PIP implant whitewash: Department of Health insists it took 'appropriate' action despite mass panic

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UPDATED:

12:26 GMT, 14 May 2012

A government review into the PIP breast implant scandal has warned the UK medicine's regulator that it must take decisive action to prevent any similar incidents in the future.

However, it insisted both the MHRA and Department of Health acted 'appropriately' to the health scare at the time, even though conflicting advice caused mass panic among tens of thousands of affected women.

Pip implant scare:

Scare: Implants from the French company Poly Implant Prothse did not contain medical-grade silicone

PIP implants were banned in 2010
in France and the UK after they were found to contain industrial grade silicone gel suitable for mattresses, rather
than medical grade, and had an increased risk of rupturing. It is believed this fraudulent practice began before 2001.

The French government recommended removing the implants after finding a rupture rate of five per cent in December 2011. However, the MHRA insisted there was no need for removals as they had found no evidence of health issues or increased rupture rates.

The conflicting advice caused mass anxiety among tens of thousands of women in Britain, with hundreds protesting outside private clinics that refused to remove and replace their implants for free.

In January this year, the
Government said anxiety caused by the implants was a sufficient reason
to have them taken out. However, Health secretary Andrew
Lansley said it was ‘not advisable for women to
routinely have implants removed’.

Then in March the Government agreed to
perform removals but not replacements for private patients in cases of
'medical need', which included distress.

Now Health Minister Lord Howe has published a report looking at how the MHRA and the Department of Health acted both before and
after information about the problems with the implants came to light.

Amazingly, it found both bodies acted 'appropriately' at the time.

However, it said the scandal revealed major flaws in how both bodies communicated with the public as well as how they gathered evidence on medical devices.

Anger: PIP breast implant protesters outside The Harley Medical Group who refused to remove and replace them for free

Anger: PIP breast implant protesters outside The Harley Medical Group who refused to remove and replace them for free

The report said both the MHRA and Department of Health needed to improve how they provided information on subjects likely to cause 'understandable anxiety' among the public.

'We need to 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 individuals who are affected by doubts over the safety of specific medical devices,' it said.

The report, published by the Department of Health today, also found that the Medicines and Healthcare Regulatory Authority (MHRA) had struggled to advise women because of data gathering issues.

'The MHRA was attempting to draw evidence-based conclusions about the performance of a device from data that were incomplete, and which we now know were filtered through a manufacturer that turned out to be fraudulent, while working on the assumption that all parts of the system were acting in good faith,' the report said.

It means even now it is not clear to what extent PIP implants fail more frequently or earlier than expected.

Therefore Lord Howe found the MHRA need to obtain evidence from a wider and more detailed set of sources for higher-risk medical devices, including robust outcomes data from clinicians

WHAT TO DO IF YOU HAVE AN IMPLANT…

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.

The
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
not replace.

The report also found that the
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.

It said such changes should uncover problems with medical devices earlier and place the regulators in a better position to take quick and decisive action.

Lord Howe said today: 'This report won’t prevent 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.'

However, he added: '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.'

Sir Bruce Keogh – the NHS Medical Director – is currently carrying out a separate review of the wider system of regulation for cosmetic interventions.

His review will also look at whether a breast implant registry could be put in place in this country, to help monitor any problems that occur and perhaps make it easier to trace people affected if there is ever a problem in the future.