Friday, October 12, 2007


While world-wide, there is at least half a dozen of brands of adjustable gastric bands, the USA market had one brand, the Lap Band (manufactured by Inamed, a subsidiary of Allergan, Santa Barbara, California). (see "Adjustable Gastric Band" in the Glossary)

On Sept. 28, 2007, Ethicon Endo-Surgery, Inc. , Cincinnati, Ohio (an operating company of Johnson & Johnson) announced that the U.S. Food and Drug Administration (FDA) has approved for marketing the REALIZE(TM) Adjustable Gastric Band.

In the multi-center U.S. clinical trial of 276 patients with the REALIZE Band, patients who completed the three-year U.S. clinical trial (n=228) lost an average of 42.8 percent of their excess body weight. Thirty-five percent of patients who completed the three-year trial lost 50
percent or more of excess body weight and 10.5 percent lost 75 percent or more of excess body weight. The most commonly reported adverse events after surgery during the U.S. clinical trial were nausea, vomiting, constipation and gastroesophageal reflux (GERD). According to the report, nine (3.3 percent) patients experienced a serious adverse event that was considered unanticipated and related to the REALIZE Band.

According to the press release, the REALIZE Band, which is marketed under the name "Swedish Adjustable Gastric Band" (SAGB) outside the U.S., has been commercially available outside the U.S. since 1996 and has been used by more than 100,000 patients worldwide.