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Allergan & Realize bands recall information

Pumpkin X .
on 5/14/11 6:29 am - Califreakinfornia , CA

RECALL INFORMATION

Dec 22---Allergan recalls Lap-Band Adjustable Gastric Band SYSTEMS

Manufacturer: -See Below-

Product: Medicals

Start Date: 2010-12-22  End Date: 2011-01-22


LAP-BAND Adjustable Gastric Band System; Product codes: B-2105 (ACCSS PRT II KIT (0-10CC) US), B-2106 (ACCESS PRT II KIT (0-14CC) US), B-2210 (LP-BND SYS, 9.75, STER, US), B-2215 (LAP-BAND 9.75 W/ACC PRT II US), B-2220 (LP-BND SYS, 10.0, STER, US), B-2225 (LAP-BND 10.0,ACCESS PORT II,US), B-2255 (LAP-BAND VG W/ACS PORT II (US), B-2260 (LP-BND AP STANDARD SYS, W ACC PRT II), B-2265 (LP-BND AP LG SYS, W/ACC PRT II); The Lap-Band System is a long-term implantable device intended to induce weight loss in morbidly obese patients by limiting food consumption restrictive and satiating, rather than malabsorptive). The device is surgically implanted, using either a laparoscopic or open procedure, to create a restricted opening (stoma) and a small gastric pouch to limit food consumption and induce early satiety. The main components of the device are the silicone elastomer band, access port. and kink-resistant tubing used to connect the other two components. The inner surface of the silicone band, which is placed around the stomach, is inflatable and connected by the tubing to the access port (a remote injection site. The access port is implanted on, or attached to, the rectus muscle to permit non-surgical, percutaneous adjustments to the band and thus, the stoma diameter, using sterile saline. Recall # Z-0418-2011

CODE
All Lot Numbers for the listed Product Codes

RECALLING FIRM/MANUFACTURER
Recalling Firm: Allergan, Goleta, CA, by letter dated September 15, 2010.

Manufacturer: Allergan Costa Rica, S.A., La Aurora De He, Costa Rica. Firm initiated recall is ongoing.

REASON
The recall was initiated after Allergan received reports which have been attributed to damage to the port caused by insertion of the needle into the septum of the port at an oblique angle. Allergan issued the notice to emphasize that when performing a LAP-BAND System adjustment, failure to inject the needle perpendicular to the access port septum, as described in Directions for Use, may lead to port damage which may result in subsequent port leakage. Port leakage results in deflation of the LAP-BAND System to its widest, open position and the need for a procedure to replace the port. This is most often diagnosed through discussions between the patient and clinician, based on symptoms of reduced satiety and increased appetite. Stalling of weight loss or even weight gain may also be seen.

VOLUME OF PRODUCT IN COMMERCE
Approx. 152,000

DISTRIBUTION
Nationwide

www.totalrecallinfo.com/freerecalls.php


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
greenolive
on 5/14/11 6:39 am
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. 
Pumpkin X .
on 5/14/11 10:50 am - Califreakinfornia , CA
greenolive
on 5/14/11 1:37 pm
Pumpkin,  to read my story go to lapbandtalk.com and search under 3636millie for my story. I lived the last few months with my lapband getting IV fluids about every other day.  Took the surgeon who did the revision quite a bit longer to do the revision than normal.  Turns out I had adhesions "under the band part of that piece of crap.  Basically, everywhere any part of the lap band touched developed adhesions.

Didn't mean to be so dramatic but that is my honest feelings about the lap band.  For those who posted that don't have trouble with the band, I am glad that they aren't having problems.  I just got tired of the original surgeon/his partner I used for the band blaming things on me.  It wasn't me, it was the band.

BTW, I love reading your posts!!  I wish you well in trying to get rid of your band.  Never give up.  Believe me, it is well worth the effort to revise to something else. 
Pumpkin X .
on 5/14/11 2:21 pm - Califreakinfornia , CA
On May 14, 2011 at 1:37 PM Pacific Time, greenolive wrote:
Pumpkin,  to read my story go to lapbandtalk.com and search under 3636millie for my story. I lived the last few months with my lapband getting IV fluids about every other day.  Took the surgeon who did the revision quite a bit longer to do the revision than normal.  Turns out I had adhesions "under the band part of that piece of crap.  Basically, everywhere any part of the lap band touched developed adhesions.

Didn't mean to be so dramatic but that is my honest feelings about the lap band.  For those who posted that don't have trouble with the band, I am glad that they aren't having problems.  I just got tired of the original surgeon/his partner I used for the band blaming things on me.  It wasn't me, it was the band.

BTW, I love reading your posts!!  I wish you well in trying to get rid of your band.  Never give up.  Believe me, it is well worth the effort to revise to something else. 
Can you copy your band story here for others to read or would you post it to my failed bands group ?

The link is in my siggy.

Thanks for the encouragement. I really appreciate it.
Pumpkin X .
on 5/14/11 10:54 am - Califreakinfornia , CA
" 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."

FDA Approval Expands Use of the LAP-BAND® System, With One-Third of Louisiana Population Now Potentially Eligible

LAP-BAND® Surgery, Performed by Surgical Clinic of Louisiana, Has Been Approved by the FDA for Overweight Individuals with a BMI of at Least 30

Surgical Clinic of Louisiana

Surgical Clinic of Louisiana

Quote startThe expanded use of the LAP-BAND® System for low BMI patients is a very exciting step in the battle against obesity.Quote end

Marrero, LA (Vocus/PRWEB) February 28, 2011

Those people in Louisiana who suffer from obesity can now benefit from a minimally invasive weight-loss surgical option with a long-term success record, which until recently was reserved only for those who were about 100 pounds overweight. In February 2011, the US Food and Drug Administration (FDA) approved the LAP-BAND® Adjustable Gastric Banding System for patients who have a body mass index (BMI) as low as 30 and have at least one weight-related comorbid condition, and who have failed more conservative weight-loss therapies, such as diet and exercise and prescription drugs.

