PIP Breast Implants Scandal – Who should pay for removal and replacement of the implants?

The PIP breast implants scandal is symptomatic of a wider regulatory failure affecting all medical devices according to Professor Brian Toft, patient safety expert at Coventry University.

Poly Implant Prothèses (PIP) breast implants have been in the news around the world in the past few weeks after several cases of these bursting or leaking were brought to light by the distraught victims. These implants contain an industrial grade of silicone never intended for use in a medical device and are also more likely to burst or leak than other models.

Jean-Claude Mas, the former boss of the French implants firm PIP admitted to the police in late 2010 that the products used to make the PIP gel were not industry standard, so everything was done to avoid official checks but has still called France “criminal” in recommending removal of the implants when there is no medical reason to do so.

Sparking further outrage after he labelled women taking legal action against him as “moneygrabbers”, Mas claimed that the company is bankrupt and is unable to pay compensation to hundreds of thousands of women with PIP breast implants.

While most arrangements that have been made around the world so far include removal of these faulty implants, women are understandably concerned about their replacement costs the bill of which are expected to run up to thousands of pounds for each woman, which they will have to bear for no fault of theirs. In some countries that authorities, including Venezuelan and French governments, have declared that they will bear costs of removing the implants, however they have stressed that the state will not bear the cost of replacing them with new ones. The latest advice from Department of health in the UK is that NHS will remove the implants if the GP’s advice is that this is necessary, but will not replace them unless it is clinically necessary. This of course will mean a cost of tens of millions of pounds to the NHS which in turn will be borne by the British public.

Some private cosmetic surgery companies, like Harley Medical Group and Transform have “blamed a catastrophic failure of the regulation” by the government’s Medicines and Healthcare products Regulatory Agency – MHRA who approved these who in turn say its role was to “investigate adverse incidents”. Professor Toft said that medical devices are given CE marks without quality checks on the devices and he warned that these provide a smokescreen for faulty and dangerous devices that place patients at risk. Incidentally these implants were not authorized for use in the United States and as confirmed by Health Canada they were not distributed in Canada.

So the question really is two-fold –

1. Who should pay for the removal and/ or replacement of these implants?
2. How were these approved by the various government regulatory agencies in the first place?

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