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The Role of Consent and Individual Autonomy in the PIP Breast Implant Scandal

The Role of Consent and Individual Autonomy in the PIP Breast Implant Scandal The current scandal surrounds the global breast implant scare of silicone implants made by France's Poly Implant Prothese (PIP) Company. An ensuing review recognized that efforts in investigating the distress caused to so many women were hampered by a lack of reliable and comprehensive information about all the adverse incidents relating to PIP breast implants, as well as uncertainty about comparative data on similar products. One of the recommendations following the review was the investigation of the potential for re-establishing a breast implant registry, which could facilitate the availability of adverse incident reporting in cases such as these. The insistence of compulsory inclusion in such registries would override the debate on informed consent in epidemiological studies and public health. The ethics of clinical research with its focus on individual consent is difficult to reconcile with the ethical requirements of research at a population level as in the case of registries. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Public Health Ethics Oxford University Press

The Role of Consent and Individual Autonomy in the PIP Breast Implant Scandal

Schofield, Behnaz
Public Health Ethics , Volume 6 (2) – Jul 15, 2013
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References (6)

Publisher
Oxford University Press
Copyright
The Author 2013. Published by Oxford University Press. Available online at www.phe.oxfordjournals.org
ISSN
1754-9973
eISSN
1754-9981
DOI
10.1093/phe/phs036
Publisher site
See Article on Publisher Site

Abstract

The current scandal surrounds the global breast implant scare of silicone implants made by France's Poly Implant Prothese (PIP) Company. An ensuing review recognized that efforts in investigating the distress caused to so many women were hampered by a lack of reliable and comprehensive information about all the adverse incidents relating to PIP breast implants, as well as uncertainty about comparative data on similar products. One of the recommendations following the review was the investigation of the potential for re-establishing a breast implant registry, which could facilitate the availability of adverse incident reporting in cases such as these. The insistence of compulsory inclusion in such registries would override the debate on informed consent in epidemiological studies and public health. The ethics of clinical research with its focus on individual consent is difficult to reconcile with the ethical requirements of research at a population level as in the case of registries.

Journal

Public Health Ethics – Oxford University Press

Published: Jul 15, 2013

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