How Should We Evaluate Lap-Band Candidates?
Allergan lowers BMI requirement and raises questions about its effectiveness and appropriateness.
You've tried Atkins, South Beach and Nutrisystem. You've enlisted the help of a personal trainer, busted your butt at your gym's boot camp and sweated it out in Bikram yoga. Desperate to trim inches, you've even bought into gimmicky weight-loss pills, fasting and cleanses. But the stubborn scale still tells you that you're overweight.
Where should you turn now? If you have a body mass index of 30 or higher (a man standing at 5'9" and weighing in at 203 pounds) and one weight-related medical condition (high blood pressure, diabetes, etc.), you now qualify for quick and easy gastric bypass surgery. (Click here to calculate your BMI.)
In February, the Food and Drug Administration announced that Allergan, the maker of the Lap-Band Adjustable Gastric Banding System, can market the medical procedure for a person with a BMI of 30, lowered from the former requirement of 40. This opens the device's market to 26.4 million more Americans; 45.6 million Americans, or 1 in 7, now meet criteria for the Lap-Band surgery. In short, it's moved from the last hope of the morbidly obese to a sort of lifestyle choice for the plump.
With the device already advertised on billboards across the country (with the phone number 1-800-GET-THIN), this widening of the market begs the question: How should potential patients for weight-loss surgery be evaluated? A body of academic research finds that this evaluation should include both the waist and the mind.
The most common form of gastric bypass surgery is Roux-en-Y gastric bypass, in which a surgeon clips off part of the stomach to create a smaller pouch. This tinier tummy becomes the way station between the passage where chewed food enters and the small intestine, while the larger part of the stomach is sewn shut.
The Lap-Band does not require the removal of any part of the digestive system, and, unlike stomach stapling, it's reversible. A surgeon makes a few incisions in the abdominal wall and inserts an adjustable band – think of a pants belt — around the upper wall of the stomach. Depending on how tight or how loose the band is pulled, a person's stomach is restricted to anywhere from about half of a cup to six cups of food.
That relative ease comes at a price.
A February 2011 study in the Archives of Surgery reported that both gastric bypass and adjustable bypass banding surgeries are generally safe and have similar complication rates when performed at "high-volume centers by expert surgeons," although Lap-Band did have more occurrences where a second surgery was required.
But the researchers concluded that Roux-en-Y gastric bypass surgery had "a better risk-benefit profile" than the Lap-Band, in large part because it is more effective: Roux patients lost 64 percent of their excess weight during their first year post-procedure, compared to Lap-Band's 36 percent.
The Lap-Band is not a foolproof weight-loss device. The failure rate (defined as failure to achieve a certain percentage of weight loss or a particular BMI) ranges from 10 percent to 20 percent during the first several years after surgery. That rate grows the longer the band is in place.
The Lap-Band's less-invasive nature and ability to be reversed gives it a less serious air than other forms of gastric bypass surgery, but it also comes with the risk of various, albeit rare, complications, such as band erosion, pouch dilation, band slippage and an inflamed esophagus. And, like any aggressively marketed medical device, with awareness comes notoriety when something goes dramatically wrong, as when four Southern Californians died after their Lap-Band surgery.
And then there are issues with nutrition post-procedure. Some who have had the Lap-Band develop an intolerance to meat, particularly red meat.
Whether the band is the best solution for the obese, it remains a reasonable one. A recent 14-year long study in the Journal of Obesity that tracked the health of 200 formerly obese Germans who had gastric banding in 1995 found the operation to be "a safe and efficient procedure when performed by an experienced surgeon using a standardized operation technique." The authors stressed the importance of a standardized follow-up procedure to ensure a healthy recovery, greater weight loss and fewer conditions such as diabetes or hypertension.
Mind and Body
While the Lap-Band can provide a solution for weight loss, the procedure may not solve all of an obese person's problems. More than 28 percent of potential bariatric surgery patients have been reported to have a lifetime history of a major depressive disorder. Lifestyle habits, such as a poor diet and a lack of exercise, are not immediately solved with the Lap-Band.
Weight-loss surgery is less successful when people exhibited binge eating habits and poor eating habits linked to psychological problems. For more effective weight loss, a person's psychological profile and relationship with food needs to be analyzed for eligibility and for the best post-operation results. Obesity can be a psychological problem, and having weight loss surgery serves to treat the consequences of psychological problems, rather than unearthing and treating the emotional reasons that people overeat.
