Public Health Ethics 6 (2):226-229 (2013)

Jacob Van
United States Air Force Academy
The clinical introduction of medical devices often occurs with relatively little oversight, regulation and (long-term) follow-up. Some recent controversies underscore the weaknesses of the current regime, such as the complications surrounding the metal-on-metal hip implants and the scandal surrounding the global breast implant scare of silicone implants made by France's Poly Implant Prothese (PIP) Company. The absence of national registries hampered the collection of reliable information on the risks and harms of the PIP breast implants. To warrant long-term safety, a case can be made for mandatory post-marketing surveillance by means of the establishment of compulsory registries. In this edition of Public Health Ethics, Schofield calls for debate on how such a registry system should be initiated and maintained and how it would relate to the ethical requirement of consent. Here we use breast implant registries as a case to discuss whether and when a so-called ‘thick opt-out’ would be an appropriate method to include people in medical device registries. We conclude that a thick opt-out procedure for medical device registries is only justifiable in cases where inclusion does not involve burdens (or very low), when it does not involve a sensitive subject and when the data are stored anonymously (or at least not directly linked to the medical record). Otherwise, inclusion should be sought by means of an opt-in
Keywords No keywords specified (fix it)
Categories (categorize this paper)
DOI 10.1093/phe/pht021
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

PhilArchive copy

Upload a copy of this paper     Check publisher's policy     Papers currently archived: 71,464
Through your library

References found in this work BETA

Harm to Self.Joel Feinberg - 1986 - Oxford University Press, USA.
Four Essays on Liberty.Isaiah Berlin - 1969 - Oxford University Press.
Harm to Self.Joel Feinberg & Donald Vandeveer - 1988 - Ethics 98 (3):550-565.
Rethinking Research Ethics.Rosamond Rhodes - 2005 - American Journal of Bioethics 5 (1):7 – 28.
Rethinking Research Ethics.Rosamond Rhodes - 2010 - American Journal of Bioethics 10 (10):19-36.

View all 9 references / Add more references

Citations of this work BETA

No citations found.

Add more citations

Similar books and articles

Autonomy, Consent and the Law.Sheila McLean - 2009 - Routledge-Cavendish.
Ethical Issues in the Use of Implanted Medical Devices.Anne Moates - 2006 - Chisholm Health Ethics Bulletin 11 (3):9.


Added to PP index

Total views
93 ( #127,210 of 2,520,426 )

Recent downloads (6 months)
2 ( #270,555 of 2,520,426 )

How can I increase my downloads?


My notes