Regulatory requirements for breast implants
The European Medical Device Directive (93/42/EEC) starts from the premise that no medical procedure can be without risk and that an appropriate level of safety must be achieved by balancing any risks associated with the use of a medical device against anticipated benefits to the patient. The regulations do not require the absence of all risk. This would be impossible either to achieve or to prove. Instead they require that any risks must be compatible with a high level of protection of patient health and safety. Where risks cannot be eliminated, users must be advised by the manufacturer of factors that are relevant to the professional judgments they have to make.
In the case of breast implants, this advice would include information on potential health hazards, expectations about device performance (including expected lifetime) and other information that may be relevant to consent. Further details are in the Medical Device Directives section of our website.
The Medical Devices Directives specify essential requirements for safety and performance that all medical devices must meet. One means by which conformity with the essential requirements may be demonstrated is by compliance with relevant and appropriately authorised standards.
Some of the European standards relevant to breast implants include:
- BS EN ISO 14971:2009 Medical devices. Application of risk management to medical devices.
- BS EN ISO 14630:2009 Non-active surgical implants – General requirements.
- BS EN ISO 14607:2009 Non-active surgical implants. Mammary implants. Particular requirements.
