Allergan Inc. announced that an FDA Advisory Committee has recommended with an 8-2 vote that the FDA extend the currently approved use of the company’s Lad Band® System, used for weight loss surgery, to patients that have a body mass index below 40.
The Lap Band, which is an inflatable silicone device that gets placed on the upper portion of the stomach, limiting the patient’s intake of food and suppressing hunger, is currently indicated for patients with:
- BMI of 40 or higher
- BMI of 35 or higher combined with a health problem such as diabetes or high blood pressure
The change would make the Lap Band available to patients who are at BMI of 35 or higher or patients with a BMI of 30 or higher and at least one additional weight-related health problem.
The FDA committee’s decision came after a five-year study of 149 obese patients treated with the Lap Band that found over 80 percent lost at least 30 percent of their weight after one year.
The FDA will make a final decision on the wider use, but the agency typically follows the advice of its advisory panels, according to an msnbc article.
Wider approval could make millions more people eligible for the Lap Band surgery. About 15 million Americans are candidates under the current guidelines for use and about 27 million more fit under the broader group, Allergan said.
To learn more about the Lap Band procedure and to discuss whether you are a good candidate, contact the Advanced Cosmetic Surgery office of Dr. Frenzel to schedule a consultation.