Safety & Effectiveness

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

The following information is from peer-reviewed published studies that were not part of the United States clinical trial in which the FDA approval was based. Click here for additional Safety and Effectiveness information on the United States clinical trial.

Safety:

The LAP-BAND^® System is safe and is designed to minimize the potential for complications.

• Minimally invasive procedure, with no stapling or dividing of native tissue required
• Lower short-term mortality rate than standard Roux-en-Y gastric bypass (RYGB) or vertical banded gastroplasty (VBG)⁵
• Fewer total complications than with RYGB or biliopancreatic diversion (BPD) (9% vs 23% with RYGB and 25% with BPD—P<0.001)⁴
• Shorter hospital stays and faster recovery times than with RYGB or BPD⁵

Effectiveness:

Weight Loss

The LAP-BAND^® System provides weight loss comparable to that seen with standard gastric bypass.

• Experience in a recent U.S Study has shown a 62% +/- 20.9% mean excess weight loss at 36 months, which is comparable to the weight loss seen after gastric bypass. By month 36, follow-up data were available for 68 patients³

• A meta-analysis of multiple studies showed that weight loss with laparoscopic adjustable gastric banding (LAGB) is comparable to standard Roux-en-Y gastric bypass surgery (RYGB) at 36 months and beyond⁴

Health Improvements

Weight loss with the LAP-BAND^® System has been associated with a rapid resolution or improvement of some comorbid conditions.

• 90% resolution or improvement of asthma, type 2 diabetes, sleep apnea, and gastroesophageal reflux^7,8,9,10

• 79% resolution or improvement of hypertension based on a subset of obese, diabetic patients⁸

• Surgically induced weight loss, in general, is also associated with resolved or improved¹¹:

• Urinary incontinence
• Infertility
• Complications of pregnancy and delivery
• Degenerative joint disease
• Venous stasis disease
• Nonalcoholic hepatic steatosis (NASH)