Regulatory Focus™ > News Articles > UK Convenes Expert Panel to Assess New Regulatory Framework for Implants

UK Convenes Expert Panel to Assess New Regulatory Framework for Implants

Posted 15 August 2012 | By

The UK's Department of Health (DOH) is preparing to launch an expert inquiry into ways to protect consumers from potentially dangerous cosmetic implants, just months after UK regulators concluded there was significant room for improvement.

In a 15 August press release, DOH said a panel of experts led by Sir Bruce Keogh, the National Health Service's medical director, would examine the regulatory framework for cosmetic products in the UK, the information available to patients and follow-up procedures.

An earlier report by Health Minister Lord Howe recommended regulators reassess the postmarketing surveillance of implantable devices and improve their ability to collect information from various sources, including regulatory authorities across the EU.

"A vigilance system is only as good as the information that is reported to it," Howe wrote. "More needs to be done to ensure that problems with medical devices are reported, so problems can be identified and action taken to address them."

Howe's report was conducted in response to widespread outrage over breast implant products manufactured by now-defunct French manufacturer Poly Implant Prothese (PiP), whose devices were made using unapproved industrial silicone and were found to be rupturing at a higher-than-expected rate.

New Framework for Implantable Devices

DOH's new expert panel is expected to construct a new surveillance framework for the UK, it said.

"I am concerned that too many people do not realize how serious cosmetic surgery is and do not consider the life-long implications - and potential complications - it can have," Kough said. "That's why I have put together this Review Committee to advise me in making recommendations to government on how we can better protect people who choose to have surgery or cosmetic interventions."

Among the items to be discussed by the committee will be a national implant register, DOH said. "The information could include the date and place of the operation, the clinical outcome as well as a method of identifying the patients who received the product."

Notably absent from the committee, however, are any regulators from the Medicines and Healthcare products Regulatory Agency (MHRA). Members of the committee include an editor of Marie-Claire magazine, a broadcaster and a "media doctor."

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