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News for Your Practice


FDA warning: Don’t use unapproved IUDs

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

August 2010 · Vol. 22, No. 08

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.

In an OBG Management Web-exclusive article in 2009, Andrew M. Kaunitz, MD, raised concerns about the practice of buying IUDs from offshore Web sites. Dr. Kaunitz is professor and associate chairman of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville, Fla. He serves on the OBG Management Board of Editors.

Dr. Kaunitz noted that some physicians have been lured by substantial discounts for IUDs—both the copper T380A (ParaGard) and the levonorgestrel-releasing intrauterine system (LNG-IUS; Mirena)—offered at some Web sites. The prices for these devices are lower, but the IUDs themselves are knockoffs—counterfeits. ParaGard costs approximately $494, but counterfeit models are offered online for as little as $199. As for Mirena, the legitimate device costs $717, compared with $270 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 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 7 years, that is not the case for the “T-Safe” device. Besides lacking FDA approval, the T-Safe is not intended for use in nulliparous women, is designed for use only if the uterus is at least 6.5 cm in depth, and is effective for 4 years.

“The common scenario is ordering these devices online from Canadian pharmacies or offshore Web sites,” Kaunitz said. “Most physicians who frequent these Web sites are just trying to save money,” he added.

FDA raises safety, fraud concerns

In its warning letter to providers, the FDA outlined three main concerns:

  • “potential lack of safety and efficacy, and especially the risk of reduced efficacy for preventing pregnancy”
  • harm to public health—namely, the fact that unapproved devices can come from unknown sources and “may not have been manufactured, transported or stored under conditions required as part of the FDA approval process”
  • “the use of and subsequent billing for unapproved medical products, which raises the possibility of insurance fraud, particularly Medicaid fraud.”

The letter also warned against inserting an IUD provided by the patient without verifying that it is an FDA-approved device “that was purchased from a licensed pharmaceutical or device supplier in the US.”

Not all Canadian Web sites offer Canadian products

“To reduce the chance of receiving an unapproved or adulterated medical product, your Internet purchases should be made from state-licensed distributors or pharmacies located in the U.S.,” the FDA advises. “FDA is aware of several Web sites that appear to be Canadian Web sites but ship products from countries other than Canada.”

The FDA is not the only entity sending letters about the issue to providers. The problem has also come to the attention of the manufacturer of ParaGard. Last year, 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 a significant discount.

“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,” the DuraMed letter said.

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 (www.caremark.com), he said.

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

You can report the distribution of unapproved IUDs by contacting the FDA Office of Criminal Investigations at www.fda.gov/ICECI/CriminalInvestigations/default.htm.

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