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UK regulator criticized over implant scandal

Article-UK regulator criticized over implant scandal

London — Healthcare regulators in the U.K. were criticized in a recent government review of the Poly Implant Prothese (PIP) breast implant scandal.

The review follows a worldwide scandal in which hundreds of thousands of women, including nearly 50,000 in Britain, received unsuitable silicone breast implants from French manufacturer PIP, Reuters reports.

The review said that although the British Medicines and Healthcare Products Regulatory Agency (MHRA) followed sound advice, it was advised to gather evidence from a larger group of sources in the future, especially from clinicians.

It was noted in the review that PIP committed deliberate fraud, which the MHRA was not responsible for, but the agency needs to identify areas where “improvements can and should be made in the future,” health minister Earl Howe said in the review.

"(The MHRA) needs to be at the forefront of using more sophisticated and rich sources of data to determine if there are problems with a device. It must have the ability to review routinely the sum total of the information about specific higher-risk devices, to ensure that the need for any further action is identified promptly," Lord Howe said.

MHRA CEO Kent Woods responded to the review in a news release, noting that the agency sympathizes with patients affected by the PIP breast implant scandal.

“We will act quickly to implement the recommendations and use the lessons learned from this episode to improve the regulatory system for medical devices in the U.K. and Europe,” Professor Woods said.

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