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

2007 – High complication rates seen with laparoscopic adjustable gastric banding

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 2007 report titled “Benchmarking hospital outcomes for laparoscopic adjustable gastric banding.” by MA Edwards et al. published in Surgical Endoscopy set out to review the safety and efficacy of gastric banding systems in obese patients.  Gastric banding is a procedure by which an adjustable plastic band is placed around the stomach to make patients feel full after consuming less food.

Researchers studied “87 consecutive patients with a mean age of 43 years” over 24 months, and “conducted a retrospective review of the outcomes including conversion, reoperation, mortality, perforation, erosion, prolapse, port dysfunction, excess weight loss, and changes in comorbidities, then compared the data with published benchmarks.”

Complications surrounding surgery included “acute stoma obstruction” (one patient), and respiratory complications (two patients).  “Delayed complications included gastric prolapse” (four patients) “and port reservoir malposition” (also in four patients).  Researchers also noted that 5 of 87 bands had to be removed.  All of this was seen at the two-year endpoint.

Excess weight loss, on average, was 30% at 6 months, 41% at 12 months, and 47% at 24 months.  Furthermore, researchers found that “Comorbidities resolved included diabetes (74%), hypertension (57%), gastroesophageal reflux disease (55%) and dyslipidemia (38%).” (hyperlink added)

However, it is important to realize that the rates for the above complications are significantly higher than the rates for the same complications reported in the LAP-BAND Warning Label, a popular gastric banding system manufactured by Allergan.

That warning label suggests that about 2.7% of LAP-BANDs will require removal, and the above study suggests the rate is closer to 5.7%.  Further, the LAP-BAND Warning Label suggests that only about 1.34% of patients will suffer port problems, while this study found about 4.6% of patients will face that complication.

In the face of such discrepancies, a number of LAP-BAND lawsuits have been filed.

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