09 May 2012

FDA comments on approving WL devices

Ok.. so you know I am into the pharma compliance stuff and every once in a while, I get motivated to dig...  This is very dry material.. but I thought I would just put it out there for anyone who might be interested in learning how WL studies are designed and what points are considered when approving products.. so if you are having a rough time falling to sleep.. keep reading!!!

Within the FDA, there are various centers that have the responsibility for approving drugs, biologics and devices.. A gastric band is considered a device and within FDA, the Center for Device and Radiological Health (CDRH) has responsibility for the review and approval of medical devices, including those for the treatment of obesity.  So, now that alot of new products are being introduced (new diet pills an devices) FDA has decided to come up with a Risk/Benefit profile to determine who should be approved to use which WL product that is regulated by FDA.
What FDA has to say... you can read it HERE

The paper discusses postmarketing studies to see how effective devices are in maintainig weightloss and also goes into significat detail on co-morbidities. 

Points of Interest

Several studies have been undertaken to determine the profile for those who are successful at weight loss. In a survey of 108 obese women,53 most of the 30 women who were able to maintain their weight loss exercised regularly, were conscious of their behaviors, used available social support, confronted problems directly, and used personally developed strategies to help themselves. In contrast, among the 44 women who relapsed after weight loss, few exercised, most ate unconsciously in response to emotions, few used available social support, and few confronted problems directly.

Effects of Weight Cycling:

Many obese persons can achieve short-term weight loss by dieting alone, but successful long-term weight maintenance is much more difficult to achieve. "Weight cycling" and "yo-yo dieting" are popular terms used to describe repetitive cycles of weight loss and subsequent regain.

Using data from 5,127 participants in the Framingham population, Lissner and colleagues
59 reported that subjects with highly variable body weights had increased total mortality, mortality from coronary heart disease and morbidity due to coronary heart disease. Another review of 13 observational studies which included 62,633 patients performed by Andres and colleagues60 in 1993 showed that weight loss or weight fluctuation increases mortality. Weight cycling may also have negative psychological and behavioral consequences. Studies have reported an increased risk for psychopathology, life dissatisfaction, and binge eating.61

In contrast, Stevens and colleagues 
recently reviewed the association of weight cycling with death among 55,983 men and 66,655 women in the Cancer Prevention Study II Nutrition Cohort from 1992 to 2008. A weight cycle was defined as an intentional loss of 10 or more pounds (4.5 kg) followed by regain of that weight, and the lifetime number of weight cycles was reported on a questionnaire administered at enrollment. After adjustment for BMI and other risk factors, low numbers of weight cycles (1–4 cycles) were associated with slightly lower mortality rates (hazard ratio = 0.93). In addition, higher numbers of weight cycles (20 cycles) were not associated with increased mortality.

Despite some controversy, the recommendation from the National Task Force on the Prevention and Treatment of Obesity is that the possible detrimental health effects of weight cycling are inconclusive, and should not deter obese persons from attempting to lose weight.


  1. Great article! It is no surprise to me that exercising regularly contributes to my successfully being able to maintain my weir loss. In all honesty, regular exercise is the only thing I never did in all the years of dieting. I would eat less but not exercise. I'd lose and regain. WLS allowed me to eat less and at the same time I added the exercise. Less than two years later, I am maintaining a 90+ lb. weight. Loss! Who knew?

  2. I wonder what will be the reaction when the new weight loss drug comes on the market soon. It is supposed to be approved in July. Although it still,doesn't "keep it off" once they stop. Exercise is good but I don't believe you have to be an excessive exerciser--just be more active and away from sitting in front of the TV. I'm sure we can all think of others activities! I see the support system invaluable and that's why I stay around here.

  3. Thank you for this! It's interesting to compare study results to the blogosphere and the same patterns emerge.