Allergan & Realize bands recall information

[pumpkin]

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

[2011Mommy]

Hi! I posted on the other board in the Failed Lapband Forum for more info on the recall. Since then, I have contacted the doctor and was provided the following information about my band:
Band Type: Inamed Band
Band Size: 11 cm
Fill Capacity: 9 cc saline
Serial #: 11559956
How do I know if it was recalled? What are they doing about the recall?
I work for a medical manufacturer myself (CPAP devices) and my understanding is that if there is a recall there needs to be a solution of some sort...

[pumpkin]

Dec 20, 2011 23:28:02 GMT -5 2011Mommy said:

Hi! I posted on the other board in the Failed Lapband Forum for more info on the recall. Since then, I have contacted the doctor and was provided the following information about my band:
Band Type: Inamed Band
Band Size: 11 cm
Fill Capacity: 9 cc saline
Serial #: 11559956
How do I know if it was recalled? What are they doing about the recall?
I work for a medical manufacturer myself (CPAP devices) and my understanding is that if there is a recall there needs to be a solution of some sort...

Maybe you could try contacting this guy at the FDA. His current job in regards to Allergan is described below, I bet he would be able to point you in the right direction.

Whatever happens, can you please update me on this thread and quote this when you do ....THANKS.

www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc m283455.htm

FDA issues Warning Letters for misleading advertising of Lap-Band
Ads lack information on risks of gastric banding

The U.S. Food and Drug Administration today announced that it has taken action against eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, an FDA-approved device used for weight loss in obese adults.

The FDA issued Warning Letters to Bakersfield Surgery Institute Inc.; Beverly Hills Surgery Center; Palmdale Ambulatory Center; Valley Surgical Center; Top Surgeons LLC; Valencia Ambulatory Center LLC; Cosmopolitan Plastic & Reconstructive Surgery; San Diego Ambulatory Center LLC; and to 1-800-GET-THIN because Lap-Band is a restricted medical device that is misbranded as a result of misleading advertising by these groups.

In the letters, the FDA warns that billboards and advertising inserts used by recipients of the Warning Letters to promote the Lap-Band procedure fail to provide required risk information, including warnings, precautions, possible side effects and contraindications. The FDA also is concerned that the font size of information related to risks on the advertising inserts is too small to be read by consumers. [what about the TV ads??]

"The FDA takes seriously its responsibility to protect consumers from products promoted without adequate warnings,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “It's particularly troublesome when advertisements don’t communicate the serious risks associated with medical devices."

If the affected companies do not change the advertising and promotion strategies to address the concerns raised by the FDA, the agency is prepared to take further action, which could include product seizure or civil money penalties.

The Lap-Band is a gastric band, an implanted medical device used in a surgical procedure for weight loss in obese adults who have a body mass index (BMI) of 30-40, with one or more obesity-related medical conditions (such as type II diabetes and hypertension), or in patients with a BMI of 40 or over with or without an obesity-related medical condition. Gastric banding is used when non-surgical weight loss methods (such as supervised diet, exercise and behavior modification) have not been successful. Patients considering gastric banding must be willing to make major changes in their eating habits and lifestyle.

“The decision to undergo a gastric banding procedure should be done in close consultation between a patient and his or her health care provider,” said Kimber Richter, M.D., deputy director for medical affairs in the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “It is important for the patient to fully understand both the risks and the benefits of the procedure and for the health care provider to be sure the procedure is appropriate for the patient.” [like maybe not implanting it in patients with a BMI > 45?]

The Lap-Band has not been approved for use in children younger than 18. Only those who are able and willing to follow dietary and other health and lifestyle recommendations should consider the procedure. It’s important that patients and their physicians are aware of and understand the limitations of gastric banding.

Health care providers who choose to promote the gastric banding procedure are required to educate patients about the risks involved, which must also be included in any advertising and promotional materials. Patients considering the surgery should read the patient information provided by their doctor and should ask any questions they have about gastric banding before having surgery.

