C.R. Bard, the manufacturer of the well-litigated hernia mesh implant, began using Marlex polypropylene as a component in its hernia mesh products in the 1970's. It had been using the component in vaginal mesh devices prior to its adaptation in hernia mesh devices. These decisions were made prior to 1976 when the FDA began regulating medical devices.
Because the Marlex-based device was on the market prior to the FDA's involvement in 1976, the Marlex polypropylene devices were grandfathered in as acceptable devices. An important if not controversial loophole in the guidance given the FDA's regulatory authority in this area concerned the 510(k) clearance process which allowed similarly designed and manufactured medical devices to bypass the usual regulatory hurdles and thus receive an expedited approval process.
Now we know that the Marlex polypropylene component was never intended to be implanted in humans. In 2018, Chevron Phillips issued a cautionary warning about such use in human beings.
"MEDICAL APPLICATION CAUTION: Do not use this material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues fluids or tissues.Do not use this 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 Chevron Phillips Chemical Company LP or its legal affiliates under an agreement which expressly acknowledges the contemplated use.Chevron Phillips Chemical Company LP and its legal affiliates 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."
Yet, the Bard hernia mesh utilized the Marlex polypropylene and patients who have had the Bard mesh implanted in their bodies to resolve hernia issues are suffering the consequences.