The Risks Of Unapproved IUD’s

The U.S. Food and Drug Administration (FDA) has issued a two page warning to doctors and consumers about the risks incurred by using intrauterine devices (IUD’s) and intrauterine systems (IUS’s).

Unapproved Items

In a July 22, 2010 letter to physicians, the agency stated that the unapproved items include those similar to products that have received approval from the FDA, for instance the Mirena (levonorgestrel IUS), ParaGard (copper-T IUD), and Implanon (etonogestrel implant) devices. On the list were also products that had not received FDA approval for use within the United States, for instance T-Safe.

Strict Standards

The FDA is concerned about these products on two levels: safety and effectiveness. One issue is that the agency has no input about the conditions under which these products have been manufactured. Other issues include lack of knowledge of transportation and storage details. The FDA has strict standards for conditions of manufacture, transport, and storage of these contraceptive items.

Doctors are instructed not to insert such products when provided by a patient who may have bought the product from an online website without receiving verification as to the product’s status in regards to FDA approval. These products must be purchased from licensed U.S. pharmaceutical concerns. There are internet pharmacies that have received state licenses and these concerns display the seal of the National Association of Boards of Pharmacy’s Verified Internet Pharmacy Practice Sites (VIPPS).

Any woman who has suspicions that she is using such an unapproved device should be using a second form of birth control. These women are also urged to speak to their doctors about whether they should have the product removed and whether a different birth control method should be considered.

The FDA gave approval for the Mirena device as a treatment for heavy menstrual bleeding in those women who also use intrauterine birth control as their preferred method of contraception, back in October 2009. This was the first IUD in the U.S. to receive approval for these specific double indications. In early 2010, Bayer HealthCare Pharmaceuticals decided to raise the price of the Mirena to $700, which is double the price the company charged back when the Mirena was just a method of birth control. This price-doubling has created a situation in which potential users may seek out a less expensive (and unauthorized) version of the device. International websites are selling the Mirena for half of the price charged on the U.S. market. Concerned consumers can anonymously report information about possible unapproved products to the Criminal Investigations section of the online FDA website.