Poly Implant Prothèse (PIP) silicone breast implants
People with PIP prostheses, also sold under the trade name M-Implant, should consult their doctors or surgeons if they suspect rupture, experience pain or inflammation, or have any other concerns. They and physicians should follow the recommendations of their national health authorities.
In March 2010, PIP implants were withdrawn from the European Union market, after an increase in ruptures was observed and French regulator AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé) confirmed that substandard silicone had been used in manufacturing the implants.
Adverse events of approved breast implants include rupture and leakage. While the rupture rate of PIP prostheses was higher than expected in France, other national authorities reported varying rates.
Specific recommendations by national regulatory authorities can be found on the Global Alert and Response site.