Compare LAP-BAND^® to Other Options

LAP-BAND^®
System Advantages

Video Transcript 

Weigh the options yourself.

While millions of severely overweight Americans do try diet, fitness, and medication programs to treat their obesity, these methods usually offer only short-term results.

When other efforts have failed, consider minimally invasive weight loss surgery with the LAP-BAND^® Adjustable Gastric Banding System.  With a track record you can trust, the LAP-BAND^® System has been proven to:

• Result in steady, healthy weight loss.^1,2
• Help patients KEEP weight off for a longer period of time than with nonsurgical treatments.³
• Be safer than, and as effective as, gastric bypass.²

No long-term studies have been conducted with sleeve gastrectomy.

See why so many people depend on the one and only original LAP-BAND^® System to help them achieve long-term weight loss success.

Diet and
Exercise OTC
Diet Aids LAP-BAND^® and
Realize™ Band Sleeve
Gastrectomy Gastric
Bypass

Although diet and exercise is the most common approach to weight loss, obese patients tend to regain their weight in a few years³ resulting in Yo-Yo dieting, which can make it harder to lose weight in the future. If you’re going to be on a weight loss program, it’s important to ensure your doctor regularly monitors your progress. Here are some other facts to consider:

• Severely overweight patients should talk to a doctor and consider weight loss surgery when other methods have failed.
• Significant long-term weight loss through surgery can improve overall wellness and obesity-related health conditions.^4-7

LAP-BAND® System	Diet and Exercise

Support
In addition to support from the experts at your doctor’s office, you’ll get practical tracking tools, recipes, articles, and advice available exclusively through My LAP-BAND® Journey, an online clinical support program	Freedom to choose the type of foods and exercise you like.  Unfortunately, self-imposed diet and exercise don’t always come with expert support or practical tools for sustaining weight loss

Results

Although weight loss of up to three pounds a week is possible, LAP-BAND® System patients average a healthy one-to-two pound reduction a week.8 Best of all, once patients meet their target weight, they often maintain it for years. In fact, according to a clinical study (N=100), LAP-BAND® System patients averaged up to a 59% reduction in excess weight after eight years9* *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%). The mean reduction in BMI was 8.5 at 12 months, 9.4 at 24 months and 8.8 at 36 months.1

Unfortunately, diet, fitness, and medication to treat obesity offer only short-term results. Studies show that obese patients on diets, exercise programs, or weight loss medications lose approximately 10% of their body weight, but tend to regain two-thirds within one year — and most of the weight within five years3

When you choose the LAP-BAND^® System, you will receive medical advice and support throughout your weight loss journey. With most over the counter (OTC) diet treatments, you’re on your own. Plus, OTC diet aids are not as strictly monitored by the FDA.

LAP-BAND® System	OTC diet treatments

Medical Support
• Patients have access to a comprehensive online support program throughout the weight loss journey with My LAP-BAND® Journey	Unlike with the LAP-BAND® System, no medical supervision is required for OTC drugs or diet treatments

FDA Approval
The LAP-BAND® System is monitored by the FDA (and has been approved since 2001)	The FDA does not monitor weight loss drugs and diet treatments sold over the counter as strictly as prescription drugs

Safety & Effectiveness
Nine years of safety and effectiveness — proven in clinical studies	The effectiveness of OTC dietary supplements is not frequently studied in large clinical trials

Long-Term Results
The LAP-BAND® System is a more permanent weight loss solution, lasting as long as the band remains implanted in your body	OTC drugs can offer effective weight loss. However, they have not been shown to lead to significant long term weight loss

There are several key reasons why more patients and surgeons choose LAP-BAND^® AP System over Realize™ Band. First, together with My LAP-BAND^® Journey and your LAP-BAND^® certified surgeon; you will receive support along every step of your personal journey. Next, the LAP-BAND^® System is the #1 selling gastric banding system in the world — remember to ask for it by name. In 2001, LAP-BAND^® became the first gastric band system approved by the FDA. Most importantly it has proven weight loss results. And you’re not alone on your weight loss journey, with My LAP-BAND^® Journey you have a clinical online support program every step of the way.

