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Biomedical Expert on Regulatory Parellels of Pelvic Mesh to Breast Implants, Federal Preemption and There’s No Medical Grade Mesh

William A. Hyman Biomedical expert

William A. Hyman Biomedical expert

MND, January 13, 2016 ~ Dr.William A. Hyman, a Biomedical expert has been brought in as a consultant in some pelvic mesh cases. 

Dr. Hyman compares FDA’s reclassification of POP (pelvic organ prolapse) mesh to class III as a parallel to breast implant reclassification.  It forced them off the market, but they came back after anecdotal data, he says.

The Food and Drug Administration (FDA) has given POP mesh manufacturers 30 months to submit proof of safety and efficacy to satisfy the more stringent PMA (premarket approval) which is required under class III designation of a medical device.

Silicone-filled breast implants were also reclassified by the FDA from class II to class III in 1988. By 1991, the FDA required a premarket approval (PMA) for silicone gel-filled breast implants.  None of the PMA’s submitted contained sufficient date to support approval.  By 2013, the FDA approved both Allergan and Mentor’s PMA for silicone gel-filled breast implants pending post-approval studies.

William A. Hyman, Texas A &A Biomedical Engineering for 39 years retiring as Professor Emeritus in 2011 before returning to New York. , Dr. Hyman (ME’65) went from Cooper to Columbia for his ME and ScD, and then to MIT for a post doctorate degree.  His professional activities also include medical device design and system safety, human factors, FDA regulation of medical devices, and clinical engineering.

Dr. Hyman writes in July 2014, Maybe That Wasn’t Such a Good Idea (Biomedical Safety & Standards), citing two recent examples that illustrate how technology sometimes gets ahead of knowledge giving the example of a renal denervation systems sold as a treatment for high blood pressure (though not sold in the U.S.) and the laparoscopic power morcellator.

He writes in Biocompatibility of Breathing Tubes Raises Interesting Questions that biocompatibility is crucial for implants, referring to ventilators specifically breathing tubes that come in contact with the body before it enters the lungs.  Are all polymers the same?  That answer has broad implications in ongoing mesh litigation. Is one polymer is the same or different from another polymer with the same name despite the addition of additives and plasticizers as well as post-manufacturing residuals?

He believes polypropylene mesh used for implants introduces a myriad of problems not limited to a lack of inertness. The tissues in the pelvis respond to the implant, even on a mechanical level. One mechanical property ie, the polymer mesh, against the tissue of the body represents two different mechanical properties. “Something is going to happen.”

He cites porosity issue of the mesh, the body’s response to mesh and the bacterial response to mesh.   Also he’d like to make a distinction between the material and what you make out of that material. If you make a different products with different characteristics you get a different response.

Prolene Mesh

Prolene Mesh

“Just calling it polypropylene doesn’t tell you enough.  You did you get it from, the chemical structure and what else is in there?”

 

Q: On Quality Control- is there any consistency?

“No some manufacturers are buying it from people who didn’t know what they were doing despite the contrary disclaimers, that is, dummy sources. Consider, quality control issue from a single material supplier. If their purpose is carpet-backing their quality control requirements are way below that for an implanted medical device.  There is no term for medical grade polypropylene!”

“What’s supposed to happen is there is supposed to be qualified in the application form of the product. The FDA has been loose in accepting claims of biocompatibility on a broad basis. And that is only rarely brought up by the FDA.  For example the ventilator breathing tubes. I wrote basically knowing the chemical name doesn’t tell you much and certainly not enough.  The manufacturer is supposed to qualify the appropriateness of material choices for the product, but that hasn’t happened.

“Even if you had the identical polypropylene, if you make something with different mesh characteristics – mechanics and edge design – you get different performances. How it goes in also matters.   It’s not just the material but it procedure was sold as easy to do. I’ve worried about that. Does “easy to do” encourage a certain attraction to a “novel and new” approach suppress the evidence?  There are some elements of a human’s ability that’s part of the design and use challenge.  We can’t identify who they are.

“The manufacturers like to blame the patient in part because they are fat, diabetic and they smoke.  None is reflected in the contraindications. Either it’s for or not for the broad population.”

medtronicRiegel v, Medtronic Inc.  – A U.S. Supreme Court decision says consumers who are injured by a defective medical device that received FDA approval, are preempted (prevented) from suing. The manufacturer enjoys immunity under this Supreme Court ruling. The late Charles Riegel and his wife, Donna Riegel bought suit against Medtronic after a catheter ruptured in Charles Riegel’s coronary artery during surgery.  The catheter is class III device that received FDA premarket approval. They alleged the device was defective. Federal court held that clearance by the FDA pre-empted common-law litigation.  

Q: On POP mesh reclassification, you  say it opens the door to federal preemption?

“The PMA (premarket approval) route is expensive. In theory with different classes of medical devices we can discern how much scrutiny is needed to assume safety. Whether anyone will bring forward for approval mesh under class III remains to be seen.  If they do, they are exempt from product liability.  The decision is the cost and effort versus protection after you do bring it to market.”

“Take breast implants, for example, the manufacturers tried to bring in the past history as supportive but the FDA said a real study has to be done prospectively.  I’m assuming the FDA is serious; getting a PMA approved with existing data should not happen because it is not from a controlled study. It’s purely a few papers here and there and complaint-based.  They have to do prospective studies. How big they would have to be remains to be seen.  The problem is if you don’t have a good registry of who has your product and who put it in, there is a lack of control. You are hard-pressed to collect post market data.

