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Lap Band Trials - Reviewing the Results

I would like to review an issue that was recently presented to me the other day regarding lap band trials. As a number of companies produce the Lap Bands used for the surgical procedure, comparisons have been made in the past between different brands. Testing trials were held by Inamed (in the late 90’s) and by Johnson & Johnson (three years ago) and reports have attempted to compare these two bands. However, the information obtained is being manipulated with results that favor the use of one band over the other.

Under the marketing competition, the comparison focuses specifically on the Lap Band explantation (or de-banding) during these trials. The huge difference shown between the two brands of lap bands is now being used to manipulate doctors and patients into using a particular brand. The problem is that the trials were not done under the same circumstances and cannot fairly be compared.

To correctly interpret the results of the trials, we need to look at the difference in circumstances. The Lap Band trials were all done by surgeons, and placed in obese patients in both trials. However, the comparison between trials does not include details about the surgeons’ experience in placing the band. The main difference between the trials is the surgeon’s ability and knowledge of the Lap Band. At the time of the Inamed trial, the doctors were Gastric Bypass surgeons and had little to no experience with lap bands, while the Johnson & Johnson Realize Band trial was done by surgeons with more experience in Gastric Banding. Therefore, it is likely that the famous “learning curve” adversely affected the Inamed trial.

It is also true that the first three Inamed models had many factory disadvantages. Proof of this is that they have been pulled out slowly from all world markets, and Inamed has changed those first models for two different improved devices with fewer design problems.

Regardless of this last statement, we can conclude that the trials can not be compared, as the factors involved differ. I believe there is more to do to improve the lap bands and that we will see changes on this matter in the near future. I am placing the result of both trials for you to review and make your own conclusions.

Johnson & Johnson’s Realize Band trial
Realize Band - U.S. Clinical Trial N=276
Key Serious Adverse Events

Band slippage 9 (3.3%)17
Band erosion 1 (0.4%)17
Port displacement 7 (2.5%)17
Band explantations 417
Port revisions/replacements 2717

Inamed’s Lap-Band trial
Lap-Band® - U.S. Clinical Trial N=299
Key Serious Adverse Events

Band slippage 11 (3.7%)18
Band erosion 1 (0.3%)18
Port displacement 18(6.0%)18
Band explantations 75
Port revisions/replacements 26

Arturo Rodriguez, M.D

     

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