A review into the PiP breast implant scandal has found that, although the regulator acted appropriately and followed scientific and clinical advice, there is room for improvement and serious lessons must be learned.
Health Minister Lord Howe’s report into PiP breast implants has 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 the MHRA and the Department of Health must learn lessons so that they can continue to improve their approach to communicating with affected individuals and the general public, particularly around issues that cause such understandable anxiety. They must ensure that full, clear and accurate information is made available promptly in a way that is easily accessible and reflects the concerns that weigh so heavily on the lives of patients who are affected by doubts over the safety of specific medical devices.
The role of the MHRA is to monitor all incidents that are reported to it, make sure that these incidents are investigated fully and that any necessary action is taken. The evidence shows that the regulator did this but that improvements are needed in its communication and data collection and the whole European system and processes for gathering and analysing data where concerns arise.
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.
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