Natural Cycles, the fertility app, may have become the first contraceptive app to be approved by the U.S. Food and Drug Administration (FDA), but the Advertising Standards Authority (ASA) has banned a Facebook ad on the grounds that its claims are “misleading.”
Finding the right contraception can be a tricky decision. Whether you opt for hormonal contraceptives, like the pill and risk it affecting your mood, the more invasive coil, or the convenient yet fumbly condoms it seems there’s always a compromise.
So news that there is now a new app promising to prevent unwanted pregnancy has been welcomed by many looking for a modern form of contraception.
How does it work?
The premise is actually pretty simple.
The app, which costs around £60 a year, contains an algorithm that calculates the days of the month a woman is likely to be fertile. It’s based on her daily body temperature readings and the information she shares about her menstrual cycle.
Women take their temperature daily, first thing in the morning, using a basal body thermometer and enter the reading into the app.
Basal body thermometers are more sensitive than regular thermometers and detect the minor rise in temperature that typically happens when a woman ovulates, the FDA explains in a press release.
The app then advises women whether it is a green or red light day.
On a green day women are given the go ahead to have sex without using contraception, whereas on a red day (ie a women’s most fertile time) women are advised to use extra protection.
On first glance the app seems like the perfect solution to the modern contraception dilemma. And the fact that it was given the green light by the FDA? Even better.
Earlier this year the FDA permitted marketing of Natural Cycles, the first app to be used as a method of contraception to prevent pregnancy.
The FDA cites clinical studies involving 15,570 women who used the app for an average of eight months.
With “perfect use,” the app failed 1.8% of the time; with “typical use,” the failure rate was 6.5% (the FDA puts those down to people not using the app correctly, like having unprotected sex on fertile days).
Those numbers are actually better than those for hormonal birth control, like the pill, which fails 9% of the time, according to data from the Centers for Disease Control and Prevention.
So what’s the problem?
Earlier this year the app clocked up headlines, when Swedish news agency SVT reported that 37 people in Sweden who sought an abortion at a large hospital in Stockholm between September and December 2017 had unintended pregnancies while using the app.
And this is just one hospital, the company reports that it has 600,000 active users across the world, 200,000 of which are in the UK.
The bad news doesn’t end there.
The ASA received three complaints about a Facebook ad for the app, which was shown in July 2017 and claimed:
“Natural Cycles is a highly accurate, certified, contraceptive app that adapts to every woman’s unique menstrual cycle. Sign up to get to know your body and prevent pregnancies naturally.”
It also claimed the app was a “clinically tested alternative to birth control methods”.
And just this morning it was announced that the ASA has upheld the complaints and has now banned the ad on the grounds the claims made were “misleading.”
After the ruling Natural Cycles, will no longer be allowed to claim it is a “highly accurate” and “clinically tested alternative to birth control.”
“We told Natural Cycles not to state or imply that the app was a highly accurate method of contraception and to take care not to exaggerate the efficacy of the app in preventing pregnancies,” the ASA said.
The Family Planning Association (FPA) also previously expressed concerns about the app.
Speaking to Stylist, Karin O’Sullivan, a clinical consultant at FPA said she would not currently recommend the app alone as a contraceptive method for women.
“There’s not enough independent evidence available about the reliability and effectiveness,” she says.
And commenting about the ASA investigation, she adds, “It’s not very clear what ‘highly accurate’ means – when talking about contraceptive methods it’s much more helpful to talk about effectiveness rates and explain exactly what your chances of getting pregnant are with typical and perfect use of the method”.
In a statement, a spokesperson for Natural Cycles said it respected ASA’s ruling. “We are committed to being open and transparent in our communications to ensure our message is clear and provides women with the information they need to determine if Natural Cycles is right for them. As part of these efforts, every advertisement undergoes a strict approval process,” they said.
“Natural Cycles has been independently evaluated and cleared by regulators in Europe and the US based on clinical evidence demonstrating its effectiveness as a method of contraception.”
Contraception 2.0 or not convinced?
The founders of the app claim it is 93% effective with typical use.
In comparison, condoms are 85% effective with typical use, and the pill is 91% effective with typical use. Whereas the implant has a failure rate of just 0.05%, and the hormonal IUD a failure rate of 0.2%.
But women need to bear in mind that we probably won’t use any method of contraception perfectly, in which case Natural Cycles offers a pretty decent alternative contraception, particularly considering it is non-hormonal and non-invasive.
But users will need to consider the factors that can alter its effectiveness including a change of routine, medication, which can both alter basal temperature, and of course, the accurateness of actually taking your temperature.
So whether or not Natural Cycles is for you is an individual choice. If you’re still not sure, its probably worth checking in with your doctor to talk through your contraceptive options.
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