Speaking about the decision by the Harley Medical Group to refuse to cover the costs of removing the PIP breast implants from patients Liam Moloney, Healthcare Solicitor who is representing women affected by the scandal said today “the refusal by the Harley Group to come to the aid of their patients is astounding. The clinics provided these implants and represented that they were safe and of good quality. All cosmetic clinics should immediately put in place comprehensive review facilities to reassure affected women”.
He added “the manufacturer, PIP, gave these products the European CE mark indicating that it complied with the relevant EU regulations. This was overseen by TUV Rheinland – a German commercial organisation responsible for undertaking the necessary safety and regulatory checks required for a CE mark. Once a medical device has a CE mark it can be placed on the market in any EU member state”.
“Under those circumstances the responsibility of the Irish Medicines Board here was to investigate adverse incidents as part of its post-market surveillance role. The Irish Medicines Board has failed to safely monitor the safety of these breast implants. The failure by the Medicines Board to properly regulate the cosmetics industry will have wider implications for the regulations of implants and other medical devices”.