Doctors across U.S. implanting Unapproved IUDs and Placing Patients Health at Risk

July 22, 2010

A nationwide problem of medical practitioners implanting unapproved intrauterine devices (IUDs) has prompted the U.S. Food and Drug Administration (FDA) to issue a warning to consumers to notify them of the risks of such devices and the ongoing problem.

An intrauterine device, or IUD, is a medical device implanted in the uterus as a long-term birth control method. The FDA warns that patients who received an unapproved IUD could be at an increased risk for unwanted pregnancy.

The FDA released the consumer update entitled FDA Cautions Against Using Unapproved IUDs to inform consumers about a warning letter sent today reminding health professionals that using unapproved IUDs raises concerns about effectiveness and safety—as well as the potential for fraud and counterfeiting.

The FDA’s major concerns with the use of unapproved IUD/IUS’s are:

1. the potential lack of safety and efficacy, and especially the risk of reduced efficacy for preventing pregnancy;
2. the negative public health impact from the import and use of unapproved IUD/IUS’s that can be from unknown sources or foreign locations, and may not have been manufactured, transported or stored under conditions required as part of the FDA approval process; and
3. the use of and subsequent billing for unapproved medical products, which raises the possibility of insurance fraud, particularly Medicaid fraud.

“Federal law requires that IUD/IUSs (intrauterine systems) be FDA-approved prior to marketing. This law is designed to protect patients from products that are unsafe and ineffective,” Theresa Toigo, FDA’s liaison with health professionals, says in the letter. “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.”

According to Examiner.com, the use of illegal IUDs in Rhode Island was so prevalent that health department officials have cited about 10% of the state’s obstetricians and gynecologists.

The investigation into the use of unapproved products in Rhode Island has expanded into a broader investigation of the purchase, use and distribution of unapproved intrauterine devices (IUD) and intrauterine systems (IUS) by some medical practices throughout the United States. The investigation has found 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.

The FDA says doctors, nurses, midwives—and possibly patients themselves—might buy unapproved products from Canadian or other foreign websites in a bid to save money.

“Purchasing medical products from websites that are outside of the U.S. may be illegal and may increase the risk of receiving a potentially harmful product, since many websites sell products that are not FDA-approved and could be manufactured in other countries,” the FDA warns.

Legitimate Internet pharmacies will display a seal from the National Association of Boards of Pharmacy—known as VIPPS seal or Verified Internet Pharmacy Practice Sites. Consumers and health professionals can verify if a pharmacy website is VIPPS verified by entering the pharmacy’s web address here.

FDA says women should not try to remove IUDs by themselves. The agency is advising women who think they may have an unapproved IUD to use another form of birth control—such as condoms, birth control pills or the patch—and contact their health care professional.