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.
According to a recent U.S. Food and Drug Administration (FDA) Consumer Report, eight surgical centers and one California marketing firm have demonstrated a propensity for negligence. Each has been accused of fraudulent marketing practices that fail to acknowledge the inherent dangers associated with Lap-Band procedures. Subsequently, the FDA has distributed warning letters to each of the companies in question, requesting that they pull their misleading ads and notify the agency within 15 working days of the actions taken to correct them.
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.
While the Lap-Band has exhibited the ability to significantly reduce body weight, the FDA has suggested that 1-800-GET-THIN, a California marketing firm in association with eight surgical centers, failed to provide mandatory information about the risks and side effects of Lap-Band procedures. The following is a comprehensive list of the side effects that these companies neglected to place in their add campaigns:
- Nausea and vomiting
- Difficulty swallowing
- Gastroesophageal reflux disease
- Upset stomach or pain
- Stretching of the stomach pouch
- Stretching of the esophagus
- Displacement of the silicone band
- Erosion of the silicone band through the walls of the stomach
- Death
Included in the warnings that were distributed by the FDA was a Pasadena based marketing firm known as 1-800-GET-THIN LLC. According to the FDA, this firm specializes in providing consultations and information sessions on Lap-Band surgeries.
The surgery centers that received the subsequent warning letters were: 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; and San Diego Ambulatory Center LLC.
According to the FDA, the aforementioned companies promoted Lap-Band procedures while neglecting to mention the inherent risks associated. “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.”
Concern regarding these potentially fraudulent marketing campaigns has grown in the wake of several adverse events since 2009. According to the L.A. Times, five people have died since 2009 after Lap-Band surgeries preformed at clinics affiliated with the 1-800-GET-THIN campaign.
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, eight surgical centers and a California marketing firm receive warning letters from the FDA. In accordance with the warning letters, the companies must pull their misleading ads and notify FDA within 15 working days of action taken to correct them.
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-(949) 557-5800.