FDA Warns Another Clinic about Misleading Lap-Band Ads

If you are obese, losing weight is not only good for your appearance, it can save your life.

There are two procedures that can effectively help you lose weight when dieting and exercise alone have failed. One is the gastric bypass surgery and a newer, less invasive alternative procedure is known as the Lap adjustable gastric band or “Lap-Band.”

The Lap-Band involves insertion of an inflatable silicone ring, which is placed around the top portion of the stomach through laparascopy. A small pouch is formed at the upper portion of the abdomen, which holds about a half cup of food as compared to a typical stomach that holds 5-6 cups of food. The main purpose of the silicone band is to slow the passage of food from the pouch to the lower part of the stomach, giving the sensation of a full stomach. It causes a person to eat small portions for a long period of time, helping to achieve considerable weight loss. Depending on how much weight a person wants to lose, the band is tightened with an additional shot of saline, which is available from a special port from within the ring.

One major advantage of Lap-Band over gastric bypass is that it is reversible. When a person starts gaining weight over time, the gastric bypass cannot be performed again but the Lap-Band can be tightened without having to perform the procedure again. The Lap-Band surgery is a day procedure, not involving a hospital stay. The cost is considerably less than gastric bypass, which staples the stomach together and re-routes the intestines.

Gastric bypass has a higher mortality rate. Only 1 in 2,000 people die using the Lap-Band compared to 1 in 250 with the various gastric bypass surgeries.

Even though the results are not as drastic with the Lap-Band compared to gastric bypass, the risks are not as high, either. Patients who have the Lap-Band see slower results, about 50% weight loss over two years as compared to gastric bypass results of 60-80% weight loss over 12-18 months’ time.

The U.S. Food and Drug Administration (FDA) is cracking down on a second Southern California firm it says is using misleading advertising to promote Lap-Band weight-loss surgery.

According to the LA Times, the FDA sent a letter to the owners of Lap-Band VIP, warning them to change their billboard and television marketing or face disciplinary action. The allegations wee similar to those the agency made in December against 1-800-GET-THIN, another company that marketed Lap-Band weight-loss surgery.

Lap-Band VIP, Tarzana, has become a known brand due to promotion of its weight loss surgery on television, the Internet and freeway billboards throughout Southern California.  One billboard featured a photograph of a thin woman with the pitch, “Tiffany lost over 100 pounds. Actual patient. Results may vary.”

Those ads were misleading, the FDA said in a June 25th letter, because they failed to include adequate warnings about the surgery’s risks. The agency said Lap-Band VIP “should take prompt action to correct the violations” or risk “regulatory action.” The FDA warned that it could seize the company’s assets, get an injunction against its operation or pursue monetary fines if it failed to comply.

The billboards were quickly removed.

Back in December, the FDA issued a warning to 1-800-GET-THIN for misleading marketing of the lap-band procedure.  There are some connections between the two companies.  The co-owner of Lap-Band VIP, Dr. Shahram Salimitari, used to work at 1-800-GET-THIN. He said he left there to form Lap-Band VIP with Dr. Hooman Shabatian.

Since 2011, five patients have died after undergoing Lap-Band implementations at clinics affiliated with 1-800-GET-THIN, according to lawsuits, autopsy reports and other public records.

Although the Lap-Band can be effective, there are a number of potential complications including implant movement, eroding, slipping and other displacement, tubing becoming disconnected from skin port, tubing kinking, band leaking, esophageal spasm, gastroesophageal reflux disease (GERD), inflamed esophagus or stomach, infection of skin/port site.

The FDA has sent a warning letter to 8 weight loss centers and a California marketing firm over what it said are misleading advertisements promoting Lap-Band surgery.

“The FDA takes seriously its responsibility to protect consumers from products promoted without adequate warnings,” Steve Silverman, compliance director for the FDA’s Center for Devices and Radiological Health said. “It’s particularly troublesome when advertisements don’t communicate the serious risks associated with medical devices.”

Once again, these medical companies care more about their profits than protecting the consumer. Even though it is a great way for obese people to finally lose weight, they should not be tricked into thinking there are no dangers associated with it.

Feel free to comment on this blog post. Contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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