ENP Newswire - 03 May 2013
Release date- 02052013 - IRVINE, Calif.,-Study results published today in the scientific journal Obesity highlight the safety and weight loss efficacy of the LAP-BAND Gastric Banding System among patients with a Body Mass Index (BMI) of 30-39.9.
Over one-third of the U.S. population is obese (BMI >30) with more than 36 million Americans with a BMI of 30-39.9 and one or more obesity-related comorbid conditions.1,2 In 2011, the U.S. Food and Drug Administration (FDA) approved the expanded use of the LAP-BAND System for adults with obesity who have failed more conservative weight reduction alternatives, such as diet and exercise and pharmacotherapy, and have a Body Mass Index (BMI) of 30-40 and at least one obesity related comorbid condition.
Data demonstrated that the LAP-BAND Gastric Banding System yielded a clinically significant weight loss and comorbidity improvement in year one that was either maintained or improved in year two with a low risk of serious complications. This weight loss exceeds what is typically seen with more conservative treatment, such as diet and exercise.3,4 The study of 143 patients who received the LAP-BAND procedure and were evaluated for two years found that:
.Patients on average lost 65 percent of their excess weight at one year.
.66 percent of patients in the trial were no longer clinically obese after one year, and results were maintained or improved at two years.
.Obese patients in the study lost on average six inches in waist and hip circumference at one year.
.Comorbidity improvement was seen in patients with Type 2 diabetes, hypertension, and high cholesterol.
This study led the U.S. Food and Drug Administration to determine the LAP-BAND was safe and effective in this population (obese patients with a BMI of 30-40 and at least one comorbid condition). The FDA approval of the expanded use of the LAP-BAND Gastric Banding System made it the first and only device available for obese adults who need to lose as little as 30 pounds and whose weight is affecting their health.
'This data demonstrates the benefits of early intervention in obese patients that I've seen in my practice. Treatment before the patient is extremely heavy and very sick can lead to clinically significant weight loss and achieve co-morbidity improvement at least as good as what I've seen with higher BMI patients,' said Jaime Ponce, MD, FACS, bariatric surgeon at Hamilton Medical Center in Dalton, Georgia. 'The weight loss that the LAP-BAND Gastric Banding System showed in this study with patients with BMI greater than 30 was extremely significant and should be considered for part of any treatment plan for obese patients.'
During the two-year study period, the types of Adverse Events (AEs) reported by patients were as expected for the surgical procedure, such as vomiting, dysphagia, and gastroesophageal reflux disease (GERD). Most AEs were mild to moderate in severity and resolved in less than four weeks. Three percent of patients (5 patients) experienced serious adverse events that lead to removal of the LAP-BAND System.
The National Institutes of Health Clinical Guidelines on the Identification, Evaluation and Treatment of Overweight and Obesity in Adults recommends weight loss therapy for individuals with a BMI greater than or equal to 30. Obesity is the second-leading cause of preventable death in the United States, second only to smoking.5 Given its known correlation to life-threatening comorbid conditions, such as heart disease, stroke, Type 2 diabetes, high blood pressure, sleep apnea and even premature death, obesity is a disease that requires medical treatment. Medical research has found that, if left untreated, those individuals who are currently obese will likely remain obese.6 However, not all weight-loss treatments are effective over the long term - as a preponderance of data, published literature and scientific research have found that diet and exercise is unsuccessful in 80-85% of patients at one year.7,8
About the LAP-BAND System
The LAP-BAND System was originally approved by the FDA in 2001 for use in severely obese adults, individuals with a BMI of 35 with one or more comorbidities or a BMI of 40, or those who are at least 100 pounds or more overweight. In addition, the LAP-BAND System has been approved internationally since 1993. The LAP-BAND System is the first and only FDA-approved device for bariatric surgery in patients with a BMI of 30-35 with one or more obesity related comorbidities. Over the past 18 years, more than 650,000 procedures have been performed, leading to over two million patient years of exposure for the device.
Important LAP-BAND Safety Information
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 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.
Contraindications: The LAP-BAND System is not recommended for non-adult patients, patients with conditions that may make them poor surgical 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.
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.
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.
Important: For full safety information, please visit www.lapband.com, talk with your doctor or call Allergan Product Support at 1-800-624-4261.
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