The FDA is warning physicians(www.fda.gov) and consumers(www.fda.gov) about risks associated with the use of unapproved intrauterine devices, or IUDs, and intrauterine systems, or IUSs.
The agency said in a July 22 letter to physicians that the items in question include unapproved versions of FDA-approved products, such as Mirena (levonorgestrel IUS), Implanon (etonogestrel implant) and ParaGard (copper-T IUD), as well as products not approved for use in the United States, such as T-Safe.
According to the FDA, such unapproved products could be unsafe and ineffective. The agency said the products may not have been manufactured, transported or stored under the stringent conditions required by the agency.
Physicians should not insert IUD or IUS products furnished by a patient who may have purchased the product online without verifying that it is an FDA-approved product purchased from a licensed pharmaceutical or device supplier in the United States, FDA officials said.
Legitimate Internet pharmacies are licensed by state pharmacy boards and display the National Association of Boards of Pharmacy's Verified Internet Pharmacy Practice Sites(vipps.nabp.net), or VIPPS, seal.
The FDA also said women who think they may be using an unapproved product should employ another form of birth control. The agency advised such women to contact their physician to discuss whether the product should be removed and to talk about other birth control options.
In October 2009, the FDA approved Mirena(www.fda.gov) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention, making it the first IUD approved for that additional indication(www.pharma.bayer.com). According to numerous published reports, Bayer HealthCare Pharmaceuticals doubled the price of the device to more than $700 earlier this year.
Meanwhile, the product -- or unapproved versions of it -- can be found on international websites for half the price charged on the U.S. market. The FDA said medical professionals and consumers might be tempted to buy products from foreign-based websites in an attempt to save money.
However, the agency said the use of and subsequent billing for unapproved medical products raises the possibility of insurance fraud if a payer thinks it's paying for an FDA-approved product when, in fact, it's not.
The agency said it is aware of the use of unapproved products in several states, and an investigation is ongoing. The investigation started in Rhode Island, where, according to the State of Rhode Island Department of Health, 10 medical practices have purchased or used unapproved devices.
Information regarding the distribution of unapproved products can be reported anonymously to the FDA's Office of Criminal Investigations online(www.accessdata.fda.gov).