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Questionable Lap-Band Marketing Leads to Federal Action

Please note, The Senators (Ret.) Firm, 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.

An onslaught of fraudulent marketing campaigns has metastasized across the country in recent months. Subsequently, the latest product to fall victim to misleading claims is a popular surgical procedure used for weight loss in obese adults. This week, the U.S. Food and Drug Administration (FDA) announced that it has taken action against eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for deceptive advertising of the Lap-Band.

The Lap-Band, more commonly known as a gastric band, is an implanted medical device used to assist in significant weight loss for those adults who are obese and who have a body mass index (BMI) of 30-40, with one or more obesity-related medical conditions. Subsequently, patients with a BMI exceeding 40, even without the presence of an obesity related medical condition, are approved for Lap-Band treatment as well.

The Lap-Band procedure, otherwise known as a laparoscopic adjustable gastric band, is characterized by the placement of a silicone band around the upper portion of the stomach, therefore creating a small pouch. The restricted opening between the newly formed pouch and the rest of the stomach regulates the speed in which food transitions through the digestive tract. Subsequently, the band may be tightened or loosened in order to control the amount of food that passes through the stomach at a given time. As a result, the band limits the amount of food intake by making people feel full sooner.

Lap-Band procedures are only to be used when other methods have previously failed to rid patients of excess and dangerous weight. Gastric banding should only be used as a last resort, when non-surgical weight loss methods (such as supervised diet, exercise and behavior modification) have not been successful.

The ambiguous nature of a surgical procedure, such as the Lap-Band, comes with an inherent degree of risk. However, several surgical centers and one California marketing firm are being accused of neglected to include the risks of Lap-Band procedures in their advertising campaigns. While such advertisements boast of the miraculous weight loss results provided by the Lap-Band, they fail to address significant risks. Neglect such as this is in direct violation of federal law. The deceptive advertisements suggest that Lap-Band procedures are without concern.

“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.”

Side effects and adverse events not included in the advertising campaigns include: nausea, vomiting, GERD, upset stomach, displacement of the silicone band, erosion of the silicone band and stretching of both the esophagus and stomach. Adverse events such as these have led to at least five deaths since 2009.

According to an FDA News Release, the following companies received warning letters for their involvement in the deceptive advertising campaign:

  • 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
  • 1-800-GET-THIN

According to federal law, advertising for medical devices, such as the Lap-Band, must contain relevant warnings and information about precautions, side effects, and contraindications. After having allegedly broken the law, by neglecting to add the appropriate risks to their advertising campaigns, the companies mentioned above received warning letters from the FDA. The letters address the neglect, on behalf of the previously mentioned companies, to provide required risk information, including warnings, precautions, possible side effects and contraindications of the Lap-Band procedure. According to the letters, the companies must pull their misleading ads and notify FDA within 15 working days of action taken to correct them.

Failure to respond in an adequately or timely manner will result in further actions by the FDA. Subsequently, the agency may conduct a product seizure of assets and products.

“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.”

Do I Have a Lap-Band Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Lap-Band lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has been injured by the Lap-Band, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

Categories: Product Liability
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