The Rhode Island Department of Health announced an investigation of 28 providers in 10 Rhode Island OB-GYN medical offices who had illegally imported non-FDA approved IUDs and inserted them into patients. Among the practices named were OB-GYN Associates, Inc, Bayside OB-GYN, Inc., and Center for Obstetrics & Gynecology, Inc. The Rhode Island Department of Health required the practices to surrender the IUDs, provide the names and medical records of all patients who had had a non-FDA approved IUD inserted or removed and notify all of the affected patients.
Who: Food and Drug Administration Office of Criminal Investigations (FDA_OCI), Rhode Island Department of Health.
When: June 29, 2010, 2008-2010.
Where:Rhode Island, U.S.A.
How: Rhode Island Department of Health Investigation.
Additional details: The Rhode Island Department of Health investigation led the FDA to issue warning letters to physicians and an alert to consumers about unapproved IUDs. The letters pointed out that the FDA could not guarantee the safety or effectiveness of imported IUDs, and that there was no way to ascertain that Canada was the real source for these non-FDA approved IUDs.
“FDA and R.I. Investigate Unapproved IUD Use,” The Free Library, International Medical News Group, 2010.
“ FDA Cautions Against Using Unapproved IUDs,”FDA Consumer Update. July 22, 2010.
“ HEALTH Issues Compliance Orders to Two Additional OB/GYN Practices for Use of Non-FDA-Approved IUDs ,”Rhode Island Health Department Archives. June 29, 2010.