FDA warns Los Angeles-area obesity doctor over informed consent violations

A Los Angeles-area doctor who lent his name to a type of stomach-shrinking surgery failed to obtain the full informed consent of 175 patients implanted with an experimental medical device, according to a federal warning letter released Tuesday.

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. The FDA posted a largely blacked-out copy of the letter to its Web site on Tuesday.

The copy did not make clear if the same device was used in all the patients.

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. It's been credited with helping obese patients shed hundreds of pounds.

It wasn't clear from the redacted letter what sort of medical device or devices Fobi was studying. However, the Fobi pouch surgery includes the placing of a band around the stomach pouch's opening to limit stretching over time that can allow patients to eat more.

Fobi was performing an operation late Tuesday and wasn't available for comment. The FDA gave him 15 working days to reply to the warning letter.

The FDA inspected Fobi's clinic Sept. 19-29, according to the five-page letter, signed by Timothy Ulatowski, director of compliance for the agency's devices division.

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On the Net:

Recent FDA warning letters: http://www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm