In the early 2000s, gastric banding was a newly discovered gem in bariatric surgery. The reimbursement situation was looking good, and the procedure offered a less expensive and less traumatic option for patients compared to gastric bypass, the main alternative at the time. Everyone expected revenues to take off, and Allergan, which developed the product, looked ready to reap huge profits.
In just a few years, things took a noticeable turn for the worse. Between 2009 and 2011, Allergan's LAP-BAND was associated with a marketing campaign among clinics in California that allegedly caused 5 patient deaths
. In 2011, the Archives of Surgery
published a study
that found that that nearly half of patients who had a LAP-BAND placed either had no weight loss at all, or had to have the device removed within 6 years; in addition, over 40% of those patients also experienced long-term complications. As a result, in January 2012, members of the US House of Representatives called for a congressional hearing
to examine whether FDA regulation had been ineffective in protecting the public from the risks of medical devices like LAP-BAND. Throughout 2012, things went from bad to worse, with various articles covering the patient deaths in California, and Consumer Reports
publishing an investigation
revealing that the LAP-BAND was initially approved by the FDA on the basis of only a single study, in which 51% of patients reported nausea and/or vomiting, and 25% required band removal due to complications or failure to experience sufficient weight loss. In response, Allergan announced in October 2012 that it was considering selling its obesity intervention product line
, giving up on the product that was once looking so promising for the company. MRG estimates that the US gastric band market plummeted about 20% in 2012, following a similar drop in 2011.
Meanwhile, as a backdrop for this controversy, a few other things have been shifting around in the bariatric surgery world. Sleeve gastrectomy, another relatively new technique, seems to be picking up the slack from gastric banding. Sleeve gastrectomy volumes in the US have exploded in recent years as this procedure has been proven as an increasingly viable alternative to gastric bypass, avoiding some of the risks such as vitamin deficiency and malnutrition that are sometimes associated with a bypass. By 2014, sleeve gastrectomies will be the most commonly performed bariatric procedure in the US.
Additionally, two companies have released new pharmaceuticals that were designed for treating obesity?I know, I was surprised that drugs could do that too. Arena Pharmaceutical's Belviq and Vivus? Qsymia are the first obesity drugs to be approved by the FDA since 1999. Obviously, a nonsurgical way to lose weight will be favored by a lot of patients.
Although the market can?t seem to decide what direction to go in, one thing is looking pretty stable: the growing number of people who are obese. So there's definitely still lots of opportunity here for manufacturers if they are able to develop a novel technique for weight loss, because let's face it, we?re not going to give up our glorious, greasy, fried food.