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, Professor 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 which 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.
Further, when products such as fillers, are used as part of a “professional service” they are exempt from the EU General Product Safety Directive – which means that some dermal fillers and implants used in cosmetic interventions in the UK are exempt from any product safety regulations. In these instances, consumers and patients are reliant on manufacturers’ and providers’ own assessment of the safety of the product. That leaves the consumer vulnerable to risks, complications and injury. The consequence is easy to predict with manufacturers or medical professionals subjected to litigation - as in the case of PIP implants.
The Commission Proposal 14493/12 recommends that products with aesthetic or other non-medical purposes such as body implants and fillers should be regulated within the medical devices legislation. This would require the establishment of an inclusive list that the European Commission would be empowered to manage. The Commission considered that for those products that can be used for both reconstructive (ie, medical) and aesthetic purposes, such as breast implants and fillers, nothing will change as most manufacturers of those devices already claim an intended medical purpose and therefore have to comply with the medical device legislation. However it would mean that the current legal lacuna is clarified. Manufacturers will know where they stand and will no longer be able to avoid medical claims through using this “loophole”.
For “purely cosmetic” implantable or injectable devices, this recommendation would have a significant impact on manufacturers. They would have to draw up technical documents, be subject to a conformity assessment procedure by a notified body and set up a system to respond to incidents - which would lead to additional costs, insurance and oversight requirements. Manufacturers who place such products on the market without prior internal quality control and incident follow up would either have to adapt or lose Europe as a market place. This recommendation might also force some products out of the market if the manufacturer cannot demonstrate conformity with the essential requirements.
The Commission considered a second option but disregarded it - to adopt separate legislation that would set the safety requirements for these products. However it was considered that this would result in manufacturers who produce the same or similar products with and without a medical purpose being subject to two different product related legislations. That would be more burdensome and increase compliance costs.
When discussing the Commission proposals, the ministers considered there was a need to strike a balance between reinforcing patient safety and accelerating access to innovations both through pre-market measures and post-market measures.
Pre-market measures include strengthening the scrutiny mechanism or the certification of notified bodies, reinforcing the powers of notified bodies and subjecting them to further requirements. A notified body is a certification organisation which carries out conformity assessment procedures in a particular member state. The assessment procedures include full quality assurance, examination of the design and the testing of every unit or every batch of product to ensure that it meets the requirements before the manufacturer can place them on the market. These measures were also recommended in the Review of the Regulation of Cosmetic Interventions in the UK where it was considered that all European notified bodies should be regularly and rigorously assessed and audited, to ensure they all work to the same high international standards – and reports of these assessments should be made public.
The post-market measure discussed, namely the tracing of medical devices, was also considered in the Review. It came about after the PIP implant scandal hit the medical sector and highlighted the fact that it was so difficult to reliably trace people who had received cosmetic implants. It recommended that a breast implant registry should be established and extended to other cosmetic devices as soon as possible to provide better monitoring of patient outcomes and device safety. It was reported in December that this register, the details of which are still to be clarified, would be piloted from January 2014.
The Review also recommended that the scope of the EU Medical Devices Directive be extended to include all cosmetic implants including dermal fillers - and that UK legislation should be introduced to enact the changes sooner.
We are yet to see how the Commission proposals and those of the Review Committee will be implemented in the UK. A successful implementation of the recommendations would have an impact on a number of stakeholders, not least manufacturers. Manufacturers would be subject to greater quality control requirements and the regulation would inevitably lead to a reduction of the number of products available on the market that do not meet the safety and performance requirements set out in the medical device legislation. We will continue to report on progress, on recommendations around the tighter regulation and training of those involved in offering services using such products and on the ongoing discussions around effective redress when things go wrong.