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FDA: Surgical Centers Warned For Fraudulent Lap-Band Marketing

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.

Having already become an established practice in the healthcare industry, Lap-Band procedures have been helping patients manage their weight for approximately ten years. However, recent allegations by the U.S. Food and Drug Administration (FDA) suggest that a number of surgical firms are conducting fraudulent advertising campaigns. The FDA has warned eight surgical centers and the marketing firm 1-800-GET-THIN LLC in California about misleading advertising of the Lap-Band.

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.

February of this year witnessed the FDA expand their approval of this surgical procedure to include patients with a body mass index (BMI) between 30 to 40 and one weight-related medical condition such as diabetes or high blood pressure. Ads promoting the use of the Lap-Band suggest that the procedure is capable of miraculous results, sometimes promising patients they may lose up to 90 pounds.
The expanded approval was intended to assist in the improvement of weight complications associated with obesity.

According to a recent FDA Consumer Report, officials are concerned with the marketing practices of several surgical centers that provide this procedure. There are serious risks associated with Lap-Band procedures that are not addressed in promotional ads. Promotions placed on billboards, bus placards, newspaper advertisements, the Internet and elsewhere, feature slender patients 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.”

The implementation of a procedure such as this implies an inherent degree of risk. “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. The following is a comprehensive list of the risks associated with the use of the Lap-Band:

  • 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

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 after receiving Lap-Band treatment, 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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