LAP-BAND Surgery

Recently you see a lot of commercials about LAP-BAND surgery on TV. It looks effective because real patients are dancing happily. They say most PPOs cover the surgery cost. It sounds good. LAP-BAND was created by Allergan, Inc. in Irvine, California. The LAP-BAND® Adjustable Gastric Banding System is the first adjustable medical device approved by the U.S. Food and Drug Administration (FDA) in the United States for individualized weight loss for obese patients whose weight is affecting their health. The LAP-BAND® System was originally approved by the FDA in 2001 for use in weight reduction for severely obese adults with a Body Mass Index (BMI) of 40 or more, or for adults with a BMI of at least 35 plus at least one severe obesity-related health condition, such as Type 2 diabetes, hypertension and asthma. In February 2011, the FDA approved the expanded use of LAP-BAND® 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. In addition, the LAP-BAND® System has been approved internationally since 1993. The LAP-BAND® System is now the first and only FDA-approved device for weight-loss surgery in patients with a BMI of 30-35.

Designed to be placed laparoscopically (via small incisions in the abdomen, usually 0.5 - 1.5 centimeters in length), the LAP-BAND® System does not require stapling of the stomach. Instead, an inflatable band is placed around the top portion of the patient's stomach, creating a small pouch that limits or reduces food consumption. The LAP-BAND® System is adjustable, which means that the inflatable band can be tightened or loosened to help the patient achieve a level of satiety while maintaining a healthy diet, supporting a patient's long-term weight loss success.

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.

The expanded approval is based on a review of data from a five-year study of the LBAGB system in patients with a BMI between 30 and 40, either with or without a co-existing obesity-related health problem. The study included 149 patients who had been obese for an average of 17 years.

In order for the trial to be considered successful, at least 40% of patients had to lose a "clinically meaningful" amount of weight in one year. That meant each patient had to lose at least 30% of their excess weight or lose the weight above their medically determined ideal weight.

About 84% of patients in the study lost at least that much weight within a year of the Lap-Band surgery. In fact, more than 65% were no longer considered obese after that time. Patients kept the weight off during the second year of the study. The manufacturer plans to continue to follow the progress of the Lap-Band patients for five years.

What is the difference between LAP-BAND surgery and another surgery method? Roux-en-y gastric bypass is currently the most commonly performed procedure in the United States; approximately 75% to 80% of all bariatric operations in the U.S. involve gastric bypass. It involves two things that we do to the intestinal track:

We staple across the stomach to make a very small stomach pouch, reducing stomach volume by about 95%.

We bypass a small portion of the upper intestinal tract. The small stomach pouch allows an individual to feel full with a small amount of food and reduces appetite. The bypass also aids weight loss by decreasing the absorption of some of the calories that are eaten.

That's the gastric bypass procedure. The average patient tends to lose about 65% to 75% of the excess weight they're carrying. So the patient that is 100 pounds overweight will typically lose 65 to 70 pounds and keep that weight off long term -- five, ten, fifteen years and beyond.

Patients who have this operation do need vitamin supplements such as iron, B12 and calcium in order to offset deficiencies that could occur after the surgery.

Nearly 10% of people have complications after gastric bypass surgery. These are usually minor and include:

Wound infections

Digestive problems

Ulcers

Bleeding

Nearly 1% to 5% of people have serious or life-threatening complications

after gastric bypass surgery, such as:

Blood clot (pulmonary embolism)

Heart attack

Leak in the surgical connections with the intestines

Serious infection or bleeding

The risk of complications is lower at centers that perform more than 100 weight loss surgeries per year. And, when performed by a highly experienced surgeon, deaths in the month following gastric bypass surgery are rare: about 0.2% to 0.5% (less than 1 in 200 people).

The LAP-BAND has part of the components of the bypass. It has the small stomach component, the pouch, but doesn't have the bypass. So the band is two-thirds as effective as the bypass because it has just the restrictive component of the operation and not the bypass component. However, the LAP-BAND surgery has less complications than the Roux-en-y gastric bypass.

Private insurance (HMO or PPO) or Medicare will often cover some, if not all, of the costs of your LAP-BAND® System procedure. Usually an approval is required before you can have the surgery.

SOURCES: Allergan website; medicinenet.com; WebMD.com