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WHY LAP BAND TRIALS WERE AWFULY DONE AND WITH POOR RESULTS

I would like to state an issue that came to me the other day. It is about the reports done for the trials held by Inamed first (late 90’s) and by Johnson & Johnson later (3 years ago) and how 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 and the huge difference shown is now being used to manipulate doctors and patients. The truth is that they weren’t done under the same circumstances.

The Lap Band trials were done by surgeons and placed in obese patients in both trials… so far so good. What they don’t talk about is the surgeons’ experience in placing the Inamed -Lap Band- during the first trial. The surgeons that were on the first trial were “Gastric Bypass surgeons” with no experience at all on Gastric Bands.

If we want to interpret correctly the results of the trials we must be placed first on the right perspective. The main difference between the trials is the surgeon’s ability and knowledge on the Lap Band. At the time of the Inamed trial the doctors had none, while the Realize Band trial was done with more experienced surgeons on Gastric Banding. The famous learning curve affected adversely 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 that 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 differs.

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 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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