Lap Band 03

Weight loss is about more than your outside

Change your lifestyle to discover a healthier you

If you're struggling with obesity, the impact goes far beyond your appearance. Excess weight not only affects how you look and feel on a daily basis, it can also affect your present and long-term health.

Being obese can increase your risk of3:
  • Type 2 diabetes
  • Stroke
  • Heart disease
  • Sleep apnea
  • Joint pain
  • Many other serious medical conditions
  • But there's good news—significant weight loss can reduce your risk for these conditions and may improve, and even help resolve, any you currently have. And the LAP-BAND® System is an effective tool that can help get you there.

    Ask your doctor about the LAP-BAND R System

    The LAP-BANEY Adjustable Gastric Banding System is the #1 selling gastric band worldwide.8 There are many success stories about people who have used the LAP-BAND' System to achieve significant weight loss and discover a happier, healthier life. In fact, many surgeons and doctors have chosen the LAP-BAND® System for themselves.

    Indications: The LAP-BAND® System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity-related comorbid conditions. It is indicated for use only in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.

Keep your insides and keep the weight off with LAP-BAND®

Excess weight loss with LAP-BAND has been proven in clinical studies

The LAP-BAND® System provides significant short-term weight loss within the first 1-2 years.2.9.10*1.

  • 52% excess weight loss at 2 years, in an ongoing clinical study of people with a BMI of 35 or above9
  • In a separate study, the LAP-BAND® System was shown to provide 65% excess weight loss at 1 year and 70% excess weight loss at 2 years for people with a BMI between 30 and 401°
  • That translates into shrinking an average of 6 inches off the waistline and 6 inches off the hips2

The LAP-BAND") System can also help provide weight loss that lasts.

  • In a long-term study, severely obese patients maintained an average excess weight loss of 60% at 5 years after the LAP-BAND® System procedure"

Weight loss matters on the inside too

In 4 separate studies, weight loss following gastric banding was shown to improve or resolve several serious obesity-related health conditions, including asthma, hypertension, diabetes, sleep apnea, and GERD (gastroesophageal reflux disease) In many cases, 90% or more of the patients being studied had improvement or total resolution of their conditions.3-6

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%).

Data based on interim analysis of ongoing LAP-BAND AP' trial.

Contraindications: The LAP-BAND® System is not recommended for non-adult patients, patients with conditions that may make them poor surgial candidates or increase the risk of poor results (e.g., inflammatory or cardiopulmonary diseases, GI conditions, symptoms or family history of autoimmune disease, cirrhosis), who are unwilling or unable to comply with the required dietary restrictions, who have alcohol or drug addictions, or who currently are or may be pregnant.

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The LAP-BAN [Y) System vs other weight loss procedures the difference is on the inside

Gastric banding was shown to be safer than sleeve gastrectomy and gastric bypass

Based on recent data from the American College of Surgeons* database and BOLD'

Compared to gastric banding, sleeve patients had the following at 30 days:

'The American College of Surgeons Bariatric Surgery Center Network (ACS-BSCN) database was developed as part of the ACS-BSCN accreditation program. This analysis of the ACS database includes data from 28,616 patients. t The Bariatric Outcomes Longitudinal Databasesm (BOLDS") was developed to help ensure ongoing compliance with the American Society for Metabolic and Bariatric Surgery (ASMBS) Bariatric Surgery Center of Excellence (BSCOE) program and develop general knowledge about optimal bariatric surgery practices. This analysis of the BOLD database includes data from 57.918 patients.

Warnings: The LAP-BAND System is a long-term implant. Explant and replacement surgery may be required. Patients who become pregnant or severely ill, or who require more extensive nutrition may require deflation of their bands. Anti-inflammatory agents, such as aspirin, should be used with caution and may contribute to an increased risk of band erosion.

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Comparing surgical procedures what's happening inside?

Take a closer look at what's involved with different procedures

Adverse Events: Placement of the LAP-BAND"' System is major surgery and, as with any surgery, death can occur. Possible complications include the risks associated with the medications and methods used during surgery, the risks associated with any surgical procedure, and the patient's ability to tolerate a foreign object implanted in the body. Band slippage, erosion and deflation, reflux, obstruction of the stomach, dilation of the esophagus, infection, or nausea and vomiting may occur. Reoperation may be required. Rapid weight loss may result in complications that may require additional surgery. Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.

The LAP-BAND® System how it works

The basics of the LAP-BANDP System procedure205

As the band inflates, the stomach outlet becomes smaller. This helps reduce the amount of food you eat and slows the emptying into the lower stomach, helping you feel full sooner, stay full longer, and reduce hunger urges. This procedure does not require any rerouting or stapling of the anatomy.

Lap Band and Sleeve

In 2012, over 90% of LAP-BAND System cases were reimbursed in full or in part by insurance? Insurance coverage and out-of-pocket costs may vary. Talk to your insurance provider for more information.

