Birth control app Natural Cycles approved in US despite controversy

Natural
Cycles founders Elina Berglund Raoul Schewitzl
Natural Cycles

• 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’

Unsplash/Brooke Lark

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/Facebook

Natural Cycles’ approach puts it in a larger category of birth
control known as
fertility awareness, which is similar to the calendar-based
approach people have used for decades.

The company’s founders published a study on the app’s
effectiveness in
the European Journal of Contraception and Reproductive Health
Care in 2016. The research involved 4,000 women between
the ages of 18 and 45, and the results showed that out of every
100 women who used the app in a “typical” way for a year (meaning
certain common slip-ups were accounted for),
seven of them got pregnant.

That rate is and significantly lower than the traditional
calendar method, which has an average fail rate of 24%, according
to the CDC.

The “typical use” scenario for the pill leads to about
nine out of 100 women getting pregnant within a year, so the
study suggests Natural Cycles is on par with an oral
contraceptive. But the app still leads to more pregnancies
than would be seen among people using injectable birth control or
an IUD. The typical use fail rate for an IUD is 0.2-0.8%, or

less than one out of 100 women getting pregnant each year.

Apps can ‘provide encouragement,’ but still have key limitations

As far as the women who got pregnant while using the Natural
Cycles app are concerned, the same European study found that more
than half of them had unprotected sex with men on the days when
the app advised against it. Those instances are evidence of a
longstanding human reality: behavioral control is difficult,
especially when it comes to sex, and not a guaranteed way to
prevent pregnancy.

“While smartphone apps may provide encouragement, they can’t stop
[men and women] from … sex altogether,” Susan Walker, a
professor of sexual health at Anglia Ruskin University,
wrote in an article for The Conversation.

A handful of other factors
can also get in the way of the app working correctly,
including having multiple sex partners and having a partner who
is not equally committed to birth control.

So if you’re planning on using the app — or one of the dozens
like it that have not been approved as medical devices — experts
say you should have a predictable sex schedule, regular periods,
be willing to check your temperature every day, and have the
ability to abstain from sexual activity on consecutive days every
month.

If you can do all that, the app could work for you.

“In the end, what we want to do is add a new method of
contraception that women can choose from without side effects,”
Scherwitzl said. “I think there are many women who this will be
great for.”