FDA NEWS RELEASE
For Immediate Release: Dec. 13, 2011
Media Inquiries: Morgan Liscinsky, 301-796-0397, Morgan.Liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA issues Warning Letters for misleading advertising of Lap-Band
Ads lack information on risks of gastric banding
The U.S. Food and Drug Administration today announced that it has taken action against eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, an FDA-approved device used for weight loss in obese adults.
The FDA issued Warning Letters to Bakersfield Surgery Institute Inc.; Beverly Hills Surgery Center; Palmdale Ambulatory Center; Valley Surgical Center; Top Surgeons LLC; Valencia Ambulatory Center LLC; Cosmopolitan Plastic & Reconstructive Surgery; San Diego Ambulatory Center LLC; and to 1-800-GET-THIN because Lap-Band is a restricted medical device that is misbranded as a result of misleading advertising by these groups.
In the letters, the FDA warns that billboards and advertising inserts used by recipients of the Warning Letters to promote the Lap-Band procedure fail to provide required risk information, including warnings, precautions, possible side effects and contraindications. The FDA also is concerned that the font size of information related to risks on the advertising inserts is too small to be read by consumers.
"The FDA takes seriously its responsibility to protect consumers from products promoted without adequate warnings,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “It's particularly troublesome when advertisements don’t communicate the serious risks associated with medical devices."
If the affected companies do not change the advertising and promotion strategies to address the concerns raised by the FDA, the agency is prepared to take further action, which could include product seizure or civil money penalties.
The Lap-Band is a gastric band, an implanted medical device used in a surgical procedure for weight loss in obese adults who have a body mass index (BMI) of 30-40, with one or more obesity-related medical conditions (such as type II diabetes and hypertension), or in patients with a BMI of 40 or over with or without an obesity-related medical condition. Gastric banding is used when non-surgical weight loss methods (such as supervised diet, exercise and behavior modification) have not been successful. Patients considering gastric banding must be willing to make major changes in their eating habits and lifestyle.
“The decision to undergo a gastric banding procedure should be done in close consultation between a patient and his or her health care provider,” said Kimber Richter, M.D., deputy director for medical affairs in the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “It is important for the patient to fully understand both the risks and the benefits of the procedure and for the health care provider to be sure the procedure is appropriate for the patient.”
The Lap-Band has not been approved for use in children younger than 18. Only those who are able and willing to follow dietary and other health and lifestyle recommendations should consider the procedure. It’s important that patients and their physicians are aware of and understand the limitations of gastric banding.
Health care providers who choose to promote the gastric banding procedure are required to educate patients about the risks involved, which must also be included in any advertising and promotional materials. Patients considering the surgery should read the patient information provided by their doctor and should ask any questions they have about gastric banding before having surgery.
If you suspect a problem with a gastric banding device, the FDA encourages you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
For more information:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
How Gastric Banding Works
A surgeon places a circular silicone band around the upper part of the stomach, creating a small pouch. The narrowed opening between the pouch and the rest of the stomach controls how fast food passes to the lower part of the stomach. The band is connected with tubing to a button-like part (port) placed close to the skin above the stomach. A doctor can adjust the band, without surgery, by inserting a needle through the skin into the port to add or remove fluid in the band. This changes the size of the opening, which controls how fast food passes into the lower stomach. The band limits the amount of food that can be eaten at one time, helping people to feel full sooner and eat less.
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Ready to be the next weight-loss success story?
Let your new life begin!
I lost 90 pounds with the Lap-Band!
Sounds tempting, doesn’t it? The Food and Drug Administration (FDA) has seen many claims similar to the ones above, but there’s a catch.
There can be serious risks with the weight-loss surgery and medical implant promoted by these ads, so FDA is taking action.
FDA has warned eight surgical centers and the marketing firm 1-800-GET-THIN LLC in California about misleading advertising of the Lap-Band—a device implanted in a surgery called gastric banding to help adults eat less and lose weight.
The ads—splashed on billboards, bus placards, newspaper advertisements, the Internet and elsewhere—feature slender, smiling men and women claiming they lost massive amounts of weight and gained control of their lives after Lap-Band surgery.
“FDA’s concern is that these ads glamorize the Lap-Band without communicating any of the risks,” says Steven Silverman, director of the Office of Compliance in FDA’s Center for Devices and Radiological Health. “Consumers, who may be influenced by misleading advertising, need to be fully aware of the risks of any surgical procedure.”
By federal law, product advertising for certain medical devices, such as the Lap-Band, must contain relevant warnings and information about precautions, side effects, and contraindications (medical reasons that make a treatment inappropriate).
FDA’s warning letters direct the California marketing firm and surgical centers to pull their misleading ads and to notify FDA within 15 working days of action taken to correct them.
Two Gastric Bands Approved
FDA has approved two gastric bands: Lap-Band, by Allergan Inc., and Realize Adjustable Gastric Band, by Ethicon Endo-Surgery Inc. These devices are implanted around the upper part of the stomach to create a “pouch.” The small pouch limits the amount of food that can be eaten at one time, making you feel full faster and potentially lose weight.
Both bands are approved for use in adults age 18 and older who have not lost weight with non-surgical methods, such as diet, exercise or behavior modification, and have
- a body mass index (BMI) of at least 40. (BMI is a measure of body fat based on an adult’s height and weight. A 5-foot-6-inch person weighing 248 pounds has a BMI of 40.)
- a BMI of at least 35 (217 pounds at 5-foot-6 inches) and at least one health condition linked to obesity, such as diabetes or high blood pressure.
Allergan’s Lap-Band is also approved for those with a BMI of 30 to 34 who have a health condition related to their obesity.
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"Surgery itself has risks, including death, and those risks are heightened for people who are obese," says Herbert Lerner, M.D., a general surgeon and supervisory medical officer at FDA.
There are risks after the surgery, too, including
- nausea and vomiting
- difficulty swallowing
- gastroesophageal reflux disease (GERD)
- upset stomach or pain
- stretching of the stomach pouch
- stretching of the esophagus
- moving of the gastric band, requiring another surgery to reposition it
- erosion of the band through the stomach wall and into the stomach, requiring another surgery
“Most people lose weight with the gastric band,” says Lerner. “However, one should not assume that a gastric band is a permanent device. A good number of people require another operation to reposition, replace or remove the gastric band sometime during their life due to complications or because they have not lost weight.”
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No Binging Allowed
Gastric banding requires a drastic diet change—you need to eat small portions frequently to prevent complications and ensure weight loss, says Lerner. “If you eat or drink more than your stomach pouch can hold, the pouch will stretch and food may back up into the esophagus. You may have nausea and vomiting, and require an adjustment of the band.”
And if patients eat a lot of fattening foods or drink milkshakes or other high-calorie liquids, they may not lose a lot of weight.
If you are considering gastric banding, it is important that you read the information booklet provided by your surgeon and discuss any questions you have with your surgeon before deciding to have surgery. If your surgeon does not provide you with a booklet, ask for one.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Dec. 13, 2011
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