This Contraception App Fails 6.5% of the Time – and It Was Just Approved by the FDA

An app that can serve as effective birth control sounds like a futuristic sci-fi plot. But as of this week, there’s an FDA-approved contraception method that does exactly that.

Tonic reports that Natural Cycles, an app that uses temperature measurements to monitor ovulation, became the first-ever app billing itself as a contraceptive available in the United States. It was approved by the FDA on August 10th.

If Natural Cycles seems too good to be true, that's because it is. The app launched in Sweden prior to its US rollout, but 37 users reported the app to Swedish police after experiencing unintended pregnancies while following Natural Cycle’s method.

Prior to its FDA approval, Natural Cycles devised a marketing strategy for the American market, positioning the app as a fertility-monitoring program rather than a birth-control measure. And because the app requires users to measure their basal body temperature on a daily basis and dispenses advice on when to engage in (or avoid) sexual intercourse based on your pregnancy-related goals, Natural Cycles could actually be a game-changer for keeping track of your ovulation.

But as a contraceptive method, Natural Cycles still has some work to do. In addition to the ongoing investigation of the Swedish customer complaints, Natural Cycles released data from its clinical trials, indicating that it has about a 93% success rate. Natural Cycles claims that the app’s monitoring software can lead to 99% effectiveness if used perfectly, but because the system requires considerable discipline and timeliness, the company admits that 93% is a more realistic figure. This places it ahead of the birth control pill (which is effective 99% of the time when used perfectly, but only 91% of the time in real life) but very far behind the IUD, which is effective 99% of the time.

The most concerning factor is Natural Cycle’s very high dropout rate, which currently stands at 45%. Women with inconsistent menstrual cycles, unpredictable schedules, and a lack of interest in the stringent monitoring requirements of the app won’t find Natural Cycle a viable replacement for the pill or the IUD, leaving the app’s potential in the birth-control market up for debate.