FDA warning: Don’t use unapproved IUDs

Physicians who insert counterfeit IUDs may be putting themselves and their patients at risk, the FDA warns

Senior Editor, OBG Management

AUGUST 2010—Some intrauterine devices (IUDs) purchased from offshore Web sites are not the devices they purport to be. The FDA is disturbed enough about the problem to have issued a warning letter late last month to women’s health care providers outlining its concerns:

The FDA has become aware of the purchase, use, and distribution of unapproved [IUDs] and intrauterine systems (IUS) by some medical practices throughout the United States. The violative products include unapproved versions of FDA-approved products such as Mirena, Implanon, Copper-T, and ParaGard; as well as products not approved for use in the United States, such as T-Safe.