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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

2007 – 66% and 76% of Patients Face 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, LF Martin et al. published a paper in American Journal of Surgery titled “Treating morbid obesity with laparoscopic adjustable gastric banding.”.  This paper aimed to evaluate the safety and efficacy of laparoscopic adjustable gastric banding for weight loss in obese patients.

For this study, Martin et al. (2007) “reviewed 2 multicenter prospective, open-label, single-arm surgical trials–trial A (3 years) and trial B (1 year)–with ongoing safety follow-up.”  The first trial included 292 patients, and the second included 193 patients.  Researchers write that about 70% and and 73% of the patients completed the 3- and 1-year follow-up periods, respectively.

While this team found gastric banding to be effective in weight loss, there were a high number of complications observed.  “The percentage of initial body weight lost at 1 year was 17.7% +/- 9.4% for trial A subjects and 18.2% +/- 8.9% for trial B subjects, whereas the 3-year total for trial A subjects was 18.3% +/- 13.1%.”

Concerning complications, “At 1 year, 76% of patients in trial A and 66% of patients in trial B had complications, mostly related to upper gastrointestinal symptoms. By 9 years after surgery, 33% (96 of 292) of trial A subjects had their devices explanted because of complications or inadequate weight loss.”

Since these complication and explantation rates are so much higher than those reported in the Allergan LAP-BAND gastric banding system warning label, a great number of LAP-BAND lawsuits are currently being filed.

 

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