Allergan & Realize bands recall information

www.realizemysuccess.com/VoluntaryRecall.htm

This was posted on the lapband, main and realize boards back in December when it occurred.  It is for a part that prevents the tubing from kinking and for older inventory that hospitals might have had on hand...no need for anyone to panic.

All patients have the right to be informed if they have one of the recalled bands Steph.
This is about being informed not " panic "

Was referring to this,

Your ****tin me!!!!!!  Does this mean it isn't the fault of the banded person being non compliant, not following the rules, etc????  Say it ain't so!!!!!  Ya mean all those azz wipe surgeons who blame the patient for everything may be mistaken?????  It just might be the piece of **** band that could be the problem?????  Well......I never..........!!!

Holey ****** ****Why doesn't the FDA do something about all the problems with the band?  Must be all the money the band manufactures line the pockets with.  Any other medical device that was causing as many problems as the band would have been taken off the market by now.

Case ya can't tell, I'm very bitter towards the band and the original surgeon who put it in. 

of course everyone has the right to know...don't know the facts about the Lap-band recall, but as far as Realize, there haven't been any posts from people on this site that have had issues with this part of their band, that I have seen.  This was a pretty active topic when it came out for us RBand folks.

Well it seems that that poster had a bad experience with their band so I don't blame them for being dramatic with their reply. The band can be terribly painful to live with and when one lives with chronic pain as I know you would understand.
One can on occasion feel bitterness toward the offending product which caused one to feel that pain.

I feel very passionate about when I see people who are using the fentanyl patch, as well as those who are suffering with their bands.

I'd like to address your comment below.

" as far as Realize, there haven't been any posts from people on this site that have had issues with this part of their band, that I have seen."

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

HEALTHCARE FACILITIES WERE INFORMED NOT PATIENTS.......

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.

NO CASES THAT DOCTORS ARE REPORTING....GEE I WONDER WHY.



REALIZE BAND




< Back to News

FDA Classifies Previous Field Action of Ethicon Endo-Surgery's REALIZE^®  Adjustable Gastric Band As Class II Recall

Cincinnati - November 03, 2010

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.

For media inquiries, please contact:
Bridgett Golden
Manager, Corporate Communications
513-337-7387

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.
 

www.ethiconendosurgery.com/newsinfo/healthcaremanagers/1066 NEW Failed Band group:
www.obesityhelp.com/group/failed_lap_bands/

When your Realize band is placed, you get access to their websitewww.realizemysuccess.com and that is where the information for the recall was placed to notify patients.  I also received an email notifying me.  I signed up for email alerts for any issues with my band when I registered on the site post-op.

I have no idea what the protocol is for the lapband, nor do I know what part the products listed play in the placement or maintenance of the lapband, so cannot speak to that.

I wonder how many people actually sign up for email alerts,change their email address without think of re-registering their bands, have Internet access.

Thanks for the data, Pumpkin!  Checked my product code and I'm good, but glad I checked. 

I'm glad I was able to provide it Lisa and I am very happy that you have been extremely successful with your band.

Awww thanks.  Yes, *SO FAR*, so good...but I will never put blinders on and tell myself nothing could ever happen.  I'm too much of a realist to go that route.  I'm sorry your experience has been nothing short of ****ty though, Pumpkin.  I hope things turn around for you soon!

Thanks Lisa, I appreciate that.