FDA Loosens Belt on Gastric Banding Criteria

Posted on February 19, 2011

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Obesity comorbidities after surgery

Reductions in comorbidities following weight loss surgery

(The Health Wrap-Up is on hiatus this weekend)

Some people are up in arms over the FDA’s decision to sanction the use of gastric banding in a wider range of patients.  This news coming in the wake to reject three more weight-loss drugs – solutions many physicians (bariatric surgeons included) have been hoping for.

Many sources have misreported the change in policy (including CNN’s health blog, The Chart, I’m disappointed to see).  Here are the indications for bariatric surgery a surgeon would use before the FDA decision:

  • BMI >40 kg/m^2
  • OR, with BMI >35 to 39.9 kg/m^2 with significant comorbidities (hypertension, diabetes, sleep apnea, arthritis of weight-bearing joints)
  • AND that prior dietary and exercise attempts at weight control have been ineffective
  • Select patients who will be compliant with their operation and will exercise, while making good food choices

The FDA decided to extend the criteria for the second bullet point down to a BMI >30 (the definition of obesity).  Research found that, for restrictive procedures like banding, the mean excess weight loss was around 50%, with a 30-day post-operative mortality of 0.1% (Buchwald et al.).  The same review (which included more drastic procedures like bypass surgery) found the following effects on obesity-related comorbidities:

  • Diabetes:  86.0% resolved or improved
  • Sleep apnea:  85.7% resolved or improved
  • Hypertension (high blood pressure):  78.5% resolved or improved

My personal philosophy is that surgical and medical interventions are not favored when viable alternatives exist.  The problem is, however, that for some people, who truly have “tried everything,” there are no options left.  In fact, according to research, only 5% of people restricted to diet, exercise & behavior modification had any significant weight loss in the long-term; those who underwent weight loss surgery experienced 40-75% excess weight loss over the long term (Atkinson et al.).

The change in guidelines, much like my earlier mention of HPV vaccine guidelines, does not mean that everyone who meets the criteria will undergo the procedure.  In fact, because insurance companies do not yet reimburse according to the new criteria, it’s not likely that there will be any significant increase (the procedure can cost upwards of $25,000 out-of-pocket).  However, for those of you who simply can’t wait for your insurance company to cover the procedure, I have found your home-based solution.

I would argue that the vast majority of those with a BMI of 30 do not need bariatric surgery to manage their obesity or their diabetes. The new guidelines simply make them candidates if their team of health care providers deem the procedure appropriate. If an obese patient with diabetes is not managed on lifestyle modification and medication, and their disease is progressing, I would not be opposed to allowing them to go this route.  Being able to get off prescription medication when you’re diabetic or hypertensive is actually a big deal, and shouldn’t be dismissed.

Sources:

Buchwald et al.  JAMA. 2004;292:1724-1737 

Atkinson et al.  JAMA. 1994;272:1196-1202

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