• PIP Executive Arrested in France, Could be Charged With Manslaughter

    • 26 January 2012
    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 g...
  • Bloomberg: French Breast Implant Scandal May Alter US Medical Device Regulation Debate

    As the uproar over the faulty breast implants manufactured by French manufacturer Poly Implant Prothese (PIP) continues to unfold, an unwitting casualty may be the US medical device lobby , which has spent the last several years urging the US Food and Drug Administration (FDA) to loosen regulations to be more in line with EU regulatory standards. The US medical device lobby, led by an association of medical device manufacturers called AdvaMed, has labeled the way the Ce...
  • Lansley Seeks Additional Data Collection, Looks to Improve UK & EMA Regulations

    United Kingdom Health Secretary Andrew Lansley announced a new initiative aimed at "ensuring the safety of people seeking cosmetic interventions" on 11 January in response to the recent Poly Implant Prothese (PIP) breast implant crisis. Lansley announced that an expert review group led by National Health Service (NHS) Medical Director Professor Sir Bruce Keough will look at how NHS can better collect quality data on their devices, whether cosmetic products and interven...
  • UPDATED: EMA, AFSSAPS Call for Stricter EU Regulations on Medical Devices

    European Medicines Agency (EMA) Executive Director Guido Rasi and French Health Minister Xavier Bertrand called on the EU to require medical device makers to go through a more rigorous approvals process that would require the sort of marketing authorization currently given to pharmaceutical products, according to Reuters articles . "I see an urgent need to regulate devices at the same level of science and attention as with drugs," said Rasi, the new head of EMA. Curren...
  • Reuters Analysis: Breast Implant Scandal Shows Shortfalls of Post-marketing Registries

    The Poly Implant Prothese (PIP) scandal raging across Europe right now highlights the failings of regulatory agencies to effectively use post-marketing registries, claims Reuters journalist Anna Yukhananov. A registry, Yukhananov argues, would have allowed regulatory authorities around the world to identify patterns of implant failures and risks associated with the products. To date, no unified registry of breast implants exists in the United States, and US Food and Drug...