RECALL Relize band

[redone 0]

I have this band and can't believe it's a voluntary recall. WTF. So if you want to fix it do you have to pay for it and you have to surgury again. I am not a happy camper!!!:cursing:

[LarraineM 6]

Are you kidding ????????????????????seriously. When did th erecall happen?

[mrsbure 0]

I spoke to Ethicon yesterday and was told that it is a 1 in 10,000 chance that you will have an issue. The reason for the recall is that the tubing can get kinked at the strain relief on the port side which makes it hard to get a fill. She also told me the fix is done in the Dr.'s office under local anesthetic. I just got the Realize band almost 3 weeks ago. I go for my first fill next week. I'm not going to worry about it unless there is a problem.

[ElfiePoo 109]

For those worried, I found this...have to say I'm not worried at all about my band.

VOLUNTARY RECALL OF REALIZE® ADJUSTABLE GASTRIC BAND

CINCINNATI - October 13, 2010 - Obtech Medical Sàrl, a medical device manufacturer, and Ethicon Endo-Surgery (EES), in cooperation with the U.S. food and Drug Administration (FDA), have initiated a voluntary worldwide recall of existing inventory of adjustable gastric band systems sold under the brand name: REALIZE® Adjustable Gastric Bands. There is no action required for patients who already have received these gastric bands, and removal (explantation) of the gastric band is not required.

The voluntary recall was undertaken 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. In these rare cases, the Tubing Strain Relief may slide along the catheter tubing that connects to the Injection Port. If this happens, the Tubing Strain Relief can no longer aid in preventing kinking where the tubing connects to the port. The Tubing Strain Relief was an enhancement made to the gastric band system to address tube kinking, a complication common to all gastric bands.

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 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. The reported incidence of the Tubing Strain Relief sliding out of its intended position is less than 1 in 1,000. The reported incidence of tube kinking at the port related to the Tubing Strain Relief sliding out of position is 1 in 10,000. There have been no reported cases of gastric band removal due to the Tubing Strain Relief sliding out of position.

As part of our ongoing commitment to improve the safety and effectiveness of the band, EES identified this issue as part of the company's continuous improvement program and developed an enhanced design of the component that was approved by the FDA. Hospitals and clinics will receive the enhanced replacement product upon returning the recalled product. All new orders will receive the updated product.

About the Realize® Adjustable Gastric Band

The Realize® Adjustable Gastric Band is used in one type of weight-loss surgery. It contains two main components: the first is a fluid-filled balloon that is placed around the stomach; the second is an injection port to adjust the degree of Fluid in the band. Thin flexible tubing connects these two main components. The recall involves an ancillary component called the Tubing Strain Relief.

If surgeons or patients have any additional questions, they may call our Customer Support Center at 1-866-REALIZE (1-866-732-5493) for more information.

[redone 0]

Thank you> I wish they would have put more info on there web site. Maybe they did and I couldn't find it. I'm not as worrierd now. Thanks again!

[LarraineM 6]

Thats not true ! my fix was in surgery at the hospital. I was put under for the correct to be made

[samomom 19]

One more reason I'm glad my doctor won't use the Realize band. I asked about this Tuesday and it made no sense that you can leave a product in the body, but they'll take back the unused ones.

[BetsyB 9]

I have a Realize band and couldn't be less concerned about the issue they're addressing. It is not apt to ever pose a problem for any of us; if it does, it is easily correctible.

[ElfiePoo 109]

One more reason I'm glad my doctor won't use the Realize band. I asked about this Tuesday and it made no sense that you can leave a product in the body, but they'll take back the unused ones.

It's because they realize (no pun intended) that this is a weakness which has not necessarily been a problem. They've addressed the issue and corrected the problem. It makes sense to replace the old with the improved verions, but it makes no sense to put someone through surgery to replace the band when it may never cause a problem.

.

[tolpednurse 0]

I just had a port replacement last Friday for this exact reason... and I have the Lap Band AP!! From day 1 my doctor could fill but not withdraw Fluid. He explained there was a kink at the connection of the port and tubing. Not a fun repair, still really sore almost a week later and it was done in the hospital under consious sedation. On the positive note, I had to have fluid removed before I left the recovery area and the port worked like a champ.

[slm2007 7]

I'm assuming that because this was a voluntary recall in October 2010, taht the bands they used from say November 2010 forward were "corrected"?

[ElfiePoo 109]

I'm assuming that because this was a voluntary recall in October 2010, taht the bands they used from say November 2010 forward were "corrected"?

Assuming your surgeon did stop using the old ones...yes.

.

[Ryno 0]

Thats interesting to know.

Luckily my Band has no issues with adding or removing fliud so I'm at least at this point not the 1 out of 1000. lol