PIP Breast Implants Update

MHRA is aware of the recent report in France of the death of a woman implanted with Poly Implant Prosthese (PIP) Breast Implants associated with an anaplastic large cell lymphoma (ALCL). This is a rare form of cancer which affects cells of the immune system. MHRA is also aware that it has been widely reported in the Press that the French government will, on Friday 23 December 2011, recommend that all women who have PIP Breast Implants should have them removed as a preventative measure because of health concerns about high rates of implant rupture and cancer. The French regulatory authority (AFSSAPS) have confirmed to MHRA that a statement on the safety of the implants will be made on that day although they have not indicated what advice will be given in relation to patient health and the need to remove these implants.

• MHRA have continued to monitor the safety of these breast implants. In 2010 MHRA commissioned testing on the silicone gel filler. Results from this testing demonstrated that there was no evidence of genotoxicity (potential for cancer) or chemical toxicity.
• In addition the MHRA was aware of the US FDA's January 2011 Medical Device Safety Communication entitled "FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma in Women with Breast Implants".
  
  The MHRA informed UK healthcare professionals about the FDA's communication via a Medical Device Alert (MDA/2011/017) which was issued in February 2011.
• MHRA has also continued to review available evidence for association of cancers of women with breast implants in consultation with the relevant UK Professional Bodies for breast surgery and surgical oncology and has concluded that there is no evidence to indicate an association with cancer. Additionally the MHRA worked with the Cancer Registry and could find no evidence for an association. The MHRA has not received any reports of women with breast implants of any type in the UK with a diagnosis of ALCL.
• Also, the MHRA consulted with experts to discuss whether there was any danger to babies having been breastfed by mothers with these implants. It was concluded that there were no safety issues.
• MHRA continues to monitor any associations of all types of breast implants, including PIP, with cancers and any other health implications. We continue to liaise with AFSAPPS and will study the French evidence, discussing these findings with our experts as a matter of priority.
• MHRA's current advice to women with PIP Breast Implants continues to be that should they have any questions about their breasts or implants, that they should seek clinical advice from their implanting surgeon.
• There is currently no evidence to support routine removal of PIP Breast Implants.