Weight Loss Surgery continued...
The Belgian research, published in the Archives of Surgery, is thought to be the first study that follows gastric banding patients for more than 10 years.
Himpens and his colleagues set out to follow 151 patients who had the procedure from 1994 to 1997. They wanted to assess a number of outcomes, including death rate, complications both minor and major, amount of weight loss, number of corrective operations, effect on other problems such as high blood pressure and patient satisfaction.
The median age of the patients was 50 (half were older, half were younger). Many patients were lost to follow-up, with just 54.3% or 82 having full data available.
Among the findings:
- The death rate from the operation itself was zero, although 3.7% of patients died during the study period from unrelated causes.
- 39% had major complications such as erosion of the band, in which it erodes into the stomach and typically requires removal.
- About 50% required band removal and nearly 60% needed additional procedures.
- Average excess weight loss overall was 42.8% of excess weight after 12 years, but 48% among those who still had their band at the end of follow-up. Greater than 50% is considered a good result, experts say. Overall, 60.3% of patients were satisfied.
- About 6% of patients had type 2 diabetes before band insertion while 14% had diabetes 12 years after their procedure.
Himpens reports consultant work for Ethicon Endosurgery, which makes another gastric band, Realize, and for Covidien, a health care products company.
In an email, Cathy Taylor, a spokeswoman for Allergan, the maker of Lap-Band, says: "While Allergan encourages and is committed to the ongoing publication of important, balanced and robust scientific information to advance the practice of medicine, we are disappointed to see the publication of an ill-construed, single-center clinical assessment that does not meet the high clinical standards one should expect from peer-reviewed data, and is not reflective of today's clinical standards."
Among the flaws of the study, she says, are the incompleteness of patient follow-up. Bands have improved, she says, as have surgical techniques.
''The erosion rate is uniquely high," she says, ''strongly suggesting technical errors." She cites other research finding rates of 1.4% to 15%.