New Hampshire Lawmaker Asking FDA for Answers After 60 Minutes Report

//New Hampshire Lawmaker Asking FDA for Answers After 60 Minutes Report

New Hampshire Lawmaker Asking FDA for Answers After 60 Minutes Report

Mesh Medical Device News Desk, June 20, 2018 ~ A U.S. Senator from New Hampshire wants some answers from the Food and Drug Administration (FDA) following a controversial 60 Minutes report on Boston Scientific and the means it went to to secure a new supply of polypropylene (PP) from China to make its pelvic meshes.  

Image: Sen. Jeanne Shaheen

New Hampshire Lawmaker Asking FDA for Answers After 60 Minutes Report

U.S. Senator Jeanne Shaheen (D-NH) is asking the Food and Drug Administration for answers about the Boston Scientific gynecologic meshes named in a recent 60 Minutes report!

The report that aired May 13, (here) showed how the Massachusetts-based company, fearing it would run out raw resin for its Marlex polypropylene (PP) pelvic implants, contacted a known smuggler in China.

PP resin

EMAI Plastics told company executives this was the real Marlex the company was used to using to make its Pinnacle and Obtryx meshes. But the story didn’t check out.  The lot numbers didn’t match anything issued by the original supplier, Phillips Chevron, which reportedly informed Boston Scientific three times that the lot numbers on the bags from China were wrong.

“How did all this resin end up in China if it was made in Texas?” wrote a Boston Scientific compliance coordinator, internal company e-mails show.

No matter, the company executives purchased the raw PP resin and arranged for it to be smuggled into the U.S. in a way to evade U.S. customs agents.

It has been used to manufacture all of Boston Scientific’s pelvic mesh implants made from late 2012 forward.

Boston Scientific is just one of seven companies being sued by more than 104,000 women in one court in Charleston, West Virginia, making it the largest multi-district litigation since asbestos.

BOSTON SCIENTIFIC REACTS 

Boston Scientific replied that its plastic mesh is safe and the 60 Minutes story is “irresponsible and misleading.”  The company CEO issued a videotaped press release.

“The FDA conducted its own testing of the finished product for specific mechanical properties and physical characteristics and determined that all samples met the appropriate specifications,” BSC said in a statement.

Mesh News Desk covered the Boston Scientific/ Chinese smuggling issue extensively, here and here.

Mr. M . Tom Margolis MD

THE BROADCAST

In the May 13th segment, Dr. M. Tom Margolis told 60 Minutes this is at best an experimental material.

“Implantation of this into anyone is human experiment but without consent because this is novel material.  We don’t know how its effecting humans it’s never been tested before.”

“They don’t know where the material is coming from. Nobody knows who the original manufacturer is.  Nobody knows and that’s a big deal right?  You have to take record of every lot, was it contaminated? Has it been tested? And they don’t know any of those, any of those answers,” said plastics expert Chris DeArmitt, to 60 Minutes.

Dr. Duane Priddy, plastics expert on 60 Minutes

Perhaps the most startling confession within the segment was voiced by plastics engineer,  Dr. Duane Priddy, who told 60 Minutes,  “I can’t in my wildest imagination, imagine anybody that’s knowledgeable in the science of plastics ever deciding that it was appropriate to use polypropylene in the human body.”

“It’s well known that it’s oxidatively unstable.”  Dr. Priddy is not involved in pelvic mesh litigation.

Scott Gottlieb, M.D. Food Safety News

THE SENATOR’S LETTER TO FDA

In her letter to FDA administrator Scott Gottlieb, Sen. Shaheen said the PP Marlex product sourced from Chevron Phillips and the Chinese version “raise potential concerns relating to the FDA’s oversight of Boston Scientific’s production activities.”

The Senator questions the FDA’s own testing of the mesh products from China after 2012 when the FDA said “all samples met the appropriate specifications” of mesh made before.

“The claims made in this 60 Minutes report are deeply disturbing and raise important questions regarding the FDA’s oversight of this product,” says Sen. Shaheen.