Louisiana is number two on the list of obesity prevalence among the US states, with over 33% of the population classified as obese, according to the Centers for Disease Control and Prevention (CDC). The clinical definition of obesity is a BMI of at least 30, or excess weight of 50-70 pounds. Dr. David Treen and Dr. Todd Belott at the Surgical Clinic of Louisiana (SCLA), a comprehensive weight-loss surgery program and a certified Bariatric Surgery Center of Excellence®, consider the FDA-approved expanded use of the LAP-BAND® System for significantly less obese people very timely for Louisiana patients.

“The news of the expanded use of the LAP-BAND® System for lower BMI patients is a very exciting step in the nationwide battle against obesity, especially here in Louisiana”,” said Dr. Todd Belott. “Patients with a BMI of 30, or about 50 to 70 lbs overweight, have not been able to access surgical weight loss in the past. Now LAP-BAND® Surgery is available to help these patients, if they have struggled to sustain weight loss through exercise, diets and pharmacotherapy, and are looking for a long-term solution and a happier, healthier life.”

The FDA approval of the low BMI indication for the LAP-BAND® System was based on a review of the 24-month data from a multi-center study to determine the safety and effectiveness of the device as an obesity treatment for adults with a BMI between 30 and 40. The expanded LAP-BAND® System indication specifically qualifies obese patients with an obesity-related comorbid condition, such as heart disease, Type 2 diabetes, high blood pressure, sleep apnea or joint problems, as significant weight loss achieved through surgery is often associated with improved, or even resolved, health problems.

LAP-BAND® System is the first and only FDA-approved weight-loss surgery option for patients with a BMI of 30 to 35. Many insurance plans cover LAP-BAND® surgery in Louisiana, and Surgical Clinic of Louisiana provides insurance assistance and financing options to patients. The SCLA staff also specializes in pre- and post-op counseling and long-term support personalized for every patient.

About Surgical Clinic of Lousiana
Surgical Clinic of Louisiana offers a comprehensive weight-loss surgery program that includes counseling, education, and support before and after the procedure. Surgical Clinic of Louisiana and West Jefferson Medical Center are certified by the Surgical Review Corporation as a Bariatric Surgery Center of Excellence® and specialize in the LAP-BAND® System, gastric bypass and gastric sleeve surgery. Headquartered in Marrero, Louisiana, SCLA offers free informational weight-loss surgery seminars on a weekly basis. To learn more, please visit http://www.sclaweightloss.com or call 504-349-6860.


Emily F.
on 5/14/11 7:06 am
DS on 04/05/10 with
It says end date 1/22/11, does that mean just the lapband during that time frame or that's the only time they will replace them?? My sil has a lapband from 3 years ago so now I'm worried.
Pumpkin X .
on 5/14/11 10:35 am - Califreakinfornia , CA
I'm not exactly sure, but if you can call your doctor and get the serial number of you band then you can go from there. The way I read it was that those were the dates those particular bands were manufactured. You may have a band that was manufactured before that date. If I were you I would look into it.

I'm betting Diana would be able to answer your question(s) better then I can.
Emily F.
on 5/14/11 10:39 am
DS on 04/05/10 with
On May 14, 2011 at 10:35 AM Pacific Time, Pumpkin X . wrote:
I'm not exactly sure, but if you can call your doctor and get the serial number of you band then you can go from there. The way I read it was that those were the dates those particular bands were manufactured. You may have a band that was manufactured before that date. If I were you I would look into it.

I'm betting Diana would be able to answer your question(s) better then I can.
 I know she kept the box and everything with the product code, so I will check it when she gets back in town next week.  I can't believe I didn't hear about this before. Do they have to contact patients legally ??
Pumpkin X .
on 5/14/11 10:49 am - Califreakinfornia , CA
There is a lot of information about it on Google. I did read that Allergan and Johnson and Johnson had to send letters to their customers AKA Your doctor.

www.google.com/search For Realize bands and,

www.google.com/search For Allergan bands.
Stephanie M.
on 5/14/11 11:16 am
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.

 

  6-7-13 band removed. No revision. Facebook  Failed Lapbands and Realize Bands group and WLS-Support for Regain and Revision Group

              

Pumpkin X .
on 5/14/11 11:23 am - Califreakinfornia , CA
All patients have the right to be informed if they have one of the recalled bands Steph.
This is about being informed not " panic "
Stephanie M.
on 5/14/11 11:38 am
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.

 

  6-7-13 band removed. No revision. Facebook  Failed Lapbands and Realize Bands group and WLS-Support for Regain and Revision Group

              

Pumpkin X .
on 5/14/11 11:53 am - Califreakinfornia , CA
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/

Stephanie M.
on 5/14/11 12:24 pm
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.


 

  6-7-13 band removed. No revision. Facebook  Failed Lapbands and Realize Bands group and WLS-Support for Regain and Revision Group

              

Pumpkin X .
on 5/14/11 2:17 pm - Califreakinfornia , CA
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.


(deactivated member)
on 5/14/11 2:27 pm - San Diego, CA
Thanks for the data, Pumpkin!  Checked my product code and I'm good, but glad I checked. 
Pumpkin X .
on 5/14/11 2:33 pm - Califreakinfornia , CA
I'm glad I was able to provide it Lisa and I am very happy that you have been extremely successful with your band.
(deactivated member)
on 5/14/11 3:22 pm - San Diego, CA
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!
Pumpkin X .
on 5/15/11 6:58 am - Califreakinfornia , CA