Cosmetic interventions and regulation

By Stephen King and Namita Matkar

While group litigation concerning the issues around PIP implants continues, there were developments last month in the ongoing discussions around the need for greater regulation of cosmetic medical devices in terms of product quality and record keeping.

The regulation of the supply and use of increasingly popular cosmetic medical devices such as implants and fillers, in the UK and Europe, is known to be unclear and insufficient. Unsurprisingly, this has been the subject of scrutiny both in the UK (through the Review of the Regulation of Cosmetic Interventions led by NHS medical director Prof Sir Bruce Keogh) and Europe (where ministers recently discussed the Commission Proposal 14493/12 aimed at creating greater safety and transparency regarding available medical devices).

Breast implants are classified as medical devices under the EU medical device regulations and so must carry a CE marking that indicates that the product meets essential safety requirements. It is unclear whether all implantable or invasive products that have a cosmetic purpose, such as calf or buttock implants, fall under the same regulations. This is because they may not be considered to have a medical purpose. Any implants that fall outside the medical devices regulations are covered by the general provisions of the EU General Product Safety Directive, which only places a very general responsibility on distributors to place products on the market that are safe in normal or reasonably foreseeable use…

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