The Food and Drug Administration approved the Miudella copper intrauterine device (IUD) in 2025, with the device expected to be available to patients in the first half of 2026, offering a new option for non-hormonal birth control. The approval marks the first new copper IUD in the U.S. In over 40 years.
IUDs are small, T-shaped devices inserted into the uterus to prevent pregnancy, and are more than 99% effective. There are two main categories: copper and hormonal. Currently, six IUDs are FDA-approved. The Miudella joins the Paragard copper IUD, and four hormonal IUDs – Mirena, Skyla, Liletta, and Kyleena – in the U.S. Market.
Unlike Paragard, which can be used as emergency contraception within five days of unprotected intercourse, Miudella is approved for up to three years of contraception. Though, Miudella is smaller than Paragard and made of a flexible material called nitinol, designed to ease insertion. Clinical trials evaluating its potential for long-term apply are ongoing, according to Sebela Pharmaceuticals, the device’s manufacturer.
The emergence of Miudella comes amid increasing IUD use in the U.S., though rates remain lower than in other countries. A 2024 KFF Women’s Health Survey found that 17% of women ages 18 to 49 who used contraception reported using an IUD in the last 12 months. IUD use is highest among women ages 26 to 35, and among Black and Asian women.
Despite growing acceptance, the history of IUDs in the U.S. Is marked by controversy. The Dalkon Shield, introduced in 1968, was linked to severe pelvic infections and deaths in the 1970s, leading to its removal from the market. This history contributed to widespread misconceptions about IUD safety, and prompted the removal of all but one IUD from the U.S. Market by 1986. The first new generation IUD was introduced in 1988, following revised FDA safety and manufacturing requirements.
Recent concerns have focused on potential coercion in contraceptive counseling, particularly regarding long-acting reversible contraceptives (LARCs) like IUDs. Some patients have reported feeling pressured to choose a LARC method, and some physicians have been resistant to removing IUDs early. Researchers recommend that providers first discuss a patient’s reproductive goals and preferences before discussing contraceptive methods.
Postpartum IUD insertion is an effective strategy for preventing unintended pregnancy, with less than 1% of users experiencing pregnancy within a year. However, some patients prefer delayed insertion due to concerns about expulsion rates and side effects.
Social media has also played a role in shaping perceptions of IUDs, with some influencers sharing negative experiences and focusing on insertion pain and side effects. Healthcare providers are now encouraged to administer lidocaine as a local anesthetic prior to IUD insertion to reduce patient pain, and to provide thorough, individualized counseling.
Access to IUDs remains a challenge for some, particularly for those who are uninsured or have limited financial resources. The cost of an IUD can range from $0 to $1,800, in addition to provider visit fees. The Affordable Care Act’s contraceptive coverage requirement eliminated out-of-pocket costs for many women, but some still face expenses for insertion and follow-up visits.
Medicaid programs vary in their coverage of IUDs, with some states limiting coverage to certain brands or types. The 340B program provides reduced cost pharmaceuticals to providers that serve low-income populations, and Liletta was specifically developed to be low cost and available to clinics enrolled in this program.
The federal Title X National Family Planning Program funds a network of clinics that provide family planning care to low-income and uninsured individuals. These clinics are consistently more likely to offer IUDs compared to those that do not receive Title X funding. However, the uninsured rate is expected to increase substantially over the next decade due to forthcoming federal policy changes.
