Studies Demonstrate Long-Term Weight Loss Outcomes for LAP-BAND® System

[Alex Brecher 10,512]

Studies Demonstrate Long-Term Weight Loss Outcomes for LAP-BAND® System

Studies Add to Data Supporting Use of Safe and Least Invasive Weight Loss Surgical Procedure

AUSTIN (April 4, 2014) —Two recent studies show the laparoscopic adjustable gastric banding (LAGB) procedure to be a safe and effective long-term obesity treatment. While most published studies on bariatric surgery show only short-term follow-up data of less than three years, two studies published in the Annals of Surgery provide long-term data. Both studies also addressed historical concerns with a high rate of reoperation after LAGB, showing that revision is safe and effective and does not impact long-term weight loss.

“Long-term effectiveness data for the LAP-BAND is important because it is the only surgical option available to the millions of people in the United States who are in the 30 to 34 range of the Body Mass Index (BMI*) scale, ” said George A. Fielding, M.D., associate professor of surgery, New York University School of Medicine. “The more data healthcare professionals have about the long-term performance of available treatment options for obesity the better.”

LAGB is the least invasive surgical option among bariatric weight loss procedures. LAP-BAND® Adjustable Gastric Banding System, the number one brand in the category, remains the only bariatric weight reduction surgical procedure approved by the U.S. food and Drug Administration (FDA) for people with a BMI of at least 30 with one or more obesity-related comorbid conditions. It also is indicated for people with a BMI of 40 and above with no comorbid conditions. LAP-BAND System® is approved for use only in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs.

The most recently published study, a retrospective study published in Annals of Surgery, January 2014, shows that for certain complications, such as slip, prolapse or hiatal hernia, simply repositioning the band can have positive long-term efficacy outcomes. The study included approximately 400 patients who underwent LAGB between 2001 and 2009 and who had a subsequent reoperation for pouch-related problems three years after primary banding. At 24 months, patients whose band was repositioned still showed 49 percent excess weight loss. The study goes on to say that weight loss after reoperation was sustained and was comparable with weight loss with those without reoperation at a similar time point (four and five years after the initial procedure).

“Patients would be well advised to seek out centers that specialize in gastric banding if they wish to retain their bands,” Dr. Fielding said.

The other study, published in Annals of Surgery in January 2013, included long-term weight loss data following LAGB with 15-year follow-up. This prospective study followed more than 3,000 patients treated by LAGB placement at a single institution between 1994 and 2011. Of those who completed follow-up, patients lost half their excess weight within two years after the procedure and maintained the majority of the weight loss 15 years post procedure.

About Obesity

Approximately 80 million (one in three) adults in the United States are obese (BMI >30). Obesity causes an estimated 300,000 premature deaths in the United States each year, mostly from obesity-related medical conditions, such as high blood pressure, diabetes, heart disease, sleep apnea, stroke and cancer.

Studies show that weight loss following gastric banding improved or resolved several serious obesity-related health conditions, including hypertension, asthma, diabetes, sleep apnea and GERD (gastroesophageal reflux disease) Many people living with these diseases who have lower BMI do not realize weight loss surgery may be an option.

About LAP-BAND System®

In an LAGB procedure, a band is placed around the upper part of the stomach. As the band inflates, it shrinks the size of the stomach. This helps individuals reduce the amount of food intake and slows emptying into the lower stomach. This helps individuals feel full sooner, stay full longer and reduce hunger urge.

The LAP-BAND System was acquired in late 2013 by Apollo Endosurgery, Inc. of Austin, Texas, from Allergan, Inc.

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. 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 procedures, 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 require additional surgery. Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.

*BMI is weight-to-height ratio, calculated by dividing one’s weight in kilograms by the square of one’s height in meters and used as an indicator of healthy weight.

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Beitner, M., et al., Sustained Weight Loss after Gastric Banding Revision for Pouch-Related Problems. Annuals of Surgery. 2014.

[ii] O’Brien, P., Long-Term Outcomes After Bariatric Surgery, Fifteen-Year Follow-Op of Adjustable Gastric Banding and a Systematic Review of the Bariatric Surgical Literature. Annals of Surgery. Vol 257. Number 1. January 2013.

[iii] Centers for Disease Control and Prevention (CDC). Prevalence of Obesity Among Adults: United States, 2011-2012. Accessed on March 17, 2014 from http://www.cdc.gov/nchs/data/databriefs/db131.pdf.

[iv] Stanford Hospital and Clinics. Health Effects of Obesity. Accessed on March 17, 2014 from http://stanfordhospital.org/clinicsmedServices/COE/surgicalServices/generalSurgery/bariatricsurgery/obesity/effects.html.

[v] Dixon John, Chapman Leon, O’Brien Paul. Marked Improvement in Asthma after LAP-BAND® Surgery for Morbid Obesity. Obesity Surgery. 1999.

[vi] Dixon John, O’Brien Paul. Health Outcomes of Severely Obese Type 2 Diabetic Subjects 1 Year After Laparoscopic Adjustable Gastric Banding. Diabetes Care. Vol 25. Number 2. February 2002.

[vii] Dixon John, Schachter Linda, O’Brien Paul. Sleep Disturbance and Obesity: Changes Following Surgically Induced Weight Loss. Arch Intern Med. Vol 161. January 8, 2001.

[viii] Dixon John, O’Brien Paul. Gastroesophageal Reflux in Obesity: The Effect of LAP-BAND® Placement. Obesity Surgery. 1999.

[chasingadream 1,311]

Thanks for this Alex!

[Alex Brecher 10,512]

I can personally attest to the above....I'm almost 11 years out with my LAP-BAND and at my lowest weight ever!

[Bandista 7,466]

Love this data -- many thanks! So happy for my band. I feel very fortunate to have it.

[enjoythetime 1,457]

This is awesome!! Thanks for sharing!

[parisshel 1,892]

and maintained the majority of the weight loss 15 years post procedure.

For me, this is the most important takeaway from this article, and the reason I chose WLS. I wanted to not only lose weight, but maintain the loss over time. Only WLS does this, with its mind and body-altering properties.

[SandyM 1,956]

I love reading about long term success. With all the band bashing I try to avoid reading, I occasionally need a little reassurance. I'm almost a year out and don't regret my decision.