A 12-month study analyzed the pre-surgical and post-surgical eating behaviors of 129 recipients of the Lap-Band. Although the prevalence of binge-eating disorder, uncontrolled eating and night-eating syndrome dropped from 14 percent, 31 percent and 17.1 percent, respectively, to 3.1 percent, 22.5 percent and 7.8 percent, other eating problems cropped up. Binge-eating disorder is often a side effect of emotional eating, or "eating in response to a range of negative emotions such as anxiety, depression, anger, and loneliness to cope with negative affect."
Researchers found that a high level of psychological distress accompanied a loss of control over one's eating ability, and the consumption of small amounts of food over an extended period of time — "grazing" — became the coping mechanism for participants whose bodies do not allow them to binge eat as they had pre-surgery. Individuals feeling a loss of control over their eating habits may be more inclined to avoid clinical follow-up post-surgery.
Ranesa McNally, therapist, gastric bypass patient and author of Gastric Bypass Surgery: The Psychological Journey, writes that gastric bypass surgery is not a quick fix and requires an overhaul of a patient's perspective.
"Those who succeed long term tend to be those individuals who fully understand that an entire lifestyle change is necessary; this is not as simple as changing eating habits," she writes. "This also means looking at how food has played a part in one's upbringing, when exactly one began struggling with the weight, the social and cultural implications related to obesity, as well as the role food plays in social settings. Also to be examined is one's outlook regarding exercise, the ability to follow directions and issues of control,"
Allergan requires a psychological evaluation before prospective Lap-Banders go under the knife. Allergan is not involved in the evaluation, said Cathy Taylor, the company's director of corporate communications.
"Allergan is not involved in the psychological evaluation – we do not develop the questions nor do we provide input," she said. "Allergan is only the manufacturer of the Lap-Band System, so we don't manage the psychological evaluation. The psych department of the hospital/surgeon office is responsible for development of the psychological evaluation."
Dr. Mafa R. Kamal, a psychiatrist at Good Samaritan Hospital in Los Angeles, screens potential Lap-Band patients before they can be considered to have the procedure. He said that the hospital is not choosing as many patients for the procedure as it did in the past, but that if a patient is morbidly obese, the hospital will authorize the surgery because it could save their life.
"After having the surgery, a lot of patients are not willing to change their life patterns," he explained. "They think that if they do the surgery, they're going to be slim, but they discover that actually they're not going to have new friends or a new personality. After surgery, many patients don't want to exercise or stop eating junk food. They want to do what they want to do. The surgery is risky, and there are complications. Some patients are not going to be compliant with anything."
Deciding to have the Lap-Band inserted into your body to restrict your food intake is a tough call. One study warns that "we must remember that idiopathic morbid obesity probably is the result of a complex metabolic and psychological disturbance in the fine-tuned chain of events that governs the intake of food." Although some may call psychological screening before bariatric surgery prejudicial, a surgeon must ensure that a patient is ready to deal with the consequences of the Lap-Band procedure. The Lap-Band's consequences can be positive when a person has a healthy psychological profile: self-esteem and improved body image can increase with weight-loss surgery.
For some people, weight-loss surgery has given them a start at living a new, healthy life. Jasmine Myers, author of the blog Eat Move Write, said that she was facing death before she had Roux-en-Y gastric bypass surgery six years ago.
"Six years ago, all I could see ahead of me was a long dark tunnel. Today, I am healthy," Myers said. "I enjoy hiking, walking, and working out with my husband. I have a blog dedicated to pursuing my own healthy lifestyle. And, children are no longer an impossibility. They are an eventuality. I am not just existing now. I am alive."
For other recipients of weight loss surgery, the ordeal gave them temporary relief but didn't reach the roots of psychological issues that drive them to overeat. One 46-year-old woman who had the surgery three years ago told me that it has been a struggle to adapt to eating less after decades of overeating.
"When I first had the Lap-Band, I was excited and enthusiastic about my weight loss prospects," she said. "Now I feel trapped, and my mind hasn't caught up with my body. I still overeat, and the food stacks up in my esophagus."
Food can be an addiction, and cutting the ties from the drug of food does not necessarily rehabilitate someone's emotional health. Now the floodgates have opened for almost 50 million Americans with the lowering of the BMI requirement, Allergan should thoroughly analyze the mental health of potential Lap-Band recipients. Even though the Lap-Band is reversible, its psychological consequences can leave scars.