How adequate is the European regulatory framework for breast implants?
Haroon Atchia from Quality First International examines the regulatory framework that is at the core of one of the biggest current international health scandals
London, 25 September 2012
The European Union continues to deal with a scandal about breast implants made and placed on the market with the CE mark of conformity by the French company Poly Implant Prothèse (PIP). Thousands of women have undergone difficult and potentially risky explant procedures based on physician recommendations while physicians have had only contradictory and confusing guidance from governments and regulatory agencies on which to base their judgements.
Haroon Atchia - CEO of the London-based medical device consultancy Quality First International - has written a research summary on the PIP breast implant case. In his summary he examines the questions: Is the product in question actually inferior and faulty? Are current European regulations adequate for examining and regulating breast implants? The author also reviews the origin of the regulatory problem and asks whether the authorities involved in ensuring the safety of the public acted appropriately and timeously. Mr Atchia’s summary also looks briefly at the US Food and Drug Administration breast augmentation approval process, which is instructive in understanding the significant differences between the approval process in the USA versus the system that may have allowed the on-going PIP situation.
Mr Atchia has also written a Guest Editorial - which will be published in the November 2012 issue of the Journal of Medical Device Regulation (www.globalregulatorypress.com) - based on his research summary.
About Quality First International
Quality First International (QFI) is a London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. Quality First International provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian and Chinese marketplaces. All submissions made by Quality First International have fulfilled the compliance requirements first time round, consistently. Quality First International’s clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting edge, minimally invasive and cardiovascular products and implants.
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