MHRA Working to 'Quickly Implement' Recommendations from Commission
Posted 15 May 2012 | By
The UK's Medicines and Healthcare product Regulatory Agency (MHRA) said it is moving to act on recommendations made by a Commission in the aftermath of a scandal involving breast implant products made by now-defunct medical device manufacturer Poly Implant Prothese (PIP).
Breast implants manufactured by PIP were purportedly manufactured using industrial-grade silicone, leading British authorities to recommend patients have the implants removed. In light of patients' concerns and the failure of MHRA to stop the products from entering the UK market, an inquiry was launched into future scandals could be avoided.
The inquiry's findings, published 14 May 2012, both chided and defended the agency in equal measure. While the case involved "deliberate fraud" beyond the exclusive capacity of MHRA, the episode still left "serious lessons" to be learned and "room for improvement" at the regulatory agency.
"The MHRA needs to look at how it gathers evidence so it is able to identify problems early. It needs to better analyze reports about higher-risk medical devices. And it needs to improve the way it communicates with the public," said Health Minister Lord Howe in the report. "This report won't repair the distress caused to women who have PIP implants, but it should give them and the public reassurance that we have identified the lessons; that we will take all steps to act on them; and that, should something like this happen again, our systems for dealing with it will be stronger."
MHRA's Chief Executive, Sir Kent Woods, responded to those remarks on 14 May.
"We sympathize with all the women affected and we welcome Earl Howe's review and the recommendations," said Woods. "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 UK and Europe."
MHRA - Press statement: MHRA statement on Earl Howe review
Regulatory Focus - UK Publishes Review of PIP Breast Implant Scandal, Calls for Improvements