Explanted Poly Implant Prosthése (PIP) Breast Implants - An Independent Examination
International Medical Device Expert, Haroon Atchia, examines the investigation and analysis conducted by the Competent Authority Sweden
London, 9 January 2014
The scandal about breast implants made and Placed on the Market with the CE Marking of Conformity according to Council Directive 93/42/EEC (as Amended) by Poly Implant Prothèse (PIP) revealed numerous deficiencies in the way in which such product is regulated. The Competent Authority Sweden (Läkemedelsvertet, LMV) is the latest regulatory authority to promulgate a series of 4 test reports related to PIP silicone breast implants on the Swedish market. Mr Atchia provides an unbiased, independent and in depth analysis of the 4 LMV reports on the following subjects:
- chemical analysis
- material composition and topology (surface structure)
- toxicological evaluation (mixture of test results and literature review)
- survey of surgeon experience of the implant in Sweden.
This research examines the latest deliberations and conclusions promulgated by Sweden, in an attempt to discover if science supports conclusions, inferences of association and causation particularly relating to the shift in policy and advice to women and health service promulgated by the Läkemedelsverket.
According to Atchia, “evidence available to the LMV varies in completeness and detail, particularly regarding epidemiology, which is exceedingly patchy. Generally, scientific method applied by LMV was of high standard although statistical relevance of samples tested is questionable and certain errors in analysis of data were evident. As with other Competent Authority analyses of this long running scandal, there seems for be a tendency toward protectionism supporting less than fully supported conclusions”.
The report is written in English and is supplied as a PDF. It is available for purchase from the QFI website. 129 pages. Price: £199.
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. QFI 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 QFI have fulfilled the compliance requirements first time round, consistently. QFI clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting-edge, minimally invasive and cardiovascular products and implants.
For further information, please contact: