Hernia mesh is made of polypropylene (PP), a cheap polymer that comes from the petroleum industry.
At least one trial gave us a closer look at how that polymer is treated before it is made into a permanent medical device – surgical mesh – used for hernia repair and for prolapse and incontinence implantable mesh treatments in women.
In the 2014 trial of Huskey v Ethicon (2:12-cv-05201), a pelvic mesh case filed in the Southern District of West Virginia, a chemical scientist told jurors that Prolene is treated with Procol LA-10, a lubricant to promote tissue passage and reduce tissue drag. Santonox R is an added antioxidant that protects the PP from thermal oxidation during the making of the mesh threads.
Another added lubricant is Calcium Stearate. DL TDP is an added as an antioxidant to improve the long-term storage of the resin.
To complete the sterilization process, the mesh is exposed to ethylene oxide (EtO) gas, considered by the Environmental Protection Agency to be a carcinogen.
Any chemical used by U.S. workers is required by OSHA (the Occupational Health and Safety Administration) to be accompanied by a Material Safety Data Sheet (MSDS). That lets the plant understand how to protect workers who come in contact with the chemical.
The MSDS for PP resin for Marlex, a Phillips Petroleum polypropylene, clearly says:
“Do not use this Phillips Sumika Polypropylene Company material in medical applications involving brief or temporary implantation in the human body or contact with internal body fluids or tissues unless the material has been provided directly from Phillips Sumika Polypropylene Company or under an agreement which expressly acknowledges the contemplated use.”
Lawyers for Phillips Sumika might craft such language to protect the company from any liability associated with complications that might arise from the medical devices made from its proprietary polypropylene.
Note* implanted surgical mesh, whether for hernia or pelvic repair, is not a temporary or brief fix. It is a permanently implanted medical device!
Once implanted polypropylene undergoes a degradation process. Oxidation is incited by the inflammatory process which begins as the body reacts to the presence of the implant and presumably whatever the polypropylene has been treated with and the bodily fluids and tissues nearby.
Since surgical mesh is approved using the Food and Drug Administration’s 510(k) clearance process, there was never any requirement to find out how this smorgasbord of chemicals reacts once implanted forever in the body.
Unfortunately, we are finding this out through the adverse event reports of complications called into the FDA.
Jane Akre is an American journalist based in Florida. In 1997, she was fired from a Fox News while working at a Fox affiliate in Tampa for refusing to include knowingly false information in a report on the safety of a product produced by the Monsanto Corporation. Currently, she is the National News Editor for the Mesh News Desk (MND)—an online news source that covers the complications associated with surgical meshes. Through such reporting, MND looks to put a face on adverse events that affect everyday people.