FDA Issues Lap-Band Warning to Clinic

Some misleading Lap-Band ads have prompted the U.S. Food & Drug Administration (FDA) to issue another warning to a Lap-Band surgery center. The controversial device is a silicone ring implanted around the stomach to curb an obese person’s appetite.

Manufactured by Allergan Inc., the device is designed to promote rapid weight loss, but has been linked to a growing number of unexpected complications and side effects blamed on the device and the surgeons’ implanting the Lap-Band.

The FDA’s most recent warning was issued to oBand Centers of Marina Del Rey, California, over misleading claims in its marketing material for the Lap-Band, said Medical Marketing and Media (MMM). The agency, in its letter, stated that the oBand web site neglects to discuss significant facts about the risks associated with the Lap-Band and states that a web video meant to discuss indications for use, contraindications, warnings, and adverse events can not be accessed by viewers as it only briefly provides information in tiny, blurry print that, said MMM, “renders the content illegible.” OBand Centers was advised by the agency to correct the violations and respond with a list of specific steps it will take, the documentation of those steps, and a timetable of when those steps will be completed, said MMM.

We wrote that, last year, the FDA issued a warning letter to Lap-Band VIP owners, advising them to either change their billboard and television ads or face disciplinary action. Those allegations are fairly similar to those made by the FDA against 1-800-GET-THIN the prior December.

In the case of Lap-Band VIP, based in Tarzana, California, the firm touted its results on television, the Internet, and highway billboards. In its June 25 letter, the FDA said the ads were misleading and omitted warnings about the risks associated with Lap-Band surgery and warned Lap-Band VIP to “take prompt action to correct the violations” or risk “regulatory action.” Dr. Shahram Salimitari, Lap-Band VIP co-owner, told the LA Times that it was taking the billboards down. Lap-Band VIP says is not connected with 1-800-GET-THIN, which removed most of its marketing last year following regulator probes and an agency warning. Salimitari told the LA Times he performed Lap-Band surgeries at a clinic affiliated with 1-800-GET-THIN; he left and formed Lap-Band VIP with Dr. Hooman Shabatian.

Lap-Band VIP was quick to point out that it has a better record than 1.800-GET-THIN, which is connected with five deaths at its affiliated clinics. “There have been no deaths associated with LapBandVIP.com,” Shayla Reed, the firm’s general manager, told the LA Times. “LapBandVIP.com’s complication rate is less than the national average, as published in recognized medical journals.” In fact, the Lap-Band VIP web site said it offers “better care, better results” and uses a team of “highly trained physicians.”

Speaking of its “highly trained physicians,” Sheila Mattia, a Lap-Band VIP patient alleged in a lawsuit that, during her 2010 surgery, a Lap-Band VIP anesthesiologist cut her esophagus while placing a breathing tube into her throat, causing her “to be hospitalized for months,” according to court documents. Defendants deny wrongdoing.

Interestingly, Salimitari was described on the Lap-Band VIP web site as a specialist in “gastric banding procedures”; however, his profile does not mention his arrest by Los Angeles County sheriff’s deputies in 2008 over threatening to kill both a sheriff’s deputy and a flower shop owner over a parking issue. The deputy sheriff told the LA Times he needed to use pepper spray to control the surgeon and required help from another deputy to handcuff the 220-pound man. Also, in 2011, Salimitari was sued by former employee, Criswell Abel, who accused him of “continuous unwelcome sexual harassment” and of touching her inappropriately and telling her to show him her breasts in exchange for a promotion.

Meanwhile, Dr. David Nazarian’ profile states his medical degree was received from “Sackler School of Medicine/NYU.” The Sackler School of Medicine is based in Tel Aviv, noted the LA Times and, while the school does have a branch in New York, it is in no way affiliated with New York University, according to officials with both universities.

This entry was posted in Defective Medical Devices. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.