FDA Approves New Hormone-Free Copper IUD, Miudella
This approval marks the first new copper IUD to come to market in more than 40 years.
Great news for anyone with a uterus in the market for a new hormone-free birth control option! On Tuesday, the Food and Drug Administration (FDA) approved Miudella, a copper intrauterine system from Sebela Women's Health Inc.
This marks the first new hormone-free, copper contraceptive device that will come to the U.S. market in more than 40 years. Personally, we love that it looks kind of like a female reproductive system in and of itself: that’s just great branding right there.
Miudella is made from nitinol — a special alloy composed of nickel and titanium — which is wrapped with copper. It’s the copper that makes this method of long-term birth control effective, and the mechanism behind it is equal parts fascinating and pretty funny. Essentially, once the device is in place (inside the uterus) copper ions are released and, fun fact, copper is basically sperm kryptonite. They just don’t like it, and so they avoid the IUD, which prevents them from reaching an egg and creating a pregnancy.
According to a press release, three trials of Miudella found the device to be 99% effective over a three year period, which is on par with Paraguard, the only copper IUD currently on the market in the U.S. It’s a great option for those looking for long-acting, “set-it-and-forget-it” reversible birth control, especially if hormone-based options (most other IUDs and birth control pills) aren’t well tolerated. Furthermore, of the more than 1,900 women who participated in the trial, more than 74% of the ones who discontinued participation to try to have a baby became pregnant within 1 year of removing Miudella.
“Sebela Women's Health is thrilled to be able to bring this hormone-free IUD option for birth control to women in the United States,” said Kelly Culwell, MD, the division’s Head of Research and Development.
Because of the flexibility of nitinol, the copper that prevents pregnancy can be strategically placed in such a way that Miudella uses less than half the amount of copper of similar IUDs without losing efficacy. So it’s also the smallest hormone-free IUD frame available in the U.S. If you’ve ever had an IUD inserted, you know that’s lovely news.
“We believe these and other features of Miudella may help address barriers to use, while also providing women with the hormone-free option some prefer,” Culwell concludes.
Last year, the Centers of Disease Control and Prevention (CDC) urged healthcare providers to better address patient pain when it came to IUD insertion. While many people who opt for an intrauterine device tolerate insertion well, others (understandably) find inserting the device into the uterus via the cervix extremely painful.
New guidelines to better manage patient pain do not suggest one specific medication to address this issue, though misoprostol — which works to soften and dilate the cervix — and lidocaine, a numbing agent, are offered as potentially good options.
Miudella will be available later in 2025 through your healthcare provider.
