Federal regulators are seeking public input about how to best weigh the benefits against the risks for weight loss surgery and weight loss devices, before moving forward with draft guidance.
The FDA issued a discussion paper, “Consideration of Benefit-Risk Approaches for Weight-Loss Devices,” on September 5, which seeks to assess the best methods of how to decide whether the benefits of weight loss medical devices offset the risks.
The FDA has approved nine weight loss devices since 1985. Only six are still available, including the gastric band, or lap band, to help reduce stomach size, or gastric balloon systems, like Obalon. However, a number of severe complications have been linked to weight loss surgery and devices designed to help control weight, raising questions about whether the benefits outweigh the risks.
The paper presents four categories of benefit for weight loss devices: short-term limited weight loss, limited weight loss, short-term weight loss, and weight loss. Devices with short term indications should be used for six to 12 months, and devices with long term indications can be used for 12 months or longer.
The FDA discussion paper asks if the benefit categorizations and durations are appropriate and if the proposed superiority margins are clinically meaningful.
Additionally, the FDA proposed a five-tier grading classification for adverse events adapted from the Clavien-Dindo Classification for surgical complications. The grades range from least severe at Grade I to most severe at Grade V. For example, Grade I is any deviation from the normal treatment course without the need for surgical, endoscopic, and radiological interventions and Grade V is an adverse event resulting in death.
The agency also requests feedback on whether the adverse event classification matrix is appropriate for the types of complications anticipated for weight loss devices and surgery, and if there are types of adverse events that are not captured by the proposed system.
Significant research has been devoted to the effectiveness and risks posed by weight loss devices. A 2018 study indicated gastric bypass was more effective for weight loss than gastric sleeve and gastric banding, but carried higher rates of complications including higher risk of death and venous thrombosis.
Another study published this year concluded weight loss surgeries, including sleeve gastrectomy and gastric bypass, carry high risks of side effects, including nutritional disorders, gastrointestinal complications, and alcohol dependence. Another study indicated patients who undergo weight loss surgery face a higher risk of suicide compared to patients who don’t have weight loss surgery.
While the side effects can be many and vary widely, it is important to note patients experience benefits beyond weight loss. Many patients gain relief from serious diseases, such as diabetes, high blood pressure, high cholesterol, heart disease, and face lower risks of heart attacks and strokes.
The agency is accepting public comments for 90 days. Comments can be submitted to the Regulations.gov website under docket number FDA-2019-N-4060.