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Government review exonerates MHRA over PIP scandal

Government review exonerates MHRA over PIP scandal

Woman after surgery - Credit: thinkstock

A government review has found the Medicines and Healthcare products Healthcare Regulatory Agency (MHRA) acted “appropriately” and made the “right decisions” in the wake of the PIP implant scandal.

Health Minister Earl Howe said even the most “exhaustive testing regime” would not have prevented the “deliberate fraud” of Poly Implant Prothese (PIP).

It is estimated around 47,000 women in the UK are affected by the PIP scandal, where implants were made using unauthorised silicone gel – developed to fill mattresses among other uses.

The review considered the available evidence on MHRA and DH action relating to PIP implants up to 24 December 2011.

The MHRA was said to be “actively fulfilling its obligations” when reviewing and responding to incidents involving PIP implants, while being “focused” on determining any “underlying problems” with the implants.

“Up until March 2010, there was no evidence available to the MHRA that PIP were not sing the filler they were supposed to be,” said Earl Howe.

“Looking closely at the response of the MHRA to the French regulator’s discovery, I have found no evidence that the MHRA acted inappropriately or significantly failed to do its job.”

Nevertheless, he called upon the MHRA to review the processes and governance it uses to ensure “timely and appropriate action is taken in pursuing responses from manufacturers, notified bodies and others, and in ensuring appropriate regulatory actions take place in a timely manner”.

In response to the government review, Professor Sir Kent Woods, Chief Executive of the MHRA, said the regulator will “act quickly” to implement the recommendations and use the lessons learned to “improve the regulatory system for medical devices in the UK and Europe”.

In its report published in March, the Health Committee deemed the action taken by the DH and MHRA in communicating with women after the fraud was exposed in March 2010 was “inadequate”.

“Although we are disappointed that the Government does not agree with our conclusion that more creative approaches should have been used as soon as the fraud was discovered to raise public awareness of the potential danger to patients (both NHS and private) from the use of PIP breast implants, we welcome Earl Howe’s recommendation the MHRA should review its processes to ensure more timely regulatory action takes place,” said Stephen Dorrell, Chair of the Health Committee.

“[We] intend to ask the MHRA to provide the Committee with evidence about how it intends to implement this recommendation.” 

A further review chaired by NHS Medical Director Professor Sir Bruce Keogh is expected and will examine the wider issues around the regulation of cosmetic surgery.

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