Rush to get faulty implants removed
Model Jasmine Lennard underwent an emergency operation to replace her breast implants after discovering they contained banned silicone. The 26-year-old admits that she became ‘hysterical’ after discovering her implants came from French firm PIP, which is at the centre of a global health scare for using industrial-grade materials deemed unfit for medical use. And she believes last week’s procedure could have ‘saved my life’.
She says she got the implants when she was 18 but she later began to feel ‘rippling’ sensations in the implants and pains under her arms, and sought medical advice after the birth of her son, Phoenix, in August 2010. She said, “I checked if it was safe to breastfeed and I was assured it was. But it was very painful. The surgeon couldn’t find anything wrong but the only way to tell if the implant had split was with a mammogram which would cost £400. As the problem was classed as cosmetic, I would be very low down the NHS list.”
Six months ago the clinic sent out a letter warning the implants could be prone to tearing, but Miss Lennard thought no more about it until seeing a news report last month about French authorities urging women to get PIP implants removed after a spate of ruptures. They were also linked to the death of a woman from an extremely rare cancer – although every type of implant increases this risk.
EU to tighten laws on medical devices
Led by calls from Nicolas Sarkozy's government, a new EU directive on medical devices would tighten inspection regimes for silicone implant manufacturing companies and ensure each faulty implant could be traced back to production – two of the major factors behind the current French implants scandal.
The European Commission has confirmed it is considering updating existing controls to ensure that every EU country applies the same tough measures to production and surgery. The French health minister, Xavier Bertrand, said on Friday that tougher regulation “must be done at European level”, adding: “Unlike drugs, where there is an authorization on the market, there is not one today for medical devices.”
The disclosure emerged after the Department of Health announced on Friday it would pay for the removal of implants for all 40,000 women who received the industrial-grade silicone devices manufactured by Poly Implant Prothèse (PIP). The Health Secretary, Andrew Lansley, said where implants were fitted on the NHS, it would pay for replacement, leaving taxpayers with a bill as high as £150m. But women who had implants fitted at private clinics would have only their removal funded – leaving potentially thousands of women forced to find more money if they wanted fresh implants.
Mr Lansley said private clinics had a “moral duty” to pay for patients who requested the operation. But Labour's health spokesman, Andy Burnham, said the Government's statement was “inconclusive”. “By implication, the suggestion was that the best course of action is to have implants removed. But they provided no practical help to the vast majority of people affected. It is an unacceptable state of affairs for any woman now to be left in a position where she is worrying about her health, but is unable to afford to do anything about it.”
Surgery Company defends PIP
A leading cosmetic surgery company which carried out a large proportion of PIP implant operations on British women has insisted that its “rupture record” left them with no cause for concern.
The Harley Medical Group said it had conducted 13,900 procedures with the implants in the UK between September 2001 and March 2010. Since starting to collect rupture data in September 2004, it had recorded 213 ruptures by November last year, resulting in an aggregate rupture rate of 1.8%. “This is well within available measurements,” the company said. While experts have concluded there is no evidence to recommend routine removal of the implants, they have said they could not entirely rule out that some were toxic.
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