FDA Lowers Hurdle for Lap-Band Surgery

BMI Range is Lowered for Eligibility Criteria

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The US Food and Drug Administration (FDA) expanded the eligibility criteria for patients qualifying for bariatric surgery using Allergan, Inc’s Lap-Band Adjustable Gastric Banding System. The expansion approved Lap-Band surgery for an estimated 27 million more individuals at that time of the February 2011 ruling. Most notably, the FDA approved Lap-Band use to include patients with a BMI of 30 or higher with an existing obesity-related health condition.  Previously, the FDA requirements only permitted patients with a BMI of 40 or higher, a BMI of 35 or higher with an existing obesity-related condition, and patients who are 45 kg or more overweight. This decision was based on recommendations made by the Gastroenterology and Urology Panel of the FDA’s Medical Devices Advisory Committee.


While evidence supports that Lap-Band surgery is an effective procedure for weight loss, and that weight loss does impact diabetes and high blood pressure, some critics still question its long-term results and safety for patients with lower BMIs. For example, Dr. Edward Livingston of the University of Texas Southwestern Medical Center is dubious of the benefit that bariatric surgery provides for patients in this newly eligible lower BMI range.  He claims that 80% of the people in question are young and relatively healthy women who are not at high risk of developing life-threatening obesity-related health problems.


On the other side of the argument, Dr. Bruce M. Wolfe, President of the American Society for Metabolic and Bariatric Surgery, testified to the panel that the FDA’s actions were correct. He believes that evidence is there to conclude that obesity, defined by BMI of 30 and above, is a disease and that weight loss does impact diabetes and high blood pressure. Although, he admits that the evidence of benefit from bariatric surgery in patients with BMIs between 30 and 35 is more limited, and not as strong, making some critics take pause.


The panel was compelled to expand eligibility based on unpublished data from a five-year study that began in 2007.  The study used data from 143 participants with BMI’s between 30 and 40 who had Lap-Band surgery, and the results show that 83.9% of patients had lost 30% or more of their excess weight at the 12-month mark. It further showed that 65% of patients were no longer classified as obese and that the weight loss was maintained in year two. Critics continue to challenge this data drawing attention to the lack of testing on patients over 55, as well limited diversity among the study group participants. The FDA now requires Allergen to provide yearly reports to help evaluate long-term effectiveness and any negative incidences associated with the device.


Source: The Journal of the American Medical Association

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