Polypropylene Resin Not Meant for Human Implants

//Polypropylene Resin Not Meant for Human Implants

Polypropylene Resin Not Meant for Human Implants

Polypropylene raw resin pellets

Mesh Medical Device News Desk, January 6 2017 ~ The polypropylene resin material  that is used to make mesh used for hernia repair and transvaginal mesh, is not supposed to be used in the human body. But that’s exactly what’s happened for more than one million patients.  

Evidence revealed in transvaginal mesh trials show its basic material, a raw polypropylene resin, also known as PP, is accompanied by a warning not to use it to make implanted medical devices.

But that’s exactly what has happened.

And the PP mesh resides in as many as one million women around the globe, implanted to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The same PP resin is used in to make hernia mesh in about one million procedures in the U.S. every year.

Polypropylene resin is crafted into mesh used by all of the manufacturers currently facing defective product litigation – Boston Scientific, Johnson & Johnson, American Medical Systems, C.R. Bard, among others.

The warning is contained in the Material Safety Data Sheet or MSDS that accompanies the resin.

The MSDS is required by the Occupational Safety and Health Administration or OSHA. The MSDS gives detailed information about a chemical, its properties, safety and environmental hazards. It’s designed to alert workers who come in contact with the chemical during its processing so they can avoid any hazards it may impose.

It says – “MEDICAL APPLICATION CAUTION:  Do not use this Phillips Sumika Polypropylene Company material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”

It couldn’t be clearer.

What’s disturbing is that polypropylene mesh, naturally will come into contact with both bodily fluids and tissues for the rest of that patient’s life.

We could already surmise that in the case of Boston Scientific (BSC), counterfeit polypropylene resin, smuggled in from China with no oversight, might not be suitable for implantation.

That’s because any resin product from China, where there are no regulations, might be tainted with toxins incompatible with the human body, such as selenium, which has already been found in the BSC resin.

Polypropylene is a byproduct of the petroleum industry. The plastic resin is spun into fibers used to weave hernia and pelvic mesh. PP is also used for indoor-outdoor carpets, car parts and Tic-Tac box tops. It’s a cheap and plentiful plastic.

Phillips Sumika Polypropylene Co. formed in 1992 from a merger between Chevron Phillips and Sumika Polymers America, a Japanese company, creating the petrochemical, plastics producer.  It closed its Texas plant and moved to Saudi Arabia in 2011.

“Phillips Sumika Polypropylene Company makes no representation, promise, express warranty or implied warranty concerning the suitability of this material for use in implantation in the human body or in contact with internal body fluids or tissues.”

It could be argued that the MSDS warning provides some degree of legal immunity to Phillips Sumika if any harm comes from products made from the raw resin.

But Judge Joseph Goodwin, overseeing pelvic mesh litigation in his Charleston, West Virginia federal court, says the MSDS represents “a genuine issue of material fact,” and it has been shown to jurors.

Jurors who have seen the MSDS, as well as other evidence in the 19 mesh trials, have decided for manufacturers only six times, raising the question, what did manufacturers know and when did they know it.   ###

 

By | 2017-11-07T06:21:28+00:00 January 6th, 2017|Medical News|31 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

31 Comments

  1. Hope Pagano January 7, 2017 at 7:02 am - Reply

    Great article Jane. Thank you so much for documenting this information for all of us.

    • Diva64 February 17, 2017 at 4:04 pm - Reply

      I posted this on my site in 2016 maybe 2015 also to Mesh Groups. An engineer sent me a basically MSDS sheet. The courts the attorneys, the doctors their not that far behind. The MSDS sheet also states it will cause autoimmune illness

      • Jane Akre February 18, 2017 at 6:10 am - Reply

        The material safety data sheet has been shown to jurors in most of these trials! Likely it will be shown in the Mullins case coming up! March 6th Charleston, WV

  2. Disgusted January 7, 2017 at 7:50 pm - Reply

    And it is still being used and produced. What in the world is going on here? What does it take to get the attention of the FDA, of Congress etc.? My friends father just died from hernia mesh that entangled his intestines. He literally had it wrapped through the intestinal track and it dragged stool through the abdominal cavity. I doubt mesh will be cited as the reason for death. He was also a diabetic. There was nothing the doctors could do, so they closed him up and watched him die over two weeks. Sickening.

