REALIZE Band Benefits and Risks

Bariatric surgery typically results in a weight loss of 25% to 35% of total body weight, which is well maintained over the first decade.¹ However, weight loss surgery doesn’t guarantee that patients will lose weight and keep it off in the long term. Success depends on a willingness to make long-term lifestyle changes in diet and exercise. Gastric banding should only be considered after traditional options have been evaluated and ruled out.

Clinical experience
The REALIZE^® Adjustable Gastric Band is supported by more than 20 years of worldwide clinical experience and innovation. Outside the United States, the REALIZE Band is known as the Swedish Adjustable Gastric Band (SAGB), and it has been used in patients since 1986. No adjustable gastric band is safer or more effective than the REALIZE Band.²

REALIZE Band weight loss benefits

Patients in a 3-year clinical trial:

• lost a mean of 40% of their excess weight at 1 year and 43% at 3 years²
• were able to reduce their (average) BMI from 44 to 36 in the first year after surgery²
• were able to maintain their reduced BMI through their third year²

Health benefits

The 3-year U.S. clinical trial showed resolution of the following co-morbid conditions:

• Type 2 diabetes in 48.7% of patients²
• High cholesterol in 78.3% of patients²
• Sleep apnea problems in 94.6% of patients²

In the same trial, patients saw a 22% increase in good cholesterol (HDL) 36 months after surgery,² as well as reductions in bad cholesterol (LDL), total cholesterol, and triglycerides.

Gastric band and port design benefits

• The REALIZE Band features a high-volume, low-pressure balloon, designed to reduce the potential for tissue trauma.² More than 20 years of data confirm the successful performance of the original soft, low-pressure balloon design.

• The REALIZE Band is the widest band available (23 mm), which means it decreases the potential for band slippage. ² That’s important because if a band slips, another surgical procedure is required to replace or adjust it.

• No adjustable gastric band has a lower leak rate than the REALIZE Band.⁶ If a band leaks, a second surgical procedure is required to replace it.

• The REALIZE Port Applier enables the surgeon to place the port in less than 1 minute²–reducing the time patients spend under anesthesia by up to 19%⁸ (from 38 minutes to 31 minutes).

• The REALIZE Injection Port is the lowest profile injection port available,² to minimize the appearance under the skin, even as patients lose weight.

Laparoscopic surgery benefits
The REALIZE Band is placed during a laparoscopic procedure, which is performed using small incisions. No part of the stomach is stapled or removed during adjustable gastric banding surgery and the intestines are not re-routed, so patients can continue to absorb nutrients from food.

Laparoscopic surgery typically results in shorter hospital stays, faster recovery, smaller scars, and less pain than open surgical procedures.

Patient support benefits
The REALIZE Band is the only gastric band that includes the REALIZE mySUCCESS^® Program. It is a Web-based clinical support tool designed to help patients build and reinforce habits that are important for maintaining weight loss over time.

REALIZE mySUCCESS^® was developed in conjunction with bariatric surgeons, dietitians, and behavior modification specialists to guide patients through two stages for success after surgery: Stage 1: Building healthy habits over the first 18 months. Stage 2: Staying motivated, on track, and connected with the bariatric practice over the next 18 months and beyond.

REALIZE mySUCCESS^® helps patients adjust to life after surgery, develop healthy habits in the areas of eating, exercise, and emotional well-being, and connects patients to their surgeons. This type of support is important, because it can help patients lose more weight. According to a recent 12-month study, REALIZE Band patients who frequently use REALIZE mySUCCESS^® lose significantly more weight in the first year after surgery.*

Most online weight loss programs are intended for use by anyone wishing to lose weight. REALIZE mySUCCESS^®has tools and features tailored to the unique needs of bariatric patients.

REALIZE mySUCCESS^® helps bariatric patients:

Learn more about ongoing support after surgery.

Risks associated with gastric banding

• Migration of implant (band erosion, band slippage, or port displacement)
• Tubing-related complications (port disconnection or tubing)
• Band leak
• Esophageal spasm
• Gastroesophageal reflux disease (GERD)
• Inflammation of the esophagus or stomach
• Port-site infection

Note: Bariatric surgery complications may result in reoperations. Refer to the REALIZE Band Patient Guide for a full description of risks and side effects. Order a free patient guide.

Weight loss surgery side effects and discomfort
After surgery, the body needs to adjust to the newly implanted REALIZE Band. Each recovery experience is different. Typical side effects include regurgitation, nausea, acid reflux, constipation, and diarrhea. Abdominal pain that lasts more than 3 hours is an indication that the patient should contact his or her surgeon right away or go to a local emergency room. People who lose a lot of weight, regardless of the weight loss method, are at high risk for developing gallstones. Surgery or other procedures may be necessary to remove the stones and/or the gallbladder. There may be other side effects that are specific to each patient. Patients are advised to report any unusual experiences to their surgeons.

Risks associated with bariatric surgery

• Abdominal hernia
• Chest pain
• Collapsed lung
• Constipation or diarrhea
• Dehydration
• Enlarged heart
• Gallstones, pain from passing a gallstone, inflammation of the gallbladder, or surgery to remove the gallbladder
• Gastrointestinal inflammation or swelling
• Stoma obstruction
• Stretching of the stomach
• Surgical procedure repeated
• Vomiting and nausea
• Note: Weight, age and medical history play a significant role in determining specific risks. Surgeons can inform their patients about their specific weight loss surgery risks.

Risks associated with abdominal surgery

• Bleeding
• Pain
• Shoulder pain
• Pneumonia
• Complications due to anesthesia and medications
• Deep vein thrombosis
• Injury to stomach, esophagus, or surrounding organs
• Infection
• Pulmonary embolism
• Stroke or heart attack
• Death

Note: Risks are associated with any type of surgery, including abdominal surgery. These risks are greater for individuals who suffer from obesity.

For more information, please visit our sponsor’s Web site, www.REALIZE.com, or request a free REALIZE Band brochure.

© Ethicon Endo-Surgery, Inc. 2009 DSL#09-1077

*Patients who frequently use REALIZE mySUCCESS^® lose significantly more weight. Based on 12 months of patient-reported data from REALIZE Band patients using REALIZE mySUCCESS^®. Frequent users were in the top third of patients based on frequency of entering a weight into REALIZE mySUCCESS^®. Source: Ethicon Endo-Surgery, Inc. data on file.

This information is provided by Ethicon Endo-Surgery, Inc. Ethicon Endo-Surgery is not responsible for any other content on this Web site. The REALIZE^® Adjustable Gastric Band is used in morbidly obese adult patients for significant long-term weight loss. It may not be right for individuals with certain digestive tract conditions. All surgery presents risks. Weight, age, and medical history determine your specific risks. Ask your doctor if bariatric surgery is right for you.

For more information, visit the official site for the REALIZE^® Adjustable Gastric Band, www.REALIZE.com, or call 1-866-REALIZE.

Footnotes

¹ Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA.2004;292(14):1724-1737.

² SAGB PMA. P070009.

⁶ SAGB PMA P070009 and LAP-BAND PMA P000008.

⁸ Miller K, Pump A. Mechanical versus suture fixation of the port in adjustable gastric banding procedures: a prospective randomized blinded study. Surgical Endoscopy. 2008:22(11): 2478-2484. DSL 08-0561.1

 

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