Harms and responsibilities associated with battery-operated implants (BOI): who controls postmortem explantation?

ABSTRACT

The postmortem issues raised by battery-operated implants (BOI) are complex and issues of consent, setting (clinical vs research), and environmental risks have received little attention in bioethics literature. Analyzing the issues, the following are argued (1) Patients receiving BOIs should sign a consent form that includes a requirement for postmortem explant of the device; (2) BOI consent forms should require the explanted devices be returned to their manufacturers for Returned Product Analysis; (3) Failure to explant and analyze devices from the research setting fails the research goal of generation of knowledge for the benefit of future patients; (4) Failure to explant and analyze devices from the clinical setting allows product defects to be potentially hidden from patients, families, clinicians, manufacturers, and regulatory agencies; (5) Bodies buried with BOIs potentially harm the environment; (6) Religious or philosophical objections to autopsy should not supersede the duty to explant and analyze BOIs; (7) The concepts herein for BOIs could potentially extend to non-BOI if the device has failure modes that can lead to a potentially life-threatening event or can cause permanent debilitating health issues, and the burial or cremation of the device poses environmental harm. In these situations, neither the patient (premortem) nor family (postmortem) should have the right to refuse explant.