Mesh Medical Device News Desk, March 7, 2017~ By now readers may understand that most mesh, whether for hernia repair or to treat prolapse and/or incontinence, is made of the plastic polypropylene (PP).
But you may not know about the additional chemicals that are introduced with polypropylene mesh.
There is no other way to say it – polypropylene (PP) is a cheap plastic mesh material and a dominant polymer used by the medical device industry.
Besides pelvic and hernia mesh, uses include catheters, tubing, syringes, and contact lenses. And PP use for medical devices is predicted to grow, despite the indications it might not be biocompatible.
Any chemical handled by workers as part of industrialized production is accompanied by a Materials Safety Data Sheet or MSDS. It is required by OSHA, the Occupational Health and Safety Administration.
The MSDS for polypropylene (PP) resin states clearly it is not to be made into implantable medical devices.
What does industry know that patients do not?
In 2011, Dr. Donald Ostergard, past president of the American Urogynecologic Society (AUGS), told its members that “mesh is not inert.”
Mesh is able to incite an inflammatory response or foreign body reaction in the body. In other words, there is a continuing process of change and degradation. Electronic microscopy showed the deep cracks in the PP as it degrades in the body. It can shrink up to 50 percent.
Without chemical additives to slow the process, PP was seen to degrade in live animal tests (Liebert, 1976) and that degradation process occurred as soon as a few days after implantation.
An added antioxidant retarded the degradation process.
That insight, opened the door to a chemical smorgasbord of additives to PP mesh, the effects of which are unknown.
CHEMICAL ADDITIVES TO MESH
According to testimony from the September 2014 case of Huskey v. Ethicon, (2:12-cv-05201), filed in the Southern District of West Virginia, the proprietary formulation of Ethicon/ Johnson & Johnson’s Prolene (PP) show the addition of Procol LA-10, a lubricant to help reduce tissue drag and promote tissue passage.
Santonox is an added antioxidant. Its role is to protect the resin from thermal oxidation during the extrusion process during the making of sutures or threads.
Also added is the lubricant, Calcium Stearate.
Chemical polymer expert Dr. Shelby Thames, brought in as an expert for Johnson & Johnson, testified that DL TDP, also known as dilauralthiodipropionate, is an added antioxidant that improves the long-term storage of the resin, reducing any impact of oxygen or ultraviolet light. See the background story on MND here.
A copper-based pigment is added to make the mesh more visible in the body.
The U.S. Food and Drug Administration (FDA) clears PP mesh for market and we know from inside those clearance documents that PP mesh implants are exposed to ethylene oxide (EtO) gas, a low-temperature sterilization agent.
EtO is considered toxic by the Environmental Protection Agency and a carcinogen. Exposure is regulated by the EPA in the workplace under the rules of OSHA.
Europe is light years ahead of the U.S in these concerns.
In May 2016, the European Parliament and EU Council of Ministers agreed to limit the use of devices that contain carcinogenic, toxic, mutagenic or hormone-disrupting properties.
That would include plastics.
The effort there comes after a disaster in France when a manufacturer used industrial grade silicone to fill breast implants.
The EU data will list all implantable devices that are on the market.
The U.S. has yet to establish a national database for medical devices that go wrong, though the MAUDE database is a start. Reporting can be voluntary, the database is difficult to decipher and adverse event reports often go first to the manufacturer, which can under FDA guidance decide if the complication is related to its medical device or not. ###