Earlier this month, popular period-tracking app Clue announced it had received FDA clearance for a digital birth control feature in its app. Now, per a Verge report, Natural Cycles, the other FDA-cleared birth control app, is pissed because of how the FDA granted that clearance, sparking some beef between the two apps. Meanwhile, I’m sitting here wondering why we’re even discussing companies squabbling over regulatory semantics when we should be questioning why birth control apps are a thing in the first place.
There’s no lack of fertility apps out there. Some come with thermometers so you can measure your basal body temperature. There’s even a wearable that tracks metrics like heart rate, perfusion, and body temperature to predict a woman’s fertile window. Likewise, Natural Cycles and Clue’s forthcoming birth control feature are both iterations of Fertility Awareness Methods (FAM). FAM generally requires you to either chart your menstrual cycle, check your cervical mucus, or log your basal body temperature every morning before getting out of bed. It’s most accurate if you do a combination of all three. If done perfectly, FAM can be effective at preventing pregnancy. The reality is that with typical usage, FAM has a failure rate of about 25%, according to both the CDC and Planned Parenthood.
Part of the reason why there’s such a high failure rate for FAM is human error. People have a hard time being consistent every day, 100% of the time. This was true before apps, when women marked their cycles on a physical calendar or an Excel sheet. Period-tracking and fertility apps simplify the logging process and make your data much more accessible. And if you add a predictive algorithm to the mix—especially one like Natural Cycles’, which has FDA clearance and some clinical studies to back it up—it confers an air of accuracy and reliability, whether it’s warranted or not.
That’s fine if you’re a couple trying to have a baby. If you’re a woman who isn’t trying to get pregnant and absolutely does not want a baby, FAM-based birth control apps are a tragedy waiting to happen. If the app fails—as Natural Cycles did for at least 37 women women in 2018—the cost is high.
But surely, if the FDA gives the OK, that means it’s accurate, right? When the FDA granted Natural Cycles de novo clearance, it said in its press release that the app’s typical failure rate was 6.5%, or about 93% efficacy. Clue claims to be 92% effective at preventing unwanted pregnancy. Those seem like pretty high numbers and a marked decrease from the 25% failure rate of traditional FAMs. But those numbers don’t tell the whole story.
The problem is there’s still a boatload of things we don’t know about women’s health. Clinically speaking, there’s a lack of foundational data, because in the past, trial subjects were almost always male and women were frequently excluded from studies because of their periods. (Fun fact: Congress did not require women to be included in clinical trials until 1993.) To this day, women receive poorer medical care due to medicine’s male bias. While Clue and Natural Cycles have conducted their own studies, they’re mere drops in a very empty bucket. Their studies also focus on perfect use scenarios, which few women achieve. We don’t know crucial data like how well app-based birth control works for women with conditions like PCOS or endometriosis. We also don’t know how many women were too embarrassed to report unwanted pregnancies after using the app, and how that might impact its failure rate.
Both Natural Cycles and Clue basically got their clearance because the FDA deemed them to be a low to medium risk for harm. Try telling that to the women who used the app and still became pregnant. A Guardian article detailed the experiences of women who experienced unwanted pregnancies from using the app. Two ended up having abortions, with one saying the experience was traumatic, led to a breakdown of her relationship, and thrust her into “a pit of despair.” Another kept the baby but noted the experience had taken away her sense of control. None of those experiences particularly feels like a “low to medium” risk, especially when you consider the potential threat of violence against women with unwanted pregnancies.
In the case of the 37 Swedish women, Natural Cycles was reported to the Swedish Medical Products Agency. After an investigation, they found that the failure rate was in line with expectations, but that the company should be clearer about the risk of unwanted pregnancy. However, the danger of birth control apps isn’t necessarily in their failure rate. We’ve all learned in school that all methods of birth control can fail. It’s in the fact that it subtly encourages women to skip the doctor’s office.
To be fair, Clue’s product hasn’t launched yet so we can’t say for certain what it’ll be like. We can, however, look at how Natural Cycles has marketed itself. If you go to the Natural Cycles website, it touts its FDA clearance and the fact that it’s prescription-free all over its homepage. It encourages me to “take control of my fertility” and tells me that it has no unwanted side effects. It also says that if you forget to measure your temperature, the app doesn’t become less effective. That sounds too good to be true, though there is a disclaimer at the bottom of the website that acknowledges the app cannot guarantee a user will not get pregnant.
Out of curiosity, I took the Natural Cycles quiz about whether this contraceptive was “right” for me. It shouldn’t be, as I have polycystic ovary syndrome (PCOS) and am terrible at taking my medication every day, let alone my temperature before I get out of bed. Instead, my quiz results gently asked if I could consider changing my routine. It said that my current method of birth control—the NuvaRing—was hormone-based and asked if I had noticed any side effects. It proceeded to say Natural Cycles was hormone-free and just as effective as the ring. My results also said my PCOS, which means I have highly irregular and infrequent cycles, wouldn’t impact the app’s efficacy—just that I might be told to not have sex on more frequently until the algorithm “got to know me.” This is subtly manipulative, and of course, designed to convince me to give Natural Cycles a try. If the quiz were designed with my health in mind, it should’ve told me that I wasn’t a great candidate, detailed the reasons why, and encouraged me to consult a doctor before making any decision.
Instead, my quiz results contradicted every conversation I’ve ever had with my gynecologist and doctor. Because I have PCOS, my doctor advised that I should be on a hormonal contraceptive if I wanted regular periods, and then took the time to figure out which method would work best for me. She answered all my questions and walked me through the pros and cons of each. In an ideal world, every woman seeking birth control would have this conversation with a medical professional to make an educated choice about what was best for her health—not a company’s bottom line. These are absolutely not conversations that should be skipped because it’s more convenient to download an app. What’s worse is that you’re most likely to see ads for Natural Cycles from influencers and on social media sites frequented by younger users—users who may be more tempted to fudge their age in order to get access to “birth control” without parental knowledge.
There’s nothing wrong with Natural Cycles or Clue using FAM to help couples who want to be pregnant. There wouldn’t be any controversy if they marketed their products as fertility app. But considering the risks that unwanted pregnancy poses, the FDA should re-examine what it considers “low risk.” In the meantime, prescription-free birth control apps shouldn’t be a thing.
Correction, 03/18/2021, 5:50 pm: This article has been updated to clarify that while Natural Cycles had been reported to Swedish officials after 37 women experienced unwanted pregnancies, they have not been sued. We regret the error.
After initial publication, Natural Cycles CEO and Co-founder Elina Berglund sent the following statement:
“There are often a lot of misconceptions around Natural Cycles and digital birth control in general, which we have aimed to clear up over the past four years. Unfortunately, when we read an article like this, it’s clear we still have a ways to go and our concern grows as other forms of digital birth control begin to enter the market, which could add even more confusion. Natural Cycles is proud to offer women a non-hormonal option that is backed by not only four published clinical studies that outline our 93% typical use effectiveness, but more than four years of real-world evidence that includes follow ups with 98% of users.”
Correction, 03/19/2021, 12:05pm: A previous version of this article implied there was no disclaimer on Natural Cycle’s homepage. The text has been updated. We regret the error.