portions of the deposition from both doctors were shown in the courtroom via videotape.derin rominger

Dr. Rominger said he and Dr. Byrkit still worked together as they had during her training calling it “more efficient” that way. He attends every procedure she performs though Jo Huskey was never his patient. He still uses the TVT-O while Dr. Byrkit says she implants “zero to two a month” and has so since she started using the mesh, but she didn’t remember when that was.

Dr. Byrkit said she discussed potential complications with her patient – those listed in the IFU –  but admitted she probably had not read the IFU since she started doing procedures with the TVT-O. She had never attended an Ethicon training program but relied on Dr. Rominger for her training. Jo Huskey had signed an informed consent form.

No there was not a contraindication for a patient in the IFU who was an active exerciser. If there had been would Dr. Byrkit have still used the TVT-O on Mrs. Huskey?

“I don’t think I would,” said Dr. Byrkit. #

 

18 Comments

  1. Kitty says:

    Thankj You for reporting Jane. I appreciate it so much.

  2. jade says:

    If your implanting doctor read the IFU and knew the potential risks and complications; was a “training” doctor for other physicians; worked for and was paid for by a manufacturer; lectured other doctors on the mesh procedures; wrote articles on the risks and complications; gave webinars on the proper patient selection clearly stating that “active, thin, sexually active women were not candidates”; admitted after your surgery that “I made a mistake”; stated to you and others that “I did the wrong surgery on you.”; ignored your symptoms for nearly a year before admitting your suffering and complications were due to the mesh implant; put you through a year’s worth of narcotics, grueling PT, intravaginal injections, constant courses of antibiotics; told you that you were “unique”; implied that you were neurotic; made you feel your pain was your fault and that you were “too active” – knowing going into the surgery your active lifestyle – WHY in the name of HELL isn’t this considered MALPRACTICE? Why are all these “pretending-to-be-ignorant, uniformed implanting doctors” being let off FREE without any accountability? Their job is “To do No Harm” – they should pay for what they did and not just given a “pass”.

    • Mary pat says:

      Well said! I agree entirely!

    • Dawn says:

      Jade, I thought you just wrote my story… These Dr.’s knew enough to at least tell us about erosion. Was anybody told this by their Dr.’s ?????????

    • Jackie says:

      All that Jade & MORE!

      Went they vaginal & pubic bone injections every 6 weeks with up to 5 (!!) entry sites at a time; multiple narcotics Rx’s; and 3 ‘revision’ surgeries back to back to back! All the while NEVER admitting anything was wrong except with me! I would limp out of office from injections and barely made it to my car! I had to phone family to come pick me up because my right leg wouldn’t work to drive!

      Also given a multitude of other medications to MASK THE PAIN & SYMPTOMS so I would not know what the issue was coming from. I was so doped that I hardly knew my own name!

      Dear God when did this become common & ethical practice?!

  3. Marie says:

    If Christie Jones, is so confident in representing this horrible life altering product, why doesn’t she undergo this procedure? She is nothing more than a high priced traitor to all women.

  4. jennifer says:

    If I would have been told by either of my doctors on both surgeries the side effects I would of never had them. This absorbs cause I feel they are blaming the doctors for there product.

  5. jade says:

    FYI: The law firm of Mazie & Slater, NJ will NOT take any malpractice cases against any doctor that is “mesh-related”. Hm-m-m-m. I believe that means they know that there is NO chance that they could win a malpractice case involved with TVM against the implanting doctor? In my opinion, none of these doctors where dooped by the manufacturers – they knew EXactly what they were doing. They wanted to be the first to claim this “experiment” worked! They were greedy just like the J&J email stated – “there was no time to hesitate to make sure it was safe – because they’d be losing market share.” So, why, why, why are they not guilty of malpractice and why doesn’t Mazie & Slater want to take any malpractice claims against any doctor involved with TVM? I believe many of these implanting doctors were well-versed in the complications, knew the experimental status of the mesh implants and chose NOT to inform their patients because they were coached not to by the manufacturers so as not to scare women away! A total conspiracy, medical malpractice and criminal action! PERIOD.

  6. Dawn says:

    So let me get this straight…. It should not be implanted in thin, active and sexually active women ??? So does that mean it only goes in fat , lazy and non-sexually active women ??? But I thought the manufacturers and Dr.’s are blaming the failures on women being overweight ???? Why would they put it in fat women to begin with then ??

    I wasn’t fat until polypropylene got put into me !!!!!

    • Jane Akre says:

      it works very well in cadavers…..

      • MarieAnn says:

        I guess they are trying to make cadavers out of us…

        I am forever changed from this mesh crap. I mourn over the loss of the woman I was. Yep, I was thin too, a (working) RN, can’t work now,rode my bike and walked, hiked, went on long car tips (without pain)… and enjoyed frequent sexual relations with my wonderful husband. I drove 40 mins today and now need an ice pack to sit on…

        None of this should have happened to any of us. Praying for the madness to stop soon. Thanks for the coverage of this trial!

      • Kitty says:

        so funny

  7. jade says:

    Mesh should NOT be implanted in anyone. PERIOD. These defense doctors are talking up the mesh as “gold standard”, but I can guarantee they would NOT have mesh implanted in themselves, their mothers, daughters, or sons for hernia repair! They feel empowered when their on the witness stand and called “Expert”; they feel safe in supporting the mesh because no one can touch them! Yes, there are caps on medical malpractice, but $500,000 is better than $40,000 or less! And, there is also the moral issue of a doctor being punished. Right now, none of these doctors will be actually hurt by this – they are claiming ignorance.

    ANOTHER TOPIC:

    Can anyone answer this question – What IF the doctor who implanted your mesh and is claimed on your lawsuit as having NOT been aware of complications and warnings, BUT actually shows up as an “Expert Witness” for the DEFENSE saying he knew everything? How does that play out in the system?

    • MarieAnn says:

      The only reason it is the gold standard is because the so called medical schools DO NOT teach the Burch Procedure or fascial slings anymore. They must be in cohorts with the mesh companies too, or are just producing lazy doctors who don’t want to spend the time in the OR on procedures that take a little more time to perform, but are SAFE and effective!!!!

      • Jane Akre says:

        how can anyone argue slings are safe and effective when a devastatingly injured woman is sitting in the courtroom. What is she, a good actress? Hello!!! There is your proof of defective.

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