Note: This advice is given by the CAP Executive about non-broadcast advertising. It does not constitute legal advice. It does not bind CAP, CAP advisory panels or the Advertising Standards Authority.
The US Food & Drug Administration (FDA) requires all silicone gel-filled breast implants to be approved before going on sale. CAP understands that an Independent Review Group (IRG), set up by the UK Government, concluded in 1998 that marketers could continue to offer implants as long as they made consumers aware of the risks. The IRG continues to meet to discuss new evidence but to date its conclusion remains:
• silicon gel breast implants are not associated with more health risk than other surgical implants;
• despite local complications, such as capsular contracture and gel bleed, the incidence of ill-health in women implanted with silicone gel breast implants is no greater than in the general population and no evidence exists of an association with an abnormal immune response or typical or atypical connective tissue diseases or syndromes;
• children of implanted women do not have an increased risk of connective tissue disease.
As well as information available on its website, the Department of Health published a booklet titled "Information for women considering breast implants". The booklet was updated by the Medicines and Healthcare products Regulatory Agency (MHRA) in November 2005 and is available on www.mhra.gov.uk/Publications/Postersandleaflets/CON2022635. The booklet gives information about breast implant surgery and provides a checklist of questions that the woman is advised to discuss with her surgeon so that she is adequately informed about the procedure, including expectations and the need for follow-up visits and surgery.
In Europe, breast implants are regulated under the general Medical Devices Directive 93/42/EEC, which classifies medical devices according to risk and stipulates minimum requirements that the device must fulfill. Breast implants have been classified as Class III medical devices, the highest risk category, and must meet the most stringent requirements set out in the Directive.
The ASA has looked into very few complaints about ads for breast implants: in one investigation, Grosvenor House Centre For Aesthetic Plastic Surgery, October 2000, it concluded that no breast implant was guaranteed for life and another, London Centre For Aesthetic Surgery, May 1999 (complaint 5), related to the safety record of Soyabean Oil implants.
As with other cosmetic surgery procedures, marketers should not imply that breast augmentation or reduction is “safe”, “easy” or entirely without risk (Harley Medical Group, 5 December 2007). Marketers using visuals should be mindful of where they place ads in case they offend readers not in the target audience.
See other entries on ‘Breast Enhancing Products’ and ‘Cosmetic Surgery’ and ‘Medical Devices’.
Last modified : 26 July 2010