Written by Arielle Schecter, MD

Miudella is now the second nonhormonal intrauterine device (IUD) available in the United States, following ParaGard, which was approved in 1984.^1,2 With its nitinol (nickel-titanium) frame, Miudella is smaller and more flexible than the rigid polyethylene frame of ParaGard. Miudella has a lower dose of copper (175mm² vs. 380mm²) and a thinner, tapered insertion tube. Miudella comes pre-loaded in a sterile inserter, has pre-cut removal strings, and is FDA-approved for prevention of pregnancy for up to three years. 

Risks of the Miudella are similar to the other IUDs, including perforation, expulsion, infection, and altered uterine bleeding patterns.^1,3,4 Contraindications to Miudella are the same as other IUDs, with the additional contraindication for Wilson’s disease and hypersensitivity to any component. Miudella’s use as post-coital/emergency contraception is specifically contraindicated by the FDA.

No trial directly compares Miudella and ParaGard. Their respective trials included different study designs, participant compositions (e.g., parity, age, body mass index, and race/ethnicity) and monitoring parameters. As such, definitive comparative claims on effectiveness, insertion pain, bleeding, expulsion, side effect profile, discontinuation, and patient satisfaction cannot be made.

The FDA-approved duration of Miudella use is currently three years, although follow-up data provide evidence for maintained effectiveness to five years.⁵ Of note, ParaGard is FDA-approved for up to ten years, with evidence supporting effectiveness for at least 12 years.^2,6,7

A secondary analysis of a randomized copper IUD trial – which did not specifically study Miudella – found an association between menstrual cup use and accidental IUD self-removal.⁸ The Miudella prescribing information notes that menstrual cups and discs are not recommended due to risk of IUD displacement or expulsion.

Unlike other currently available IUDs, Miudella is subject to a Risk Evaluation and Mitigation Strategy (REMS). Clinicians must enroll in the Miudella REMS and complete required online training before they are able to provide the device.

Key Takeaways:

• Miudella is FDA-approved for three years of contraception.¹
• Miudella is smaller, more flexible, and has a lower dose of copper than ParaGard. Its inserter is also tapered and smaller in diameter than ParaGard’s.^1,2
• Miudella comes pre-loaded in its inserter and has pre-cut strings.¹
• Miudella seems to have similar effectiveness rates to ParaGard at five years, based on separate studies.^5,9,10
• Miudella’s smaller size, smaller and tapered inserter, lower copper dose, flexible frame, and copper placement may confer benefit with regard to insertion pain and patient satisfaction (ex: bleeding, discontinuation rates)  when compared to ParaGard; however, direct head-to-head trials have not yet been conducted.^{10,11,12,13,14,15}
• Menstrual cups and discs are not recommended with Miudella.^1,8
• Miudella is contraindicated as an emergency contraceptive.¹
• REMS enrollment and online training are required for Miudella prescribers.¹