Posts Tagged ‘Inamed Band’

Are you Talking about Several Lap Bands? The Hidden Story Behind the Lap Band…PART II

Thursday, December 1st, 2011

Are You Talking About Several Lap Bands? The Hidden Story Behind the Lap Band…PART II

Since 2006, it has been reported world wide, that 200,000 Lap Band surgeries have been performed and that the Lap Band procedure is the fastest growing weight loss surgery in United States.  There are many different types and brands of lap bands available.  Take some time to read through the following details.

“Lap Band”

Inamed-Allergan Lap Band Models:

Lap Band Model 1: Lap Band 9.75 cm; maximum volume of 4 cc (high pressure balloon)

Lap Band Model 2: Lap Band 10 cm; maximum volume of 4 cc (high pressure balloon)

Lap Band Model 3: Lap band 11 cm; maximum volume of 9 cc (high pressure balloon)

These first 3 models of the Lap Band are almost out of the market or obtained for a very low price because of a high rate of complications such as slippage and de-banding.

Lap Band Model 4: Lap Band VG 11 cm; maximum volume of 10 cc (one inch without the low pressure balloon)

Lap Band Model 5: Lap Band AP 11 cm; maximum volume of 14 cc (360 degree low pressure balloon)

“Realize Band”

The Swedish Band was introduced in 1985.  As of 2007 in the United States, it’s now referred to as the Johnson & Johnson Realize Band, and is known as the Quick Close in Mexico. The changes made to the Realize Band and Quick Close have been to the fastening mechanism and to the port, but the length of the Lap Band or the balloon have not been altered.  Other Lap Bands available in the Latin and European markets are a lot less expensive, are not FDA approved and do not meet the minimum quality standards. By using these non FDA approved bands, the Lap Band procedure can be inadequate.

Why is the complication rate in the United States higher than in the rest of the World?

Facts:

Since June 5, 2001 the Gastric Band or Lap Band, as it is known in the United States, was FDA approved for use as an alternative for weight loss (small model). 

The only FDA approved Lap Band Model used for the first 3 years was the Inamed 9.75 cm (First out of five generations of the Lap Band).

In Mexico, this first Lap band Model hit the market in 1995.

The trials for getting the Inamed Lap Band approved by the FDA were done by surgeons with little experience in Lap Band technique and the very important Lap Band follow up and after care.

Many Bariatric Surgeons still have a poor conception of the Lap Band Procedure due to the inadequate results of the first trials.

The trials were performed with the short lap band model and without a comparative study with other Lap band devices, therefore the reports received from the Lap Band Centers, regardless of weight loss and complications, were collected incorrectly, falsely or insufficiently.

Inamed’s first three Lap Band models were short in length, very rigid and had a small high pressure balloon, resulting in more complications than the Swedish Lap Band.

The reports coming out of the United States indicate Lap Band slippage and erosion rates were higher in the USA vs. the rest of the world, because the only model used was the first Lap Band (9.75 cm).

In the end, we knew long before that poor quality and the rudimentary design of the Lap Band were responsible for the inadequate weight loss achieved and complications such as slippage and erosion because of the rigidity of the Lap Band, the small circumference and the high pressure balloon.

Promoters and brokers conceal this information to American patients traveling to Mexico for the Lap Band Surgery because they receive (and still receive) great deals and prices for selling the Lap Band (any model) across the border, resulting in high profits for them with no regard to the patient’s outcome.

 

Arturo Rodríguez, MD

http://www.thebariatric.com

http://www.bandstersforum.com

Originally posted 2008-10-11 08:04:24. Republished by Blog Post Promoter

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Lap Band Trials – Reviewing the Results

Wednesday, September 7th, 2011

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

http://www.thebariatric.com

Originally posted 2008-08-13 07:55:28. Republished by Blog Post Promoter

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