When Blis Savidge sought to switch her birth control method last year, she found her options in the United States limited to a single nonhormonal intrauterine device (IUD): Paragard. Concerned that her hormonal IUD might be contributing to her depression and anxiety, she aimed to try a copper IUD, which prevents pregnancy without hormones. However, the only copper IUD available domestically, Paragard, is relatively large and associated with side effects such as heavy bleeding and cramping, particularly in women who have not given birth.

In contrast, Canada has offered multiple nonhormonal IUD options for over 15 years. Taking advantage of this, Savidge traveled from Atlanta to Victoria, British Columbia, to have a copper IUD inserted at a clinic there. She highlighted the irony of having to cross an international border within one of the world’s wealthiest nations to access a broader range of contraceptives.

Copper IUDs function as a contraceptive by releasing copper, which acts as a natural spermicide. In comparison, hormonal IUDs release hormones to prevent pregnancy. Physicians note a growing interest among women for nonhormonal methods, driven by a cultural shift toward “natural” medical interventions and concerns, sometimes based on misinformation, about hormonal contraception. Dr. Katharine White, chief of obstetrics and gynecology at Boston Medical Center, said demand for nonhormonal birth control is higher now than at any point in her career.

Despite the demand, the U.S. copper IUD market has been stagnant for decades. Paragard has been the sole copper device available since the 1980s, while Canada and several European nations offer more than a dozen alternatives. In February 2025, the U.S. Food and Drug Administration (FDA) approved a second copper IUD, Miudella, marking the first new copper device in 40 years. However, Miudella is not expected to be commercially available until later this year.

Copper IUD usage has grown gradually in the U.S., increasing from approximately 5.5 percent of contraceptive users two decades ago to around 16 percent according to the latest National Survey of Family Growth conducted by the Centers for Disease Control and Prevention in 2022-2023. Historically, sales have been affected by the legacy of the 1970s Dalkon Shield device, which was linked to serious health complications, including infections and maternal deaths, ultimately leading to its manufacturer’s bankruptcy. The resultant caution among both consumers and pharmaceutical companies has slowed innovation in the IUD market.

Some women, including Noel Zhu of Westmont, Illinois, have experienced problems with Paragard, citing issues such as device dislodgement and heavier menstrual bleeding, and are seeking alternative options. One such device available outside the U.S.—the Mona Lisa 5 Mini—is designed specifically for women who have not had children and has shown lower rates of removal due to pain or bleeding compared to Paragard in recent clinical trials conducted at 16 U.S. sites.

Legal challenges have also clouded the copper IUD market. Thousands of lawsuits have been filed against Paragard’s manufacturers, including Teva Pharmaceuticals and CooperSurgical, alleging the device can break during removal and cause injury. Teva defended Paragard as a “safe, effective” option and noted possible risks, such as breakage and surgical removal, are disclosed in the product labeling. CooperSurgical did not respond to requests for comment.

Several copper IUD manufacturers from Europe face regulatory hurdles preventing market entry into the United States. Unlike Canada, which classifies these devices solely as medical devices, the U.S. treats copper IUDs as both drugs and devices, requiring costly clinical trials even for products with long-standing use abroad. Emily Hilliard, an FDA spokeswoman, stated this rigorous process ensures safety, efficacy, and quality.

Luis McRae, operations manager for Mona Lisa’s Belgian manufacturer, said that nonprofit and National Institutes of Health funding made participation in recent U.S. trials possible but that prohibitive costs and product liability insurance requirements have hindered U.S. market entry.

Similarly, Control Europe’s CEO Rina Weidemersich recounted conversations with the FDA in 2009 but cited financial constraints as the reason their device GyneFix has not entered the U.S. market. The device has been available in Europe since 1996.

Sebela Pharmaceuticals, based in Roswell, Georgia, successfully navigated the FDA approval process for Miudella, which took over a decade and required substantial outside investment. Miudella features a specially designed insertion device and, per FDA requirements, will only be available through trained physicians in designated healthcare settings.

Organon, holding exclusive global licensing rights for Miudella, has begun training physicians ahead of the device’s market debut. While the introduction of Miudella marks a pivotal expansion in copper IUD options after decades of limited choice, experts urge further diversification.

“I want more choices than two for a copper nonhormonal IUD,” said Dr. White, reflecting a broader call within the medical community for expanded contraceptive options.