Informed consent and the use of transvaginal synthetic mesh.

Abstract

In 2008 and again in July of this year, the U.S. Food and Drug Administration (FDA) issued safety communications regarding the use of transvaginally placed surgical mesh. These FDA communications have been the subject of much discussion in the literature. One issue raised by these communications and in the medical literature is the matter of informed consent. Informed consent is an established bioethical principle in modern health care, but it is evolving. The legal interpretations of informed consent are also in flux. A review of contemporary ethical and legal elements of informed consent is presented as it relates to the use of medical innovation, with a focus on transvaginally placed surgical mesh.