19 January 2012
We have recently been made aware of a problem with certain silicone implants manufactured in Europe and used in other countries. The implants involved are Poly Implant Prosthesis (PIP) and Rofil Implants. These implants were reportedly filled with an inferior industrial silicone and have been associated with a higher rupture rate. Since the industrial grade silicone may have impurities not yet determined, it has been recommended that the implants be removed.
Implants manufactured in the United States must be inspected by the FDA, which provides assurance against such risks. Our practice has not used either of the above named implants. Countries where the recalled implants were likely available include England, France, Argentina, Venezuela, Brazil, Germany and the Czech Republic.
We are happy to provide assistance if you or someone you know may have been affected by this recall.