OB-GYN group disciplined for IUDs

PROVIDENCE – The R.I. Department of Health has issued a compliance order to OB-GYN Associates Inc., a large group practice with seven offices across the state and in Swansea, Mass., after learning that it had been buying intrauterine devices (IUDs) from an unapproved source.
Since last year, officials said, OB-GYN Associates had been buying Mirena and ParaGard IUDs from “international sources” not approved by the U.S. Food and Drug Administration.
An estimated 400 to 500 women have had IUDs implanted at the practice since January 2009, officials said, though not all were from an unapproved source. OB-GYN Associates still billed insurers, including the Medicaid program, at the usual rate, though that is forbidden.
“Our main concern is the effectiveness of these IUDs in preventing pregnancy,” said Dr. David R. Gifford, the state health director. “Because the effectiveness of non-FDA-approved devices cannot be verified, [the department] recommends that women who may have these IUDs use another form of birth control such as condoms or abstinence.”
Gifford added that there is “no immediate need” for women to have the devices removed, as the main concern is not that they are dangerous, but that they might not be effective. However, he said, “we anticipate that many women will want to talk to their doctor about next steps, including whether the IUD should be removed,” though he added that it is “especially important” that women don’t try to remove the IUDs themselves, but rather see a doctor.
IUDs are small, T-shaped devices that are inserted into the uterus to prevent pregnancy. The Mirena device also delivers small amounts of a hormone to further help prevent pregnancy.
Official documents suggest that OB-GYN Associates was turned in to the authorities by Bayer Healthcare Pharmaceuticals Inc., the only manufacturer of Mirena. The practice used to buy Mirena from CVS Caremark Corp. subsidiary TheraCom, an FDA-authorized dealer of BHP, but then it found another source.
BHP “suspected that OB-GYN Associates Inc. was purchasing non-FDA approved IUDs through sources that could not be readily identified and traced,” the compliance order says, and Bayer representatives confronted the practice with its suspicions.
“OB-GYN Associates Inc. admitted that it was purchasing the non-FDA approved IUD and asked the BHP representatives to leave,” the document says.
In what officials described as an “ongoing investigation,” OB-GYN Associates has been barred from implanting any IUDs in patients until further notice; to surrender all IUDs it has in stock – officials already went and confiscated all the devices they could find; and to provide the Health Department with the names of all patients who have had IUDs inserted by the practice’s doctors in 2009 and 2010, as well as details on the devices.
The practice must also notify all the patients in writing within 10 days if they received an IUD that wasn’t from an approved source.
All physicians, nurse practitioners, nurse midwives, and nurses from the practice have also been referred to their respective boards of licensure to determine their level of involvement in this matter, officials said.
IUDs are small, T-shaped devices that are inserted into the uterus to prevent pregnancy. The Mirena device also delivers small amounts of a hormone to further help prevent pregnancy.
The compliance order is posted here. Patients who wish to find out more, or to file a complaint, may also call the Department of Health at 222-8022. Specialists from Women & Infants Hospital will also be available to answer questions; the line will be staffed Monday through Friday from 8:30 a.m. to 4:30 p.m., with help available in Spanish as well.