Now available: Inadequacies of the European regulatory framework for breast implants – An in-depth analysis
The internationally known medical device regulatory expert, Haroon Atchia, has published an objective analysis of the regulatory framework that is at the core of one of the biggest current international health scandals
London, 26 December 2012
Haroon Atchia - CEO of the London-based medical device regulatory consultancy Quality First International - has written a research report on the Poly Implant Prothèse (PIP) breast implant case. The publication provides an in-depth analysis of the scandal about breast implants made and placed on the market with the CE mark of conformity by PIP.
The report provides the only unbiased, independent scientific and regulatory scrutiny of the scandal, exposing underlying deficiencies in regulations and incompetence culminating in inadequate safeguard of patients and mis-handling of their care. It also questions the thoroughness and motives of the investigation conducted by the authorities. “This is particularly concerning with regard to whether decisions reflect evidence available publicly and if such decisions were in the public interest”, emphasises the author, Haroon Atchia. According to him, the investigation of the scandal reveals improper and poor analyses, rash decisions and conclusions plus predisposition to conclusions that the product concerned was of unsatisfactory quality although publicly-available evidence shows that there are no grounds for such assumption.
In his report Mr Atchia examines the questions:
- Is the product in question actually inferior and faulty?
- Are current European regulations adequate for examining and regulating breast implants?
- What is the origin of the regulatory problem?
- Did the authorities involved in ensuring the safety of the public act appropriately and timeously?
Mr Atchia’s report 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.
Title: Poly Implant Prothèse (PIP) silicone breast implants -
Inadequacies in regulation in the EU resulting in improper safeguard of patient
safety and precipitate, ill-conceived and confusing decisions
Specifications: 159 pages, PDF. Including tables and graphs.
Available for sale from: 3 January 2013
To order a copy, click here.
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, Mexican 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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