Dreaded words "YOU HAVE A LEAK"

[okiekatt 40]

So, last Monday I went in for my 6th fill and was told that my band was only holding 3cc and the Doctor thought I might have a leak and had been watching it for the last couple of months?!?!?!?!, I was devistated. up until then I had believed everything was peachy and I just needed to keep getting my fills that eventually I would reach my green zone, they set me up for a "portagram" this morning and yes, it was confirmed that I have a leak in the port assembly, and I am scheuduled to have port replacement surgery this Wed. I have spent the last week searching this forum for any and all related experences, I have been praying please please pleaszzzzzzz dont let me have a leak...........but, I find myself not being upset at all, one of our fellow bandsters whos encourging word got me threw this last week, " I chose a lapband because if there was any problems it could be fixed" Yes it can be fixed and My new reformed hope thinks maybe this can work for me and maybe one day, I can be one of those people posting "I AM IN ONEDERLAND" sooooo to all you posters out there THANK YOU! you never know who you help!

[SlimbandSexy 1]

Such a positive post in spite of the complication you are having! Thank you!

I just posted about an infection around my port site today. I am worried about the possibility of having 2 more surgeries (1 to remove the band and another to put it back in) but you are so right.... It can be fixed!

So thanks for your post. It helps me feel a little better about this situation.

Hope your port replacement surgery goes well!!

[CheckYes 46]

So, last Monday I went in for my 6th fill and was told that my band was only holding 3cc and the Doctor thought I might have a leak and had been watching it for the last couple of months?!?!?!?!, I was devistated. up until then I had believed everything was peachy and I just needed to keep getting my fills that eventually I would reach my green zone, they set me up for a "portagram" this morning and yes, it was confirmed that I have a leak in the port assembly, and I am scheuduled to have port replacement surgery this Wed. I have spent the last week searching this forum for any and all related experences, I have been praying please please pleaszzzzzzz dont let me have a leak...........but, I find myself not being upset at all, one of our fellow bandsters whos encourging word got me threw this last week, " I chose a lapband because if there was any problems it could be fixed" Yes it can be fixed and My new reformed hope thinks maybe this can work for me and maybe one day, I can be one of those people posting "I AM IN ONEDERLAND" sooooo to all you posters out there THANK YOU! you never know who you help!

Do you have a REALIZE band? There was some issue with the port become detached from the tubing or something along those lines. Perhaps your doctor can determine whether your band fits within the recall and you might be able to make a claim to the manufacturer.

Here is the information:

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

Cincinnati - November 04, 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.

[CheckYes 46]

P.S.: I wouldn't normally have posted this for a leak, but when you said you were having a port replacement and not a band replacement, it made me wonder...

[okiekatt 40]

Do you have a REALIZE band? There was some issue with the port become detached from the tubing or something along those lines. Perhaps your doctor can determine whether your band fits within the recall and you might be able to make a claim to the manufacturer.

Here is the information:

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

Cincinnati - November 04, 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.

WOW! That is alot of useful info! I do not have a REALIZE band but I also did not ever know there had been a recall, Thank you for your post!

[okiekatt 40]

Such a positive post in spite of the complication you are having! Thank you!

I just posted about an infection around my port site today. I am worried about the possibility of having 2 more surgeries (1 to remove the band and another to put it back in) but you are so right.... It can be fixed!

So thanks for your post. It helps me feel a little better about this situation.

Hope your port replacement surgery goes well!!

Thank you very much SLIMANDSEXY, I hope everthing goes will with you too! its crazy when I think about all the time I read about lapband complications, I would see leaks and remember thinking what are the chances??? lol

I also have thought the same about the publishers clearing house.......sooooo maybe