The first app to get approved as birth control in Europe has now been green-lit in the US, despite controversy


Natural Cycles founders Dr Elina Berglund and Dr Raoul Schewitzl

Birth-control app Natural Cycles has been approved by the US Food and Drug Administration — the first app to be approved for contraception in North America.
The app uses an algorithm to tell women when they have the highest and lowest chances of getting pregnant, but it ultimately relies on men and women changing their behavior.
The app recently came under fire in Sweden when 37 women reported getting pregnant while using it.

A birth-control app called Natural Cycles has been approved by the US Food and Drug Administration, marking the first time an app has been approved for contraception in North America.

Designed by physicist couple Elina Berglund and Raoul Scherwitzl, the app doesn’t involve a pill and contains no medication. It works by giving heterosexual couples recommendations about when to avoid sex or use protection, based on a woman’s daily temperature measurements and the regularity of her period.

“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 women’s health at the FDA’s Center for Devices, said in a statement. “But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device.”

Natural Cycles only helps prevent pregnancy if people using it behave in the way it prescribes. The app also recently gained regulatory approval in Europe — the first app to do so there as well — but it came under fire in Sweden several months later when 37 women reported getting pregnant while using it.

Those pregnancies ignited a small controversy about how the app works and what it can — and can’t — do. But Scherwitzl told Business Insider in January that he was not surprised women had become pregnant.

“We give red and green days and clear recommendations on which days to abstain and which days we consider the risk of pregnancy to be negligible,” he said.

The problem with saying ‘as effective as the pill using only math’

Natural Cycles was initially portrayed by multiple news outlets — including Business Insider — as being “as effective as the pill using only math.”

When is used properly, Natural Cycles may be comparable in effectiveness to the pill. But that doesn’t always happen, as the controversy in Sweden revealed.

So the problem with these types of statements is that the app relies on couples to change their behavior and either not have sex or use protection based on the app’s recommendations.

“Just like with the pill, you have scenarios where women take the pill everyday” and it’s as reliable as possible, Scherwitzl said, and then there are “scenarios where they don’t take it every day” and the reliability decreases.

How Natural Cycles compares with simply using a calendar

Natural Cycles’ approach puts it in a larger category of birth control known as fertility awareness, which is similar to the calendar-based …read more

Source:: Businessinsider – Finance

      

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