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Is the IUD you inserted a counterfeit?

If you ordered it from an offshore Web site, it probably is. The counterfeit may be cheaper, but it is also unapproved and less effective than the FDA-sanctioned device.

September 2009 · Vol. 21, No. 09

One of the challenges of offering the intrauterine device (IUD) as a method of birth control is the need to keep a supply in stock until the patient requests it. The IUD isn’t cheap, and reimbursement doesn’t occur until it is actually inserted in the patient.

Some physicians have been lured by substantial discounts for IUDs—both the copper T 380A (ParaGard) and the levonorgestrel-releasing intrauterine system (Mirena)—offered at some Web sites (FIGURE). The prices for these devices are lower, but the IUDs themselves are “knockoffs,” or counterfeits. ParaGard costs approximately $494, but counterfeit models are offered online for as little as $178. As for Mirena, the legitimate device costs $586, compared with $218 for the online knockoff.

In the case of the copper IUD, what may at first appear to be the ParaGard device is typically the “T-Safe CU 380A QL.” Although ParaGard is approved by the US Food and Drug Administration (FDA), has no labeling restrictions for use in nulliparous women, is indicated for a uterus that ranges in depth from 6 cm to 9 cm, and is effective for as long as 10 years, that is not the case for the “T-Safe” device. Besides lacking FDA approval, the T-Safe is contraindicated for use in nulliparous women, is safe for use only if the uterus is at least 6.5 cm in depth, and is effective for as long as 4 years.

How prevalent is the counterfeit IUD problem?

“Prevalent enough,” says Andrew M. Kaunitz, MD, professor and associate chairman of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville, Fla. Dr. Kaunitz serves on the OBG Management Board of Editors.

“The common scenario is ordering these devices online from Canadian pharmacies or offshore Web sites,” Kaunitz says. Some physicians who frequent these Web sites are just trying to save money. Others may be ordering cheap devices to increase revenue through fraudulent billing, he adds.

“Either way, it hurts the patient.”

Company warns of health risks associated with counterfeit IUDs

The problem is widespread enough that it has come to the attention of the manufacturer of ParaGard. In March, DuraMed, a subsidiary of Barr Pharmaceuticals, carried out a broad-based mailing to physicians, warning them of the problem of offshore Web sites offering the device at significant discount.

“DuraMed is not alone in its concerns about the safety risk related to unlawful importation from Web-based pharmacies,” wrote Kathleen Reape, MD, vice president of medical affairs and clinical affairs for the company. “The FDA has unequivocally stated that ‘in our experience, many drugs obtained from foreign sources that purport and appear to be the same as US-approved prescription drugs have been of unknown quality.’”

“This is of particular concern with respect to intrauterine contraceptives because they are implanted into the human body for up to a decade, and because inferior quality and improper use may result in an increased risk of pelvic inflammatory disease, ectopic pregnancy, hysterectomy, infertility, and other serious complications,” Reape continued.

To avoid the risk, use conventional ordering

That is Kaunitz’s advice. The best way to ensure that the device you order is an FDA-approved IUD is to order it directly from a legitimate distributor such as CareMark, he says.

“I think you can put yourself and your patients at risk by using counterfeit and unapproved devices,” he adds.

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