
PIP founder jailed for fraud
pharmafile | December 11, 2013 | News story | Medical Communications, Sales and Marketing | breast, implants, pip, silicone
The boss of a French firm at the centre of a global health scare over faulty breast implants has been jailed in France for four years.
Jean-Claude Mas, founder of Poly Implant Prothese (PIP), was also handed a fine of €75,000 by a court in Marseille, although it is thought that he will appeal.
PIP marketed and distributed silicone gel breast implants – largely in Europe and South America – but the company went out of business in 2011 when concerns over the safety of its product came to light.
It subsequently emerged that its implants were made with industrial-grade silicone – rather than medical grade – leading to concerns that they could rupture.
Four more ex-PIP executives were also convicted and given lesser sentences.
More than 300,000 PIP implants were sold worldwide in 65 countries (not including the US), with around 40,000 patients believed to have the implants in the UK.
About 30,000 French women received the PIP products, as well as 25,000 women in Brazil, 15,000 in Colombia and 16,000 in Venezuela.
It was not recommended that women in the UK should have them removed as a matter of course – but French, German and Dutch health authorities all said women fitted with banned PIP implants should have them taken out as a precaution.
Harley Medical Group, which fitted more PIP breast implants than any other UK cosmetic surgery firm, said at the time it would not replace them free of charge, arguing that it had been an ‘innocent victim’ of fraud like everyone else.
The scare led the European Commission to suggest tighter rules on authorising Phase III medical devices, which include breast implants, pacemakers and hip replacements.
Tougher rules are likely to take another couple of years before they are adopted by member states.
Once a product is on the market it is the responsibility of national bodies to monitor such medical devices.
Adam Hill
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