Product Specifications

LAP-BAND^® System: A Minimally Invasive Approach to Treating Obesity

The LAP-BAND^® Adjustable Gastric Banding System is specially designed to limit food consumption in obese patients. And since the LAP-BAND^® System is the first and only FDA-approved device for bariatric surgery in patients with a BMI of ≥ 30 kg/m² with one or more obesity related comorbid conditions, doctors and surgeons now have a new tool in the treatment of obesity.

When placed around the patient's stomach, the saline-filled LAP-BAND^® forms a small gastric pouch and stoma. Inflation of the band can be adjusted to control the amount of food a patient can comfortably consume.

Because the LAP-BAND^® System is placed laparoscopically, it is intended for use by surgeons with advanced laparoscopic skills. Click here for more information on becoming a certified LAP-BAND^® System surgeon.

Laparoscopic placement of the LAP-BAND^® System through very small incisions using instruments passed through ports negates the need for a large, open incision. The LAP-BAND^® System does not involve cutting or stapling of the stomach. The minimally invasive nature of the LAP-BAND^® System means patients are usually back home the day after the surgery and are generally able to resume their regular activities soon after surgery. Shorter hospital stays reduce strain on hospital resources.

Stoma size can be changed post-operatively to help control food intake — and therefore weight loss — by changing the amount of saline in the band through a subcutaneous access port. This eliminates the need for additional surgery for band adjustments. Adding saline to the band reduces stoma size while removing saline from the band increases stoma size.

Safe, Successful Weight Loss

The LAP-BAND^® System is an effective and safe strategy to support weight loss in morbidly obese patients. One year after surgery:

• In a recent publication, weight loss with the LAP-BAND^® System averages 44%¹

94.1% of patients were satisfied with the LAP-BAND AP^® System (N=272)^2*

Five-year post-operative weight-loss results with the LAP-BAND^® System are comparable to those achieved with gastric bypass surgery.³ Parikh et al report that the LAP-BAND^® System has a very low perioperative severe complication rate (less than 1%).⁴

For those with a Body Mass Index (BMI) between 30 and 40, a new study (N=149) shows that the LAP-BAND^® System provides significant results.⁵

In the first 12 months (N=143):

• The mean Excess Weight Loss (EWL) was 64.5%⁵
• The mean reduction in Body Mass Index (BMI) was 6.5 points⁵
• The mean reduction in waist circumference (in inches) for men was 6.1 inches; women 5.9 inches⁶

• Weight loss results were maintained at year 2⁶

Nutrient absorption is not altered in patients with the LAP-BAND^® System because the gastrointestinal tract is not drastically altered after placement of the LAP-BAND^® System. In contrast, gastric bypass patients may require vitamin supplements for the rest of their lives because their ability to properly absorb nutrients may be compromised following gastric bypass surgery.

RISK INFORMATION

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References

1. Ren CJ, Weiner M, Allen JW. Favorable early results of gastric banding for morbid obesity. Surg Endosc. 2004;18:543-546.

   The LAP-BAND AP^® System was approved in the United States on the basis of a nonrandomized, single-arm study (N=299). Significant improvement in percent of excess weight loss vs baseline was achieved at 12 months (34.5%), 24 months (37.8%), and 36 months (36.2%).

2. Data on File. Allergan, Inc. Irvine, CA. October 2009.
   *Patient satisfaction data was collected during the APEX study, an observational study that used a global questionnaire to ask patients it they were: very satisfied, satisfied, indifferent, or dissatisfied with their LAP-BAND AP^® experience. 84.1% of patients completed the questionnaire at their 48 week follow-up visit (272/323).

3. O'Brien PE, McPhail T, Chaston TB, et al. Systematic review of medium-term weight loss after bariatric operations. Obes Surg 2006;16:1032-1040.

4. Parikh MS, Laker S, Weiner M, Hajiseyedjavadi O, Ren CJ. Objective comparison of complications resulting from laparoscopic bariatric procedures. J Am Coll Surg. 2006; 202:252-261.

   Background: Several surgical treatment options for morbid obesity exist. Since no studies have objectively compared complication rates after laparoscopic bariatric operations, a retrospective review of all patients (n=780) undergoing these surgeries at a single institution from September 2000 to July 2003 was performed.

   Complications were categorized according to a standard classification system for surgical procedures. Grading based on the classifications set by Clavien and colleagues.

   Grade I - Events carrying minor risks
   Grade II - Events requiring intervention, eg, drug therapy, TPN, blood transfusions, therapeutics imaging, or reoperation
   Grade III - Events with residual and lasting disability and/or requiring organ resection
   Grade IV - Death as a result of any complication
   

5. Directions For Use (DFU). LAP-BAND AP^® Adjustable Gastric Banding System with OMNIFORM^® Design. Allergan, Inc. Irvine, CA. 02/11. The LAP-BAND^® System was approved in the United States on the basis of a nonrandomized, single-arm study (N=299). Significant improvement in percent of excess weight loss vs. baseline was achieved at 12 months (34.5%), 24 months (37.8%), and 36 months (36.2%).

6. LAP-BAND^® Adjustable Gastric Banding System P000008/S017. Gastroenterology and Urology Devices Panel, Food and Drug Administration. Accessed March 25, 2011 at: http://www.fda.gov/downloads/AdvisoryCommittees /CommitteesMeetingMaterials
   /MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM237422.ppt.