Belfast Telegraph

Monday 22 September 2014

UK regulator didn't approve PIP breast implants

YOUR article, headlined 'This Belfast mum had breast implants to give her the curvy figure she longed for. But the first ones were removed due to the PIP scandal. A second op also went disastrously wrong. This is her warning to other women' (Life, August 11), misrepresents the role of the UK's health regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA).

The quote by the Harley Medical Group incorrectly states that the Poly Implant Prothese (PIP) breast implants were approved by the MHRA. This is not the case.

Like all medical devices, they are approved via the Europe-wide system of regulation for medical devices. Responsibility for supervising the system is shared by the EC and participating national authorities. In this case, the MHRA was not directly involved.

The PIP implants were fraudulently manufactured and the deceit was carefully managed so as to conceal the activity from the German authorities.

The founder of the company involved was imprisoned for four years by a French court in December 2013. No regulatory system can completely protect against criminal activity.

Under this Europe-wide system, the MHRA monitors the performance of medical devices, such as breast implants, once they are approved and in use and can take action to remove them from sale if there is evidence that they are not safe, or effective.

The MHRA advised surgeons not to implant PIP breast implants in March 2010.

DR NEIL McGUIRE

Clinical director for medical devices

Medicines and Healthcare Products Regulatory Agency

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