Breast Implant Scandal Shows Need for Greater Regulation

An investigation into how the Irish system of regulation of the cosmetic industry allowed hundreds of women to be put at risk should take place immediately, said Liam Moloney, a Healthcare Solicitor today.

Mr. Moloney whose firm is advising women who received the affected silicone PIP Breast Implants has called on the Irish Medicines Board to impose stronger regulations on private healthcare cosmetic clinics. Mr. Moloney said, “it was not until October 2010 that the Irish Medicines Board became the competent authority in Ireland for cosmetic products. Until then the private cosmetic industry in Ireland was left completely unregulated”.

“The Medicines Board was aware in March 2010 that the French Medical Device Regulatory Authority had suspended the marketing, distribution and export of the PIP breast implant product. This action was taken following an inspection of PIP’s manufacturing plant where it was found that most implants manufactured since 2001 were filled with an unauthorized silicone gel. The inspection was conducted by the French authorities as a result of the increase in the number of incident reports regarding device rupture.

At that time the IMB recommended that implanting surgeons and clinics identify women who were implanted with the PIP silicone fillers implants and to assure them that there was no evidence of health risk associated with them”.

Mr. Moloney also criticised the Department of Health for failing to introduce a mandatory indemnity insurance scheme for private health care providers to ensure that people who were affected by the PIP implants are not left without a route of legal redress if a manufacturer goes bust, like PIP, the breast implant company. He added “the position at the moment is that many hundreds of women who are affected may not be able to obtain compensation. The industry, both manufacturers and private hospitals, should bear the costs of all remedial surgeries required to replace the implants and compensate patients fully.”