According to medicalplasticsnews.com, Boston Scientific used counterfeited plastic in their vaginal mesh leading to medical complications in many patients. A report on 60 Minutes indicated that Boston Scientific was facedwith a shortage of the plastic they were using for their vaginal mesh implants after the company that supplied the material, Chevron Phillips, stopped providing the product because it was concerned that the plastic was not suited for use in the human body.
The plastic used was called Marlex, and it was the product that the Food and Drug Administration (FDA) had approved for use in theimplants. Boston Scientific had a supply of the product but knew that they would have to source more somehowbefore they ran out and were unable to continue to manufacture the devices.
After an additional supplier refused to sell them Marlex, Boston Scientific began searching for the product in Chinaand withholding the fact that they intended to use the plastic in implant devices because they were concerned that this would scare away potential sellers. Finally, Boston Scientific was able to purchase a product that was said to be Marlex. Tests indicated the plastic was quite different from the Marlex that Boston Scientific purchased from Chevron Philips and was quite alikely counterfeit. Still, the company used the product to make implant devices which were ultimately usedin patients.
Doctors and plastics experts have stated that the plastic was not suitable for implants in the human body. Surgeons have removed the devices and indicated that the plastic shrunk down and was dissolving in the women’s bodies, indicating that it was not a viable material to be used in implants that are meant to remain in patients for life.
The mass litigation filed over vaginal mesh implants is the largest since asbestos claims.