Have Realize bands been recalled? What is the danger of not replacing it?

Question

Have Realize bands been recalled?  What are the dangers of not having it replaced?

Shawn Garber, MD, FACS, FASMBS · Answer

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.

Lloyd Stegemann, MD, FASMBS · Answer

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.

Ricardo M. Bonnor, MD, FACS · Answer

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.

Michael F. Sedrak, MD - Account Suspended · Answer

if the realize band is fine and not causing problems, you can leave it alone. if it needs to be replaced for any reason, it would need to be replaced with an apollo lap band, or you would need to be converted to an alternate weight loss surgery to maintain weight loss.  but in and of itself, the recall does not mean something about the realize band is going to cause a problem and needs to be removed or replaced

Have Realize bands been recalled? What is the danger of not replacing it?

Answers (4)