By: Staff Writers | Published: April 1st, 2011
About six out of every 10 people who undergo gastric Lap-Band surgery may experience complications that require additional surgery and nearly half may have to have the banding removed, according to a recent study by Belgian researchers.
The researchers looked at patients who had received the Allergan Inc. Lap-Band over a period of 12 years and reported their findings last week in the Archives of Surgery. They found that nearly a third of patients who undergo the procedure, known as laparoscopic adjustable gastric banding (LAGB), discovered that their bands had eroded the wall of their stomach over time.
The study used data from 82 patients who underwent LAGB surgery between January 1, 1994 and December 31, 1997. Researchers found that 61% suffered some kind of complications, usually major. Overall, 28% were found to have suffered Lap-Band erosion, and just under 50% had the band removed within 12 years. Overall, the Lap-Band recipients lost about 43% of the excess weight they carried before undergoing to procedure.
The researchers said that the lap band erosion, complications, and an overall lukewarm satisfaction rating by the patients in the study led them to determine that Lap-Band side effects lead to relatively poor long-term outcomes for LAGB.
Allergan has criticized the findings, saying that a 2010 Lap-Band study in Surgical Endoscopy found only a 12% complication rate among nearly 3,000 patients who had the bands implanted in 2001, which was the year the FDA approved the Lap-Band for use in the U.S. The company said that the study focused on the beginning of LAGB surgery, before doctors became experienced with the procedure.
According to Allergan, more than 500,000 people worldwide have received the Lap-Band and said both the band itself and LAGB surgery have changed since the subjects of the Belgian study received their bands.
The new study comes less than a week after the FDA announced that it was expanding the approved use of the Lap-Band to include people who were less obese.