    P.S. Thank you Jane!

  3. Dawn January 7, 2017 at 9:09 pm - Reply

    How much clearer does it need to be for the judicial system ??
    Every person who has been implanted with polypropylene should be compensated for life. The pain that accompanies this toxic mesh is beyobd comprehension .. worst pain of my life. And it will never end until I die.
    THANK YOU BIG PHARMA MANUFACTURERS..
    Hope you sleep well.
    God knows????????

  4. Yolanda January 9, 2017 at 1:19 pm - Reply

    I have this and I am in constant pain

  5. Sue Mc January 10, 2017 at 10:43 am - Reply

    To make matters worse is if you are allergic to polypropylene there is a 100% chance of developing fibromyalgia. It took me 4 years to finally get tested for polypropylene allergies, which proved that I am highly allergic to it. This was the cause of my fibromyalgia. I am including a link for a great article on the subject. Also, due to my being allergic to the polypropylene I ended up having the rest of the tvt sling removed (after one surgery to remove it from my side, it was out of place), even though it caused more damage and scar tissue. They also had to remove the polypropylene stitches from the previous surgeries. I am currently starting physical therapy to help with the incontinence that I developed after having sling removed. I have had pain throughout this whole ordeal starting in 2001. I may have to have a third surgery.
    http://meshproblems.weebly.com/linking-the-research-from-fbr-to-implant-materials-to-autoimmune-disease-initiation-or-exacerbation.html

    • Jane Akre January 10, 2017 at 12:05 pm - Reply

      Wow Sue- the name of the test? This might be like a latex allergy? Very interesting.

      • Sue M February 1, 2017 at 12:17 pm - Reply

        The test I had done was by Dr. Jacob-Soo, dermatologist at Loma Linda Hospital. She actually sewed a piece of the polypropylene mesh into the inside of my upper arm, as well as polypropylene stitches, and then covered it with a waterproof bandage. I wore it for a week. When she took off the bandage, the area was very red, and sore. This indicated that I was very allergic to polypropylene.

        • Jane Akre February 1, 2017 at 12:43 pm - Reply

          Very interesting…. does Dr. Jacob-Soo do that often?

          • Sue M February 3, 2017 at 7:14 am

            After I had part of the TVT sling removed, my fibromyalgia kicked into over time and I became more physically ill. Dr. Jacob-Soo came up with that test to determine if I was allergic to the TVT sling, As research shows that people who are allergic to polypropylene have a 100% chance of developing fibromyalgia.

    • Anon January 10, 2017 at 7:46 pm - Reply

      Sue Mc………….. Great article. I am going to email it to my implanting doctor.

  6. Diva64 January 10, 2017 at 11:33 am - Reply

    EXCELLENT ARTICLE.I DIDN’T THINK I WOULD MAKE IT THROUGH LAST NIGHT.LEFT COMMENT UNDER AUTOIMMUNE DISEASE OF MESH MEDICAL DEVICE NEWS DESK.WISH I COULD READ THAT TO THEM IN COURT BUT DON’T EVEN HAVE THE STRENGTH TO.
    HOPE ALL THAT ARE ABLE WILL KEEP FIGHTING.
    I DOUBT THAT DR RAZ WOULD BE ABLE TO HELP ME IT HAS ALREADY ERODED THROUHOUT MY BODY. I Haven’t found any miracles to help fiance the cost of going or place to stay. So it is what it is. Slow negotiations slow settlements and for me it has been a 12 year long problem I feel is coming close to the end.
    I wish Judge Goodwin would ask the MANUFACTURES and their attorneys would you let your mother or daughter have this procedure with the knowledge you have now. Do you think it is safe ?

  7. Undisclosed January 11, 2017 at 1:32 pm - Reply

    Dear Jane, I had the pleasure to talking with you! Come to find out, I to am extremely allergic to latex! They knew this when implanted! No wonder I feel so sick 24/7 days a week along with all the 27 counts against this horrible lawsuit!!!!!!!!

