Clinic That Implants Lap-Band Devices Gets FDA Warning. People who might visit oBand Centers near Marina Del Rey, Calif., are not getting enough information on the potentially dangerous risks associated with a Lap-Band surgery offered through these facilities. According to an MMM-Online.com report, the Food and Drug Administration has sent a Warning Letter to oBand […]
Clinic That Implants Lap-Band Devices Gets FDA Warning. People who might visit oBand Centers near Marina Del Rey, Calif., are not getting enough information on the potentially dangerous risks associated with a Lap-Band surgery offered through these facilities.
According to an MMM-Online.com report, the Food and Drug Administration has sent a Warning Letter to oBand Centers there regarding information on their Web site that lacks clear distinctions and descriptions of the side effects associated with its service and specifically, the Lap-Band device and the surgery to implant it.
The FDA has been cracking down on surgery centers that offer Lap-Band, a device that is inserted around a person’s stomach that’s designed to severely restrict a person’s appetite and promotes rapid and extensive weight loss. Lap-Band is typically only approved in rare circumstances, usually for morbidly or severely obese people. Since this restriction has not been drawing in the expected clientele volume, clinics that offer the Lap-Band procedure have resorted to a flooding of the market with advertisements for these clinics and procedure.
In many cases, these promotionals have fallen short of FDA regulations for advertising medical devices, surgeries, or any other medical procedures that dictate how much of a product’s side effects must be discussed in an ad and whether that information is readily available to would-be patients of a center.
oBand Centers, according to several other sources, is actually a referral service for weight loss clinics that offer the Lap-Band procedure, much like the Web site 1-800-Flowers is for participating florists.
In fact, it was an aggressive billboard campaign, 1-800-GET-THIN, that first called attention to questionable marketing practices exercised by the makers of Lap-Band and the clinics that offered the outpatient surgeries. The pitch told prospective patients that they would “get thin” and that it’s a routine procedure but that’s farthest from reality as the Lap-Band procedure can have serious complications and create disastrous results for the wrong recipients.
The Lap-Band can migrate from its original location, voiding the purpose of the surgery and putting a recipient in severe pain and at grave risk of serious injuries and maybe death.
The letter from the FDA to oBand Centers orders the company to alter its marketing campaigns, specifically information on its Web site, to call more attention to the side effects and risks of these surgeries. According to the report, “the company’s website fails to reveal material facts about Lap-Band risks.
The letter also says that a web video that is intended to convey indications for use, contraindications, warnings and adverse events is not accessible to viewers, due to the brief appearance of the information and tiny, blurry print that renders the content illegible.”
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