PIP Breast Implant Rupture Prevalence
Silicone breast implants have been used for breast augmentation and breast reconstruction for many decades. Silicone breast implants were re-released onto the market in the United States in November 2006 for cosmetic purposes following a moratorium that was lifted. The new generation of silicone gel implants have been shown to be very safe. Since that time, there have only been two companies in the U.S. that have manufactured and distributed breast implants: Mentor and Allergan. This year, Sientra added a third option with their Silimed silicone breast implant. In Europe however, there was never a moratorium on silicone implants. Further, the Poly Implant Prothese implant (i.e. PIP) was one of the most popular implants until they were removed from the market in 2010 due to higher than normal device rupture rates. Recently, a group of plastic surgeons from the Netherlands reviewed their own experience with PIP implants to help clarify what the real breast implant rupture rate in these devices by imaging their own patients using MRI (Maijers and Niessen, Prevalence of Rupture in Poly Implant Prosthese Silicone Breast Implants, Recalled fro the European Market in 2010, Plast Recon Surg, Vol 129, No 6, p1372, June 2012). They imaged 224 PIP devices(all round, textured devices) in 112 patients with MRI screening after ten years of implantation; 54 implants were ruptured (24%). 37 women showed rupture in at least one of their devices (33%), of which 17 were ruptured on both sides. Importantly, of the 37 women with leakage of at least one of their devices, only 12 had any symptomatic complaints (i.e. symptomatic rupture). The remaining 68.6% of the ruptured devices presented as “silent ruptures.” Currently, any patient who has PIP implants in place should have them removed or replaced with a different type of implant.