The Rhode Island Department of Health (HEALTH) Board of Medical Licensure and Discipline has discovered that the Rhode Island offices of OB-GYN Associates, Inc. have been purchasing non-US Food and Drug Administration (FDA)-approved versions of the Mirena and ParaGard intrauterine devices (IUDs) from a source also not approved by FDA. (An IUD is a small, "T-shaped" device often made of flexible plastic that is inserted into a woman's uterus to prevent pregnancy. The Mirena device also delivers small amounts of hormone to further help prevent pregnancy.) HEALTH estimates 400-500 women may have had this device implanted since January 2009 by OB-GYN Associates. Not all the IUDs implanted during this time period were non-FDA-approved Mirena or ParaGard IUDs.
The use of non-FDA-approved drugs and devices is prohibited by law, except in rare circumstances (e.g. pre-approved product testing). Therefore, today, HEALTH issued a Compliance Order prohibiting OB-GYN Associates, Inc. from implanting any IUDs in patients. (To view the compliance order, visit http://www.health.ri.gov/discipline/physicians/OBGYNAssociates062310.pdf.) All physicians, nurse practitioners, nurse midwives, and nurses from the practice have been referred to their respective boards of licensure to determine their level of involvement in the use of non-FDA-approved medical devices. This morning, HEALTH confiscated all IUDs the practice had in stock at Rhode Island offices. HEALTH also is requiring the practice to notify, within 10 days, all patients who have had any non-FDA-approved IUDs implanted since January 1, 2009 and provide copies of their medical records to HEALTH. The compliance order only applies to the implantation of IUDs. The practice remains open and can continue to provide all other OB/GYN services and care.
“Our main concern is the effectiveness of these IUDs in preventing pregnancy. Because the effectiveness of non-FDA-approved devices cannot be verified, HEALTH recommends that women who may have these IUDs use another form of birth control such as condoms or abstinence,” said Director of Health David R. Gifford, MD, MPH. “We anticipate that many women will want to talk to their doctor about next steps, including whether the IUD should be removed. There is no immediate need for women to have them removed as the main concern is lack of effectiveness. It is especially important that women do not try to remove IUDs themselves. IUDs should only be removed by a healthcare professional. This investigation is a reminder to all healthcare providers that federal and state laws require that all drugs and devices be FDA-approved and purchased through FDA-approved sources.”
Women who had a Mirena or ParaGard IUD implanted by OB-GYN Associates after January 1, 2009, and want to receive future updates about this investigation or want to file a complaint, should call the Department of Health at 222-8022. Reproductive health specialists from Women & Infants Hospital will also be available to answer questions. The line will be staffed until 8 p.m. on Wednesday, June 23 and thereafter, Monday through Friday, 8:30 a.m. – 4:30 p.m. Staff speak English and Spanish. This is an ongoing investigation and HEALTH will provide regular updates to providers and patients as more information is available.