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RI officials: More doctors used unapproved IUDs

June 29, 2010

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PROVIDENCE, R.I.—Rhode Island health officials on Tuesday confirmed that two additional medical practices implanted unapproved birth control devices in patients, on top of one that was punished last week, and said there may be more they don't know of yet.

"I hope there aren't a lot more, but I suspect we'll get a couple," Department of Health Director David Gifford said.

Department officials said Bayside OB-GYN and the Center for Obstetrics & Gynecology told them that they purchased and implanted intrauterine devices, or IUDs, from international sources. The devices were not approved for use in the United States by the U.S. Food and Drug Administration.

The practices were ordered to turn over to the health department the names and medical records of all the patients who got the unapproved IUDs and to notify the patients within 10 business days that they were implanted with them.

Officials at the Center for Obstetrics & Gynecology and Bayside didn't immediately return calls seeking comment. Annemarie Beardsworth, a spokeswoman for the health department, said both had used the unapproved devices in the past but had since stopped.

Another practice, OB-GYN Associates, got in trouble last week for the same thing. That practice was ordered to stop implanting IUDs altogether.

The three practices have offices in a combined 13 locations in Rhode Island and Massachusetts, and are among the larger gynecological practices in Rhode Island. Twenty-four doctors are covered by the three compliance orders, about 10 percent of the 235 obstetricians and gynecologists in the state, Beardsworth said.

Gifford said OB-GYN Associates got the devices after responding to a faxed ad to call an 800-number for an organization that claimed to be a Canadian pharmacy, although officials don't know if that's where the supplier is located. He did not know whether all used the same supplier.

It's not clear whether the devices are approved for use in another country or are counterfeit, Gifford said. The FDA is working with a manufacturer, Bayer, to try to trace them, he said.

Beardsworth said the FDA-approved version of the Mirena IUD usually sells for around $500, while a non-FDA-approved version might sell for half that.

The health department has asked every obstetrician, gynecologist and family practitioner in the state to tell it by noon Friday whether it bought or used unapproved IUDs. Gifford said it was to reassure patients that most practices do not have problems.

"Many women are beginning to raise questions about their existing practices. That's unfair to the practices out there that have not been doing this at all," he said.

He said the department has been getting calls from workers and patients saying they have information about an office that might be using unapproved IUDs.

"We will eventually find out," he said.

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