Breast implants are regulated as medical devices and
The Medicine and Health Products Regulatory Agency (MHRA), the UK government agency responsible for ensuring that medicine and medical devices work effectively, ensures that breast implants meet appropriate standards of safety, quality and performance and that they comply with the UK Medical Devices Directive. The MHRA has published a
booklet available from their website (originally developed by the Department of Health) to assist women who are considering having breast implant surgery and will investigate and issue advice to the health service if safety concerns arise.
On its web site the
Department of Health reminds patients that breast implants do not last forever and will probably need to be replaced with further surgery and expense.
Between 1993 and March 2006 the UK Breast Implant Registry (UKBIR, the Registry) collected data on breast implant usage on behalf of the MHRA, but as this agency no longer exists any incidents involving breast implants should be reported to the MHRA directly at The Adverse Incident Centre, Medicines and Healthcare products Regulatory Agency, 2/2 G Market Towers, 1 Nine Elms Lane, LONDON SW8 5NQ. Telephone 020 7084 3080. Email:
aic@mhra.gsi.gov.uk.
The
Independent Review Group (IRG) was set up by the Chief Medical Officer in 1997 to review the evidence relating to the possible health effects associated with silicone gel breast implants and to examine the issues relating to pre-operative patient information. Their findings are available on their
website.
