New Jersey Bariatric Center Comments on Potential New Guidelines for LAP-BAND® Surgery

December 7, 2010 Statement

On December 3, 2010 the Federal Drug Administration [FDA] accepted Allergan’s application to use its LAP-BAND system for weight reduction in patients with a BMI greater than 35 kg/m2 or BMI greater than 30 kg/m2 for patients with one or more health-related conditions such as type II diabetes, hypertension, sleep apnea, etc. The FDA will make its final decision in the upcoming months.

Multiple recent studies show that the risks of laparoscopic adjustable gastric band (LAP-BAND® or REALIZE®) are significantly less when compared to gastric bypass; serious complications with gastric band are less than 1% vs. 5% for gastric bypass and 0% mortality vs .2% with bypass. In addition, current bariatric surgery (LAP-BAND®, REALIZE® Band, Sleeve Gastrectomy and Gastric Bypass) guidelines in the US is recommended for patients with BMI greater than 40 kg/m2 or BMI greater than 35 kg/m2 for patients with one or more health related conditions. These original guidelines were based on a 1991 NIH consensus panel recommendation that set BMI guidelines based on risks and benefits of gastric bypass surgery, and then were applied to gastric band surgery too.

With a lower surgical risk coupled with improvements in health-related conditions and decreased premature death, it is time to re-evaluate the BMI threshold to perform laparoscopic gastric band (LAP-BAND® or REALIZE® Band) and we look forward to the FDA’s final recommendation.

While we welcome the FDA’s acceptance of the application, whether we work under the current BMI standards or a potential new guideline set by the FDA, the decision to have gastric band surgery - LAP-BAND® or REALIZE Band – is still a serious one and should be made in consultation with a board certified, fellowship-trained bariatric surgeon. Weight loss surgery is a tool; it only works in conjunction with lifestyle modifications including exercise and healthy eating.

New Jersey Bariatric Center

The New Jersey Bariatric Center, led by Dr. Ajay Goyal, has offices in Union and Hoboken, New Jersey. Dr. Goyal’s approach to patient care has resulted in zero mortality to date and a complication rate that is lower than the national average. These surgical results stand out as some of the best in New Jersey. If you or someone you love is considering bariatric surgery – Gastric Bypass, LAP-BAND® or REALIZE® Band procedures - please join us for one of our free educational seminars. To register, visit us at www.njbariatriccenter.com .

Contact Information

Dr Ajay Goyal

Director

NJ Bariatric Center

Contact via E-mail