The FDA has issued warnings regarding the misleading information and advertising with regards to the Lap-Band device designed for weight loss, which is band that is surgically implanted around the stomach to limit the amount of food a person can ingest at one seating.
Presently, the FDA has approved of two stomach bands, the aforementioned and the Realize Adjustable Gastric Band.
The FDA has sent letters directly to the marketing company and the eight surgical centers located around California to stop advertising the Lap-Band medical device because their pamphlets failed to include important information to patients, such as risks involved, warnings, side effects, and contraindications that the FDA requires. Furthermore, when risks were listed, they were done so with the text being too small to be legible.
According to Steven Silverman, the director of the Office of Compliance in FDA’s Center for Devices and Radiological Health in the Consumer Update, the FDA’s concern is that the advertisements for this device have been glamorized without any of the risks being communicated. Consumers who may want to undergo such a surgical procedure would need to be fully aware of any and all risks involved, and gastric banding is reserved for obese patients of a certain criteria. The Lap-Band was approved by the FDA for use in morbidly obese patients whose BMI was registered at 40, or anywhere between 30 and 40 if it was in conjunction with other conditions related to obesity, like heart disease, diabetes, high blood pressure, and such. The FDA has approved Realize Adjustable Gastric Band for patients with a BMI of 40, or a 35, but in combination with conditions also related to obesity.
It is important for people to understand that a gastric band operation is not a cure-all for obesity. Instead, lifestyle changes must be made in order for a patient to achieve successful weight loss, including taking weight loss supplements.
Band surgery weight loss also comes with several serious complications aside the risks involved with the surgical procedure. Those who undergo a gastric band procedure may end up suffering from: GERD, stretching of the esophagus, abdominal pain, nausea, vomiting, indigestion and more.
The LA Times reported 4 deaths as a result of bariatric surgery lap band procedures at centers affiliated with this campaign, with a fifth one currently under investigation.
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