Non-FDA-Approved IUD Information

Through an ongoing investigation of its Board of Medical Licensure and Discipline, the Department of Health discovered that Rhode Island offices of OB-GYN Associates, Inc. had been purchasing non-FDA approved versions of the Mirena and ParaGard intrauterine devices (IUDs) since January 2009. The use of non-FDA-approved drugs and devices is prohibited by law, except in rare circumstances (e.g. pre-approved product testing).

Following a Compliance Order issued to OB-GYN Associates on June 23 requiring the practice to stop inserting IUDs, the Department received reports that additional OB/GYN practices also have been purchasing and using non-FDA-approved IUDs from international sources. The Department is now working to confirm each of these reports. This website will be updated as more information becomes available.

The Department's main concern is the effectiveness of these non-FDA-approved IUDs in preventing pregnancy. 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.

Practices that have used non-FDA-approved devices

Rhode Island practices that have purchased or used non-FDA-approved IUDs from international sources are listed here, along with the name of the non-FDA-approved products and the time period during which they may have been used. If you are aware that other practices have been using non-FDA-approved devices, please call the Department at 401-222-8022 / RI Relay 711.

Practice Name	Practice Location(s)	Non-Approved IUD(s) Used	Time Period Used
Bayside OB-GYN, Inc.	Providence, Wakefield, Woonsocket	Mirena	May 2008-May 2010
David A. Carcieri, M.D.	North Providence	To be determined	To be determined
Center for Obstetrics & Gynecology, Inc.	East Greenwich, Providence, Woonsocket	Mirena	February 2009-March 2009
Mary Catherine DeRosa, M.D.	Warwick	Mirena	April 2008-April 2009
Cynthia M. Hanna, M.D.	Pawtucket	To be determined	To be determined
Marc A. Jaffe, M.D.	East Providence	Mirena	June 2008-November 2009
Carol A. Manning, M.D.	Warwick	Mirena	April 2008-April 2009
Beth G. Marcaccio, M.D.	Warwick	Mirena	April 2008-April 2009
OB-GYN Associates, Inc.	East Greenwich; East Providence; Providence; Newport; Wakefield; Swansea, MA; North Attleboro, MA	Mirena and ParaGard	January 2009-June 2010
Partners in Obstetrics and Gynecology, Inc.	Pawtucket	To be determined	To be determined

What you should do

Not all women who had an IUD implanted at a practice that has used non-FDA-approved IUDs received the non-FDA-approved version. The Department is requiring the practices who have been using non-FDA-approved devices to notify, within 10 days of receiving a Compliance Order, all patients who have had the non-FDA-approved IUDs implanted. If you think you may have had a non-FDA-approved IUD implanted:

Use backup birth control

Because our main concern is that the IUD may not be as effective in preventing pregnancy, the Department recommends using another method of birth control such as condoms or abstinence. Oral contraceptive pills, contraceptive patches, and contraceptive vaginal rings can be started but may take several days to weeks to work, so you will still need a backup method of birth control.

You should continue to use a backup birth control method until your IUD is replaced or you begin a new birth control method, as directed by your healthcare provider. If you become pregnant, talk to your healthcare provider about having the IUD removed as soon as you find out that you are pregnant.

Talk to a healthcare provider

There is no need to have your IUD removed immediately. Talk to your healthcare provider about the benefits and risks of removing the device. It is especially important that you do not try to remove the IUD yourself. IUDs should only be removed by a healthcare professional.

Women and Infants' Hospital has a physician referral line, which can help you find a new physician, if you want to do so. They can be reached at 1-800-921-9299. They also have a Contraceptive Consult Clinic, which can help you understand the risks and benefits of removing your IUD and perform the removal if you so choose. Call 401-274-1122 x2721 between 8:00 a.m. and 4:00 p.m. Monday through Friday to make an appointment with the clinic. Spanish speaking staff are available.

Stay informed

For more information or to file a complaint against your OB/GYN provider, call the Health Department at 222-8022 / RI Relay 711 Monday through Friday, 8:30 a.m. – 4:30 p.m. Staff speak English and Spanish.

Frequently asked questions in English and Spanish, including information about non-FDA-approved and FDA-approved IUDs, will be updated as more information becomes available.

What we are doing

On June 23, the Department issued a Compliance Order prohibiting OB-GYN Associates, Inc. from implanting any IUDs in patients. All physicians, nurse practitioners, and nurse midwives 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. The Department has confiscated all IUDs the practice had in stock at Rhode Island offices.

The Department has asked any practice or healthcare professional who has purchased or inserted a non-FDA-approved IUD to notify us by 12:00 noon on Friday, July 2, 2010. The Department is working to confirm several reports and will update this website as new information is available.