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HEALTH Issues Compliance Orders to Two Additional OB/GYN Practices for Use of Non-FDA-Approved IUDs

Following the Compliance Order issued to OB-GYN Associates on June 23, two other OB/GYN practices, notified the Department of Health (HEALTH) that they also have been purchasing and utilizing non-FDA-approved IUDs from international sources. After confirming each of the reports, HEALTH has issued Compliance Orders to the following practices: Bayside OB-GYN, Inc. and Center for Obstetrics & Gynecology, Inc.

The Compliance Orders require each of the practices to stop using non-FDA-approved IUDs, notify all patients, within 10 days, who received a non-FDA-approved IUD and provide that patient list to HEALTH. To view the Compliance Orders, visit http://www.health.ri.gov/discipline/physicians/Bayside062910.pdf and http://www.health.ri.gov/discipline/physicians/CenterForObstetricsAndGynecology062910.pdf

HEALTH issued an advisory to all licensed OB/GYNs today urging any practice or healthcare professional who purchased or inserted a non-FDA-approved IUD to notify HEALTH by noon on July 2, 2010. HEALTH will confirm any additional reports received. To read the complete provider advisory, visit http://www.health.ri.gov/news/nonfdaapprovediuds/IUDProviderAdvisory062910.pdf

“Use of non-FDA-approved IUDs is illegal,” said Director of Health David R. Gifford, MD, MPH. “Our primary concern right now is lack of effectiveness as a form of birth control. Any patient who received a non-FDA-approved IUD needs to be informed so that she can use an alternate form of birth control such as condoms or abstinence.”

A list of all practitioners and practices who used non-FDA-approved IUDs can be found on HEALTH’s website at http://www.health.ri.gov/news/nonfdaapprovediuds/ or by calling 401-222-8022/RI Relay 711. This list will be updated if any additional Compliance Orders are issued to other practices.

Related links

Department or agency: Department of Health

Online: http://www.health.ri.gov

Release date: 06-29-2010

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