A new report by 60 Minutes examines a lawsuit brought by more than 100,000 women against Boston Scientific for life altering pain and injuries caused by their gynecological mesh product. While Boston Scientific and several medical societies claim the medical implant is safe, more than 100,000 women, as well as doctors and plastics engineers disagree.
Chevron Phillips, the company that originally supplied the polypropylene — a plastic used in packaging — to Boston Scientific for the mesh, warned in 2004 that the plastic must not be used for “permanent implantation in the human body.” 60 Minutes examined the history of this medical device and how Boston Scientific maneuvered to find another plastic supplier when Chevron Phillips cut off the supply of plastic to the company in 2005.
The gynecological mesh has been used to help with urinary incontinence and as an internal sling to help lift organs that shift during pregnancy. At issue is the fact that the mesh has been found to fold, contract and become embedded in scar tissue — causing chronic inflammatory reactions, pain and injuries in some women. Dr. Michael Margolis, a surgeon who has removed 350 mesh implants, has removed slings that have shrunk by 50% and are “substantially altered in their architecture.” The implant is not supposed to change. Duane Priddy, a plastics engineer and fellow of the American Chemical Society, noted that the oxygen in the body eats the plastic.
In 2004, Chevron Phillips became concerned about medical use of the plastic and by 2005 had cut off supply of the plastic to Boston Scientific. Unwilling to give up the $120 million per year revenue generated by the mesh, Boston Scientific reached out to 20 companies for new stocks of plastic material. Eventually, they found a plastics broker in China — Emai — that claimed to have supplies of the Chevron Phillips plastic. Company documents reveal that Boston Scientific didn’t want to tell Emai how the plastic would be used because “it could scare them away.”
Around the same time Boston Scientific was looking for new sources of plastic, the FDA issued a report detailing the “injury, death and malfunction” of mesh used to support organs after pregnancy, including “pain, infection, urinary problems, bleeding and organ perforation.” In light of this report, Boston Scientific sought to avoid finding a new source of plastic because they feared the FDA would require a new round of tests. The company proceeded to secure the plastic from Emai despite the fact that they couldn’t verify the plastic’s source or authenticity of the product. According to 60 Minutes, Boston Scientific ran 11 tests to compare the Chinese plastic to that of Chevron Phillips. Nine of the tests indicated the plastics were different or very different. Despite those findings, Boston Scientific concluded the plastics were the same. The FDA has noted that the Chinese plastic “does not raise new safety or effectiveness concerns.” However, 60 Minutes had an independent plastic engineer test the Emai plastic and he noted the product was inferior and would only last “a few months” in the human body.
In short, Dr. Margolis concluded the plastic currently being used in this mesh is an “experimental material” and implanting it is “human experimentation without consent.” Boston Scientific noted that, “any allegations continuing to question the integrity or legitimacy of our [plastic] resin are false and irresponsible.” 60 Minutes tested 15 Boston Scientific kits and all matched the Chinese plastic.
The complete 60 Minutes piece can be viewed here. If you have suffered injury or pain from a vaginal mesh impact, contact Tlusty, Kennedy & Dirks, S.C. today at 715.359.3188.
