Header graphic for print
Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

2002 – Federal Study Shows LAP-BAND Complications More Common than Company Reports

Posted in Allergan LAP-BAND

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.

A study titled “Laparoscopic adjustable gastric banding at a U.S. center with up to 3-year follow-up.” by RB Rubenstein published in 2002 in Obesity Surgery presented “results from the “B” trial (the 2nd U.S. FDA-approved clinical trial) with the laparoscopic adjustable gastric band (LAGB) or Lap-Band System, regarding weight loss, complications, and effect on co-morbidities with up to 3-year follow-up.”

This federally-commissioned study was surprisingly small, studying only 63 morbidly obese patients who underwent LAP-BAND implantation between March 1999 and June 2001.

Rubenstein writes that complications surrounding surgery “included 1 intraoperative gastric perforation,” the tearing of the stomach, “which was closed and did not prevent band placement, and 5 port problems.”  Post-surgical complications included “Gastric slippage occurred in 9 patients (14.2%), 3 of whom were revised to a gastric bypass and 6 who had the band removed.”  And, “Three additional bands were removed due to infection (1), band erosion (1) and a cluster of gastric symptoms (1).”

While the LAP-BAND system was found to be effective, demonstrating “Percent excess weight loss averaged 27.2 at 6 months (range 1-68), 38.3 at 1 year (range 10-77), 46.6 at 2 years (range 16-89), and 53.6 at 3 years (range 21-94)”, the rates for complications found by Rubenstein are significantly higher than those reported in the Allergan LAP-BAND Warning Label.

For example, LAP-BAND reports that gastric slippage occurs in only about 8% of patients, and that erosion only occurred in 1 of 149 patients, whereas Rubenstein found a rate more than twice as high.

As a result of this data discrepancy, a number of LAP-BAND lawsuits were filed against Allergan, the manufacturer of the LAP-BAND.

Our Allergan LAP-BAND Lawsuit Information page is a great place to start if you have any questions about the Allergan LAP-BAND.