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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.
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