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

2002 – “Late complications” in 30% of Gastric Banding Patients

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.

Published in 2002, JB Dixon and PE O’Brien co-authored a paper titled “Health outcomes of severely obese type 2 diabetic subjects 1 year after laparoscopic adjustable gastric banding.” that aimed to “examine the effect of weight loss 1 year after laparoscopic adjustable gastric band surgery on a broad range of health outcomes in 50 diabetic subjects.”  This paper appeared in the February 2002 edition of Diabetes Care.

Researchers found that before surgery, mean weight was “137 +/- 30 kg,” and mean body mass index (BMI) was 48.2 +/- 8kg/m2, and that after one year using the gastric banding systems, “weight and BMI were 110 +/- 24 kg and 38.7 +/- 6 kg/m2, respectively.”  Clearly, gastric banding is an effective means of weight reduction in obese patients.  Further, relating to diabetes, “There was significant improvement in all measures of glucose metabolism” and “Remission of diabetes occurred in 32 patients (64%), and major improvement of glucose control occurred in 13 patients (26%)”.

While the study found “Improvement in diabetes was related to increased insulin sensitivity and beta-cell function” and that “Weight loss was associated with significant improvements in fasting triglyceride level, HDL cholesterol level, hypertension, sleep, depression, appearance evaluation, and health-related quality of life”, the team also found evidence of serious complications associated with the use of gastric banding systems.

“Early complications occurred in 6% of patients (wound infections in 4%, respiratory support in 2%), and late complications occurred in 30% of patients (gastric prolapse in 20%, band erosion in 6%, and tubing leaks in 4%). All late complications were successfully revised surgically.”

According to the warning label for LAP-BAND by Allergan, only about 1-2% of patients will suffer band erosion, and only about 8% are expected to suffer gastric prolapse.  The rate for tubing leaks is also lower according to Allergan.

As a result of such discrepancies between independent studies and Allergan’s LAP-BAND Warning Label, a number of 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.