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*** IMPORTANT ANNOUNCEMENT ***
The Poly Implant Prothese (PIP) company was ordered to close by the French government for allegedly making the implants fraudulently using unsanctioned silicone gel.
At the end of March 2010, the French medical regulatory authority (AFSSAPS) informed our own MHRA (Medicines and Healthcare products Regulatory Agency) that it had suspended the marketing, distribution, export and use of the silicone gel filled PIP breast implants manufactured by a French company. The French authority recalled all of these devices at that point.
On inspecting the PIP manufacturing facility, the AFSSAPS found that breast implants made by the company since 2001 had been filled with a silicone gel with a composition different from that used to obtain their original European CE Mark approval, making it illegal.
This discovery cast much concern over the safety of the products and the MHRA advised all U.K. patients fitted with the PIP implants to consult their implanting surgeon if they had any concerns; whilst the British Association of Aesthetic Plastic Surgeons (BAAPS) has urged all women fitted with the devices to undergo an ultrasound scan in the next six months, to determine whether there is any rupture or weakening of the implant.
Following delays on the French side the UK’s MHRA has decided to conduct its own toxicology tests into the gel contained within the PIP implants, which they state should be completed in mid-August 2010.
Reported: March 2010 |