“This product has led to painful experiences for many women across the country and they deserve answers about the manufacturing oversight process.  Needless to say, a product this invasive should be subject to the utmost scrutiny to ensure the health and safety of the patient, both at the time of the product’s initial approval by FDA and through ongoing post-market oversight after the product is approved.”

She asks the following questions:

* When did FDA officials become aware that Boston Scientific had switched polypropylene suppliers, from Chevron Phillips Chemical Company to Chinese suppliers, and were FDA officials aware at that time that the Chevron Phillips Chemical Company had raised concerns about the use of Marlex polypropylene products in implantable medical devices?

*According to reporting from the Boston Globe, following notification of Boston Scientific’s change in polypropylene suppliers, the FDA “conducted its own testing of the finished product for specific mechanical properties and physical characteristics and determined that all samples met the appropriate specifications.”  Can you provide additional details on the scope of this finished product testing?

* The FDA’s response to the Boston Globe reporting indicates that “FDA concluded that the new resin does not raise new safety or effectiveness concerns.”   Did the FDA obtain samples of the new polypropylene resin that was used following the supplier change and compare the physical properties of the resin itself with the Marlex polypropylene resin that was previously used to produce the device?

* The FDA’s response also suggests that in its review of the adverse event reporting database, FDA “did not find any indication that the change in resin led to an increase in adverse events.”  Can you provide additional details on the types of patient circumstances that rise to the level of being included as “adverse events” for the purposes of adverse event reporting in the database?

 

Sen. Shaheen is the first woman in U.S. history to be elected both a U.S. Senator and Governor.  She sits on the Senate Committees on Armed Services, Foreign Relations, Appropriations, and Small Business and Entrepreneurship.

 

LEARN MORE:

How To Contact Senator Shaheen
https://www.shaheen.senate.gov/contact/contact-jeanne

Her Facebook Page
https://www.facebook.com/SenatorShaheen/

The May 29, 2018 letter is here:
https://www.shaheen.senate.gov/imo/media/doc/05-29-18_Letter%20to%20Commissioner%20Gottlieb%20on%20Transvaginal%20Mesh%20Safety.pdf

 “60 Minutes Looks at Lawsuits Against Boston Scientific,” Boston Globe, May 14, 2018. J.D. Capelouto.
https://www.bostonglobe.com/metro/2018/05/13/lawsuits-filed-against-boston-scientific-featured-minutes/PRpJAgD3ByTsu7lHd3aHYM/story.html

U.S. Food and Drug Administration, September 19, 2017, Uregynecological Surgical Mesh Implants
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm
 

AUGS Reacts to 60 Minutes Story
https://www.augs.org/augs-is-neither-pro-mesh-nor-anti-mesh—augs-is-pro-science-and-science-and-evidence-must-lead-the-way/

BSC CEO responds to 60 Minutes story
http://www.bostonscientific.com/en-US/medical-specialties/female-pelvic-medicine/perspective-on-60-minutes-vaginal-mesh-report.html

100,000 Women, 60 Minutes May 13, 2018 https://www.cbsnews.com/news/boston-scientific-gynecological-mesh-the-medical-device-that-has-100000-women-suing/ 

Mesh News Desk, Plastics Expert on 60 Minutes Says PP is not Biocompatible, May 15, 2018
https://www.meshmedicaldevicenewsdesk.com/polymer-scientist-on-60-minutes-segment-on-boston-scientific-mesh/

Mesh News Desk, FDA Finds No Prob with Boston Sci Chinese Counterfeit Mesh, November 7, 2017
https://www.meshmedicaldevicenewsdesk.com/fda-finds-no-prob-boston-sci-chinese-counterfeit-mesh/

MND, Judge Goodwin Defers Counterfeit Mesh Allegations Against Boston Scientific to the FDA, January 27, 2016
https://www.meshmedicaldevicenewsdesk.com/judge-goodwin/

MND, Class Action Accuses Boston Scientific of Racketeering and Fraud Over Counterfeit Pelvic Mesh, November 16, 2016 https://www.meshmedicaldevicenewsdesk.com/class-action-accuses-boston-scientific-racketeering-fraud-counterfeit-pelvic-mesh/

 

By | 2018-06-25T01:06:01+00:00 June 20th, 2018|Media Reports|13 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.

