In March 2010 the MHRA was informed by the French regulatory authorities (AFSSAPS) that most PIP silicone gel breast implants manufactured from January 2001 were filled with an unapproved silicone gel material.
Health on Female First
The MHRA's (Medical Health Regulation Authority) advice for the management of women implanted with PIP silicone gel breast implants after 1 January 2001 was given in MDA/2010/078 and published in October 2010.
"There was a complete failure by the UK regulator to take the PIP breast implants off the market when they knew they were faulty in March 2010. In the meantime, innocent women who had breast implants in good faith, for a variety of reasons, are now being unfairly punished. In light of the fact the French manufacturer has gone out of business and will clearly not be making any compensation payments, the UK Government must now act responsibily. Blaming breast surgeons for a manufacturer defect is like blaming a driver for a fault in the manufacture of a car."
Updated information from AFSSAPS suggests that there is no guarantee that PIP silicone gel breast implants manufactured prior to 2001 contained the approved filler. Therefore, all women implanted with PIP silicone gel breast implants should be supported and managed in line with the Department of Health's recommendations of January 2012.
Information recently received from the UK supplier of PIP breast implants suggests that up to 7,000 women may have received PIP silicone gel breast implants prior to January 2001. This is in addition to the approximately 40,000 women previously believed to have received affected implants after 1 January 2001.
Tagged in Health