A review of the PiP breast implant scandal has concluded “serious lessons” must be learned and improvements made by the medicines and healthcare products regulator.
The probe by Health Minister Lord Howe has cleared the Medicines and Healthcare products Regulatory Agency, saying it did act appropriately.
Lord Howe found the MHRA met its obligations but “there is room for improvement” at the agency and the Department of Health, which both need to improve communication.
Between 2003 and 2010 more than 20 letters were sent from the MHRA to PiP raising concerns about the implants. The review concludes “this body of evidence could be seen as suggestive of a problematic manufacturer”.
European regulators have also been urged to work better to identify problems.
PiP breast implants were banned in 2010 after it emerged industrial grade silicone was being used. Around 47,000 women in the UK had a PiP breast implant.
The review makes clear the problem was due to fraud by the PiP manufacturer and that regulation would not stop that.
But Lord Howe added: “Serious lessons must be learned from this scandal. The MHRA needs to look at how it gathers evidence so it is able to identify problems early. It needs to better analyse reports about higher risk medical devices. And it needs to improve the way it communicates with the public.
“It is clear that problems occurred that weren’t reported to the regulator. A vigilance system is only as good as the information that is reported to it. 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.”
He added: “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.”
Sir Bruce Keogh, NHS Medical Director, is carrying out a separate review of the wider system of regulation for cosmetic interventions including a breast implant registry.
Professor Sir Kent Woods, chief executive of the MHRA, said he welcomed the review and pledged to implement the recommendations.