Weight loss surgery results in FDA warning

A bariatric surgeon who invented a type of bariatric surgery was issued a federal warning today for implanting 175 patients with an experimental, unapproved medical device without obtaining full informed consent.

Newsday also reports:

Dr. Mathias A.L. Fobi also implanted 185 patients with an experimental device before receiving approval to do so from either the Food and Drug Administration or the institutional review board overseeing the study, amid other violations of federal regulations, according to the Jan. 24 letter....Fobi, of the Center for Surgical Treatment of Obesity in Hawaiian Gardens, Calif., invented the Fobi pouch. This type of gastric bypass surgically reduces the size of the stomach to a one- or two-tablespoon pocket, vastly restricting the amount patients can eat.

The FDA warning can be read here.

It is important for anyone considering any of these surgical procedures to understand that dozens of types and variations of bariatric procedures are being regularly developed and performed by surgeons around the world, yet all remain unproven. In the more than forty years that bariatric surgeries have been performed, no randomized, controlled clinical trials have yet shown any long-term improvements to actual health or that lives are saved or extended by any of these surgeries, and especially not for the newer variations coming out. As obesity researcher, Dr. Ernsberger, Ph.D., of Case Western Reserve School of Medicine, Cleveland, Ohio, noted in an overview or risks and benefits of bariatric surgeries, only three animal tests had been reported before the procedures were begun in humans—highly unusual as most surgical operations are first perfected with extensive animal testing, he said.

Doctors discussed the ethical concerns of bariatric surgeries in the April 2003 issue of the Journal of the American Medical Association. “This is the classic problem in surgery-innovation without the research to guide it,” said Laurence B. McCullough, Ph.D., a professor of medicine and medical ethics at Baylor College of Medicine in Houston, Texas. “So all this should be brought under experimental protocols...That’s how you handle the conflict of interest. Make sure you tell the patient: ‘The procedure is investigational; we don’t know if it will help you.’”