1-800-GET-THIN Quality Concerns Spark Request for Investigation

On Friday, 3 members of congress called for an investigation into 1-800-GET-THIN, a Southern California company that markets the Lap Band and is associated with several surgical centers. The Congressmen’s request for this investigation also included an overall investigation of the safety and efficacy of the Lap Band. A strong factor in prompting this request is that the use “of lap-bands by these surgical centers appears to have been associated with significant harm to the health of a number of Southern California patients, including the deaths of five patients since 2009.”

The FDA sent out warning letters last month, telling 1-800-GET-THIN that their marketing violated the Federal Food, Drug, and Cosmetic Act, and mandating immediate action. The Congressmen’s letter says: “The tragic results of aggressive marketing by several Lap-Band surgical centers are
particularly evident in recent events in Southern California… Despite serious risks, 1-800-GET-THIN and the related surgical centers have marketed the device with ubiquitous roadside billboards, advertising inserts, and radio and television ads that display the smiling faces of thin people and catchy phrases about the benefits of the surgery. The ads include phrases such as “DIETS FAIL! The Lap-Band Works!”

In addition, on January 17, 2012, several ex-employees, patients, and potential patients filed a lawsuit against 1-800-GET-THIN. They allege that owners of 1-800-GET-THIN “instruct their surgeons and doctors to perform medically unnecessary surgical procedures… require their staff to perform medical procedures that they are not licensed or qualified to perform… do not stock their surgery centers with the necessary medical equipment to properly sterilize surgical instruments, require the staff to ‘recycle’ surgical instruments which fall apart.” Also included in the filed charges are the statement that the medical license of Julian Omidi – who ran 1-800-GET-THIN with his brother – had been revoked in 2009.

Controversy and confusion over the safety of medical devices like the Lap Band are exacerbated when the surgeons performing these operations have different levels of experience, varied techniques, and follow-up/after care programs that range from minimal to extensive. Gastric banding – the generic term for the surgery involving the Lap Band – has been shows to be both safe and effective when performed by a well-qualified surgeon with a comprehensive follow-up program. Individuals considering Lap Band or any type of weight loss surgery should speak with a surgeon who will ensure they are educated about the risks, complications, and after-care associated with any procedure. The American Society of Metabolic and Bariatric Surgery is currently conducting a review and revamping of the process where surgeons and surgical centers are designated as “Centers of Excellence”. None of the surgical centers associated with 1-800-GET-THIN were Centers of Excellence.

We spoke to bariatric surgeon Dr. Helmuth Billy of Dr Billy Bariatrics in Ventura, CA, and Medical Director for St. John’s Regional Medical Center. He advises: “Potential patients should pay particular attention to the practice they are considering. Is there a plan to see patients regularly after surgery? Does the surgeon have a plan for monthly follow up appointments? Is the practice located close enough for the patient to participate in support groups and monthly followup appointments? Does the surgeon practice at a local hospital as well as the surgery center? These are important issues in evaluating any surgeon who is performing lap band procedures. Selecting a surgeon who is truly committed to your local community and is well established in your community can make all the difference in a patients outcome. Other physicians you trust can be good resources as well. “Be sure to discuss your choice of surgeon with your family or primary physician. Your family physician may have already done the research on the practice you have selected and can reassure an individual that the practice is known for good results and excellent follow up,” Dr Billy concluded.

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