“If you are going to do a study, you want your best result, you are going to choose the top tier of doctors. You might want to walk away from your own patient population and start over with a better controlled implant procedure.”

 

Q: Let’s talk about the biocompatibility issues that seem to incite different responses from different patients, including hernia mesh reactions.  

“The FDA has been weak on biocompatibility testing in the class II arena. See the standard draft for 10993,  it’s a screening standard. That’s what the manufacturers cite on the material end. It’s been shown to pass a specific battery of tests.  There is no such thing as biocompatible material.  Your product may not work in another part of the body. 10993 becomes a screening tool which says you have to have shown at least your material has been qualified under a set of tests.  People got away with saying this is polymer x-y-z and others have used it with good results.” #

 

LEARN MORE:

AAMIBlog, January 30, 2015,  William Hyman: Biocompatibility of Breathing Tubes Raises Interesting Questions

http://aamiblog.org/2015/01/30/william-hyman-biocompatibility-of-breathing-tubes-raises-interesting-questions/

 

Medical Device and Diagnostic Industry, April 9, 2014, Are These Medical Devices Too Dangerous?

http://www.mddionline.com/article/are-these-medical-devices-too-dangerous

 

ISO-10993 International Standard for Biocompatibility, April 23, 2013

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm348890.pdf

FDA developed this guidance to assist industry in preparing Premarket Applications (PMA).

 

Maybe That Wasn’t Such a Good Idea, Biomedical Safety and Standards, July 1, 2014

 

Riegel v, Medtronics. Read more here:

http://www.law.cornell.edu/supct/html/06-179.ZS.html

 

Injuryboard National News Desk on Medtronic, by Jane Akre, March 8, 2010

http://news.legalexaminer.com/injured-by-a-medical-device-youre-still-out-of-options-.aspx?googleid=279126

Regulatory History of Breast implants in the US, reclassified to class III in 1988 requiring premarket approval. 

By 1991 FDA required PMA for silicone gel-filled breast implants. None of the PMAs contained sufficient data to support approval. By 2013, the FDA approved both Allergan and Mentor’s PMA for silicone gel-filled breast implants pending post-approval studies.

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064461.htm

 

 

 

14 Comments

  1. janet says:

    So, read the article, but is this good for us. .he is kind of confusing in his words

  2. Linda G says:

    Question?.. In the trials where the judges or jury’s have found the manufacturer was at fault, are those findings admissible in other pending trials?

    • Jane Akre says:

      There have been many, in fact, most trials are decided in the plaintiffs favor. It’s easier to count the one in defense favor… about 4 or 5 if I recall correctly. Usually motions pre-trial do not allow that information to make it in……. it may not be directly relevant. Think about it from your side, if you had been arrested 20 years ago, or filed for bankruptcy, would you want that presented to jurors? I’m not a lawyer though.

  3. Georgia Girl says:

    I realize I may be borrowing trouble for even entertaining this thought, but it seems to me that this whole PMA process may be a way out for the manufacturers. The Federal Court’s decision in the Riegel vs. Medronic suit only reinforces that possibility – if indeed they are not held accountable if they have FDA approval. What a nightmare!! Someone tell me I am wrong or misunderstood the article, please!!

    • Jane Akre says:

      He is saying, even if manufacturers spend millions to bring a pelvic mesh to market, providing they can present enough evidence of safety, is a very unlikely thing. However, if they do, they enjoy preemption.

  4. kitty says:

    They need to cage some guinea.pigs and implant them–I’m uncomfor table to say what they should do periodically to them–it’s too vulgar. Then—after they do that–check their pelvic area so often to see if damage has occurred. I don’t think PETA would like this though.

    • Bejah Blue says:

      No Gunniea Pigs, I love Gunniea Pigs, especially my little Sofie! Rats (two legged and four legged ones) would be a better choice.

      Bejah

  5. Debbie E says:

    I don’t know if it is just me, but I don’t understand what he is saying!?! Is he saying that we can or can not take J&J to court???

    • Jane Akre says:

      I thought what was interesting is there is no medical grade polypropylene. Yet, that is the material put in your bodies.

  6. Debbie E says:

    I’m totally confused, is this article and doctor on our side trying to help us or is he on the manufacturer side trying to give them a way out.?. Could somebody please explain this article so that we can understand what is being said here? It is extremely confusing and myself I can’t understand what he’s talking about. So is it a good thing or a bad thing, is the manufacturer behind him to get this information out and to go to trial for the manufacturer, or does it help up? The timing is very suspicious.

    • Jane Akre says:

      They are his observations as an expert for plaintiffs. sorry for any confusion… no suspicion necessary. Please do not use your last name if you are represented! Thank you.

  7. Bejah Blue says:

    I expect the difficulty is that he speaks as a scientific expert in a field we do not understand well. I think basically one thing he is saying is that these polymers can very greatly and are affected not only by the variations in mfg processes but also by the variations in application and the individuals own physiology. When you add to that the fact that they are not appropriate for use in the human body it creates a sort of quagmire where cause and effect are concerned. Bottom line they are all bad news for human application. This is my personal interpretation and should NOT be presumed to be true. I need to read it again in the morning!

    Bejah

    • Bejah Blue says:

      Where his comparison with breast implants is concerned I think he is saying that the mfg. in that case where the device was reclassed to cat III the mfg. simply found a way around it and marketed their product anyway rendering the cat III reclass emasculated….but I could be confused. Still the intent of the reclass stands as does the requirement for trials which it has already been extablished will be costly for the mfg of the mesh. I think it is still worth doing and it still has political value.

      Bejah

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