The FDA’s approval of Miudella marks the first new copper IUD in the U.S. in 40 years. This hormone-free birth control was approved for up to three years of pregnancy prevention, but studies are ongoing, and the manufactures anticipate expanding the duration of effectiveness up to 8 years. (Similar to how Liletta was originally approved for 3 years, then 4, 5, 6, and now 8 years).
What’s the deal with Miudella?
Miudella is made with a copper-releasing nitinol (nickel-titanium) frame, which conforms to a range of uterine sizes and shapes due to its superelastic and shape-memory properties. It contains 175mm2 of copper, less than half the copper of the currently available copper IUD, T380A (Paragard) IUD. Reducing the copper content helps to reduce the menstrual side effects of copper IUDs while maintaining contraceptive. Miudella works in the same way to prevent pregnancy as other copper IUDs (98.9% effective with typical use), primarily by creating a localized inflammatory reaction with anti-sperm effects. As with other copper IUDs, Miudella is hormone free, making it an option for people who can’t or don’t want to use hormonal contraception. We don’t yet know if Miudella can be used as emergency contraception (EC) the way other IUDs can be because it hasn’t been studied (yet).
How do I place Miudella?
Miudella uses an inserter that’s similar to other one-handed IUD inserters on the market, so providers who are already trained to place IUDs should be able to figure it out pretty quickly (just an added twist!). Miudella comes preloaded in the package and the blue strings are precut to 3-4 cm of exposed thread, so scissors are generally not required for placement. However, to place Miudella, the FDA requires that providers complete a Risk Evaluation and Mitigation Strategy (REMS) training program before offering Miudella.
Who can safely use Miudella?
Anyone who wants to use a non-hormonal IUD. Although not included in the CDC’s 2024 updates to the U.S. Medical Eligibility Criteria for Contraceptive Use (US MEC) or U.S. Selected Practice Recommendations for Contraceptive Use (US SPR), providers can align recommendations for initiation and management with those for with the other copper IUD currently on the market in the US (Paragard).
What’s are Miudella’s side effects?
In clinical trials, the most commonly reported adverse effects were menstrual changes similar to other copper IUD currently on the market in the US (Paragard)—heavy bleeding, dysmenorrhea, intermenstrual spotting. Pain with insertion and risks of placement, such as expulsion and perforation were similar were similar to other IUDs. Discontinuation rates were 8.5% in the first year, primarily due to bleeding-related concerns. Subsequent annual discontinuation rates were lower in follow-up years. As with other copper IUDs, patients should be counseled about the potential for increased menstrual bleeding and cramping, especially in the initial months of use.
Getting Miudella in your health center
Miudella isn’t quite available in the US yet but stay tuned for updates!
