Weighing Bariatric Surgery's Risks
By Amy Tsao
In an article in the Oct. 13 edition of the Journal of the American Medical Association, researchers unveiled encouraging news for people seeking surgery to reduce their weight. JAMA reviewed the results of 136 studies and found that surgery to lessen the size of the digestive tract resulted not only in weight loss but also reversed diabetes in 77% of obese patients, eliminated high blood pressure in 62%, and lowered cholesterol in at least 70%. The study was funded by Johnson & Johnson (JNJ ), a maker of instruments used in such surgeries.
This study and others like it will probably fuel the already rapid rise in weight loss, or bariatric, surgery. A staggering 61 million American adults are now technically obese -- meaning their body mass index (a calculation of body fat using height and weight) is 30 or higher. Despite the procedure's $30,000 cost, the number performed has increased 10-fold over the last decade, to a projected 140,000 this year.
But as bariatric surgery rises in popularity, it presents the health-care system with difficult questions. What are the overall benefits -- and do they justify the medical risks and financial costs? And if the payoff is so great, shouldn't more overweight people get it? But it has side effects and risks that people considering such surgery should weigh carefully.
Supporters are quick to defend the procedure. "The data are incredibly clear that on average surgery is effective," says Lee Kaplan, director of the MGH Weight Center at Massachusetts General Hospital and Harvard Medical Center. The risk of death is below 1%, while about 10% of patients experience complications, Kaplan says, and that's in the expected range for any gastrointestinal surgery.
Many private insurers now foot the bill for the surgery -- but only if the patient can prove that all else has failed. Most insurers require documentation that patients have first tried, and failed at, behavioral changes in diet and exercise. The big question now is when -- and under what terms -- the federal Center for Medicare & Medicaid Services, the nation's largest insurer, will pay for obesity surgery. A strong argument in favor of bariatric surgery is the dearth of drugs and effective medical alternatives to the procedure. A CMS committee is set to meet on Nov. 4 to review the medical evidence.
BECOMING BIG BUSINESS.
Much of the growth in such surgeries is attributable to guidelines set by the National Institutes of Health in 1991. It recommended that people with a body mass index of 40 or greater (about 100 pounds overweight), or a BMI of 35 as well as two or more significant obesity-related problems (like diabetes or high blood pressure) were appropriate candidates for bariatric surgery.
Kaplan says after several years of performing the surgeries, he believes that even people who fall outside the NIH guidelines would likely benefit. An alternative procedure is the LapBand, an adjustable stomach restricting device, which many say is less risky than other methods in patients who have a BMI of 30 or greater and have significant weight-related conditions. Beth Schrope, assistant professor of surgery at Columbia University Medical Center, is investigating its effects.
Fears are rising, however, that the surgery's downsides are being taken too lightly, especially as it has become big business. The recent data published in JAMA make obesity surgery sound like a catch-all remedy for related diseases. But the study's authors note that they didn't include the rate of surgery complications in their research. Such problems can include malnourishment (since the stomach is reduced substantially), infections, and a small rate of deaths. And the average follow-up time among the five randomized studies reviewed was 16 months, which is relatively short when trying to determine whether diseases like hypertension and diabetes have been "cured."
MAJOR LIFESTYLE CHANGES.
More and more surgeons are simply "flipping a card" and calling themselves bariatric surgeons, worries Schrope. "That's becoming more and more common" as hospitals around the country have hired surgeons and set up obesity clinics. The procedures are attractive to hospital administrators because they're thought to drive other services, including follow-up visits, X-rays, and additional surgeries.
"There are a lot of economic incentives built in," says Paul Ernsberger, associate professor of nutrition at Case Western Reserve University School of Medicine in Cleveland. "A lot of hospitals would probably be out of business, if not for bariatric surgery."
Schrope says the "vast majority [of obese patients] understand this is a major step, that it's the last thing available to them," but still too many view surgery as an "easy way out." That simply isn't the case, she warns.
"The [patient's] new anatomy forces major lifestyle changes," Schrope says. Even with a reduced stomach, a patient can gain all of the weight back if they eat poorly and don't exercise. That occurs, she figures, in about 5% of cases. Some experts also worry that surgeons are performing the procedure on younger and younger patients -- even including some preteens.
Though bariatric surgery has been performed since the 1960s, research into its pros and cons is still in its infancy. Ernsberger worries that nutritional deficiencies in some cases can possibly lead to conditions like osteoporosis or anemia over the long run. "We don't know much about these surgeries," he says, adding that relatively little basic research has been done of how and why bariatric surgery works. Clinical trials, too, have generally not been rigorous. "There aren't many studies that compare surgery to nonsurgical approaches," he says.
Two years ago, the rationale that the surgery can cut down on the health-care costs associated with being obese also took a blow. A large ongoing study in Sweden found that the use and cost of drugs in obese patients to be about the same, whether or not they had the surgery. Those who didn't have the procedure needed medication for diabetes and cardiovascular disease, while those who underwent it needed treatment for gastrointestinal-tract disorders, anemia, and vitamin deficiency.
The bottom line: It may seem like a Holy Grail of sorts for people who must lose weight to improve their health and well-being, but the procedure comes with risks and benefits that are still being explored. The use of bariatric surgery is likely to keep growing as America wages a war against obesity, but buyers beware.
Tsao is a reporter for BusinessWeek Online in New York
Edited by Thane Peterson