In a significant advancement for reproductive health, the U.S. Food and Drug Administration (FDA) has approved Miudella, a hormone-free, copper-based intrauterine device (IUD) developed by Sebela Women’s Health Inc. This marks the first approval of a new copper IUD in the United States in over 40 years, offering a fresh option for individuals seeking non-hormonal, long-acting reversible contraception.
Miudella is designed to prevent pregnancy for up to three years. Unlike traditional copper IUDs, it utilizes a flexible nitinol frame—a nickel-titanium alloy known for its super-elastic properties—allowing for a smaller device that uses less than half the copper of existing models . This design aims to reduce common side effects associated with copper IUDs, such as heavy menstrual bleeding and cramping, potentially improving user comfort and satisfaction.
Clinical trials have demonstrated Miudella’s high efficacy and tolerability. Over a three-year period, the device showed low expulsion rates and a decrease in discontinuation due to bleeding or pain—from 8.5% in the first year to 3.2% by the third year . These findings suggest that Miudella could be a viable option for those who have previously been hesitant to use copper IUDs due to side effects.
The introduction of Miudella comes at a time when nearly 42% of pregnancies in the U.S. are unintended . By expanding the range of contraceptive options, especially for those seeking hormone-free methods, Miudella has the potential to address this public health concern. Sebela Women’s Health plans to make Miudella available through trained healthcare providers later in 2025.
This approval not only diversifies contraceptive choices but also reflects ongoing efforts to innovate in women’s health, providing more personalized and acceptable options for birth control.