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This opinion article has been written on request because of the recent public controversy over silicone breast implants produced by a now-defunct company, Poly Implant Prosthese PIP in France. More than , PIP devices have been implanted. The purposes of my article are to 1. The materials covered are the silicone rubber from which the implant shells are made and the silicone gel used to fill the shell.
The materials safety issues are biocompatibility especially of the gel and biodurability of the shell. The literature reviewed indicates that biocompatibility is not an issue with other current generation implants. However, biodurability is. Information is still emerging about the PIP implants. Initial regulatory disclosures suggest the PIP implants may have both biocompatibility and biodurability problems.
They also suggest that PIP implants may have been produced using silicone materials not certified as medical grade. Governmental health and regulatory agencies are just now in the process of deciding what actions should be taken to protect patients. Login Register. Forgot your password? Skip to main navigation menu Skip to main content Skip to site footer. Login Register Forgot your password?