24/07/2014

A government report on the actions of a regulator and the Department of Health during the PIP breast implant scandal has concluded that serious lessons must be learned from the affair, which affected as many as 47,000 women in Britain.

The health minister Earl Howe concluded that the Medicines and Healthcare Products Regulatory Authority (MHRA) acted “appropriately” before and after the scandal, but needed to improve in key respects in order to better identify problems early and communicate with the public.

He put the blame for the health scare on the “deliberate fraud” of the now defunct French company Poly Implant Prothèse, whose owner is in prison awaiting trial.

But Howe stressed that the scandal had revealed ways in which both the MHRA and the Department of Health should improve. They should work to improve their communications, he said, and ensure that full and accurate information was made available as early as possible.

Last month a report by MPs said the action taken to communicate with the public as the scandal broke in December was inadequate.

Howe said: “It must be emphasised that this case was one of deliberate fraud by the PIP manufacturer which purposefully misled European regulators. Regulation alone cannot prevent fraudulent activity such as this. But 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.”

He added: “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.”

The review found that the MHRA began to receive reports of potential problems with PIP implants in 2002, almost a decade before the scandal broke in December. It also says that a director’s post at the MHRA, whose occupant would have had strategic oversight of medical devices such as implants, was vacant from September 2010 until February 2012.

Shadow public health minister Diane Abbott said these and other findings contributed to a “damning indictment” of the health secretary, Andrew Lansley, and the relevant authorities.

“Their handling of the issue has caused confusion and anxiety to thousands of women,” she said, adding: “The review doesn’t really explain the gap between the French authorities deciding to recall all silicone PIP implants and the British authorities taking action.

As many as 47,000 women in Britain are estimated to have been given substandard PIP implants, the vast majority of them – at least 37,000 – in private clinics. According to the latest government figures, 6,632 of them have been formally referred to the NHS. Of that total, 3,865 have already had scans and more than 400 have decided to have their implants removed.

Last month’s report by the Commons health select committee said most women learned of the potential problems with their implants in December, 21 months after the MHRA became aware of the fact that the silicon in them was substandard. As well as the clinics themselves, the regulator was criticised for not having done more to warn people.

Howe said the MHRA had fulfilled its role of monitoring all incidents reported to it, making sure that those incidents were investigated fully and that necessary action was taken. He said the MHRA needed to “review and develop” its communications capability, and obtain evidence from a “wider and more detailed set of sources”.

The regulator must also be able to routinely review information about potential risks in order to identify any problems early. Howe also called for improved coordination between the European regulators.

He 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.”

Professor Sir Kent Woods, the MHRA chief executive, welcomed the report. “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,” he said.

Fazel Fatah, president of the British Association of Aesthetic Plastic Surgeons (BAAPS), said: “Poor post-marketing surveillance of medical devices lies at the root of the PIP crisis. At the BAAPS we feel there needs to be significantly more stringent monitoring of all medical devices including breast implants and all cosmetic injectables, via compulsory, regular reporting of adverse effects and mystery shopping which are all part of our regulation proposals.

“This is an opportunity for the Department of Health to get it right, and put the necessary systems and checks in place to avoid a repeat fiasco. Clearly changes are also needed at European level of the CE marking process.”

Rajiv Grover, BAAPS president-elect, said a compulsory implant register should be reinstated, a proposal that is being examined by Sir Bruce Keogh, the NHS medical director, in a separate review of the wider system of cosmetic surgery regulation in the wake of the PIP scandal.

Article source: http://www.guardian.co.uk/world/2012/may/14/regulator-lessons-breast-implant-scandal

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