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

2008 – LAP-BAND associated with high complication rates

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 2008 article titled “Laparoscopic adjustable gastric banding in an ambulatory surgery center.” published in Surgery for Obesity and Related Diseases by B.M. Watkins et al. published finding regarding the safety and efficacy of LAP-BAND gastric banding systems in 2,411 patients who were implanted with the system between November 2002 and August 2007.  The team reported “changes in mean body mass index (BMI), percentage excess body weight loss (%EBWL), and incidence of complications at 1 year, as well as the slippage rate up to 3 years.”

“The majority of operations were completed in less than 1 hour” and the overwhelming majority were performed as outpatient procedures.  After one year, 1,144 patients were available for follow-up examination to determine excess weight loss and changes in body mass index, and it was found that on average patients lost 60% of excess weight after one year and BMI lost about 8.8 points.

However, complications were found to occur in “241 of 2,411 (10%) patients” and one patient died.  Further, “Cumulative slippage at 1, 2, and 3 years, respectively, was 0.4%, 2.4%, and 10%. There were 56 (2.3%) port-related problems, and 13 band explantations (0.54%).”

Unfortunately, the manufacturer of LAP-BAND systems, Allergan, underestimates the rate at which these and other risks are associated with their product in the LAP-BAND Warning Label, mainly focusing on the benefits.  As a result of this, 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.