13 Comments

  1. Wren June 21, 2018 at 1:31 pm - Reply

    Chalk one up for meshed up women. Finally a USSenator from New Hampshire has heard and is responding to the 60 Minutes story on CBS, May 12,2018. This is the beginning of an investigation into fraudulent schemes developed by big Pharma and ok’d by FDA. I feel she is just beginning to scratch the surface and uncover the harmful truths this medical mesh debacle has brought women and men alike. We need to send letters to her and tell our stories. Get the attention to our legislators and bring this info into the light so the public can weigh in. Also call and write to your own congressmen and women. Let’s get behind anew movement in America. Go get ’em.

    • Jane Akre June 21, 2018 at 2:37 pm - Reply

      Anyone from new Hampshire, she would be particularly interested in hearing from her constituents, but anyone should add their voice.

  2. anonymous June 21, 2018 at 2:49 pm - Reply

    Jane,
    I definitely appreciate this government official taking notice of the government activities and their part in the mesh fiasco. I have Boston Scientific mesh implanted and went to the ER recently with severe side cramps that the doctor chalked up to scar tissue surrounding the mesh. I can’t get a doctor to remove the mesh and today I had a conversation with my attorneys that was even more disappointing. I am in a settlement group and originally we were told it would take 9-12 months to get us our “settlement packages” but now they are saying that the 9-12 months was just an outlook date. It could take much longer to review. First, we were told by our doctors that the mesh was safe with just the standard complications surrounding surgery, first disappointment and then the mesh failed and we were stuck with pain all the time, no sex, and the possibility of death even, second disappointment and we couldn’t have this garbage removed from our bodies even with begging, third disappointment and now the legal system is failing us too.
    I definitely understand that life is full of disappointments but we expect that our well educated doctors, legal system and more health care professionals to take care of us that aren’t as educated.
    Ok, my rant is over. Thanks for listening.

    • Jane Akre June 21, 2018 at 3:15 pm - Reply

      Rants allowed!!! Whether you wanted to or not, you were thrown into a massive medical scheme to put experimental medical devices on the market. It may be your time to speak your own words loudly so others listen. It’s the only way things change. speaking to your own representatives is an excellent idea. If you need a list of removal doctors please ask janeakre@meshnewsdesk.com Thank you

  3. Still Standing June 21, 2018 at 7:32 pm - Reply

    US Senators and representatives offices generally forward any correspondence they receive from people outside of their voting constituency to that persons legislators as professional courtesy. All correspondence, including phone calls are logged by senate staffers , mostly unpaid interns or low paid staffers fresh from college. So, a letter or email to Sen. Shaheen from people outside of New Hampshire will probably have a zero to limited impact. If you call, they will ask your address and zip code to assure that they are communicating with a constituent, However, a letter or email or phone call to your legislators asking them to support Senator Shaheen’s efforts to investigate Boston Scientifics use of counterfiet mesh and the FDA oversight of it is appropriate. Remember, this is a particular investigation about Boston Scientific and the Chinese Mesh. Stick to that subject instead of going into a long narrative about your personal mesh experience. Keep your correspondence brief and focused. If you are calling, write down what you want to say and acknowledge that you realize they get hundreds to thousands of calls a day and you will be mindful of their time. Another good start for correspondence is your senator’s state offices. Call there first and you will have better luck getting your point across and the staffer can pass your concern up the chain of communication. They will be more inclined to do that if you stick to facts and are not aggressive with them. Staffers rarely look at twitter or facebook posts.

  4. LOUISE GROULX June 22, 2018 at 4:25 pm - Reply

    JANE, I’M FORM CANADA, ONTARIO AND I WAS WONDERING IF YOU CAN FIND OUT IF A SENATOR IN CANADA, CAN HELP US, CANADIANS. I TRIED A WHILE BACK BUT I DON’T KNOW HOW TO DO IT AND HOW TO CONTACT THE GOVERNMENT. I’M NOT GOOD ON A COMPUTER AND SOMEBODY MUST KNOW SOMETHING..I’M 67 YR.OLD AND I HAVE A BOSTON SCIENTIFIC MESH AND HAVE REAL PROBLEMS WITH IT…PLEASE CAN YOU HELP, US…THANK YOU

    • Jane Akre June 25, 2018 at 12:36 am - Reply

      Noni Wideman might be able to help. She lives in BC. I’ve alerted her to your question…. thank you. Find Noni on Facebook and Links On Mesh on Facebook.