Talk to your doctor about the LAP-BAND® System

These questions can help you start a discussion about LAP-BAND®

For your primary care doctor:
1. What do you think my ideal weight should be?
2. Does my current weight affect my health?
3. Can the LAP-BAND® System work as a tool to help me get to a healthier weight?

For a qualified LAP-BAND"' surgeon:

1. If I start to regain my weight, is there a way to adjust the sleeve to reverse the weight regain and begin losing weight again?
2. If I start to regain my weight with the LAP-BAND' System, is there a way to adjust the LAP-BAND''' System to reverse the weight regain and begin losing weight again?
3. What types of lifestyle or behavioral changes are required after weight loss surgery? What are some differences between LAP-BAND® and sleeve?
4. How long will I be in the hospital with the LAP-BAND'''' System procedure? How does this hospital stay compare with other procedures, such as sleeve gastrectomy and gastric bypass?
5. What is the follow-up like after LAP-BAND surgery? Will I see my surgeon for regular visits?
6. How quickly will I be able to return to work after LAP-BAND''' surgery?

Important: For full safety information please visit www.lapband.com, talk with your doctor, or call Allergan Product Support at 1-800-624-4261.

CAUTION: Rx only.
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You've read what's Inside—Now find a LAP-BAND® Specialist in your area
Visit www.lapband.com to learn more

The LAP-BAND' System is...

  • Proven to take inches off the waist and hips, with obese individuals losing an average of 6 inches in waist and 6 inches in hip circumference in l year2
  • A minimally invasive, adjustable proceduye
  • that requires no cutting or stapling of the intestines2'i435
  • Designed for long-term use, but can be removed if desired1405
  • The only FDA-approved weight loss device for patients who are at least 30 pounds overweight with a BMI' of at least 30 kg/m2 with one or more obesity-related conditions, or a BMI of at, least 40—often 100 pounds above your ideal weight2

References: 1. Weiner RA, Weiner S, Pomhoff I, Jacobi C, Makarewicz W, Weigand G. laparoscopic sleeve gastrectomy—influence of sleeve size and resected gastric volume. Obes Surg. 2007;17:1297-1305.2. LAP-BAND' [directions for use (DFU)]. Santa Barbara, CA: Allergan Inc; 2011. 3. Weight-control Information Network (WIN). Overweight and obesity statistics. NIH Publication Number 04-4158. Updated February 2010.4. Dixon JB, Chapman 1, O'Brien P. Marked improvement in asthma after LAP-BAND' surgery for morbid obesity. Obes Surg. 1999;9:385-389. 5. Dixon JB, Schachter LM, O'Brien PE. Sleep disturbance and obesity: changes following surgically induced weight loss. Arch intern Med. 2001;161:102-106.6. Dixon JB, O'Brien PE. Gastroesophageal reflux in obesity: the effect of LAP-BAND placement. Obes Surg. 1999;9:527-531. 7. Dixon JB, O'Brien PE. Health outcomes of severely obese type 2 diabetic subjects 1 year after laparoscopic adjustable gastric banding. Diabetes Care. 2002;25:358-363.8. Data on file, Allergan, Inc. LAP-BAND System Historical Sales Summary,12/17/2012. 9. Data on file, Allergan, Inc. The LAP-BAND AP' Experience (APEX) Study-2010 Interim Analysis; October 14, 2010.10. LAP-BAND' Adjustable Gastric Banding System P000008/S017. Gastroenterology and Urology Devices Panel, Food and Drug Administration. http://www.fda.gov/ downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/MedicalDevice/MedicalDevicesAdvisoryCommittee/ Gastroenterology-UrologyDevicesPanel/UCM237422.ppt. Accessed March 16, 2011. 11. Ray 1B, Ray S. Safety, efficacy, and durability of laparoscopic adjustable gastric banding in a single surgeon U.S. community practice. Surg Obes Relat Dis. 2011;7:140 -144. 12. DeMaria EJ, Pate V, Warthen M, Winegar DA. Baseline data from American Society for Metabolic and Bariatric Surgery-designated Bariatric Surgery Centers of Excellence using the Bariatric Outcomes Longitudinal Database. Surg Obes Relat Dis. 2010;6:347-355.13. Hutter MM, Schirmer BD, Jones DB, et al. First report from the American College of Surgeons Bariatric Surgery Center Network—laparoscopic sleeve gastrectomy has morbidity and effectiveness positioned between the band and the bypass. Ann Surg. 2011;254:410-422. 14. O'Brien PE. Bariatric surgery: mechanisms, indications and outcomes. 1 6astroenterol Hepatol. 2010;25:1358-1365. 15. The LAP-BAND System Surgical Aid in the Treatment of Obesity—a decision guide for adults. Irvine, CA: Allergan, Inc; 2011. 16. Needleman B.1, Happel LC. Bariatric surgery: choosing the optimal procedure. Surg Chn NAM. 2008;88:991-1007. 11. Data on file, Allergan, Inc. Bariatric Surgeon Market Share Tracker—November 2012 data. All people featured in this piece are paid spokespeople and successful LAP-BAND ' patients.

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