FDA Takes Action Against Gastric Band Sugical Centers and 1-800-GET-THIN

Tweet

Please note, Schmidt & Clark, LLP is no longer accepting lap band claims. If you feel that you may have a potential case, we urge you to locate another law firm adequately suited to handle your claim.

The U.S. Food & Drug Administration (FDA) has recently sent warning letters to eight surgical centers and the marketing firm 1-800-GET-THIN LLC for violating the Federal Food, Drug, and Cosmetic Act.  According to the FDA, the advertisements used by these companies to promote the lap band procedure fail to reveal material facts, including relevant risk information regarding the use of the LapBand, age and other qualifying requirements for the LapBand procedure, and the need for ongoing modification of eating habits, as provided in the approved LapBand labeling.

Under federal law, product advertising for medical devices such as the Lap-Band must contain relevant warnings and information about side effects. Potential complications from gastric band implantation include stretching of the stomach pouch or esophagus, moving of the gastric band (which requires additional surgery to correct), and erosion of the band through the stomach wall.

Free Gastric Band Lawsuit Evaluation: If you or a loved one has been injured by a gastric band, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the gastric band and we can help.

What’s the problem?

December 13, 2011 - Prompted by a series of claims about extraordinary, risk-free weight loss in gastric band users, the FDA has sent warning letters to the California marketing firm and surgical centers.

“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.”

Yet despite the risks, the administration has approved the so-called ‘Lap-Band’ by Allergan Inc., and the ‘Realize Adjustable Gastric Band,’ by Ethicon Endo-Surgery Inc. These products are designed to be fitted around the upper part of the stomach to create a ‘pouch’ which limits the amount of food that can be eaten at one time. This is supposed to help you lose weight by making you feel fuller after eating less food.

Both devices have been approved for use in adults who have been unable to lose weight through conventional methods, and have:

• a body mass index (BMI) of 40 or more;
• a BMI of at least 35 and at least one adverse health complication associated with the patient’s obesity, such as diabetes or high blood pressure.

Body mass index is an estimation of body fat based on the individual’s height and weight. A 5’6” person weighing 248 pounds has a BMI of 40.

Gastric Band Side Effects

Commonly reported side effects in gastric band recipients include:

• 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

The FDA cautions individuals considering gastric band surgery that the devices are not permanent implants. A high percentage of patients require revision surgeries to reposition, replace or remove the bands due to complications or because they have failed to aid the patient in losing weight.

If you decide to have a gastric band implanted, you will be required to make drastic changes in your diet. You will have to eat small portions of food frequently to avoid complications and to ensure weight loss. If you eat or drink more than the artificially-created stomach pouch can hold, the pouch will stretch, and food will back up into the esophagus. If this happens too often, a surgical adjustment of the band may be required. Additionally, if you maintain a diet that is high in fatty foods, you may fail to lose weight even with the gastric band.

Before making your final decision about gastric banding, the FDA advises you to consider these issues carefully and read the information booklet provided by your surgeon. Be sure to discuss any questions you may have in-depth before deciding to have surgery.

Do You Have a Gastric Band Lawsuit?

The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in gastric band lawsuits. We are handling individual litigation nationwide and currently accepting new gastric band injury cases in all 50 states.

Free Gastric Band Lawsuit Evaluation: If you or a loved one has been injured by a gastric band, you should contact our law firm immediately. You may be entitled to compensation by filing a Lap-Band injury suit and we can help.