Federal health officials are warning medical practitioners around the country not to use unapproved intrauterine devices (IUDs).

In a July 22 letter, the Food and Drug Administration (FDA) reminds health professionals that using unapproved IUDs raises concerns about effectiveness and safety—as well as the potential for fraud and counterfeiting.

"Federal law requires that IUD/IUSs (intrauterine systems) be FDA-approved prior to marketing. This law is designed to protect patients from products that are unsafe and ineffective,” Theresa Toigo, FDA’s liaison with health professionals, says in the letter. “The recent issue with patients in Rhode Island unknowingly receiving imported, unapproved IUD/IUSs highlights the unacceptable risk patients may be exposed to when a product’s identity, purity, source, handling, and storage cannot be verified.”

Still, patients can use their FDA-approved IUDs with confidence, Toigo says.

FDA experts say women who received unapproved IUDs from practitioners in Rhode Island, Massachusetts, and Kentucky could be at an increased risk for unwanted pregnancy.

The small, T-shaped devices—often made of flexible plastic or copper wire—are inserted into a woman’s uterus to prevent pregnancy. Some IUDs also deliver small amounts of hormone as added protection from pregnancy.

FDA says women should not try to remove IUDs by themselves. The agency is advising women who think they may have an unapproved IUD to use another form of birth control—such as condoms, birth control pills, or the patch—and contact their health care professional.