The MHRA today issued new information to surgeons and doctors that women in the UK who received Poly Implant Prosthese (PIP) silicone gel breast implants before 1 January 2001 should now be managed in the same way as those who had the implants after that date.
The MHRA has issued a new Medical Device Alert today after the French regulator (AFSSAPS) provided updated information to the MHRA that PIP breast implants used in surgery before 1 January 2001 could contain unauthorised silicone gel.
The new information updates previous advice issued to surgeons and doctors in a Medical Device Alert in October 2010 that women who had PIP breast implants from January 2001 could have implants filled with unauthorised silicone gel.
The MHRA is working closely with the Department of Health and other regulators to communicate this information to women, surgeons and doctors.
Dr Susanne Ludgate, Clinical Director of the MHRA, said:
“We have received new information from the French regulator that women who had PIP breast implants before 2001 could have implants that have been filled with unauthorised silicone gel.
“As a precautionary measure, we are now issuing updated information to surgeons and doctors that women who had PIP silicone gel breast implants before 1 January 2001 should now be managed in the same way as those who had the implants after that date
“A proportion of these women are likely to have had these implants removed and changed for new implants since this time. If women have any questions, they should speak to their surgeon or doctor.”
Health Secretary Andrew Lansley said:
“The French regulator has confirmed this week that more women may be affected by the criminal activity of the French breast implant manufacturer PIP. These women are the victims of a fraudulent company and I know this situation is causing a huge amount of anxiety.
“I want to reassure those affected by the news today that they will be provided with all the help they need from the NHS.
“We are still working to get private clinics to live up to their responsibilities and look after their patients. Our commitment is to ensure support for all women from the NHS if needed; we will continue to press for the same standard of care or redress from private providers.”
Professor Dame Sally Davies, the Chief Medical Officer said:
“The expert group advises that there is no evidence to suggest that every woman with a PiP implant should have them removed. But we know this is a worrying time for them and want them to be able to see a GP or specialist to get reassurance and have them removed if necessary.
“All women who had the implants put in on the NHS will be able to have them removed and replaced by the NHS. We expect private clinics to offer their patients the same care. If they refuse, the NHS will provide advice, a scan and, if necessary, remove the implants. Private patients will not, however, be able to have their implants replaced on the NHS unless this is clinically necessary.
“We will be placing adverts in the weekend papers again to inform all women with PiP implants about the advice from the experts and how they can get help if they are concerned. I have also written to GPs today to remind them that we want them to help women with PiP implants.”
The MHRA’s Medical Device Alert can be found here:
The Department of Health’s press notice can be found here:
Update on PIP breast implants (external link)