MHRA Update – Results from AFSSAPS
In early September the Medicines and Healthcare products Regulatory Agency (MHRA) announced encouraging preliminary results of the UK testing on the silicone gel breast implants manufactured by the French company PIP. The French medical device regulatory authority (AFSSAPS) has today announced the results of their testing. The French results confirm the UK findings reported at the beginning of September 2010 that there is no conclusive evidence of genotoxicity (potential for cancer) or chemical toxicity of the filler material in the implants. One of the French genotoxicity tests was however inconclusive and further testing will be conducted by AFSSAPS with results expected in early 2011.
Mechanical testing of the implant shell carried out by AFSSAPS confirmed that there may be an increased risk of rupture.
The MHRA Clinical Director for Devices, Dr Susanne Ludgate said, “We are currently seeking further advice from UK clinical and toxicology experts following publication of these results. In the meantime, if women have any concerns they should speak to their implanting surgeon.”
The MHRA was informed in March 2010 by AFSSAPS that they had suspended the company’s marketing, distribution and export of these products. This was due to an inspection of PIP’s manufacturing plant which found that most implants manufactured since 2001 had been filled with an unauthorised silicone gel which differed from the originally approved material.
Policy for Patients of The Hospital Group
The Hospital Group have not used PIP implants since early 2009, when they chose to switch to Allergan CUI and Natrelle implants. However, if you think you were a PIP implant patient with The Hospital Group and have any concerns about them, they are offering a FREE CONSULTATION with a clinic nurse for initial discussion/assessment (this can be via telephone or in clinic). Please contact your local clinic, or call the central appointment line on 0121 445 0213. Where necessary or appropriate, the nurse will then refer you to see a surgeon for assessment – again, this is provided free of charge. Each case would be assessed individually, but the priority is to ensure the patients’ welfare at all times. If a clear case of rupture was diagnosed and implant removal were advised, their intention would be to REPLACE the implants at NO COST to the patient.