Government health agencies and professional medical organizations around the world have issued recommendations on how to deal with the French made PIP silicone gel breast implants. Now, the largest American organization of aesthetic plastic surgeons has offered guidelines for its surgeon members.
According to the American Society for Aesthetic Plastic Surgery (ASAPS), the French made PIP (Poly Implant Prostheses) implants and Dutch made Rofil implants have a higher rupture rate than other breast implants. Also, since the silicone used was industrial grade, and not medical grade, the possible impurities and potential side effects are not known. For this reason, implant removal should be recommended.
The implants that are affected are the PIP silicone gel (not saline-filled) breast implants used since 2011. They were also sold as the M-implant by the company Rofil Medical in the Netherlands and distributed in Germany by the company Rofil Medro. Affected Rofil implants are designated as IMGHC-TX, MX-IMGHC, and IMGHC-LS. There is strong suspicion that PIP and ROFIL implants that were manufactured before 2001 are also affected and are prone to a higher rupture rate and therefore silicone leakage. These implants were never F.D.A. approved in the United States and so women who had their implants placed in the U.S. should not be affected.
The ASAPS agrees with The International Society of Aesthetic Plastic Surgeons (ISAPS) who strongly supports the recommendation of the French authorities to remove the implants as a precaution, even if no symptoms or hints of rupture or leakage are present.
- Source: American Society for Aesthetic Plastic Surgery
- Copyright: Karol A. Gutowski, M.D., Chicago, IL, 2012