Important LAP-BAND® System Safety Information
Indications: The LAP-BAND® System is indicated for weight reduction for patients, with a Body Mass Index (BMI) of at least 35 kg/m2 or a BMI of at least 30 kg/m2 with one or more weight-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.
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 click here, or talk with your doctor.
CAUTION: Rx only.
* Results are from individual customer testimonials and your results may vary.
References:
1. Ray James, Ray Shahla. Safety, efficacy, and durability of laparoscopic adjustable gastric banding in a single surgeon U.S. community practice. Surgery for Obesity and Related Diseases. 2011.
a. https://www.ncbi.nlm.nih.gov/pubmed/21145297
2. Robert Michaelson, Diane K. Murphy, Todd M. Gross, and Scott M. Whitcup. LAP-BAND® for Lower BMI: 2-Year results from the Multicenter Pivotal Study. Obesity (2013) 21: 1148-1158
a. https://www.ncbi.nlm.nih.gov/pubmed/23637029
3. Dixon John, O’Brien Paul. Health Outcomes of Severely Obese Type 2 Diabetic Subjects 1 Year After Laparoscopic Adjustable Gastric Banding. Diabetes Care, Volume 25, Number 2. February 2002.
a. https://www.ncbi.nlm.nih.gov/pubmed/11815510
4. Dixon John, Schachter Linda, O’Brien Paul. Sleep Disturbance and Obesity: Changes Following Surgically Induced Weight Loss. Arch Intern Med/Vol 161. Jan 8, 2001.
a. https://www.ncbi.nlm.nih.gov/pubmed/11146705
5. Dixon John, O’Brien Paul. Gastroesophageal Reflux in Obesity: The Effect of LAP-BAND® Placement. Obesity Surgery. 1999.
a. https://www.ncbi.nlm.nih.gov/pubmed/10638476
6. Hutter Matthew, 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. September 2001.
a. https://www.ncbi.nlm.nih.gov/pubmed/21865942
7. DeMaria Eric, Pate Virginia, Warthen Michael, Winegar Deborah. Baseline data from American Society for Metabolic and Bariatric Surgery-designated Bariatric Surgery Centers of Excellence using the Bariatric Outcomes Longitudinal Database. Surgery for Obesity and Related Diseases 6. 2010.
a. https://www.ncbi.nlm.nih.gov/pubmed/20176512
8. The Longitudinal Assessment of Bariatric Surgery (LABS) Consortium. Perioperative Safety in the Longitudinal Assessment of Bariatric Surgery. The New England Journal of Medicine Vol. 361 No. 5. July 30, 2009.
a. https://www.ncbi.nlm.nih.gov/pubmed/19641201
** Data on File: Reshape Lifesciences.
** Dixon, John, et al. Birth Outcomes in Obese Women After LAGB. Obstetrics and Gynecology. 2005.
** Skull A. J., et al. Laparoscopic Adjustable Banding in Pregnancy: Safety, Pateint Tolerance and EFfect on Obesity-Related Pregnancy Outcomes. Obesity Surgery. 2004.
** Carelli A.M., et al. Impact of Laparoscopic Adjustable Gastric Banding on Pregnancy, Maternal Weight, and Neonatal Health. Obesity Surgery. 2011.
** LAP-BAND Information on file MKT-01250-00R02
** Lapolla A. Pregnancy Outcome in Morbidly Obese Women Before and After Laparoscopic Gastric Banding. Obesity Surgery. 2010.