Lansley orders review of risks facing British women who have had faulty breast implants from French company

  • Lansley worried over data on implant ruptures
  • Firm accused of using cheap silicone
  • Wealthy founder – an ex butcher – faces charges

By
Craig Mackenzie

Last updated at 5:28 PM on 31st December 2011

An urgent government review of the risks to thousands of women from faulty breast implants was announced today by the Health Secretary.

Andrew Lansley is concerned that existing evidence about potential dangers like ruptures was not reliable.

Around 40,000 women in Britain are believed to have had silicone implants made by the French firm Poly Implant Prothese (PIP).

Defective: Plastic surgeon Denis Boucq holding e silicone gel breast implants, which were removed from a patient

Defective: Plastic surgeon Denis Boucq holding e silicone gel breast implants, which were removed from a patient

The company has been accused of using cheaper industrial silicone rather than approved medical material.

Hundreds of women in the UK have also undergone reconstructive breast surgery through the NHS using PIP implants.

Mr Lansley said new data provided yesterday conflicted with previous information supplied to the health watchdog Medicines and Healthcare Products Regulatory Agency (MHRA).

It had previously indicated the risk of the implants rupturing was one per cent rather than the 3.6 per cent estimated by France.

French health chiefs shut down PIP last year and Paris has since recommended that women have the implants removed because of fears over rupture.

Wealthy: Jean-Claude Mas, pictured holding a breast implant, is facing charges including manslaughter following the collapse of Poly Implant Prothese

Wealthy: Jean-Claude Mas, pictured holding a breast implant, is facing charges including manslaughter following the collapse of Poly Implant Prothese

Jean-Claude Mas, the 72-year-old former butcher who founded PIP, remains at his luxury villa on the Riviera, after being arrested following an Interpol hunt.

He is facing criminal proceedings with regard to a series of offences, including manslaughter – resulting from the death of a French woman who was fitted with the implants.

It has emerged many of the implants
were missing a protective coating designed to stop them from splitting
and prevent any gel that leaked from spreading through the body.

So far tests have failed to find any firm evidence the implants could trigger cancer.

This morning Mr Lansley repeated the government’s position last week, that there was ‘no evidence’ of a safety concern over the implants

Arrested: Jean-Claude Mas was detained by police following the defected implants that his firm sold

Arrested: Jean-Claude Mas was detained by police following the defected implants that his firm sold

But he said NHS Medical Director,
Professor Sir Bruce Keogh, would now carry out a review of the data and
report back to ministers next week.

The MHRA will also be conducting an audit of its evidence to resolve concerns about the ‘content and quality of the data that cosmetic surgery providers are sharing with the regulator’.

Review of data: Health Secretary Andrew Lansley

Review of data: Health Secretary Andrew Lansley

‘We are doing everything we can to ensure that women with these implants get the best possible advice,’ Mr Lansley said.

‘So far, all the evidence from around the world suggests that women should not be worried and that there have not been abnormal levels of problems reported with these implants.

‘But if any woman is worried, then they should contact their surgeon or GP.

‘We have, however, received data from an organisation yesterday that was not previously acknowledged or communicated to the MHRA.

‘The validity of this data still requires full assessment and evaluation, so I have asked Professor Sir Bruce Keogh to lead an urgent investigation so that we can establish exactly what has happened and whether we need to improve the regulatory regime.

‘I want to reassure women that if any new data comes to light which calls into question the safety of these implants, we will act swiftly to help them.

‘Our top priority is making sure that women get the correct advice so that they are kept safe.’

About 2,500 French women fitted with the implants have registered complaints with a court in Marseilles.

Nine others with PIP implants were also found to have a rare form of cancer.

Victim: Catherine Kydd set up a support group on Facebook for those affected by their implants

Anxious: Gemma Garrett, a former Miss Great Britain, also felt unwell after receiving PIP breast implants

Worried: Catherine Kydd set up a support group on Facebook for those affected by their implants and Gemma Garrett, a former Miss Great Britain, was in pain after hers were fitted

France’s health minister Xavier Bertrand announced that women could have the implants removed, paid for by the French health service, as a ‘preventative’ measure.

In Britain, Amanda Harrison, from Ramsgate, was one of the unlucky patients who suffered a ruptured implant four years after surgery.

Her Harley Street surgeon waived his fee to remove it this year but she still had to pay £1,500 for hospital costs and the anesthetist.

The 40-year-old is still suffering today. The leaked silicone has spread to her lymph nodes and a scan has revealed two bulging lumps on her spine.

Gemma Garrett, 30, who was Miss Great Britain 2008, and beauty therapist Catherine Kydd, 39, have also had the implants removed after suffering painful complications.

More than half of PIP’s exports went to South America, including to Venezuela, Colombia, Argentina and Chile. Some 25,000 women are believed to have had the implants in Brazil alone.

Western Europe was another major market. In addition to the UK, Spain, Italy, Germany and Ukraine are known to have imported PIP silicon sacs.

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