Bariatric Physicians Question FDA Recommendations to Lower BMI Requirements for Lap-Band Surgery

The American Society of Bariatric Physicians (ASBP) is concerned to learn that the FDA advisory panel recently recommended lowering the BMI requirement for lap-band surgery, while the FDA has denied two new obesity medications within the past six months. Bariatric surgery is a drastic and expensive measure that carries higher morbidity and mortality risks than lifestyle interventions or medication1,2. Patients who could have otherwise lost weight in a quality non-surgical medical bariatric program may now be encouraged to skip medical therapy and jump directly to surgery if the treatment qualifications are lowered.

The ASBP recognizes that significant weight loss, whether achieved through bariatric surgery or medical therapies, has metabolic effects that can drastically improve obesity-related diseases. ASBP supports the use of medically-supervised weight loss programs as the treatment of choice for patients with BMIs between 30 and 35, and believes that the recommendation of the lap-band for patients with BMIs of 30 and above is premature and carries risks that have not yet been considered3.

Effective, non-surgical approaches involving structured diet and exercise, behavioral modification and medication when indicated should be considered first for many of those patients who will now be eligible for surgery4. Before a patient ever considers surgery, the ASBP advocates that the patient first seek the help of a qualified bariatric physician, who can implement a medical program that starts with a complete patient work-up, ensuring that metabolic and overall health are not compromised. Proper implementation of a medically-managed weight loss program by a bariatric physician can lead to tremendous success, with long term reversal of obesity related co-morbidities equivalent to surgical interventions minus the risks5,6.

Bariatric surgery will continue to be an option for severely obese patients, but it should be noted that patients who have had bariatric surgery require long-term lifestyle changes and nutritional monitoring to ensure a safe and lasting weight loss7. Bariatric surgery is often accompanied by side effects and substantial failure rates7. In fact, approximately 90 percent of patients in a recent Allergan study experienced a side effect, such as vomiting or pain8. In addition, almost 30 percent of bariatric surgery patients regain the weight they initially lost or have the surgery reversed, according to long-term studies9. A recent study in the American Journal of Medicine showed that there was a five-fold increase of suicides among all patients who had bariatric surgery, most occurring within three years following the surgery10. Weight loss surgery also causes nutritional deficiencies requiring lifelong supplementation of calcium, vitamin B12, folate, multivitamins, iron, and thiamine2,3.

This does not negate the positive benefits of surgery but does demonstrate the need to develop more comprehensive longer-term surveillance and follow-up methods in order to evaluate factors associated with post bariatric surgery suicide. Surgery is, therefore, not a treatment that is an end in itself, and it should not be viewed as the first or only choice for obese patients.

It is the position of the ASBP that bariatric surgery is not a quick fix or an easy answer to the obesity epidemic. Bariatric surgery has been and should remain a second line therapy after comprehensive medically-managed weight loss. Bariatric surgery does not end one’s challenges with weight; rather, it creates new and different nutritional, medical and psychiatric challenges that must be carefully taken into consideration. In conclusion, the ASBP does not support the lowering of BMI standards to qualify for bariatric surgery.

References

1. Flum, D.R. et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med 361, 445-54 (2009).

2. Omalu, B.I. et al. Death rates and causes of death after bariatric surgery for Pennsylvania residents, 1995 to 2004. Arch Surg 142, 923-8; discussion 929 (2007).

3. Shah, M., Simha, V. & Garg, A. Review: long-term impact of bariatric surgery on body weight, comorbidities, and nutritional status. J Clin Endocrinol Metab 91, 4223-31 (2006).

4. O'Brien, P.E. Bariatric surgery: mechanisms, indications and outcomes. J Gastroenterol Hepatol 25, 1358-65.

5. Wadden, T.A., Berkowitz, R.I., Sarwer, D.B., Prus-Wisniewski, R. & Steinberg, C. Benefits of lifestyle modification in the pharmacologic treatment of obesity: a randomized trial. Arch Intern Med 161, 218-27 (2001).

6. Ryan, D.H. et al. Nonsurgical weight loss for extreme obesity in primary care settings: results of the Louisiana Obese Subjects Study. Arch Intern Med 170, 146-54.

7. Heber, D. et al. Endocrine and nutritional management of the post-bariatric surgery patient: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 95, 4823-43.

8. Hitt, E. FDA Panel Recommends Lap-Band for Lighter Patients. in Medscape Medical News (2010).

9. Salahi, L. FDA Panel Recommends Lap Band Expansion: Lap Band Manufacturer Allergan Requests Expansion to Those Less Obese. (ed. Nightline, A.N.) (2010).

10. Tindle, H.A. et al. Risk of suicide after long-term follow-up from bariatric surgery. Am J Med 123, 1036-42.

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