Two former executives of the French company Poly Implant Prothese (PIP) were arrested on 24 January by French investigators, who may charge at least one of them with manslaughter for their role in a burgeoning scandal involving the manufacture and sale of allegedly substandard breast implant products.
The executives, former chief executive officer Jean-Claude Mas and former chief financial officer Claude Couty, were arrested following reports that PIP used industrial grade silicone in their breast implant products instead of the approved medical-grade silicone, and that these implants may be rupturing at an abnormally high rate.
French authorities have 48 hours after the time of arrest to decide if they wish to charge Mas with manslaughter charges related to the cancer death of a woman who received PIP implants. French authorities, among others, have cautioned that there is no conclusive link between the PIP implants and instances of cancer. Couty was arrested in a related investigation, but does not appear to be subject to the possibility of manslaughter charges at this time.
The potential charges are just one of Mas's worries, as several thousand French women have filed complaints against Mas for his alleged role in the company's business practices.
In response to the public outcry over the allegedly substandard devices, a number of EU regulatory agencies have come out in support of tougher regulation on medical devices. European Medicines Agency (EMA) Executive Director Guido Rasi, French Health Minister Xavier Bertrand, UK National Health Service (NHS) Secretary Andrew Lansley, and European Commission (EC) Health and Consumer Policy Spokesperson Frederic Vincent have all called for tougher regulations on medical device manufacturers.
According to Rasi, this could bring the regulation of medical devices more in to line with the way drugs are currently regulated by EMA.
"I see an urgent need to regulate devices at the same level of science and attention as with drugs," said Rasi in an interview last week.
Bertrand mirrored those sentiments, while Lansley is launching his own investigation into the matter with an expert review group led by NHS Medical Director Bruce Keough.
Other non-governmental groups have also called for tougher regulations, including the British Association of Aesthetic Plastic Surgeons (BAAPS), which called for a ban on cosmetic device advertising, and the British healthcare journal The Lancet, which has called for revisions to the CE marking process and overall regulatory system.