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Tuesday June 5, 7:33 pm Eastern Time

US approves Inamed stomach band to treat obesity

By Lisa Richwine

WASHINGTON, June 5 (Reuters) - U.S. health officials said Tuesday they approved Inamed Corp.'s (NasdaqNM:IMDC - news) surgically implanted adjustable stomach band for treating severe obesity.

The product is an inflatable band that is placed around the upper part of the stomach to create a small pouch and limit food consumption.

The Food and Drug Administration said the device, called the Lap-Band Adjustable Gastric Banding System, is intended for severely obese people who have failed to lose weight with other methods such as diet and exercise.

The FDA defined the severely obese as people who are at least 100 pounds overweight or twice their ideal body weight. An estimated 11 million Americans fall in that category. Severe obesity can cause health problems such as high blood pressure, diabetes, and gall bladder disease.

Previously, the only approved surgical treatments were stomach stapling and gastric bypasses that are more invasive than lap band surgery, the FDA said. The lap band can be implanted through a small incision in what is known as ``keyhole'' surgery.

After the band is in place, it is inflated with saline and can be adjusted by surgeons through a portal under the skin. It is intended to stay in place permanently.

People with the lap band ``will need to diet and exercise in order to maintain their weight loss,'' the FDA said in a statement.

In a study of 299 patients, patients lost an average of 36 percent of their excess weight over three years. Two percent gained some weight, and 5 percent stayed the same.

During the study, patients were put on a strict diet and required to exercise 30 minutes a day. BioEnterics Corp., the Inamed unit that makes the lap band, sponsored the study.

Nearly 90 percent of patients experienced at least one side effect such as nausea, vomiting, heartburn, abdominal pain, and band slippage or pouch enlargement, the FDA said.

A quarter of patients had their band removed, mostly because of side effects, the FDA said. Some also cited insufficient weight loss as contributing to their decision to have the band removed.

California-based Inamed, which makes breast implants and other medical devices, said the lap band would be available at a ``limited'' number of centers where surgeons have the skills and training to insert the band.

Inamed shares rose $1.28, or 5.4 percent, to $24.93 on Tuesday Nasdaq trading.

http://biz.yahoo.com/rf/010605/nwat024153_5.html