FDA OK of Stomach Band Premature, Researchers SayJul 6, 2001
An adjustable stomach band used for treating severe obesity was cleared prematurely by the US Food and Drug Administration (FDA) and may not be as safe as previously thought, according to researchers who conducted a four-year study of the product.
The inflatable banding system, called the Lap-Band, received the go-ahead from the FDA in early June and is marketed by Inamed unit BioEnterics. It is placed around the upper stomach to limit food consumption. Dr. Eric J. DeMaria and colleagues, from the Medical College of Virginia at Virginia Commonwealth University in Richmond, studied the effects of the procedure in 36 of the first patients treated with the Lap-Band.
The researchers said their findings raise ``major concerns'' about the long-term effectiveness of the procedure in terms of weight loss and highlight the presence of new, previously unidentified complications.
During the four-year period, only four of the 36 patients achieved satisfactory weight loss, defined as a body mass index of 35 or less or a 50% weight reduction. Moreover, 41% of patients required surgical removal of the gastric band within 10 days to 42 months of the procedure, and many have requested removal since then, the researchers said.
The primary reasons for removing the gastric bands included infection, leakage and band slippage. Other complications included expansion of the esophagus, the tube leading from the mouth to the stomach, according to the report, which appears in the June issue of Annals of Surgery.
``Obviously we believe that FDA approval was premature,'' DeMaria told Reuters Health. ``Although the primary procedure was essentially 'low-risk,' we do not believe the secondary removal/revision procedures are so. Furthermore, the need for additional surgical treatment to accomplish the desired weight loss result is a significant 'safety' issue in our minds.
``This procedure will become available potentially to millions of Americans who are desperate for treatment for severe obesity,'' DeMaria continued.
This ``is a population that has been repeatedly victimized by unsuccessful weight loss schemes with great economic and health costs in the past,'' he said, predicting that the Lap-Band ``will provide another chapter in this sad tale.
''The FDA's clearance of the Lap-Band advised its use only in patients who are at least 100 pounds overweight or are at twice their ideal body weight and who have failed to lose weight through other methods, such as diet and exercise.
The agency made clear in its announcement of the approval that nearly 90% of patients in a premarketing study had experienced at least one side effect, including nausea, vomiting, heartburn, abdominal pain and band slippage. About 25% of the subjects decided to have the band removed, the FDA said. Most of the decisions were based on the side effects, but some were based on inadequate weight loss, according to the agency.
That study, which was sponsored by BioEnterics and enrolled 299 subjects, found that patients lost an average of 36% of their excess weight over three years.
The FDA, which makes its decisions on product approvals by weighing risk against benefit, noted that severely obese people ''usually have serious health problems such as hypertension, gall bladder disease, and diabetes, resulting from their excess weight.
''While it is not yet clear whether others will take up the banner of DeMaria and his colleagues regarding the FDA's decision on the Lap-Band, the researchers' objections come at a time when the agency's review processes are already under scrutiny from some quarters. The Washington, DC-based consumer group Public Citizen has been a particularly vocal critic, speaking out against the agency's approvals of drugs including Johnson & Johnson's Propulsid and Glaxo Wellcome's Lotronex. A spokesperson for Public Citizen said that the group ``has not yet done any work'' on the Lap-Band.
Through a spokesperson, Inamed said that ``there have been over 300 published studies on the Lap-Band and over eight years of experience with it. The vast majority have shown very positive results.``The FDA considered all of the data available, including the significant benefits of having this less-invasive option available for severely obese Americans,'' the spokesperson said.