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Toward the Ethical Evaluation and Use of Maternal-Fetal Surgery

Bioethics Institute, Johns Hopkins University, Baltimore, Maryland; Kennedy Institute of Ethics, Georgetown University, Washington, DC; Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, California; Department of Obstetrics and Gynecology, University of North Carolina, Durham, North Carolina; and Center for the Study of Medical Ethics and Humanities, Duke University Medical Center, Durham, North Carolina.

Address reprint requests to: Jeremy Sugarman, MD, MPH, Center for the Study of Medical Ethics and Humanities, Box 3040, Duke University Medical Center, 108 Seeley G. Mudd Building, Durham, NC 27710-3040; E-mail: sugar001{at}mc.duke.edu.

BACKGROUND: Important clinical, social, and ethical questions are associated with the evaluation and use of surgical approaches aimed at correcting fetal anatomic abnormalities. In particular, the expansion of maternal-fetal surgery to ameliorate nonlethal fetal conditions has intensified the need to address issues about the adequacy of technology assessment and the safety of those who undergo these novel procedures.

APPROACH: After discussions at a multidisciplinary conference, we reviewed the development and current practices of maternal-fetal surgery and analyzed the relevant ethical issues concerning the use of maternal-fetal surgery for nonlethal conditions, focusing on the correction of myelomeningocele.

FINDINGS: Characterizing nonvalidated maternal-fetal surgery procedures as "innovative therapy" blurs the boundaries between research and therapy and creates uncertainty about the obligations of clinicians and researchers. Further, maternal-fetal surgery raises ethical issues related to maternal risks and benefits, informed consent, distinguishing lethal from nonlethal conditions, withholding unproven treatments, entrepreneurship, and prioritization.

RECOMMENDATIONS: To help ensure that maternal-fetal surgery will be studied and eventually applied in a scientifically and ethically sound manner, we offer several recommendations. First, innovation in maternal-fetal surgery should be conducted and evaluated as research. Second, women must be considered research subjects in these trials. Third, the informed consent process must ensure adequate comprehension and genuine voluntariness in those considering participation. Fourth, discriminatory and fearful attitudes toward individuals with disabilities should be addressed explicitly prior to making a decision to proceed with maternal-fetal surgery in an attempt to correct such disabilities. Fifth, maternal-fetal surgery should not be performed for cosmetic indications unless and until there is reliable evidence that maternal-fetal surgery can be performed safely and that long-term side effects on women and their offspring are minimal. Sixth, centers of excellence should be established for conducting research and providing maternal-fetal surgery. Seventh, funding for research on maternal-fetal surgery should be considered in the context of societal needs.

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