FDA: Don’t Use Unapproved IUDs
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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