As if intrauterine devices (IUDs) haven't already received enough bad press throughout the last several decades, now the U.S. Food and Drug Administration is warning patients and providers to be on the lookout for impostor look-a-likes.
What started as an isolated cluster of "Canadian-imported" IUDs in Rhode Island is now becoming more wide spread. Last week, the FDA released a formal letter to providers across the country urging them to pass along a message to their female patients: imported devices may not be safe or legal.
The issue stems mainly from the fact that U.S. medical devices are part of a tightly regulated production process. This includes IUDs like the progesterone-based Mirena and copper-based Paraguard. When IUDs are purchased from foreign websites, not only is their use unapproved, it’s potentially dangerous. There is no governing body to ensure their safety and efficacy, which means these devices are coming from unknown sources and locations. There is no way to prove they’ve been made, stored, or transported under appropriate and safe conditions.
What’s more is that what seems like a potentially dollar-saving tactic for doctors--purchase IUDs online instead of through U.S. pharmaceutical companies (which can run upwards of $600 per patient without insurance)--might actually increase the possibility of insurance fraud (including Medicaid) via billing for these unapproved devices and therefore long-term costs to all.
Patients are also responsible. Some of the FDA’s concerns include even patient-purchased IUDs from similar unapproved websites.
The FDA warns that these violating devices include unapproved versions of the Mirena, Copper-T, Paraguard, and even Implanon (a non-IUD, implantable plastic rod that delivers long-term progesterone through its location in the arm). They caution patients to make Internet purchases only from state-licensed distributors and pharmacies in the U.S., and warn that not all devices claiming to come from Canada actually come from Canada.
If you or someone you know has already received one of these devices, the FDA recommends talking to a health care provider to determine if that device needs to be removed. They are also encouraging patients to report such incidences to the FDA’s office of criminal investigations at: www.fda.gov/oci.
To find a list of legitimate Internet pharmacies, visit: vipps.nabp.net/verify.asp and look for the VIPPS (Verified Internet Pharmacy Practice Site) seal of approval.
SOURCES:
www.fda.gov/ForConsumers/ConsumerUpdates