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FDA: Don’t Use Unapproved IUDs

The U.S. Food and Drug Administration (FDA) recently warned women not to use
unapproved intrauterine devices (IUDs), a form of birth control, in part
because they can potentially be counterfeited.


The FDA reminded health professionals in a July 22 letter that unapproved
IUDs may be ineffective and unsafe. In the letter, the FDA said it must
approve all IUDs to ensure that they meet federal safety standards.

The letter was partially spurred by a recent incident in Rhode Island where
women received unapproved IUDs.

“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,” Theresa Toigo, FDA’s liaison with health
professionals, wrote in the letter.

The FDA cautions that trying to save money by purchasing IUDs that are
reportedly made in Canada is not worth the risk.

“Unapproved products bring a lot of unknowns into the equation,” said FDA
compliance officer Kathleen Anderson. “An internet ad may claim to sell IUDs
made in Canada, but there’s no way to be sure. They might have been made
anywhere in the world and in unsanitary or undesirable conditions.”

The FDA also notes that legitimate online pharmacies will have a seal from
the National Association of Boards of Pharmacy, which is commonly known as
the VIPPS seal. VIPPS stands for Verified Internet Pharmacy Practice Sites.

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