‘Serious lessons’ to be learned from breast implants scandal, warns Howe

Health minister Lord Howe demanded improvements in communications from both the Department and the Medicines and Healthcare products Regulatory Agency (MHRA).

Both the DoH and the MHRA came under fire in a parliamentary report into the scandal earlier this year, which criticised delays between a safety alert being issued to surgeons over the potentially faulty implants and “urgent action” being taken to gather evidence and communicate with affected women.

Around 47,000 British women are believed to have been given the implants, manufactured by French company Poly Implant Prothese (PIP), which were filled with non-medical grade silicone intended for use in mattresses and have been linked to rupture and swelling in the body.

Lord Howe said that regulation alone could not have prevented the scandal, which was due to “deliberate fraud” by the manufacturers.

But he said “serious lessons” need to be learnt by the authorities in Britain about the way they gather information about potential risks and pass on concerns to doctors, patients and the public.

“Regulation alone cannot prevent fraudulent activity such as this,” said Lord Howe.

“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.

“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.”

His report found that the MHRA acted appropriately and followed scientific and clinical advice.

But it said that both the MHRA and the Department need to improve their approach to communicating with affected individuals and the general public, particularly over issues which cause “such understandable anxiety”.

The report said the MHRA should review and develop its communications; make efforts to obtain evidence from a wider set of sources to help determine whether there are problems with particular devices; and routinely review information about higher-risk devices in order to identify problems early.

Improvements are also needed in the whole European system for gathering and analysing data where concerns arise, with regulators in all 27 EU states sharing information and working together to detect problems earlier, said the report.

Lord Howe 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.

“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.”

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.”

Consultant plastic surgeon Rajiv Grover, president-elect of the British Association of Aesthetic Plastic Surgeons (BAAPS) said: “We welcome the findings of the Government’s review into the PIP scandal, and agree in particular that there should be a better system of reporting for medical devices, with data gathered from a wider set of sources that should be routinely reviewed.

“For the last few years, the BAAPS has been championing the reinstatement of a compulsory implant register that would monitor not just breast but all types of implant put into the body.

“The register is part of our regulation proposals put forward earlier this year and would immediately address all the recommendations put forward in this report, as would a mandatory safety audit based on the model that the BAAPS requires of all its members.”

A separate report into the PIP implants themselves by NHS medical director Sir Bruce Keogh is expected to be completed shortly.