Monday, 27 May, 2019

This FDA-Approved Birth Control Method Is Unlike Anything We’ve Seen

Now a mobile app acts as a contraceptive FDA approves 'Natural Cycles' birth control app
Gustavo Carr | 16 August, 2018, 21:00

FDA approves marketing of the app So despite all the negative press, including the unwanted pregnancies, the U.S. Food and Drug Administration felt it was perfectly alright to approve the Natural Cycles app for use by American women.

The FDA warns that Natural Cycles "should not be used by women who have a medical condition where pregnancy would be associated with a significant risk to the mother or the fetus or those now using birth control or hormonal treatments that inhibit ovulation" and that the app "does not provide protection against sexually transmitted infections".

The app, Natural Cycles, calculates when a woman is most likely to be fertile using their daily body temperature data and their menstrual cycle information.

However, officials in Britain and Sweden launched investigations into the app earlier this year after receiving reports that women using it became pregnant.

"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", Terri Cornelison, assistant director for the health of women at the FDA's Center for Devices and Radiological Health, said in a statement.

The "brain" behind Natural Cycles is a smart algorithm that can accurately determine a woman's daily fertility by analyzing changes in her basal body temperature, which increases after ovulation.

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Using data like daily body temperature and monthly menstrual cycle tracking, the app is said to have a fail rate of almost 2% for "perfect use", and a fail rate of 6% for "typical use", not unlike barrier methods and the pill.

Natural Cycles is the only app CE marked for birth control in Europe and has more than 900,000 registered users worldwide. Basal body thermometers are more sensitive than regular thermometers and detect a minor rise in temperature, about half of one degree Fahrenheit, around the time of ovulation, FDA said. It then tells users what days they should abstain from sex or use protection if they want to avoid getting pregnant. The typical use failure rate is right on par with the oral pill, which is around 9 percent, according to the Centers for Disease Control.

FDA approved the Natural Cycles app through the de novo premarket review pathway for new low- to moderate-risk devices. Flawless use would mean using the app exactly as intended, tracking every day and only having sex on "green days".

Also Friday, the FDA approved the first vaginal ring contraceptive that can be used for an entire year.

The app is called Natural Cycles.