OB-GYN Associates, Inc. Use Non-FDA Approved IUDs

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The Rhode Island Department of Health has recently discovered that several OB-GYN Associates, Inc. offices throughout the state of Rhode Island have purchased non-FDA approved versions of intrauterine devices (IUDs). The U.S. Food and Drug Administration (FDA) had previously approved particular intrauterine devices under the brand names Mirena and ParaGard. Certain Rhode Island practices have been purchasing or using non-FDA approved versions of the devices, since January 2009. The use of drugs and devices that have not been approved by the FDA is often prohibited by law. Several OB-GYN Associates, Inc. offices that have utilized unapproved IUDs were able to obtain the devices from international sources.

An IUD is a small flexible plastic device that is inserted into a woman’s uterus to prevent pregnancy. The IUD under the brand name 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.

On June 23, 2010, the Rhode Island Department of Health sent out a Compliance Order, which acts to prohibit any OB-GYN Associates, Inc. office from implanting any IUDs in patients. The R.I. Department of Health is also 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 offices of several Rhode Island practices. The R.I. Department of Health’s main concern is that several of these non-FDA approved IUDs may be ineffective at preventing pregnancy.

A list of several Rhode Island practices that have purchased or used non-FDA approved IUDs from international sources can be found at:

http://www.health.ri.gov/news/nonfdaapprovediuds/

PLEASE DO NOT STOP USING THIS PRODUCT UNTIL YOU HAVE FIRST SPOKEN WITH YOUR DOCTOR.

If you believe that you or a loved one has been given or has used a non-FDA approved IUD and has suffered as a result, you may want to speak with an attorney regarding a potential lawsuit. A lawyer familiar with new developments in the investigation of unapproved IUDs may be able to help you make important personal and legal decisions.

Please contact the law offices of d'Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.