Safety and Effectiveness

Improvement and resolution of comorbidities

The LAP-BAND^® System is a safe, minimally invasive, completely reversible procedure, with no stapling or dividing of native tissue. It is designed to minimize the potential for complications and provides comparable weight loss to gastric bypass at 3 years, without the major complications.⁸ For more information about potential complications please see Risk Information.

Advantages of LAGB over other bariatric procedures

The safest bariatric procedure. Up to one-tenth the short-term mortality rates of open roux-en-Y gastric bypass (RYGB)³⁷, and a lower short term postsurgical mortality rate than laparoscopic sleeve gastrectomy (0.05% vs. 0.50% with RYGB and 0.39% with sleeve gastrectomy)^{9, 38}
Fewer early complications than RYGB or laparoscopic sleeve gastrectomy. Early complications with the laparoscopic gastric banding were reported at a rate of 1.5% vs. 25.5% with RYGB.^14,39
Greater adjustability than RYGB or laparoscopic sleeve gastrectomy. Laparoscopic gastric banding does not require stomach stapling or cutting, is adjustable, and fully reversible. RYGB and laparoscopic sleeve gastrectomy are permanent, nonadjustable procedures. In addition, laparoscopic sleeve gastrectomy may require a second surgery, doubling the risks associated with surgery and anesthesia.

Excess Weight Loss at:	%
24 weeks⁵	34*^†
48 weeks⁵	47.5*^†
Two years^48,5	53.3*^†

Improvement or resolution of obesity-related comorbidities⁴⁹
Asthma	57-100^{18,19,21,26,40,41}
Hypertension	48-100^{18,19,27,42,43,44,46}
Type 2 Diabetes	45-80^18,27,42,47
Obstructive Sleep Apnea	33-100^18,19,28,46
GERD	69-90^{18,19,21,29,46}

Complications
Mortality⁵⁰	0.1
Band slippage and pouch dilation¹³	11
Port Complications¹⁷	2
Aggravation of GERD symptoms¹⁷	3
Band Erosion¹⁷	1

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.^6,7

In the first 12 months (N=143):

The mean Excess Weight Loss (EWL) was 64.5%⁶
The mean reduction in Body Mass Index (BMI) was 6.5 points⁶
The mean reduction in waist circumference (in inches) for men was 6.1⁷ inches; women 5.9 inches

Weight loss results were maintained at year 2⁷

*Data based on interim analysis of ongoing LAP-BAND AP^® trial.

^† The LAP-BAND AP^® System was approved in the United States on the basis of a non-randomized, 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%) with complications reported such as band removal, reoperation, band slippage, vomiting, and heartburn.

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Data on File. Allergan, Inc. Irvine, CA. November , 2010.

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%).

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.

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Reference

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Safety and Effectiveness

Improvement and resolution of comorbidities

Advantages of LAGB over other bariatric procedures

Band Slippage

Description

Symptoms Include

Recommendation

Port complication

Description

Symptoms Include

Recommendation

GERD

Description

Symptoms Include

Recommendation

Band Erosion

Description

Symptoms Include

Recommendation

Pouch Dilatation

Description

Symptoms Include

Recommendation