If you suspect a problem with a gastric banding device, the FDA encourages you to file a voluntary report through MedWatch1, the FDA Safety Information and Adverse Event Reporting program. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

For more information:

* Warning Letters2
* Gastric Banding3
* FDA Targets Gastric Banding Weight-Loss Claims4
* MedWatch, the FDA Safety Information and Adverse Event Reporting program5

[2011Mommy]

I spoke to a Robert with Allergan Santa Barbara office today. He let me know that the recall was not on the actual band, but on the directions for use (the diagram that is included with the band). He stated that it was a class 2 recall and that any patient harm was highly unlikely.
Working for a medical manufacturer myself, I know that it actually takes a lot for an official recall with retrieval of product. The best we can do it keep contacting the FDA as well as Allergan. Allergan is REQUIRED to keep a record of every complaint.
Let me know if you have any other suggestions/recommendations.

[pumpkin]

Dec 22, 2011 15:18:43 GMT -5 2011Mommy said:

I spoke to a Robert with Allergan Santa Barbara office today. He let me know that the recall was not on the actual band, but on the directions for use (the diagram that is included with the band). He stated that it was a class 2 recall and that any patient harm was highly unlikely.
Working for a medical manufacturer myself, I know that it actually takes a lot for an official recall with retrieval of product. The best we can do it keep contacting the FDA as well as Allergan. Allergan is REQUIRED to keep a record of every complaint.
Let me know if you have any other suggestions/recommendations.

Can you please bring Diana on over to this thread and see what she has to say about it ?

[pumpkin]

Dec 22, 2011 15:18:43 GMT -5 2011Mommy said:

I spoke to a Robert with Allergan Santa Barbara office today. He let me know that the recall was not on the actual band, but on the directions for use (the diagram that is included with the band). He stated that it was a class 2 recall and that any patient harm was highly unlikely.
Working for a medical manufacturer myself, I know that it actually takes a lot for an official recall with retrieval of product. The best we can do it keep contacting the FDA as well as Allergan. Allergan is REQUIRED to keep a record of every complaint.
Let me know if you have any other suggestions/recommendations.

Call the FDA guy and see if the Allercrap guy is being truthful and then get back to us PLEASE.

[2011Mommy]

Dec 24, 2011 11:35:09 GMT -5 pumpkin said:

Dec 22, 2011 15:18:43 GMT -5 2011Mommy said:

I spoke to a Robert with Allergan Santa Barbara office today. He let me know that the recall was not on the actual band, but on the directions for use (the diagram that is included with the band). He stated that it was a class 2 recall and that any patient harm was highly unlikely.
Working for a medical manufacturer myself, I know that it actually takes a lot for an official recall with retrieval of product. The best we can do it keep contacting the FDA as well as Allergan. Allergan is REQUIRED to keep a record of every complaint.
Let me know if you have any other suggestions/recommendations.

Call the FDA guy and see if the Allercrap guy is being truthful and then get back to us PLEASE.

Yes, I can do that next week if they are open during the holidays. Otherwise I will call the week after. Also, I have personal experience working with a medical device recall - I don't want to get into it on a public (or semi public forum). I'm not sure if you do as well, but if you need any info, I can let you know what I know.

[grdngrl]

The ports are crap - I had to have another surgery two months after having the band put in because the port wouldn't work. It was tested in the operating room before it was put in and it was fine.

Grrrrr, then a third surgery a year and seven months later to yank the band it out when it was making me sick, other than the barfing.

Buyer beware I guess, can't trust the companies.

[pumpkin]

Dec 24, 2011 13:01:49 GMT -5 2011Mommy said:

Dec 24, 2011 11:35:09 GMT -5 pumpkin said:

Call the FDA guy and see if the Allercrap guy is being truthful and then get back to us PLEASE.

Yes, I can do that next week if they are open during the holidays. Otherwise I will call the week after. Also, I have personal experience working with a medical device recall - I don't want to get into it on a public (or semi public forum). I'm not sure if you do as well, but if you need any info, I can let you know what I know.

Any news yet ? You can PM me if you want to keep this private.

[mindyntexas]

I Called the FDA and left a message on Friday , I will call them back on Monday to see what they say . I am very hesitant to call Allergen but I will do that on Monday as well

[mindyntexas]

I Just called Allergan and they told me there was no recall , after spending 10 minutes on the phone w/ the lady she finally " Found it " she said it was just a "re education" for the doctors. So i said " Really then why did it only involve certain bands " she said " Umm umm i am not sure, can i take your info and call you back " I said " NO I"ll call the FDA !"