It has been widely reported that French Authorities are currently undertaking further investigations into the controversial breast implants manufactured by Poly Implant Prothese Company (PIP) following the death of a woman who had PIP implants.
PIP breast implants were the subject of a Medical Device Alert (MDA) by the Medicines and Healthcare products Regulatory Agency (MHRA) on 31 March 2010 following the discovery that the implants had been produced using non-medical grade silicone.
The French Society of Plastic, Reconstructive and Aesthetic Surgery (SOFCPRE) found the implants to have an increased the risk of leakages and ruptures, however, conclusions showed that the silicone was not toxic and that there was no causal link between the implants and cancer.
Following the initial investigation the French Regulation Authority banned PIP implants and the company subsequently went into liquidation.
The French Authorities are currently reviewing their recommendations of September 2010 which stated that women with PIP implants should undergo an ultrasound and be continually monitored. They are considering whether to recommend that all women who have PIP should have them removed as a preventative measure. The French Regulation Authority (AFSSAPS) will be issuing a statement on the safety of the implants. A conclusion will be reached by Friday 23 December 2011.
The British Association of Aesthetic Plastic Surgery and The Medicines and Healthcare products Regulations Agency (MHRA) are currently advising patients not to panic and recommend that any women concerned should contact the clinic where they had their surgery.
For further information please see:-
The British Association of Aesthetic Surgery
http://www.baaps.org.uk/about-us/press-releases/691-new-uk-guidance-on-controversail-french-implants
http://www.baaps.org.uk/about-us/press-releases/1015-defective-implant-death-prompts-review
The Medicines and Healthcare products Regulation Authority