It's important to learn how different gastric bands compare to one another.

LAP-BAND AP® System	Realize™ Band

History of Use in the U.S.
FDA approved in 2001 — for a safety record six-years longer than Realize™ Band in the U.S. With three generations of improvements to the LAP-BAND® System, Allergan has the expertise in implantable silicone devices to bring ongoing innovation and advanced technology Nine years of experience in the U.S.	FDA approved in 2007 Two generations of improvements Three years of experience in the U.S.

Patient Use
LAP-BAND® System is the #1 selling adjustable gastric band chosen by surgeons and patients with over 550,000 LAP-BAND® Systems sold worldwide10	Approximately 100,000 Realize™ Bands sold worldwide11

Design Technology

Patented 360° OMNIFORM® technology is the most advanced technology available today and provides soft pillow-like sections for evenly distributed pressure Seven pre-curved, pillow-like sections embrace the stomach with a natural shape for evenly distributed pressure, to provide band stability, reliable restriction, and the ability to personalize adjustments to control food portion sizes for optimal weight loss

Realize™-C Band is one long tube-shaped balloon The single-tube balloon has the ability to kink like a rubber hose when filled with higher levels of saline (see photo below). Often referred to as a "crease-fold", over time it may cause the band to leak saline, which may require an operation to replace the band12,13

Customization
Two band sizes and two port sizes available — giving your surgeon four different combinations of options to customize your LAP-BAND® System to best fit your anatomy better and optimize your weight loss	Both Realize™ bands, including the latest Realize™-C Band, are available in one size only — with no options for customizing fit

Access Port Sizes

Two sizes — regular and slimmer, lower profile — allows you and your surgeon to select the best option for you The LAP-BAND® port is quickly and easily placed beneath your abdomen and secured with stitches. LAP-BAND® surgeons may also use surgical mesh material in which the port is sutured to the mesh and placed in the abdomen to secure the port.14 One report of 191 patients has shown that port fixation using surgical mesh may prevent rotation of the port after surgery, as well as providing better access for post-surgery adjustments.14

Available in one size, with no options for customizing fit

Adjustability
The LAP-BAND® APL System provides the largest range of adjustability of any band	Both Realize™ bands offer a narrower range of adjustability than the LAP-BAND® APL System

Patient Support

My LAP-BAND® Journey The My LAP-BAND® Journey program connects you directly with your surgeon The LAP-BAND AP® system is your "tool" to achieve your weight loss goals. Still, losing weight requires education, support, and visits to your surgeon Designed specifically for the adjustable gastric band, My LAP-BAND® Journey is your online clinical support tool and email program that helps you every step of your journey, from first learning about weight-loss options, to helping you prepare for surgery, to tracking and achieving your goals after surgery with FitDay™ tools, and living healthily ever after

Program supports multiple weight-loss surgery procedures

The LAP-BAND^® System is the #1 selling and most preferred adjustable gastric banding system in the U.S.¹⁰ Be sure to ask for it by name.

Sleeve gastrectomy (or gastric sleeve) is a restrictive procedure where the stomach is reduced to about the size of a banana using a large number of staples, and the larger part of the stomach is removed. The smaller stomach restricts or limits the amount of food you can eat but allows for normal digestion and absorption of nutrients. Sleeve gastrectomy is permanent. The procedures was originally developed as a two part treatment where the patient first has sleeve gastrectomy and once their weight reached a certain level, a second treatment such as gastric bypass was performed. In these cases, sleeve gastrectomy was designed for patients with a Body Mass Index (BMI) of 60 or higher.

