On May 13, a 60 Minutes broadcast reported on a story about thousands of women suffering injuries from vaginal mesh implants. According to the report, unstable plastic was knowingly used by Boston Scientific.
The manufacturer’s vaginal mesh implants are used by surgeons treating pelvic organ prolapse and incontinence in women.
The Food and Drug Administration has classified transvaginal mesh as Class III, the riskiest devices receiving approval, due to their high rate of complications.
Reporting on Defective Mesh Implants
In an upcoming Netflix documentary dubbed The Bleeding Edge, one victim, Tammy Jackson, details the mesh complications she’s suffered for almost a decade now. Victims like Jackson appreciate the awareness broadcasts like the 60 Minutes report bring to her struggle.
Still, she wishes they would’ve covered more about the deaths and complications caused by these mesh implants. Jackson now suffers from kidney stones, kidney atrophy, antibiotic resistance and being septic due to the defective implant.
The complications caused by the mesh implant have Jackson currently admitted to the hospital. Jackson and other victims have already filed lawsuits claiming that their transvaginal mesh implants were defective. Industry experts attribute the defects to the polypropylene plastic used in manufacturing the implants.
On the 60 Minutes broadcast, a plastics engineer named Duane Priddy described how polypropylene becomes unstable when exposed to oxygen.
Priddy has also been an expert witness testifying in lawsuits targeting Boston Scientific. According to Priddy, it’s hard to imagine anyone knowledgeable in plastics determining that polypropylene is appropriate to use for devices inside human beings.
The plastic engineer claims that polypropylene being oxidatively unstable is well-known fact in this field. However, some claim that the profitability of using polypropylene was a higher priority to Boston Scientific than the concerns shared by industry experts.
Mesh Manufacturers and Marlex
By 2004, Chevron Phillips refused to provide Marlex polypropylene to Boston Scientific for mesh implants any longer. Chevron Phillips told the manufacturer that they simply were no longer interested in that business at any price. They also warned that Marlex should no longer be used for permanent implants inside human beings.
The Chevron Phillips warning was not enough to dissuade Boston Scientific from continuing to make the mesh implants. Boston Scientific then began smuggling from Emai, a Chinese supplier who manufactured counterfeit Marlex polymer.
Even though their own tests showed several inconsistencies in the counterfeit Marlex, Boston Scientific still used the plastic to manufacturer mesh implants.