The Food and Drug Administration (FDA) approved the first new hormone-free IUD in over four decades. Miudella, a copper intrauterine device (IUD) created by Sebela Women’s Health, is designed to prevent pregnancy for up to three years. Clinical trials showed high effectiveness with fewer reported side effects, offering a welcome alternative in the limited landscape of non-hormonal contraceptives. Doctors anticipate Miudella could address concerns that have previously deterred patients from choosing copper IUDs.
Similar to its predecessor, Paragard, the only other copper IUD available, Miudella is proven to be 99% effective in preventing pregnancy. Unlike Paraguard however, Miudella offers a smaller and more flexible design, making insertion and the overall experience more comfortable. The new contraceptive contains half the amount of copper, which may lead to fewer side effects like heavier periods and cramping, making it a more appealing option for women seeking non-hormonal birth control but concerned about side effects. It is made from a flexible nitinol frame, which helps it conform to the uterus more easily. The new IUD is packaged preloaded into the inserter, eliminating extra preparation steps for medical practitioners. As a result, insertion is quicker, more precise, and potentially less painful for patients.
“This innovative intrauterine device may allow for improvements in discontinuation rates due to pain and bleeding and in expulsion rates. This would be very meaningful for women looking for hormone-free options,” said Principal Investigator David K. Turok, MD, MPH, Professor, Department of Obstetrics and Gynecology, University of Utah.
Despite their effectiveness, IUD adoption has faced barriers due to misconceptions, access issues, and complications associated with insertion. Many people believe IUDs are only for those who have already given birth, though they are safe and effective for most women. Additionally, concerns persist about pain during insertion, potential side effects like cramping and heavier periods, and the rare risk of the IUD slipping out of place or causing a tear in the uterus. The upfront cost, which can range from $500 to $1,300 without insurance, also remains a significant obstacle despite the long-term cost-effectiveness of IUDs.
However, demand for IUDs has steadily increased in recent years, and that trend is expected to grow as access to reproductive healthcare becomes more uncertain. The launch of Miudella coincides with rising concerns about initiatives like Project 2025, a conservative proposal advocating for severe restrictions on birth control. As a result, many are turning to long-term contraceptives to protect their reproductive choices, making innovations like Miudella a vital option for those looking to maintain control of their bodies.
SOURCES
https://www.plannedparenthood.org/blog/how-much-do-iuds-cost-without-insurance
https://www.drugtopics.com/view/fda-approves-first-non-hormonal-copper-iud-in-over-40-years
https://www.thecut.com/article/the-fda-approves-miudella-a-new-copper-iud.html