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

2007 – Small Study Shows High Rate of LAP-BAND Complications

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.

In 2007, a small prospective study was published by AX Holterman et al. titled “Short-term outcome in the first 10 morbidly obese adolescent patients in the FDA-approved trial for laparoscopic adjustable gastric banding.” in Journal of Pediatric Gastroenterology and Nutrition that aimed to evaluate the safety, efficacy, and reliability of the Allergan LAP-BAND gastric banding system in 10 girls.

One girl suffered pouch dilation, and this is understandable – Allergan assumes the rate of pouch dilation to be about 8% in the LAP-BAND Warning Label.

Though Allergan purports that about 1% of patients will suffer device failure that requires “port revision,” one girl in the study cohort required this, placing the rate for such complications at about 10%.

While all patients lost a significant amount of weight, it is important to understand that serious complications can occur while using the Allergan LAP-BAND system, and while the rate for complications in this study was not found to be overwhelmingly high, the rates observed by Holterman et al. (2007) were higher than those reported by the LAP-BAND manufacturer.

As a result of these findings and those of other similar studies, a number of Allergan LAP-BAND lawsuits were filed.

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