FDA approves birth control app that has been tied to unplanned pregnancies in Sweden and the UK

By On August 10, 2018

FDA approves birth control app that has been tied to unplanned pregnancies in Sweden and the UK

The Food and Drug Administration has approved a mobile birth control app despite the fact that it is under investigation in Sweden and the United Kingdom for its apparent ineffectiveness.

The app, known as "Natural Cycles," relies on the "rhythm method" of birth control, which tracks women's ovulation to determine which days of the month they are most likely to get pregnant. Family-planning grants issued by the Trump administration have signaled openness to organizations that teach women about avoiding pregnancy using this method, despite the fact that women's health organizations say it is too risky.

The app must be used precisely to work. It asks women to log their temperatures every single morning at roughly the same time using a basal body thermometer, a type that is more sensitive than a t raditional thermometer.

Users then log their temperatures in the app. On "red" days, or "fertile days," the app notifies women that they should not have sex without backup, such as a condom. On "green" days in the calendar, they are considered infertile and can proceed without additional protection.

In approving the app, the FDA warned that it doesn't protect against sexually transmitted diseases and that women whose life or health would be at risk from a pregnancy shouldn't use it. The technology, the agency warned, was imperfect.

“This new app can provide an effective method of contraception if it’s used carefully and correctly,” said Terri Cornelison, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health. “But women should know that no form of contraception works perfectly, so an unplanned pregnancy could st ill result from correct usage of this device.”

Clinical trials submitted to the FDA showed that women got pregnant 1.8 percent of the time when using the app correctly, but when the app was used incorrectly unintended pregnancies rose to 6.5 percent. Examples of using the app incorrectly include having unprotected sex on fertile days.

Natural Cycles is a 2014 startup developed by a married couple in Sweden, and in 2017, it became the first app to be certified as birth control in Europe. It reportedly has more than half a million subscribers across the world, but has faced scrutiny from other governments.

A major hospital in Stockholm reported that 37 of the 668 women who had abortions there had been using the app, and Sweden's Medical Product's agency launched an investigation as a result. Last month, Britain's Advertising Standards Authority said it was launching a formal investigation of its own, after recei ving complaints of unintended pregnancy. Women who had used the product saw it advertised on Facebook.

Some couples have used the app to try to get pregnant, but the FDA didn't specifically approve it for that purpose in its latest announcement.

[Also read: Rate of opioid abuse quadruples among women giving birth]

Source: Google News Sweden | Netizen 24 Sweden

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