The LAP-BAND^® System, on the other hand, involves no cutting or stapling of the stomach or intestinal rerouting, it is adjustable and reversible and designed for sustained weight loss. The LAP-BAND^® procedure is a restrictive procedure during which an adjustable gastric band is placed around the upper part of the stomach. This creates a smaller stomach pouch, which restricts the amount of food that can be consumed at one time and helps the patient to feel full sooner. As a result, patients achieve sustained weight loss by limiting food intake and reducing appetite while allowing for the normal absorption of nutrients.¹⁵

LAP-BAND® System	Sleeve Gastrectomy

Procedure Differences
The LAP-BAND® System is a restrictive device and requires no cutting, stapling, or removal of any part of your existing stomach. Instead, the LAP-BAND® is placed around the stomach to limit the amount of food it can hold	Similar to gastric bypass, sleeve gastrectomy (or gastric sleeve) requires stomach cutting and stapling to create a small sleeve shaped stomach, about the size of a banana — the larger part of the stomach is permanently removed

Adjustability
Can be quickly, easily, and non-surgically adjusted to affect weight loss results — during a brief doctor’s office visit	Since such a large part of the stomach is removed during the procedure, there are not really any “adjustments” to be made

Reversibility
While the LAP-BAND® System is a long-term weight loss solution, if necessary, the procedure can be reversed — with the stomach returning to its original shape	Due to stomach cutting and removal, this procedure is considered permanent and cannot be reversed Is performed as part of a two-part procedure where the second treatment can be gastric bypass, which is also permanent

Safety
LAP-BAND® is the only gastric banding system with a nine-year safety history — FDA approved since 2001	There is currently no long-term safety data in the U.S. on sleeve gastrectomy

Results
LAP-BAND® System has been proven in studies to significantly reduce weight and body mass steadily and consistently with patients maintaining their weight loss over time1,16 Weight loss with the LAP-BAND® System was shown in one study to resolve (76%) or improve (14%) gastroesophageal reflux (N=48)4	Results are expected to be similar to gastric bypass, which may result in some weight gain. Typically long-term weight loss results are comparable to adjustable gastric banding17

Risks

No risk of staple-line leakage, as there is no cutting or stapling of the stomach with LAP-BAND® System surgery Mortality rate: 0.05%19 Total complications: 9%20 Major complications: 0.2%20 Most common include: • Standard risks associated with major surgery • Nausea and vomiting21 • LAP-BAND® System slippage • Stoma obstruction Click here for important safety information. In clinical studies, there have been no reported risks for renal failure after this procedure

With sleeve gastrectomy, there is a risk of possible staple-line leakage, which may require additional surgery to resolve With this procedure, there is also a risk of gastric reflux and esophagitis18 Mortality rate: <1%18 Major complications: 2.9%18 Complications include: gastric remnant dilation, suture line bleeding and leakage,and gastric strictures22 There is a risk of renal failure after having the bariatric sleeve procedure20

Patient Support
My LAP-BAND® Journey helps doctors and patients to work together to maximize weight loss and maintain success	No standardized system for follow-up care and motivation of patients. Follow-up care varies by surgeon or practice

Gastric bypass (also known as the Roux-en-Y) is a combination procedure using both restrictive and malabsorptive elements meaning that you absorb fewer nutrients and calories. With this surgery, first the stomach is stapled to make a smaller pouch. Then most of the stomach and part of the intestines are bypassed by attaching (usually stapling) a part of the intestine to the small stomach pouch. Gastric bypass is non-adjustable and has increased risk of post operative complications.^15,20

The LAP-BAND^® System, on the other hand, involves no cutting or stapling, is adjustable, is designed for sustained weight loss and there’s low malnutrition risk. The LAP-BAND^® procedure is a restrictive procedure during which an adjustable gastric band is placed around the upper part of the stomach. This creates a smaller stomach pouch, which restricts the amount of food that can be consumed at one time and increases the time it takes for the stomach to empty. As a result, patients achieve sustained weight loss by limiting food intake, reducing appetite, and slowing digestion.¹⁵

