The FDA has approved Miudella, a new hormone-free copper intrauterine device from Sebela Women's Health Inc. This device is the first of its kind to enter the U.S. market in over 40 years, offering an alternative for women seeking non-hormonal birth control. Made from a nitinol alloy and wrapped in copper, Miudella's release of copper ions effectively prevents sperm from fertilizing an egg. In clinical trials, it demonstrated a 99% effectiveness over three years, comparable to existing copper IUDs, thereby addressing the needs of those sensitive to hormones.
"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.
Essentially, once the device is in place (inside the uterus) copper ions are released and, fun fact, copper is basically sperm kryptonite.
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.
It's a great option for those looking for long-acting, "set-it-and-forget-it" reversible birth control, especially if hormone-based options aren't well tolerated.
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