O n February 16, the US Food and Drug Administration (FDA) revised the indication criteria for gastric banding, reducing the body mass index (BMI) threshold for patients with obesity-related health problems from 35 to 30 kg/m 2 and dropping the requirement that comorbid conditions be severe. Despite a recommendation of its advisory board for a similar 5-point reduction for obese people without associated health problems, the BMI threshold of 40 kg/m 2 was left unchanged for this group. The FDA's decision is reported to make an additional 26.4 million Americans eligible for banding.
1The immediate press reactions criticized the limited evidence supporting the decision and raised concerns about the role of lap-band manufacturer Allergan, who petitioned the FDA for lower BMI thresholds and stands to profit from the new guidelines. Others expressed worries about those who do not meet the stipulated BMI thresholds and would be denied the procedure. Is the unaltered BMI threshold for patients without comorbid conditions justifiable? Is the 5-point reduction for those with obesity-related conditions sufficient, or is it going too far? Concerns about the limitations of the BMI, BMI categories, and their relationships to health outcomes 2-4 add further complexity to this debate. These and related issues have not been settled once and for all with the FDA's revisions. They are likely to resurface as new procedures for bariatric surgery and data about their risks and benefits become available because obesity remains high on the public health agenda.The deliberations of the FDA and its advisory board focused on issues of safety, effectiveness, and the quality of the available data. However, reference to medical risks and benefits alone does not resolve all current and future debates. Nor should it be assumed that no further questions arise as long as patients understand and voluntarily accept the risks that are deemed acceptable by experts. For the use of gastric banding, and bariatric surgery more generally, is caught in a moral crosswind, buffeted by business interests and the ethics of personal responsibility. Although decisions about gastric banding ideally would be based on a case-by-case assessment with due attention to patients' health status, medical histories, and circumstances, for policy purposes more robust guidance is required to determine appropriate eligibility criteria. (In practice, of course, access to the intervention will also depend on coverage criteria imposed by third-party payers; for the purposes of this commentary, we leave aside this issue.)