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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.

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.

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.)

or

• 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.

The Risks

“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.”

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

For More Information

By Michelle Andrews

Jackie Risley, before and after her bariatric surgery (Photos provided by Risley)

As obesity among young people continues to rise, a growing number of clinicians and researchers say that weight-loss surgery may be their best chance to take off significant weight and either correct or avoid conditions like diabetes and heart disease, which often go hand-in-hand with obesity.

But although health plans frequently cover bariatric surgery in adults, insurance coverage for the procedure in patients under age 18 is spotty.

Experts in pediatric obesity say that caution is warranted and that insurers shouldn’t just rubber-stamp such surgery in adolescents.

But they say emerging research may lead to more coverage for young people.

To protect yourself, your family and guests from Salmonella, E. Coli and other food-borne illnesses, follow these key food safety tips”

Wash your hands

• Wash your hands for about 20 seconds with warm water and soap to get rid of the germs that can get into food and make people sick.
• Wash your hands after going to the bathroom, after touching raw meat, fish or poultry, and after taking out the garbage, sneezing, or coughing.

Keep foods safe from cross contamination

• Avoid cross contamination, which occurs when germs from raw foods get onto foods that will not be cooked or fully reheated to 165º F before eating.

• Put raw poultry, meat and fish in the “meat” drawer of the refrigerator, or put them on the bottom shelf in the refrigerator so the juices don’t drip on foods that won’t be cooked.

• Use a hard cutting surface with no splits or holes in it.

• Wash, rinse and sanitize the cutting surface and utensils after cutting raw poultry, meat, and fish, as well as melons. Make a sanitizer with 1 teaspoon of household bleach for each gallon of cool water.

Heat foods to their proper temperature

• In order to kill all bacteria, cook turkey, dressing containing turkey parts, other poultry and wild game to at least 165º F, ground beef and ground pork to 155º F, and fish, shellfish, lamb, other pork, other beef, and eggs to 145º F. (Most people will prefer turkey that has been cooked to an even higher temperature).

• Cold foods should be kept cold (lower than 41º F), and hot foods should be held hot (above 140º F).

Cool and reheat foods properly

• Cool food properly by placing it in uncovered shallow pans in the refrigerator.

• If you are taking prepared food to share with others, be certain that you keep it hot (above 140º F) or cold (41º F or below) during the trip and until it is served.

• If food has been sitting at room temperature for not more than 2 hours, refrigerate it or reheat it. If food has been sitting out for longer than 2 hours, throw it out.

• Take care with leftovers. Be sure the food has been cooled properly, then kept cold on the journey home.

Vegetables and fruit

• Wash and scrub fruits and vegetables under cold running water.

• Scrub the exterior of melons before cutting them, and then keep them cold at 41º F or below.

• Keep “starchy foods” like cooked beans (legumes), rice, potatoes and pasta at 140º F or above, or cold at 41º F or below. Be sure to refrigerate within 2 hours after the meal.

• Keep tofu and other plant protein foods hot (140º F or above) or cold (41º F or below).

• Sprouts must be kept at 41º F or below until used.

Donated foods

Meal programs and food banks see a large amount of food donated around the holidays, and this Thanksgiving is no exception. Public Health encourages your generous food donations, and stresses that the biggest need is for high quality canned protein foods, fruits and vegetables.

If you are donating fresh produce or a perishable food that has been kept continuously refrigerated at 41º F or less, call the donor agency before delivering to make sure that they have refrigerator or freezer space, and that they can accept what you would like to donate.

For additional information on food safety, please visit:

• Public Health’s Food Protection website

• Cooking Turkey Fact Sheet

• Public Health – Seattle & King County www.kingcounty.gov/health

The mutation, called G551D-CFTR, is present in only about 4 percent of cystic fibrosis patients, but the findings suggest the drug may also benefit patients with more common mutations, either alone or, more likely, in combination with other drugs, said Dr. Bonnie Ramsey, director of the Center for Clinical and Translational Research at Seattle Children’s Research Institute and lead author on the study.

The findings also suggest that even adults with long-standing disease can recover at least some lung function, Dr. Ramsey said.  ”That was always a question: once you’ve had lung damage could you reverse it.”

Cystic fibrosis is the most common lethal inherited disease among whites, but occurs in other racial groups as well. About 30,000 Americans have the disease.

The disease is caused by mutations in the gene that provides cells with the instructions needed to make a protein called cystic fibrosis transmembrane conductance regulator, or CFTR.

This protein forms a channel through which chloride ions flow in and out of the cell. The protein also helps regulate the flow of sodium ions as well.

The flow of these ions, in turn, helps determine the viscosity of the mucous in the airways of the lung as well as the viscosity of secretions in other passageways, including those in the liver, pancreas, gastrointestinal tract and reproductive organs.

Mutations in the CFTR gene can have different effects. Patients in this study, for example, who have the G551D-CFTR mutation make channel proteins that do not open up properly. Ivacaftor binds to this protein and opens the channel so the ions can flow.

With other mutations, however, the malformed proteins may not even get to the cell surface or, if they do, not in sufficient numbers.

Without normally functioning CFTR proteins, a person’s secretions become thick and viscous. In the lungs, the thicker mucous blocks airways, leading to chronic lung infections and a relentless decline in lung function.

Blockages in other organ systems, such as the pancreas and liver, cause a variety of problems, including diabetes and malnutrition.

Despite advances in treatment, there is no cure and half of patients with cystic fibrosis die before age 37, most from respiratory failure.

In the new study, 161 patients age 12 or older were randomly assigned to either take ivacaftor or a placebo two times a day for 48 weeks.

At the end of the study, the researchers found that compared to those who took the placebo patients who took the drug saw their lung function improve 17 percent. They also saw a marked reduction in flares ups of respiratory symptoms and reported a general improvement in their overall health. In addition, on average, they gained more than 7 pounds over the 48 weeks of the study.

“It’s really the constellation of effects that’s impressive,” said Dr. Ramsey. “You have not only improvement of lung function, but also improved quality of life, a decrease in flare ups and a substantial weight gain.”

Trials combining ivacaftor with drugs that target other genetic defects responsible for cystic fibrosis are underway, Dr. Ramsey said.

Ivacaftor is being developed by Vertex Pharmaceuticals with financial support from the Cystic Fibrosis Foundation. The new study, which was funded by the company, the foundation and large number of government agencies, appears in the current issue of the New England Journal of Medicine.

Co-investigators in the Washington region are: Moira Aitken, MD, professor of medicine in the Division of Pulmonary and Critical Care Medicine at the University of Washington Medical Center and Ronald Gibson, MD, PhD, director of the Cystic Fibrosis Clinical Center at Seattle Children’s Hospital and professor of pediatrics at the University of Washington School of Medicine.

To learn more:

• Visit the National Library of Medicine’s Home Genetic Reference section on cystic fibrosis.

Additional information can be found on these National Library of Medicine pages.

• Encyclopedia: Cystic Fibrosis
• Encyclopedia: Cystic fibrosis – nutritional considerations
• Encyclopedia: Cystic fibrosis - resources
• Health Topic: Cystic Fibrosis
• Health Topic: Newborn Screening
• Tutorials: Cystic Fibrosis