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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
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 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
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
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/
