FDA OKs Lap-Band Surgery For Less Obese Folks

Millions of Americans may soon have another weapon in the battle of the bulge.

The Food and Drug Administration has approved use of the “Lap-Band” type of weight loss surgery at lower minimum weight limits, making an estimated 26 million Americans newly eligible for the weight loss procedure.

Previously, the surgery was restricted to people with a body mass index of 40, or 35 if they had an obesity-related health problem, such as diabetes, hypertension or joint pain.

The threshold approved by the FDA last week remains at 40 for those without a related health condition, but drops to 30 for those with health conditions.

While local experts believe that there is significant demand for the surgery, they don’t expect the floodgates to open just yet.

“The FDA may have lowered the requirements, but the insurance companies are the ones who really decide,” said Daniel Gagne, director of bariatric surgery for the West Penn Allegheny Health System. “I most definitely think there would be a big rush of people if their insurance covered it.”

The vast majority of the bariatric surgery procedures performed at WPAHS are not the Lap-Band surgeries covered by the recent FDA decision, but gastric bypass surgeries, which are more invasive but generally result in higher weight loss totals.

Lap-Band surgeries, in which an inflatable silicone ring is placed around part of the stomach, makes up one-quarter or less of the surgeries performed in the area.

The new weight guidelines would apply to patients who are just marginally obese.

For a 5’9″ man or woman, a BMI of 40 would be equivalent to 271 pounds, 35 would be 237 pounds and 30 would be 203 pounds.

The government considers people with a BMI more than to be 30 to be obese, while 25 is the cutoff for overweight.

For those with obesity-related health conditions, losing a relatively small amount of weight can make a tremendous difference, said Dr. Gagne.

“It often doesn’t take that much weight loss for people to feel better physically, but also to have improvements in their health,” he said.

The FDA approval of the lower weight limits for Lap-Band surgeries was not without controversy, however.

Diana Zuckerman, president of the National Research Center for Woman and Families, testified against Lap-Band manufacturer Allergan’s request to lower the weight limits and wrote an op-ed in The New York Times urging the FDA to deny Allergan’s application.

She criticized the evidence presented by Allergan that demonstrated the safety of the Lap-Band procedure, noting that it had data on only 149 patients for just one to two years after their surgery.

That data included an insufficient number of men, Asians, African-Americans and Hispanics, with 20 percent of the 14 men in the study getting their Lap-Bands removed within one year.

“Obesity can kill,” Dr. Zuckerman wrote in The New York Times, “but when people are not at immediate risk of fatal illness, the FDA does them no favors by giving its approval to an implanted medical device before it has been adequately tested.”

The marketing of Lap-Band surgeries has also come under scrutiny. The head of the Los Angeles County Department of Public Health asked the FDA to investigate billboards advertising the Lap-Band with the slogan 1-800-GET-THIN. The head of Allergan subsequently criticized the billboards as well, saying that they were done by a separate marketing company.

Anita Courcoulas, director of bariatric surgery for the University of Pittsburgh Medical Center, said that she thought the scientific evidence presented to the FDA was compelling in terms of the Lap-Band surgery’s effectiveness.

Candidates for bariatric surgery must have tried and failed to lose enough weight through traditional means, such as diet and exercise.

For patients struggling with obesity and related diseases, the delay of treatment may also be dangerous, she said.

“Non-surgical treatments have very poor results, and this has a good impact on weight loss,” she said. “It may be that treating patients earlier may be better in terms of impacting quality of life, length of life.”

Effectiveness also depends on the diet and exercise efforts of the patients post-surgery, said Dr. Gagne.

“It doesn’t work by magic,” he said. “Almost everyone loses in the first year, but to keep it off three, five, 20 years down the line, they have to work at it.”