Realize Recall

[Cocoabean 430]

Hi Everyone,

I just stumbled across this today. I don't know what the implications are or who it affects...

http://www.ethiconendosurgery.com/newsinfo/clinicians/1066

[CheckYes 46]

I figured I'd put the text here...

Obtech Medical Sàrl, a medical device manufacturer, and Ethicon Endo-Surgery (EES), today announced the U.S. food and Drug Administration (FDA) has classified the companies' previous field action related to adjustable gastric band systems sold under the brand name REALIZE^® Adjustable Gastric Bands as a Class II recall, as expected.

The voluntary recall, initiated on October 11, 2010 involves existing inventory only. Healthcare facilities were notified to immediately discontinue use of the device and return all unused REALIZE^® Bands to EES. Since then, customers have been receiving an enhanced product, recently approved by the FDA, to replace the recalled inventory and for all new orders. There is no action required for patients who already have received these gastric bands, and removal (explantation) of the gastric band is not required.

EES initiated the voluntary worldwide recall of existing inventory of adjustable gastric band systems sold under the brand name REALIZE^® Adjustable Gastric Bands due to reports of the potential for the Tubing Strain Relief, a small (2 centimeter) flexible sheath on the band’s Injection Port, to slide out of its intended position. Movement of the Tubing Strain Relief is highly unlikely to cause any serious injury or adverse health consequences and it rarely affects the band’s function. In the extremely rare instance (1 in 10,000) when tube kinking occurs at the Injection Port, the physician might be unable to adjust Fluid volume within the gastric band, which may require additional surgery to correct. In most instances, this procedure can be performed under local anesthesia and in an outpatient setting. There have been no cases of gastric band removal due to the Strain Relief sliding out of position.

Patient health and safety is our utmost concern. EES identified the Tubing Strain Relief issue through its continuous quality monitoring program. With the full knowledge of the FDA, healthcare facilities were notified of the recall by official letter beginning October 11, 2010, and then by subsequent communications from EES sales representatives. The initial letter included detailed recall instructions, including the specific product codes and lot numbers affected. EES also has provided customers and third-party advocacy organizations with information for patients on the recall. Regulatory authorities worldwide also have been informed.

If surgeons or patients have any additional questions about the REALIZE^® Band recall, they may call our Customer Support Center at 1-866-REALIZE (1-866-732-5493) between 7:30 am and 6:30 p.m. Eastern Daylight Time, Monday through Friday.

[ElfiePoo 109]

I spoke to my doctor about this. They aren't recalling them because so many have turned out to be defective and need to be replace. They're being recalled because of a 'potential' problem. That's why they're only recalling those that haven't been used and not worrying about the ones that have been installed...unless there's an actual problem..

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[Cocoabean 430]

Thanks checkyes. And elfie for the info. I did a search on the forum before I posted it and didn't find anything. Then a while later repeated the search snd found two threads.

I have a Lap Band, so doesn't apply to me, but wanted to share the info.

[pupwup 0]

anyone know how it is determind you have a bad lapband? A friend could not loose weight anymore and hers had slipped and allowed the stomachmore room!

[ElfiePoo 109]

anyone know how it is determind you have a bad lapband? A friend could not loose weight anymore and hers had slipped and allowed the stomachmore room!

My surgeon said I'd know if my band slipped because there would be pain and I'd probably start throwing up. It may be different for everyone.

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