Breast implant scare sparks medical device regulation review

A review of medical device regulation is to be launched in the wake of safety concerns around PiP breast implants, health secretary Andrew Lansley has announced.

The review of medical devices regulation will be launched in the wake of safety concerns around PiP breast implants (Photograph: SPL)
The review of medical devices regulation will be launched in the wake of safety concerns around PiP breast implants (Photograph: SPL)

Mr Lansley said the investigation would focus on how the situation with PiP implants emerged. ‘This review will enable us to learn lessons to improve future regulatory effectiveness,’ he said.

The review will be led by NHS medical director Professor Sir Bruce Keogh. It will look at the arrangements for ensuring the safety of people seeking cosmetic interventions such as breast implants and dermal fillers.

Sir Bruce Keogh will reconstitute the expert group formed last week. The group will examine how cosmetic surgery providers can improve the quality and safety of care and how regulation of the sector in the UK and in Europe can be improved.

The NHS across the UK is to fund removal of PiP implants if a patient and NHS clinicians decides the implant should be removed, and the original operation was done by the NHS. The DH said it expected private sector to do the same for their patients.

In addition to this, the Welsh government has said that all women in Wales who are assessed clinically as needing PIP breast implants removed will be offered replacement implants on the NHS, regardless of whether they received the initial implant privately or from the NHS.

However, the BBC has reported that the Harley Medical Group, which fitted more PiP breast implants than any other private cosmetic surgery provider, has said it would not replace them free of charge. The company said such action would put it out of business.

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