The world’s first contraceptive app has gained FDA approval even after months of controversy regarding how effective it is.
The app, Natural Cycles, contains an algorithm that informs women on which day of the month they will be fertile based on daily body temperature readings and menstrual cycle information. Women take their temperature from underneath their tongue, then record the data into the app which then utilises the unique algorithm, determining whether women are fertile on any specific day.
Based on the user’s readings, the app then tells them which days they should use protection if they do not want to risk getting pregnant.
Terri Cornelison, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, relates Natural Cycles’ approval to an increase in digital health technologies.
“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” Cornelison said. “But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device.”
Earlier this year, the app was reported to the Medical Products Agency in Sweden after 37 women fell pregnant whilst using it.
Responding to news, a Natural Cycles spokesperson said: “No contraception is 100% and unwanted pregnancies is an unfortunate risk with any contraception.”
“To have 37 unwanted pregnancies out of the 668 mentioned in this study at Södersjukhuset means that 5.5% of women who stated they used Natural Cycles also had an unwanted pregnancy.
“This is in line with what we communicate as the risk of unwanted pregnancy with typical use and which is comparable to other types of contraception.”
The FDA reviewed data from over 15,000 women who used Natural Cycles to assess the effectiveness of the app. The study shows that with 100 people using the app for one year, only 1.8% will fall pregnant from having sex on a day when Natural Cycles predicted they would not be fertile. When used incorrectly, such as by having unprotected sex on fertile days, the app has a “typical use” failure rate of 6.5%.
The approval of Natural Cycles comes shortly after the FDA launched its Digital Health Innovation Action Plan, which looks at how the agency should assess and regulate digital health products. Now, the approval of Natural Cycles could lead to a swathe of similar products being approved by the FDA.