LAP-BAND® System	Gastric Bypass

Procedure Differences
The LAP-BAND® System requires no cutting, stapling, or removal of any part of your existing stomach, nor any intestinal rerouting15	In this procedure, cutting and stapling of stomach and bowel as well as rerouting of the intestine is required15

Adjustability
Can be quickly, easily, and non-surgically adjusted to affect weight loss results23 — during a brief doctor’s office visit	To make any “adjustments” or to improve weight loss results from this procedure, additional surgery may be necessary

Reversibility
The LAP-BAND® System is reversible and, if necessary, can be removed — with the stomach usually returning to it’s original shape	Extremely difficult to reverse, requiring additional, complicated surgery — without guarantee of success

Results
Long-term results (three to five years) with the LAP-BAND® System yield comparable results to the gastric bypass — without the associated risks of the more invasive bypass procedure2	May offer more rapid initial weight loss but some patients with gastric bypass will regain some weight over time24 After about three years, weight loss is comparable to the LAP-BAND® System2

Risks

A less invasive operative procedure, the LAP-BAND® System also has a lower rate of operative complications20 Since none of the intestine is removed or bypassed, there are low risks of problems absorbing necessary nutrients25,26 You will not lose as much lean muscle mass and bone mass as with gastric bypass, which means you maintain more of the lean muscle mass you need to keep your metabolism working effectively27,28 There is no risk of “Dumping Syndrome” since no part of the intestinal tract is bypassed with the LAP-BAND® System Mortality rate: 0.05%19 Total complications: 9%20 Major complications: 0.2%20 Most common include: • Standard risks associated with major surgery • Nausea and vomiting21 • LAP-BAND® System slippage • Stoma obstruction Click here for important safety information. The risk of short term death following surgery is 10 times less compared to gastric bypass29

As stomach cutting, removal and stapling are involved in this procedure, gastric bypass can also have more operative complications20 As this procedure “bypasses” a portion of your intestine, it may increase the risk for anemia, osteoporosis and other medical complications due to nutritional and vitamin deficiencies24,25 In addition, you may lose more lean muscle mass than you will with LAP-BAND®27 Risk of “Dumping Syndrome” – a condition that may occur when food is rapidly passed (dumped) from stomach to upper intestine. Symptoms may include cramps, nausea, speeding or slowing of the heart, etc. Mortality rate: 0.5%19 Total complications: 23%20 Major complications: 2%20 Most common include: • Standard risks associated with major surgery • Nausea and vomiting15 • Separation of stapled areas21 (major revisional surgery) • Leaks from staple lines (major revisional surgery)20 • Nutritional Gastric bypass has a higher risk of short-term death following surgery compared to LAP-BAND®29

