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 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, “It is important that we inform implanted women in the UK of these findings.
“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.
Source: MHRA