FDA Approves Medical App for Contraception
The Swedish phone app Natural Cycles recently made headlines for becoming the first app approved by the Food and Drug Administration for contraception. Natural Cycles uses morning temperature readings and its own algorithm to predict the user’s most fertile days (about ten days a month) during her ovulation cycle. The app has widespread popularity with nearly 700,000 users worldwide.
Although Natural Cycles is celebrated as being “first of its kind,” when we examine recent trends in medical technology, we find this story has been a long time coming.
The algorithm Natural Cycles uses to predict peak fertility days relies on an old contraceptive method commonly referred to as “charting your cycle.” The popular book Taking Charge of Your Fertility uses the same method to predict fertile days and was first published in 1995. The book has helped hundreds of thousands of women avoid becoming pregnant (or increase their chances of becoming pregnant) and has its own fertility charting app (OvaGraph).
Apps which help their users chart their fertility cycles are commonplace. As a 2016 paper published in the Journal of the American Board of Family Medicine found “nearly 100 apps allow women to track their fertility and menstrual cycles and can be used to avoid or achieve pregnancy.” The paper examined the accuracy of 40 apps and concluded 75 percent of them accurately predicted the user’s fertile days. About 20 percent of the apps earned a “perfect score” for accuracy.
Although these findings are far from perfect, this is to be expected. Reproductive biology is a very complex subject. Fertility cycles can change due to unforeseeable circumstances. Human error when using contraception is more common than you might expect. These are limitations which clinical tests and FDA approval cannot eliminate. Despite these limitations, millions of women currently use apps to help chart their fertility cycles. And they were doing so confidently before the FDA approved Natural Cycles.
But recent reports indicated Natural Cycles is just as limited as its unapproved competitors. Despite impressive clinical trial results, Natural Cycles is currently under investigation in Europe after reports of 37 unplanned pregnancies emerged. As a spokesperson for Natural Cycles notes, “No contraception is 100 percent effective, and unwanted pregnancies is an unfortunate risk with any contraception.”
When we consider the widespread use of apps to avoid pregnancy before Natural Cycles and the inherent limitations of all contraceptive methods, it seems FDA approval makes relatively little difference. Instead, it seems the market has already provided, and the FDA is, ironically, late.