Pip, Breast Implants And Consumer Protection In Europe

The recent furore over the rupture of breast implants containing regulatorily unapproved clinically untested industrial grade silicone has understandably raised serious questions about the adequacy of the European regulatory legislation of products for cosmetic surgery.

Here, we review the relevant European legislation on medical devices. This note will not review the current status of the clinical and toxicological issues with these implants, suffice it to say that women implanted with these prostheses manufactured by the French company PIP are now very concerned that rupture and release into breast tissue of potentially toxic silicone may cause cancer. Although there is no evidence as yet of any long term harm from such rupture and tissue deposition, there is insufficient knowledge of the long term safety of this industrial grade product. It therefore remains to be seen with litigation under consumer protection and/ or the general consumer safety legislation will be successful.

Medical Devices Regulatory Legislation

The onus of satisfying conformity to the essential legal requirements of safety and fitness for purpose of a medical device lies with the producer, subject in most cases to the approval an independent 'notified body'. The manufacturer must apply an appropriate conformity assessment procedure and complete a declaration of conformity. The choice of conformity assessment procedure depends on a risk based classification either on a total quality management system audited to ISO 9000 series as customised for medical devices with EN4600 series standard, or individual product assessment.

The essential requirements relate to the safety of the device, including labelling requirements expressed in terms of scientific and technical performance characteristics. This should include evaluation of clinical data but not necessarily in terms of efficacy. Also manufacturers have post marketing safety surveillance and vigilance requirements. In parallel, Member States have market surveillance obligations. The national regulatory authority has the power to effect the withdrawal of the product in its jurisdiction and the matter is then referred to the Commission for coordination with other Member states.

Medical devices are defined as:

any instrument, apparatus, appliance or other article, whether used alone or in combination, including the software necessary for its proper application by the manufacturer, to be used for human beings for the...