Realize Band Recall
Doctor Answers 3
Realize band recall
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.
Realize Recall...What Does It mean For You?
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.
Realize Band recall
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.