Typically, a patient will trust, or at least give consideration to, their personal doctors’ input concerning which medical devices are the best and most effective for that particular patient. That is exactly what several individuals did in Rhode Island. Various patients who visited OB-GYN Associates, Inc. offices took their doctors’ word that the pregnancy prevention device recommended to them would be both safe and effective. However, these patients were unaware that certain Rhode Island OB-GYN Associates, Inc. offices had been purchasing and using non-FDA approved intrauterine devices (IUDs) from international sources.
After conducting a lengthy investigation of its Board of Medical Licensure and Discipline, the Department of Health discovered that, since January 2009, several OB-GYN Associates, Inc. offices in Rhode Island had been purchasing and using non-FDA approved versions of Mirena and ParaGard. The intrauterine devices under the brand names Mirena and ParaGard have been FDA approved. The use of drugs and devices, which have not been approved by the FDA, typically is prohibited by law, except under very specific circumstances.
An IUD is a small, “T-shaped,” flexible, plastic device that is inserted into a woman’s uterus to prevent pregnancy. The IUD Mirena also acts to deliver a small amount of hormones into a woman’s body to increase the effectiveness of pregnancy prevention. Often, women choose the IUD method of birth control because such a device is long lasting and inexpensive.
The R.I. Department of Health has become concerned about the effectiveness of the non-FDA approved IUDs in preventing pregnancy. On June 23, 2010, the R.I. Department of Health issued a compliance letter to OB-GYN Associates requiring that practice to stop inserting IUDs. The Department then received reports that various other OB-GYN practices had been purchasing and using unapproved IUDs obtained from international sources.
The R.I. Department of Health is requiring any OB-GYN practices that have been using non-FDA approved IUDs to notify all patients who have had such devices implanted. Additionally, the Department has confiscated all IUDs in stock at the Rhode Island offices of the OB-GYN Associates, Inc. practice.
To prevent any unintended consequences resulting from the use of unapproved IUDs, consumers who have been using intrauterine devices should ask their doctors if the birth control method they have been using is FDA-approved. Patients should be aware that several practices which have been using non-FDA approved IUDs have not yet been identified, and should continue to check the R.I. Department of Heath website for updated information and reports. Finally, patients should be aware that IUDs which have not been FDA approved may not be as effective at preventing pregnancy, and should speak with their doctors about taking precautions accordingly.