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.
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. ###