SJR: 0.332 SNIP: 0.491 CiteScore™: 0.89
ISSN Print: 1050-6934
Volumes:Volume 28, 2018 Volume 27, 2017 Volume 26, 2016 Volume 25, 2015 Volume 24, 2014 Volume 23, 2013 Volume 22, 2012 Volume 21, 2011 Volume 20, 2010 Volume 19, 2009 Volume 18, 2008 Volume 17, 2007 Volume 16, 2006 Volume 15, 2005 Volume 14, 2004 Volume 13, 2003 Volume 12, 2002 Volume 11, 2001 Volume 10, 2000
Journal of Long-Term Effects of Medical Implants
Abstract of "Ethical Issues in Male Contraceptive Implant Studies"
Sujoy K. Guha
School of Medical Science and Technology, Indian Institute of Technology, Kharagpur, 721 302 India
Single-intervention, long-acting, and reversible contraceptive for the male is an important need in health care and for societal well-being. A bioactive, sperm-inactivating polymeric drug implant instilled by an injection into the lumen of the male reproductive duct, the vas deferens, offers scope for realization of an optimal contraceptive. In clinical trials, subjects are healthy and not diseased. Also, the implant does not prevent a disease. Moreover, a normal physiological function is the target for suppression, which sets contraceptive implants apart from the general class of drugs that are administered to correct a pathology. Therefore, the ethical justification underlying development trials and dissemination of the technology lies in the psychological gains arising from the usage. Psychological gains are difficult to quantify and in consequence ethical grounds become abstract. A direct fallout is that the standards in the implant development and trials need to be very high and side effects and adverse effects have to be minimal. Complications that are a routine part of normal life are not acceptable in the context of contraceptives. Normal semen has abnormal sperms and there is a small but finite probability of a pregnancy with genetic abnormalities in the fetus. But with a vas implant, any pregnancy with genetic abnormality is not acceptable. Hence, ethics demands very strict genotoxic safety with the implant, even more so than as pertains to normal reproduction. Trial failure is a pregnancy and brings in the desire and consent for termination of pregnancy. At induction, a subject opting for pregnancy termination and later, on contraception failure, wants pregnancy continuation, generates an ethical dilemma, which is under debate. The theoretical risk of genetic abnormality being ever present, it seems that ethics would suggest that the subject be strongly advised to undergo pregnancy termination.
|Begell Digital Portal||Begell Digital Library||eBooks||Journals||References & Proceedings||Research Collections|