The UK medicines safety regulator has come in for criticism in an official review of its role in the PIP silicone breast implant controversy.
Around 47,000 women in the UK have PIP breast implants with most of the operations carried out privately. A small number of operations were carried out on the NHS, mostly for breast reconstruction following cancer.
To date 433 UK women have decided to have the implants removed following revelations that the makers used industrial grade silicone not meant for medical use in the implants.
Stressing that the case was one of deliberate fraud by the French manufacturers who “purposely misled European regulators’ health minister Earl Howe went on to say regulators had “serious lessons to learn from this scandal”.
Between 2003 and 2010 more than 20 letters were sent from the MHRA to PIP raising concerns about the implants. In hindsight, "this body of evidence could be seen as suggestive of a problematic manufacturer."
The review concludes that the MHRA regulators in all EU countries need to work better together to support early detection of problems, share the information they gather and take appropriate action to protect patients.
Earl Howe said: “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 that while his report won’t repair the distress caused to women who have PIP implants, it should give them and the public reassurance that ministers and regulators 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.
“The government is supporting women affected by this scandal, and providing information based on sound, solid scientific and medical advice. The responsibility for the distress caused to UK women, and indeed many thousands of women worldwide, lies squarely with the fraudulent manufacturer which actively covered up its deceit and showed a complete disregard for the welfare of its customers. But we openly acknowledge that we must learn lessons from this in the future so we put all possible protections in place for patients.”
In response MHRA chief executive professor Sir Kent Woods, said:
“We sympathise with all the women affected and we welcome Earl Howe’s review and the recommendations.
“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.”
The NHS is conducting a second review, led by Professor Sir Bruce Keogh, the NHS Medical Director, which is look at whether the cosmetic surgery industry needs to be more effectively regulated.
In January Prof Keogh's team concluded there was insufficient evidence to recommend the routine removal of PIP implants. But it recognised the concern that the issue was causing.
It found there was no link between PIP implants and cancer, and the evidence on increased rupture rates was inconclusive.