The Food and Drug Administration has issued another warning letter to a clinic marketing lap band surgery. According to the FDA, Los Angeles-based LapBand VIP is using false and misleading billboards and television commercials to promote the surgery. During a surgical procedure, the lap band is placed around the upper part of a patient’s stomach to create a pouch, which limits the amount of food that can be eaten at one time.
But LapBand VIP’s ads fail to provide any information about the potential health risks of the procedure or possible surgical complications. Those risks include abdominal pain, vomiting, nausea, difficulty swallowing and death, according to the FDA. Further, the agency noted that the lap band results in a drastic change in eating habits, which the advertisements also fail to mention. For example, the text of one television commercial reads:
My weight made me feel like I couldn’t participate in activities with my friends and family. When my doctor told me that I could actually die because of my weight. [sic] That’s when I made my decision to change my life and I called LapBand VIP. LapBand VIP brought out the best in me. After LapBand VIP I can now ride my Quad, walk my dog and play golf with the best of them. Make the change today call LapBand VIP.
The FDA also found fault with the company’s billboards, one of which read: “LAPBANDVIP.COM. 800.561.9000. PPO INSURANCE VERIFICATION.” The billboard included “a photo of a thin woman,” with the caption: “TIFFANY LOST OVER 100 LBS. Actual Patient. Results May Vary.” The FDA letter said:
These advertisements all 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. Therefore, the advertisements are misleading … and misbranded. Additionally these advertisements do not provide the LapBand’s relevant warnings, precautions, side effects, and contraindications.
The FDA said that LapBand VIP should “immediately stop” marketing the LapBand in a manner that violates federal regulations. Failure to comply could result in regulatory action by the agency, an injunction against LapBand VIP’s operation, the seizure of its assets or monetary penalties. LapBand VIP is the not the first clinic to receive a warning letter over its marketing of the lap band procedure. Last December, the FDA sent similar letters to eight surgical centers and a marketing company, cautioning recipients about their misleading advertisements for gastric lap band procedures. Some of the recipients of the letters have been Defendants in lawsuits, some of which involved both false advertising and wrongful death.
Source: Lawyers USA Online
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