FDA warns Los Angeles Gastric Bypass Surgeon
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.
MY DOCTOR COOPERSTONE FROM LONG ISLAND NYM HAS BEEN DOING THIS GASTRIC BYPASS OPERATION FOR OVER 12 YRS AFTER LEAVING MY LAST DR TO SHOP AROUND AND FINDING DR.COOPERSTONE YOUR ARTICLE CAUGHT MY ATTENTION BECAUSE IN MY MEETING WITH HIM HE CLEARLY EXPLAINED HE USES THIS PLASTIC LIKE BAND TO GO AROUND YOUR ASSOFACUS (EXCUSE SPELLING) SO YOU WON'T SWALLOW LARGE PIECES OF FOOD LEADING TO STRETCHING AND HE HAS OVER 6,000 OR MORE OPERATION WITH NOT ONE PROBLEM,BUT UNTIL YOUR ARTICLE I HAVE SEEN NO OTHER DR.USING THIS BAND EITHER.
Posted by: JOHN LOHMAN | June 25, 2008 at 06:56 PM
MY DOCTOR COOPERSTONE FROM LONG ISLAND NYM HAS BEEN DOING THIS GASTRIC BYPASS OPERATION FOR OVER 12 YRS AFTER LEAVING MY LAST DR TO SHOP AROUND AND FINDING DR.COOPERSTONE YOUR ARTICLE CAUGHT MY ATTENTION BECAUSE IN MY MEETING WITH HIM HE CLEARLY EXPLAINED HE USES THIS PLASTIC LIKE BAND TO GO AROUND YOUR ASSOFACUS (EXCUSE SPELLING) SO YOU WON'T SWALLOW LARGE PIECES OF FOOD LEADING TO STRETCHING AND HE HAS OVER 6,000 OR MORE OPERATION WITH NOT ONE PROBLEM,BUT UNTIL YOUR ARTICLE I HAVE SEEN NO OTHER DR.USING THIS BAND EITHER.
Posted by: JOHN LOHMAN | June 25, 2008 at 06:56 PM
I heard alot about this gastric bypass, and most of them are successful until now, It seems scary, I woudn't ask my husband to go through this, it's very dangerous, i'll just ask him to have a daily routine of exercise.
Posted by: Plastic surgery Beverly Hills | June 03, 2010 at 04:01 PM