Mesh Medical Device News Desk, August 13, 2018 ~ Marion Scott, now with The Sunday Post, has done a tireless job on following the anti-mesh campaign in Scotland. The group, Scottish Mesh Survivors and Scott testified to a Parliamentary Committee and obtained a stay on mesh implants in that country in 2014, the first in the world. Scott now reports that Scottish Mesh Campaigners are asking for criminal charges to be filed against mesh manufacturers for their alleged reckless disregard of human life.
Image: The Sunday Post, August 12, 2018
The story is reported in The Sunday Post, August 12, by reporter, Marion Scott who has brought readers news of a growing anti-mesh campaign in Scotland for nearly a decade.
After a number of deaths among Scottish women following their implants, Scottish anti-mesh campaigners are calling on criminal charges to be filed against mesh makers which includes, Ethicon (Johnson & Johnson,) C.R. Bard, Boston Scientific and American Medical Systems, now Endo International.
In “Memos reveal mesh firms were warned 21 years ago that material should not be used on humans,” Scott revisits the Material Safety Data Sheet (MSDS), that accompanies a raw material through its processing.
As far back as 1997, implant makers C.R. Bard and its subsidiary, Davol, were warned they should not use polypropylene resin to make surgical implants. Chevron Phillips, the supplier of the PP resin, Marlex, said it feared being sued if the product was being used that way.
“…that statement purported to warn against using the resin for certain medical applications, they did so only to avoid potential legal liability because they had not performed medical safety testing,” Scott quotes a spokesman from Boston Scientific.
“Do not use this Chevron Phillips Chemical company LP material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.” ~ 2004 warning from Chevron Phillips that accompanied its Marlex mesh.
That didn’t stop Bard from using Marlex for millions of hernia and pelvic meshes. In fact, to cover its tracks, Bard set up a third party, Red Oaks, to purchase the raw polymer.
The mesh manufacturers distributed their products globally including to the National Health Service in Scotland and to 11 health boards in that country.
Roger Darois said, “It is likely that they do not know of our implant application. Please do NOT mention Davol’s name in any discussions with thee manufacturers.”
Scott reports that decision has led to horrific internal injuries. She cites Michele McDougall, 55, from Edinburg, who died last May after suffering chronic infections following six mesh patches. She suffered vaginal cancer and was too ill for chemotherapy.
Claire Daisley, 48 is awaiting removal of both her bladder and bowel, following her mesh surgery.
Marion McMillan, 70, diagnosed with lung cancer, even though she never smoked, has called on Scotland’s Chief Medical officer to order rigorous monitoring of implant patients in that country. She tells The Sunday Post that her health started breaking down “from the moment I was given a mesh implant.”
Here is her story.
It’s estimated at least 1,800 Scottish women were implanted with polypropylene gynecological mesh every year to treat prolapse and incontinence, until its use was suspended in 2014.
Urogynecologist, Wael Agur, told both the Scottish and UK parliaments that, “We need to wake up and research whether there is any link between mesh, cancer and other inflammatory reaction. We have evidence that chronic inflammation and persistent infection can lead to cancer changes in the body.”
New Jersey lawyer, Adam Slater spoke to Scottish lawmakers at a parliamentary hearing and said “In my opinion, the mesh manufacturers were criminal reckless, and more. They knew women would be severely hurt but his this knowledge so they could profit.”
MSP Neil Findlay said: “Here we have yet more evidence of the outrageous lengths mesh companies will go to maximise their profits all at the expense of lives and well-being. What more evidence is needed to take forward a prosecution?”
In the U.S., the Occupational Safety and Health Administration or OSHA, requires that potential safety hazards accompany a material with the hopes that workers can be safe who handle the material.
In the case of raw polypropylene resin, a polymer that results from the petroleum industry, lawyers had crafted the MSDS that warns the material should never be made into an implantable medical device.
Lawyers for the petroleum industry wanted to cover any liability the deep-pocketed industry might face from devices gone wrong, so the language would offer cover, just in case the resin was going into the making of an implantable device.