A California Lap-Band clinic has just been named in a whistleblower lawsuit. The controversial Lap-Band is a silicone ring implanted around the stomach to curb an obese person’s appetite. The device, manufactured by Allergan Inc., 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.
Now, said UT San Diego, two former employees of a San Diego Lap-Band clinic are suing the clinic and the once ubiquitous 1-800-GET-THIN marketing campaign. The two allege that the device and the campaign put patients at risk. Jessica Meyle, a dietitian, and Amy Demonbreun, a surgical technologist, allege that several factors exposed patients at the San Diego Ambulatory Surgery Center to unsafe care, such as inappropriately sterilized equipment and a questionable business model in which quotas were required for patient referrals, said UT San Diego.
The women, according to court documents, complained to their employers, but to no avail. The case was filed last week in Los Angels County Superior court. The San Diego Ambulatory Surgery Center denies the allegations, saying that the claims about unsterilized equipment are “a total fabrication,” said UT San Diego. The women contend that some patients who received procedures at the clinic’s San Diego location on December 30th and the Beverly Hills Surgery Center in January, could have been exposed to hepatitis C, according to court papers, said UT San Diego. The women also allege that they are not aware of any steps their employer or any other defendants took to contact potentially impacted patients, said UT San Diego. Both women resigned in 2012 and, an attorney for the women explained that, “They quit because they were being ordered to do things that were not legal,” according to UT San Diego.
As we’ve written, in Southern California, the Lap-Band, and so-called boutique surgical centers created almost exclusively to implant these devices, has been tied a growing controversy. The 1-800-GET-THIN billboard promotion in that area of the state was stopped after it was learned that the surgeons at associated surgery centers were not implanting them properly and had caused at least five deaths since 2009. The surgery centers affiliated with the campaign in Southern California were accused of not providing adequate warnings of the risks associated with Lap-Band.
Other lawsuits have been filed against 1-800-GET-THIN, including one concerning ads created by or on behalf of Julian and Michael Omidi of Beverly Hills and referring patients to one of more than one dozen Omidi-owned surgery centers in Southern California. Both brothers are also named as defendants in this case; Julian Omidi’s medical license was revoked in 2009 by the California medical board and Michael just completed a three-year probation, also ordered by the board, said UT San Diego. Omidis’ attorney claims the brothers “have nothing to do” with the clinic and voluntarily resigned from their jobs.
We recently wrote that Allergan Inc. is facing a federal subpoena concerning its controversial weight-loss surgical device, Lap-Band. The subpoena was sourced to the Department of Health and Human Services and concerns a recent Congressional call for a hearing to discuss the safety of Lap-Band after a report in Archives of Surgery associated the devices with an extremely high failure rate and a link to “long term complications.” That study found that about half of all Lap-Band recipients were contemplating a removal of the devices after just six years and nearly 40% of patients were bound to suffer long term pain and injuries rooted to the devices.
Recently, despite growing evidence that Lap-Band could be defective and dangerous by design and that a vast number of surgeons have not been well-versed in proper procedures for implanting them, the FDA approved the surgery for people with less severe cases of obesity, potentially putting thousands more people at risk for similar injuries. The Lap-Band design has been linked to erosion of the band through the stomach wall, stretching the esophagus and stomach pouch, stomach pain, gastroesophageal reflux disease, difficulty swallowing, nausea, and vomiting.