Surgeons told watchdog about PIP breast implant fears SIX years ago
21:44 GMT, 14 May 2012
Surgeons raised official concerns over the safety of PIP breast implants as long ago as 2006, it emerged last night.
However, watchdogs failed to issue a warning, fearing that to do so would lead to an ‘unwarranted scare which could have serious commercial implications’.
The doctors revealed the implants were rupturing during demonstrations to patients and one even demanded they be taken off the market. But the medical devices watchdog, the MHRA, decided not to take the matter further because the evidence was ‘anecdotal’.
Scare: Implants from the French company Poly Implant Prothse did not contain medical-grade silicone
The concerns were revealed in an offical report into the scandal which was released yesterday. It concluded the MHRA and Department of Health have ‘serious lessons’ to learn but said they acted appropriately.
Latest figures show up to 47,000 British women, most of whom were private patients, have French-made PIP implants filled with mattress gel. The industrial-grade silicone, which was never intended for medical use, has been linked to rupture and swelling in the body.
A review by Health Minister Lord Howe says regulation alone could not have prevented the scandal, which was due to ‘deliberate fraud’ by the manufacturers.
‘Nothing about this case provides evidence to suggest the system for regulating medical devices is fundamentally unsound,’ it concludes. But Mark Harvey, of Cardiff-based Hugh James solicitors, which represents 1,000 women claiming damage from PIP implants, said patients remained at risk from a system which cared more about manufacturers than public safety.
He said: ‘This report is a whitewash. Why was the public not alerted to potential problems earlier There is nothing in this report that suggests the same scandal could not happen again tomorrow.’
Earlier this year, the MHRA and Department of Health came under fire from MPs who said they showed a lack of urgency and vigilance before March 2010 when French investigators discovered the fraud.
Lord Howe said his report found the Medicines and Healthcare products Regulatory Authority acted appropriately, following scientific and clinical advice, with no evidence that it or the wider Department of Health ‘significantly failed to do their job’.
Anger: PIP breast implant protesters outside The Harley Medical Group who refused to remove and replace them for free
‘But serious lessons must be learned from this scandal,’ he 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. 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 report highlights concerns from three surgeons in 2006, including the ‘catastrophic disintegration’ of two implants and claims that ‘countless PIP implants break in my hand while demonstrating them to patients’. They had stopped using them and one doctor called for their removal from the market pending further testing.
WHAT TO DO IF YOU HAVE PIP IMPLANTS…
Women who have PIP implants and who are concerned are advised to:
Find out if they have a PIP implantSpeak to their specialist or GP, if they had them done on the NHS, or clinic if they had them done privatelyAgree what's best. Get advice on whether or not they need further
assessment, and discuss appropriate action with their doctor.
NHS will support removal of PIP implants if, following a clinical
assessment, a woman with her doctor decides that it is right to do so.
The NHS will replace the implants if the original operation was done by
the NHS. If a clinic that implanted PiP implants no longer exists or
refuses to care for their patient, the NHS will remove the implants but
There could have been further investigation into claims made by two of the doctors of ‘definite problems’, said the report. The MHRA said acting on such personal or anecdotal information would damage patient and professional confidence and have serious commercial consequences.
‘It could well be open to challenge by manufacturers or other stakeholders for initiating an unwarranted scare,’ it told the review.
It said it was already pursuing Poly Implant Prothese (PIP) about an apparent high rupture rate. The report noted the obvious concerns of the MHRA and high volume of correspondence with PIP over a seven-year period.
The report recommends that a review into the regulation of the cosmetic industry by NHS medical director Sir Bruce Keogh investigate setting up a breast implant registry which could also cover other higher-risk medical devices.
So far 647 women have decided to accept the Government’s offer to have PIP implants taken out, of more than 6,600 cases referred to the NHS for investigation. Official tests show the implants have no chemical toxicity.
Labour public health spokesman Diane Abbott said the review had failed to explain the gap between the French authorities deciding to recall PIP implants and the British authorities taking action. She said: ‘The Government never really gained proper control of the situation.’
MHRA chief executive Professor Sir Kent Woods said it would act quickly to implement the report’s recommendations.