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

2011 – Research shows 33% of Allergan LAP-BAND systems result in erosion

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 some highly obese patients, one weight loss technique that may be beneficial is gastric banding.  This involves the surgical insertion of an adjustable plastic band around the stomach that reduces the size of the stomach.  Thus, patients become full more quickly, and tend to eat less.  While this technique has been found to be successful in many patients, gastric banding carries serious side effects such as erosion of the plastic band into the flesh, infection, pouch dilation, and other complications that may require painful reoperations.

Published in 2011, a paper Belgian team of medical researchers aimed to determine the long-term safety of the Allergan LAP-BAND gastric banding system, as seen in 151 consecutive patients.  This study was titled “Long-term outcomes of laparoscopic adjustable gastric banding.” and appeared in the journal Archives of Surgery.

Of the initial 151 patients, 82 were available for long term follow-up.  After 12 years of LAP-BAND use, the authors found that “Twenty-two percent of patients experienced minor complications, and 39% experienced major complications (28% experienced band erosion)” and note that “Thirty-six patients (51.4%) still had their band, and their mean excess weight loss was 48% (range, 38%-58%).”

That means that nearly half of LAP-BAND users required the device to be removed due to complications.  Sadly, “Overall, the satisfaction index was good for 60.3% of patients.”

As such, the authors made the following conclusion: “because nearly 1 out of 3 patients experienced band erosion, and nearly 50% of the patients required removal of their bands (contributing to a reoperation rate of 60%), LAGB appears to result in relatively poor long-term outcomes.”

Astoundingly, Allergan reports that only about 1.33% of patients would suffer LAP-BAND erosion.  Because the study summarized above found rates of erosion more than 20 times higher than those reported by the manufacturer, this study can be used as evidence in an Allergan LAP-BAND lawsuits to demonstrate to a court that Allergan knew, or should have known, the rates of complications associated with its product.

 

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