1. Directions For Use (DFU). LAP-BAND AP^® Adjustable Gastric Banding System with OMNIFORM^® Design. Allergan, Inc. Irvine, CA. 08/09. 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%).
2. O’Brien PE, et al. Systematic review of medium-term weight loss after bariatric operations. Obes Surg. 2006;16(8):1032-1040.
3. American Association of Clinical Endocrinologists/American College of Endocrinology Obesity Task Force. AACE/ACE Position Statement on the Prevention, Diagnosis, and Treatment of Obesity (1998 Revision). Endocr Pract. 1998;4:297-350.
4. Dixon JB, O’Brien PE, Gastroesophageal reflux in obesity: the effect of Lap-Band placement. Obes Surg. 1999;9:527-531.
5. Dixon JB, Chapman L, O’Brien P. Marked improvement in asthma after Lap-Band^® surgery for morbid obesity. Obes Surg. 1999;9:385-389.
6. Dixon JB, O’Brien PE. Health outcomes of severely obese type 2 diabetic subjects 1 year after laparoscopic adjustable gastric banding. Diabetes Care. 2002;25:358-363.
7. Dixon JB, Schachter LM, O’Brien PE. Sleep disturbance and obesity. Arch Intern Med. 2001;161:102-106.
8. A Surgical Aid in the Treatment of Morbid Obesity, LAP-BAND^® System Information for Patients (P/N 94829). Allergan, Inc. Irvine, CA. April, 2008.
9. Weiner R, Blanco-Engert R, Weiner S, et al. Outcome after laparoscopic adjustable gastric banding – 8 years experience. Obes Surg. 2003;13:427-434.
10. Data on File. Allergan, Inc. Irvine, CA. November, 2009.
11. FDA approves REALIZE™ adjustable gastric band for morbid obesity. Ethicon Endo-Surgery, Ind., press release. Available at: http://www.ethiconendo.com/dtcf/pages/press_room_4.htm. Accessed on September 23, 2008.
12. Mittermair RP, Weiss HG, et al. Band Leakage after Laparoscopical Adjustable Gastric Banding. Obes Surg. 2003; 13:913-917.
13. Reijnen M, Naus JH, et al. Mechanical Evaluation of a Ruptured Swedish Adjustable Gastric Band. Obes Surg. 2004;14:253-255.
14. Piorkowski JR, Ellner SJ, Mavanur AA, Barba CA, Preventing port site inversion in laparoscopic adjustable gastric banding, Surg Obes Relat Dis. 2007 Mar-Apr;3(2):159-61; discussion 161-162.
15. Weight-control Information Network (WIN), an information service of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Gastrointestinal Surgery for Severe Obesity. December 2004. Available at: http://win.niddk.nih.gov/publications/gastric.htm. Accessed May 2, 2007.
16. Data on File. Allergan, Inc. Irvine, CA. April, 2009.
17. Weiner RA, et al. Laparoscopic Sleeve Gastrectomy – Influence of Sleeve Size and Resected Gastric Volume. Obes Surg. 2007;17(10):1297-1305.
18. Lalor PF, et al. Complications after laparoscopic sleeve gastrectomy. Surg Obes Relat Dis. 2008;4:33-38.
19. Chapman A, et al. Systematic review of laparoscopic adjustable gastric banding for the treatment of obesity: update and re-appraisal. Executive summary. ASERNIP-S Report No. 31. Second edition. Adelaide, South Australia: ASERNIP-S, June 2002.
20. Parikh MS, et al. Objective Comparison of Complications Resulting from Laparoscopic Bariatric Procedures. J Am Coll Surg. 2006; 202:252-261.
21. Clegg AJ, et al. The clinical effectiveness and cost-effectiveness of surgery for people with morbid obesity: a systematic review and economic evaluation. Health Technol Assess. 2002;6:1-153.
22. Aggarwal S, et al. Laparoscopic sleeve gastrectomy for morbid obesity: a review. Surg Obes Relat Dis. 2007;3:189-194.
23. Fakhro, J. Comparison between laparoscopic gastric banding and laparoscopic sleeve gastrectomy. World Journal of Laparoscopic Surg. 2008; 1(2): 29-31.
24. Faria SL, Kelly E, Faria OP. Energy Expenditure and Weight Regain in Patients Submitted to Roux-en-Y Gastric Bypass. Obes Surg. Apr 28 2009.
25. Bernert CP, et al. Nutritional Deficiency after Gastric Bypass: Diagnosis, Prevention and Treatment. Diabetes & Metab. 2007; 33:13-24.
26. Vilarrasa, N. Evaluation of bone disease in morbidly obese women after gastric bypass and risk factors implicated in bone loss. Obes Surg. 2009; 19: 860-866.
27. Chaston TB, Dixon JB, O’Brien PE. Changes in fat-free mass during significant weight loss: a systematic review. Int J Obes (Lond). May 2007;31(5):743-50.
28. Dixon JB, O’Brien PE. Nutritional Outcomes of Bariatric Surgery. In: Buchwald H, Cowan GSM, Pories WJ, eds. Surgical Management of Obesity. Philadelphia, PA: Saunders Elsevier; 2007:357-364.
29. O’Brien PE, et al. LAP-BAND^®: Outcomes and Results. J Laparoendosc Adv Surg Tech A. 2003; 13(4):265-270.