Silicone gel filled breast implants manufactured by PIP
The Association of Breast Surgery at BASO has received a Medical Device Alert from the Medicines and Healthcare products Regulatory Agency.
On the 30th March 2010 the French medical device regulatory authority (AFSSAPS) informed the MHRA that it has suspended the marketing, distribution, export and the use of silicone gel filled breast implants by PIP (a French breast implant manufacturer). It has recalled all of these devices.
AFSSAPS recently carried out an inspection of the PIP manufacturing plant and established that most breast implants manufactured by the company since 2001 have been filled with a silicone gel with a composition different from that approved.
The MHRA does not yet know if the use of the unapproved material affects the safety of the implants. We understand that AFSSAPS is carrying out urgent testing and has undertaken to provide further information as soon as it is available.
To view the full Medical Device Alert please click here.
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