  5. Sarah June 24, 2018 at 11:42 pm - Reply

    Is hernia mesh also from China? I am a women who has had 3 inguinal hernia surgeries and have had very weird medical problems since. Not to mention all the pain, that they ignore.

    • Jane Akre June 25, 2018 at 12:35 am - Reply

      Your hernia mesh is likely made of polypropylene, which may or may not come from china…. late 2012 Boston Scientific. There are so many questions outstanding about the biocompatibility of PP that must be answered first… unfortunately we don’t require testing of this material….

  6. Laura June 25, 2018 at 8:56 am - Reply

    AMS Pharma Co.made my Sparc implant,TVM Bladder Sling.Drs ignored the severe pain with intercourse and afterwards I couldn’t walk hardly!Now I’m using a cane,bcuz I’ve dropped to the ground with sharp stabbing pain like a knife up my Vaginal Canal.Plus debilitating migraines,loosing teeth,my lymph nodes are always swollen,idk what else will be next. Have you heard from any other ladies that have any made from AMS Pharma Companies Pls?I never needed this implant in Me in the first place.My Dr said that it’s best to remove my uterus.i just wanted my endometriosis to go away, bcuz I’ve had it since I was 19yrs old.I just sneezed four times in a row during allergy season once or twice max!Not a reasonable issue to put this Medical device implant! Pls can you respond?Ty

    • Jane Akre June 25, 2018 at 11:36 am - Reply

      Laura- Unless you live in New Hampshire, this lawmaker likely will not respond, but we will…. do you have a doctor to give you an assessment? It sounds like you are having a severe autoimmune reaction to the implant…. I will write you privately…. I’m sorry. (Your email is not found…. strange. I could not write to you.)

  7. Anonymous June 29, 2018 at 9:00 am - Reply

    Jane while it is true most Senators may just be concerned with the people from their area perhaps if we addressed more the concern of polypropylene and the fact on 60 Minutes they said it was basically a poison that was being put into the body. American citizens are suffering from this and maybe this Senator can dig into more of the FDA and why they would approve such a product to be put into a person’s body, when there are experts in the field that say it will poison us. I wrote my Senator once and he told me he could not help me because I was involved in a lawsuit. So I think it’s worth the try. I don’t know if I can put personal and confidential on it or something else but I need to get to this woman. it’s worth a try for all of us to try try to get ahold of her and if not maybe a writing letter campaign Will bring light that is just not one or two people that there’s a lot of people that have been hurt. because otherwise it’s just going to keep happening. They say it’s only two or three percent of the population gets severely hurt oh, okay. Who wants to Step Up and volunteered to be two or three percent of those who get seriously hurt from this poison? I think we need to try whatever we can somehow someway our voices need to be heard. Because what we’ve been doing so far hasn’t worked a whole lot. I will continue to write whoever I can and try to get my letter noticed. It’s too bad Jane you can’t go and have a conversation with this senator. I wish I could get mine to have a meeting with mine but I always have to talk to some funky and I know they work damn hard workers and are some really nice people sometimes. But they can’t make the hard decisions they can’t make their voice be heard really. I want to meet with the Senators and the congressman who are supposed to represent me and I want them to listen to me. anyways just a few thoughts about this Senator I’m going to write her and I’m hoping somehow some way I can get through to her

    • Jane Akre June 29, 2018 at 12:30 pm - Reply

      Both of the Senators from your state are Republican and that traditionally means more likely to side with business interests. That means AMS, Boston Scientific, Ethicon and AdvaMed have a seat at the table while you may not. Both parties are very sensitive to donors in our current system, don’t get me wrong, but the other side has some sensitivity to the public good versus the corporate donors, in my opinion. But it is always worth trying. You never know when common sense and humanity might kick in. I do think that your representatives will have more of an ear to you, their constituent, than a Senator from NH…. but that is my opinion.

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