High rates of rupture in Poly Implant Prothese silicone gel implants
The sale, marketing, distribution and use of silicone gel implants manufactured by Poly Implant Prothese (PIP) has been stopped after the French medical device regulatory authority (AFSSAPS) responded to reports that the implants had abnormally high rates of rupture, the only remedy for which was for women to undergo surgery to remove them.
Following these concerns AFSSAPS carried out an inspection of the manufacturing facility which revealed that most of the breast implants manufactured by the company since 2001 have been filled with a silicone gel different from that approved by the regulator. Tests are being undertaken by AFSSAPS in order to ascertain whether these implants pose a risk to the health of patients who have already had them implanted.
Between 35,000 and 45,000 women have had an implant supplied by the French company since 2001.
The MHRA (the UK Medical and Healthcare products Regulatory Agency) issued a warning about these implants on the 30th March 2010 and advised medical practitioners that these implants should not be used in any further procedures. Concerned patients are being advised to contact their plastic surgeon in order to establish whether they have PIP implants.
Have you been affected by defective breast implants? Irwin Mitchell Solicitors has a specialist claims team who deal with defective medical devices. If you or someone you know may have been affected by this please contact us to discuss your options and the possibility of making a claim - call 0800 056 4110.