The Department of Health has recently published the report of the review into the PiP breast implant scandal, which looked at whether the UK regulator – the MHRA – and the Department of Health acted appropriately both before and after information about the problems with these implants came to light.
The report states that lessons need to be learnt by the MHRA, the Department of Health and the wider system so it can uncover problems early, be better placed to take robust action and provide clarity for the public should anything like this happen in the future.
The report has found that the MHRA:
- should review and further develop its communications capability to ensure it can rapidly establish and provide centralised communications regarding device alerts and related issues on an ongoing basis. This should be a proactive capability serving the needs of patients, professionals and the press and public;
- must be able to obtain evidence from a wider and more detailed set of sources, including robust data from clinicians. It needs to be at the forefront of using more sophisticated and rich sources of data to help determine if there are problems with a device; and
- must be able to routinely review the sum total of the information about specific higher-risk devices, so any problems are identified early.
Lord Howe, who conducted the review, said:
“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 – the NHS Medical Director – is currently carrying out a separate review of the wider system of regulation for cosmetic interventions. His review will also look at whether a breast implant registry could be put in place in this country, to help monitor any problems that occur and perhaps make it easier to trace people affected if there is ever a problem in the future.
