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Realize Band Recall

  • 1 year ago
Have Realize bands been recalled?  What are the dangers of not having it replaced?  

Doctor Answers 3

Realize band recall

March 8th, 2011
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There was a voluntary recall of Realize bands that were not yet placed in patients.  The problem was with a connector that connected the tubing to the port would sometimes disconnect.  The main issue with this is if ever the band needed to be removed the surgeon would need to make sure they do not lose this piece.  I prefer to use the Allergan Lap-Band in my patients which has been approved by the FDA for a longer period of time in the USA.

Web reference: http://stopobesityforlife.com

Shawn Garber, MD, FACS, FASMBS
March 8th, 2011

Realize band recall

{{ voteCount >= 0 ? '+' + (voteCount + 1) : (voteCount + 1) }}

There was a voluntary recall of Realize bands that were not yet placed in patients.  The problem was with a connector that connected the tubing to the port would sometimes disconnect.  The main issue with this is if ever the band needed to be removed the surgeon would need to make sure they do not lose this piece.  I prefer to use the Allergan Lap-Band in my patients which has been approved by the FDA for a longer period of time in the USA.

Learn more: http://stopobesityforlife.com

Shawn Garber, MD, FACS, FASMBS

Realize Recall...What Does It mean For You?

April 26th, 2011
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In a word?  NOTHING!

The recall of the Realize Band was voluntary and involved only bands that were still sitting on the shelf!  Patients that have had Realize Bands placed inside of them definitely DO NOT have to have their band removed.  The voluntary recall involved a technical issue with the tubing and the port that to my knowledge had never caused a reportable problem for patients.  The company had devised a way to improve the mechanics of their port-tubing connection (i.e. "a better mousetrap") to reduce the chance of a port-tubing disconnection, a problem inherenct with all types of bands.

Here's an interesting fact about the Realize Band that most people don't know.  The Realize Band is known outside of the US as the Sweedish Adjustable Gastric Band (SAGB) and was one of the very first adjustable gastric bands EVER developed!  So even though the band has only been available in the US for a few years, it has been around a long, long time.  In fact, the balloon technology of this band has essentially remained unchanged since it's development which is a testament to its durability. 

Lloyd Stegemann, MD, FASMBS

Lloyd Stegemann, MD, FASMBS
Corpus Christi Bariatric Surgeon

April 26th, 2011

Realize Recall...What Does It mean For You?

{{ voteCount >= 0 ? '+' + (voteCount + 1) : (voteCount + 1) }}

In a word?  NOTHING!

The recall of the Realize Band was voluntary and involved only bands that were still sitting on the shelf!  Patients that have had Realize Bands placed inside of them definitely DO NOT have to have their band removed.  The voluntary recall involved a technical issue with the tubing and the port that to my knowledge had never caused a reportable problem for patients.  The company had devised a way to improve the mechanics of their port-tubing connection (i.e. "a better mousetrap") to reduce the chance of a port-tubing disconnection, a problem inherenct with all types of bands.

Here's an interesting fact about the Realize Band that most people don't know.  The Realize Band is known outside of the US as the Sweedish Adjustable Gastric Band (SAGB) and was one of the very first adjustable gastric bands EVER developed!  So even though the band has only been available in the US for a few years, it has been around a long, long time.  In fact, the balloon technology of this band has essentially remained unchanged since it's development which is a testament to its durability. 

Lloyd Stegemann, MD, FASMBS
Corpus Christi Bariatric Surgeon

Realize Band recall

February 1st, 2011
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This was a voluntary recall and you can call 1 800 REALIZE to get more information on this or go to the website realize.com .  At this point there is no clear indicaton for explanation or removal.

Ricardo M. Bonnor, MD, FACS

Ricardo M. Bonnor, MD, FACS
Houston General Surgeon
5.0 out of 5 stars 8 reviews

February 1st, 2011

Realize Band recall

{{ voteCount >= 0 ? '+' + (voteCount + 1) : (voteCount + 1) }}

This was a voluntary recall and you can call 1 800 REALIZE to get more information on this or go to the website realize.com .  At this point there is no clear indicaton for explanation or removal.

Ricardo M. Bonnor, MD, FACS
Houston General Surgeon

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.