    • Still Standing January 12, 2017 at 1:58 pm - Reply

      Undisclosed, there is no latex in polypropylene. They are different substances altogether but it could be possible that you have sensitivity to both. If you have a latex allergy, there are many foods that can cause reactions. Those foods include apples, tomatoes, bananas, avocados, carrots, melons and others. Im not aware of any food allergy links to polypropylene.

      • Joshua B February 1, 2017 at 12:24 pm - Reply

        Actually polypropylene glycol is in many food sources, as well as antifreeze, and medicines. They use it as a binding agent. Since I am allergic to the polypropylene mesh I am also allergic to anything with the polypropylene glycol. As least that is what my allergist has told me.

        • Sue M February 3, 2017 at 7:19 am - Reply

          Because I am allergic to the polypropylene, I am also allergic to the propylene glycol used in foods, medicines, and beauty products. I don’t know if I mentioned this, but I think Dr. Jacob-Soo came up with my allergy patch test because there aren’t any traditional ones out there. Loma Linda is a learning hospital and she is an outstanding doctor there.

          • Jane Akre February 3, 2017 at 9:58 am

            Interesting Sue. Perhaps those reacting to PP mesh should have a patch test to see if they too show up as a reactor.

        • Edzach October 12, 2018 at 7:22 pm - Reply

          Propylene glycol and polypropylene are very different chemicals, with very different characteristics. They are made in different processes. Having an allergy to propylene glycol is not an indicator of allergy to polypropylene, and vice versa.

  8. Leslie Catherine January 23, 2017 at 6:12 pm - Reply

    I am also sensitive to so many chemicals and now I receive monthly limited support as someone
    federally disabled – only due to chemical sensitivities – my disability is Chemical Sensitivity after winning appeal in 2016. Try testing for a full range of sensitivities with the clinical team that helped me and so many others – lead by a CardioThoracic Surgeon and Environmental Science MD – Dr. Rea & Team @ the Environmental Health Center-Dallas
    8345 Walnut Hill Lane, Suite #220
    Dallas, Texas 75231 USA
    Phone:214.368.4132
    Fax:214.691.8432
    Clinic Hours
    Monday – Thursday
    9:00am – 5:00pm
    Friday
    9:00am – 4:45pm

    I pray for you all. The suffering of so many millions is horrific and unnecessary.

    Leslie
    808-419-5418 Happy to Help if I can; I’m a mediator & appealed my own disability case without professional paid legal help. (I do have legal training but gave up my law license in Texas/UT Law due to cost recently). Also, if you’re in town (Austin, TX) and would like to meet up – I’m always at St. Mark’s Episcopal in Barton Hills on Sundays (11 AM) & confirming this weekend. Look for my bike 🙂 I pray daily for you all.

    • Jane Akre January 23, 2017 at 8:16 pm - Reply

      THANK YOU!

  9. Leslie Bradford January 23, 2017 at 6:25 pm - Reply

    Hi – just to clarify – my last name is Bradford – got cut off previously.
    When I worked in mesh, without knowledge of the resin’s toxic effects (and I studied assiduously, attended clinical in-house and external trainings and worked with leading surgeons in Asia & Latin America) – never a word on this topic was mentioned, explored or identified to staff. We were actually, in global marketing strategy, trained to the contrary and taught mesh – inguinal and ventral- was inert and not subject to infection or infection-related properties. There were rumors and activities I’ve reported as suspicious such as China sourcing of resin – but as a 2014 Whistleblower against all of my prior mesh and mesh or oil/resin-friendly device prior employers, I can only help now with the disability portion of the horrific, disgusting outcomes for us all – myself included.

    In prayer & peace for all victims of this literal terror.

    Leslie Catherine Bradford (changed legally in 2013 post-divorce, to my mother’s maiden name), formerly Leslie Catherine Wright at birth (11/8/1971) & Boettcher (2007-2013), while married and/or at mesh manufacturers, in case that helps for research, etc.

