Safety and Risks of Lap Band SurgeryOn December 13, 2011, the U.S. Food and Drug Administration announced that it had issued warning letters to eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, a medical device approved by the FDA for weight loss in obese adults.

According to the FDA, the Lap-Band ads used by these companies failed “to provide required risk information, including warnings, precautions, possible side effects and contraindications.”

The “FDA’s concern”, says Steven Silverman, director of the Office of Compliance in FDA’s Center for Devices and Radiological Health, “is that these ads glamorize the Lap-Band without communicating any of the risks. Consumers, who may be influenced by misleading advertising, need to be fully aware of the risks of any surgical procedure.”

In support of this action, here are five points on the safety and risks of lap band surgery for prospective patients to consider:


1. The Lap-Band is FDA-Approved. First off, the FDA action was not against the use of the Lap-Band for weight loss, but against companies that promoted the benefits of the procedure without adequately explaining the dangers. The Lap-Band was approved by the FDA in June 2001 for qualified patients. It is a medical device that is implanted around the upper part of the stomach to create a smaller food pouch in order to limit the amount of food that can be eaten at any one time, reduce hunger, and facilitate weight loss.

2. Surgery can be dangerous, even deadly. All surgery involves risk, including death, and the risks are even greater for people who are obese or have underlying medical conditions. Although numerous studies have shown the Lap-Band is a safe and effective bariatric procedure, it is still surgery and thus involves risk. General surgical risks include (but are not limited to): adverse reaction to anesthesia and medications, bleeding, infection, blood clots, and injury to surrounding organs.

3. Some risks are specific to the Lap-Band. The Lap-Band is one of the safest methods of bariatric surgery and it does work well for the majority of patients, but there are also known complications that are specific to the Lap-Band. Some of the risks include: gastric band slippage, erosion and deflation, gastroesophageal reflux, obstruction of the stomach, stretching of the esophagus or stomach pouch, nausea and vomiting, inability of body to tolerate a foreign object implanted into the body, and need for reoperation due to moving or erosion of the gastric band.

4. The Lap-Band has not been approved for use in children younger than 18. The Lap-Band is approved by the FDA for use in adults age 18 and older who have not lost weight with non-surgical methods, such as diet, exercise or behavior therapy, and have a body mass index (BMI) of at least 40, or a BMI of at least 30 and at least one obesity-related health condition.

5. Reducing risk. Three important factors in reducing the risks and complications associated with Lap-Band surgery are surgeon selection, patient selection, and follow-up care. When selecting a bariatric surgeon to perform Lap-Band surgery, it is important to choose a surgeon with sufficient and specific experience, training, and skill in general surgery, laparoscopic techniques, and Lap-Band surgery. As for patient selection, a bariatric surgeon should evaluate each patient to determine whether or not they are acceptable candidates for the Lap-Band, based on their specific health profile and lifestyle requirements. And surgery is only the beginning, a successful outcome is greatly enhanced with proper follow-up care and compliance with Lap-Band eating and meal guidelines.

For people who are obese and considering bariatric surgery, Lap-Band surgery may be the right choice. Before making a decision, however, make sure you fully understand both the benefits and risks of the procedure. It is important that you read the information booklet provided by your surgeon (your surgeon should provide you with the Lap-Band brochure, if not, ask for one) and then ask any questions you may have before deciding to have surgery.

Source: FDA News Release, “FDA issues Warning Letters for misleading advertising of Lap-Band,” December 13, 2011.

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