Breasts: Plastic Surgery

Under existing medical device regulations, UK Medical Devices Regulations 2002, all medical devices must meet the Essential Requirements, which includes the use of designated standards that specify mandatory safety and performance criteria for those devices. As breast implants are the highest class medical device, class III, they must undergo rigorous pre-market testing by the manufacturer, which is then assessed by a third party such as a United Kingdom approved body or European Union notified body, before being registered with the Medicines and Healthcare products Regulatory Agency (MHRA) and prior to being placed on the market in the UK. Once on the market, the manufacturer must continuously review the safety of their devices. The manufacturer is subject to annual surveillance and monitoring, alongside unannounced audits to ensure claimed standards of quality and safety management are being applied in practise. The MHRA also monitors emerging signals to determine if previously unrecognised risks exist or if the nature of known risks is changing.

Following the Cumberlege recommendations in the Independent Medicines and Medical Devices Safety Review, the MHRA has introduced post-market surveillance regulations to require that safety issues with medical devices are identified early. Further information on the review is available at the following link:

https://immdsreview.org.uk/

The MHRA is also developing a future regulatory framework to strengthen pre-market requirements for medical devices. This intends to introduce requirements for unique device identifiers, implant cards, and new rules to ensure that claims are consistent with intended purpose to better reflect potential risks to patients, increase containment of safety issues, and reduce patient harm.