For the first time in more than 40 years, a new hormone-free intrauterine device (IUD) is coming to market in the U.S.—and it’s designed with patients’ comfort in mind, both during the insertion process and once it’s in place. 

The new IUD, called Miudella, comes from the pharmaceutical company Sebela Women’s Health Inc. It was approved by the Federal Drug Administration (FDA) in late February, and is the second hormone-free IUD to be approved since 1984, when the copper-based option Paragard first became available. With the addition of Miudella, there will now be six IUD options available in the U.S. 

Not only does this advancement provide patients seeking a hormone-free IUD with more than one option, it also marks a potentially major improvement in IUD design. By reducing insertion pain and post-insertion bleeding and cramping, Miudella is addressing two potential side effects of IUD placement that many women feel have long been overlooked.

According to Kelly Culwell, a board-certified OB-GYN and head of research and development at Sebela Women’s Health, bringing an IUD to market, especially in the U.S., is “a very expensive and time consuming proposition.” Because of those barriers, she says, many pharma companies simply choose not to invest as much in studying women’s health.

“There really isn’t a generic IUD, and the reason for that is it’s a very time-intensive and cost-prohibitive development process, especially for companies that aren’t really putting a lot of money or time or effort into women’s health development,” Culwell explains. “A lot of the bigger pharma companies are focusing on things that could bring in a lot more money; things like oncology or neurology—so there just hasn’t been a lot of innovation [in women’s health overall].”

These factors have resulted in a limited selection of IUD options in the U.S. compared to places........

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