    • Jane Akre January 23, 2017 at 8:16 pm - Reply

      Thank you… I would love to speak with your further if that is possible. janeakre@meshnewsdesk.com

    • Sea June 11, 2017 at 5:02 am - Reply

      I took my daughter, for another type injury concerning Hair Dye..to Dr. Rhea in Dallas …Met him, had numerous conversations concerning my daughter who is now permanently brain damaged due to one time of permanent hair dye done by a professional at her beauty shop ..I can’t say how wonderful and right on target is Dr. Rhea….a scholar and gentleman and an authority of these plus mesh issues he knows and understands about …GREAT MAN…Dr. Rhea..

      • Jane Akre June 11, 2017 at 9:21 pm - Reply

        Wow- Are you talking about the EHCD? What hair dye…. what happened? Geeezzz

      • Regina H June 12, 2017 at 8:25 am - Reply

        Oh Goodness, like Jane ask…what Hair Dye ?
        I use hair dye all the time so Iam VERY INTERESTED.

  10. John Elias January 29, 2017 at 10:16 am - Reply

    Polypropylene mesh was used to repair a right side hernia six years ago as I suffer from Multiple Chemical Sensitivity and could not afford the biological mesh
    Apart from constant pain over these years in 2016 a tumour was discovered in my cecum and removed together with a few feet of bowel and
    over 20 lymph glands. I believe that it was the proximity of this foreign object that caused the inflammation and cancer
    Today I am informed that pig skin mesh costs ten times as much

  11. Lori January 31, 2017 at 7:57 pm - Reply

    How many of our lives do they need to ruin before this becomes unacceptable? I will never be the same. Thank God I have a loving and understanding husband. We are still young and a part of our life was taken away because of PPL. Apart that should still be there at our young age. The pain, constant infections, the hole left at the top of my vagina that will never close or heal. How many years has this taken from my life? It’s just not fair!

  12. Regina H June 12, 2017 at 8:31 am - Reply

    Iam so sorry you are having to deal with this. I also am going thru what you are. After being Widowed very young I was single for 17yrs. Remarried 4 yrs ago and Praise God for a Loving Caring man because those things we should be sharing have been taken away. I will keep you in my prayers and continue to hold your husband up as well !!

  13. Michele N September 5, 2017 at 5:57 am - Reply

    Hello, I had double and Diep Flap reconstruction in Feb 2017. I’m waiting to have MRI to confirm a hernia. Anytime I bend over, I feel like something is in the way in my lower left abdomen. Very painful. My plastic surgeon has suggested a general surgeon to join him in 2nd phase of reconstruction to repair hernia with mesh. After doing some research I know I don’t want this mesh in my body. Are there any other options to this polypropylene mesh? I read about “tissue-to-tissue” repair, but sounds like it’s only used for certain hernias. And if they can perform this surgery, I’m curious as to what the sutures are made of. I appreciate any help and direction. Thank you, Michele

    • Jane Akre September 5, 2017 at 10:31 am - Reply

      Michele- Yes there are alternatives to mesh if you are a candidate. Let me run your question by Dr. Bendavid and I will post the answer here. He is a non-mesh surgeon at Shouldice Hospital in Toronto… please stay tune. Here is his answer:

      Robert Bendavid
      10:53 AM (0 minutes ago)

      to me
      Hello Jane

      Michelle likely had bilateral mastectomies for breast cancer. In the creation of a TRAM (here called a Diep), muscle is taken from the lower part of the abdomen and swung up to the breast area with its blood supply for the reconstruction of an artificial breast. The donor site invariably develops a hernia because a significant portion of the lower abdominal wall is removed.
      This is an issue she has to discuss with a general surgeon/plastic surgeon she trusts. I would also recommend she talks to former patients who had the procedure done. I personally feel it is a high price to pay because the defect left behind in the abdominal wall can be large and demand mesh for replacement. Mesh is no longer as benign as we thought it to be originally.
      The patient must also discuss the issue with her partner since that is where the problem may also lie! I hope the patient finds a balance with the choices. Kind regards. Robert.

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