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Lap Bands May Result in More Complications Than Weight Loss

Almost half of patients undergoing gastric banding for obesity needed to have the device removed, often because of erosion, according to a study that found the treatment caused more complications than weight loss.

About 60 percent of the 82 patients with the device, Allergan Inc.’s Lap-Band, followed over 12 years or more needed additional operations, according to a study by Belgian researchers published online today by the Archives of Surgery. The minimally invasive surgery led to weight loss of 18 percent in 70 patients where data was available.

More than 15 million people in the U.S. are considered severely obese, a total that has almost doubled in the past 25 years. About 220,000 people underwent weight-loss surgery in 2009, up since 2000 when 36,700 operations were performed, according to the American Society for Metabolic and Bariatric Surgery in Gainesville, Florida. Gastric banding represents about one-third of that total.

“I personally no longer perform band gastroplasty, but I think it is defendable for surgeons to continue doing this,” said Jacques Himpens, the study’s lead author who works with the European School of Laparoscopic Surgery at Saint Pierre University Hospital in Brussels. “Patients should not expect too much from the procedure. If they do get the operation, they must commit themselves to lifelong and very tight follow-up.”

Allergan Comments

Allergan Inc., the world’s largest maker of gastric banding in the U.S., called the study “ill-constructed” in an e-mail. The gastric banding products involved in the study are produced by Allergan, which acquired the product in 2006 with its purchase of Inamed Corp.

The company criticized the study for “severely deficient” follow-up, with data on nearly half of the patients in the 151-patient study never acquired, and a focus on patients that had received their devices “at the very beginning” of the use of gastric bands.

“The surgeons were at the bottom of their learning curve,” said Cathy Taylor, Allergan’s spokeswoman. The Belgian study surveyed patients who had the procedure from January 1994 to December 1997.

Allergan pointed to a study published in 2010 that showed a 12 percent complication rate among 2,909 patients who received the gastric banding in 2001, the year the Food and Drug Administration approved its use in the U.S. The study, conducted by researchers at New York University Langone Medical Center in New York, had received funding from the Irvine, California-based device maker. Allergan controls 73 percent of the U.S. gastric-banding market.

Rival Maker

Himpens and another author of the study have worked as consultants for Ethicon Endosurgery Inc., a Cincinnati unit of Johnson & Johnson, a competitor of Allergan which produces the Realize Solution band.

Body mass index is a measure of a person’s weight in relation to his height and is a reliable indicator of obesity, according to the Centers for Disease Control and Prevention in Atlanta. A 5-foot, 4-inch woman weighing 175 pounds (80 kilograms) has a BMI of 30, which is considered obese.

Weight-loss surgery had been recommended for patients with a body mass index of 35 and who are suffering from obesity-related illnesses such as diabetes. The FDA approved an Allergan application that would allow the company to market lap bands, the proprietary name of the company’s product, to patients with a body mass index of 30. A BMI of 40 or more is considered severely, or extremely obese.

Band Removal

The Belgian study is “of interest” because it looks at long-term complications and the need to remove the band, said Bruce Wolfe, president of the American Society for Metabolic and Bariatric Surgery. He said he also agrees with Himpens’s conclusion that any kind of weight-loss surgery requires regular physician follow-up.

Twenty-three patients, or 1 in 3 who responded to the survey, experienced band erosion, diagnosed after a median of four years, the study found. Almost 50 percent of the patients lost their bands within nine years.

Technological advances in the procedure and product have been made since the operations upon which the Belgian study was based, said Wolfe, who is a surgeon at the Oregon Health and Science University in Portland. Gastric bands are now wider and require using less pressure. The technique for placement of the band has changed to involve more fat tissue, which provides padding that may reduce band erosion.

“The complication rate and need for removal of the band are both concerning,” Wolfe said in a telephone interview. “But many of the changes in patient care relative to gastric banding may have addressed some of the problems.”

The American Heart Association in a policy statement March 14 said severely obese people benefit from weight-loss surgery. The group, for the first time, said the risks of the procedure aren’t as great as the help provided by the reduction in the risk of diabetes, high cholesterol and heart ailments associated with obesity.

(Updates with detail on Lap-Band in fifth paragraph.)
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