Pure Cycles is coming to Apple Watch. So is it secure to make use of as a contraceptive?

The fertility monitoring app Pure Cycles revealed at the moment it has obtained clearance from the U.S. Meals and Drug Administration (FDA) to be built-in into the Apple Watch — a tool estimated to be on the wrists of over 100 million folks worldwide. 

Pure Cycles made historical past in 2018 when it grew to become the primary digital contraceptive methodology to be accepted by the FDA, combining inputted temperature knowledge from customers with its algorithm to work out people’ fertile and non-fertile days throughout their menstrual cycle. It’s now about to be built-in into the preferred smartwatches on the planet.

The request for inclusion on the Apple Watch, which has provided physique temperature-based ovulation monitoring since its Sequence 8 model was launched in 2022, has been the best requested characteristic of Pure Cycles’ 3-million-strong consumer base in line with the corporate. It has already been used for over a yr on the Oura Ring, after successful FDA clearance for it in 2021.  

However is the tactic that Pure Cycles helps, the fertility consciousness methodology, secure for Apple Watch customers to now take into account as their contraceptive methodology?

How does Pure Cycles work?

Pure Cycles could have hailed a brand new era of contraception, however it didn’t arrive with out controversy. It helps customers apply the fertility consciousness methodology, a rebranding of pure household planning that entails closely monitoring adjustments in your physique to evaluate your fertile and non-fertile days each month; as a non-hormonal methodology, it has confirmed enticing to many who’re involved about hormonal strategies’ security and potential unwanted effects. 

The fertility consciousness methodology works on the premise that there are simply six days in a menstrual cycle {that a} lady can develop into pregnant – the day of ovulation, and the 5 days previous to it through which sperm could survive and fertilise the launched egg cell. 

Pure Cycles makes use of the temperature curve offered by knowledge to calculate the day of ovulation and the times after it, serving to it decide when you’ll be able to have unprotected intercourse safely, and when you’ll be able to’t. It’s then as much as you to make use of a barrier methodology like a condom on the unprotected days, if you wish to have intercourse. Up till this level, customers have needed to manually enter this knowledge each morning once they get up, utilizing a thermometer to measure their basal temperature. 

Credit score: Pure Cycles

Pure Cycles’ spectacular 98 p.c efficacy price as a way solely works – like many however not all contraceptive strategies – whether it is adopted constantly and accurately; have a look at ‘typical use’ and that quantity rapidly depletes to 93 p.c. For comparability, the mixed and progesterone contraceptive tablets share an analogous disparity between good and typical use, with their efficacy dropping if say a capsule is missed. 

Pure Cycles’ reliance on temperature knowledge may also be closely impacted by imperfect use all the way down to eventualities that in lots of instances aren’t the consumer’s fault. Not solely does it have to be measured on the similar time every day – one thing that’s presumably extra of a problem with handbook thermometer use than it’s with wearable tech – however Dr. Shazia Malik, a guide obstetrician and gynaecologist within the UK, is anxious that “carrying a watch isn’t in some way going to exclude the issues that make temperature readings much less correct.” 

Her listing of potential eventualities was intensive: “Ingesting alcohol the evening earlier than, battery lows in a single day, transferring, not getting sufficient sleep, in case your temperature goes up since you’re unwell, in case your cycles are irregular…”

Pure Cycles, the fertility consciousness methodology, and the realities of typical use

Because of this, Pure Cycles has had its wrist slapped in a couple of marketplace for not being extra upfront in regards to the realities of typical use. In 2018, a Swedish hospital reported that 37 of 668 girls who had sought an abortion there in a three-month interval had used Pure Cycles as their sole methodology of contraception. The Swedish Medical Merchandise Company investigated the instances and located that whereas the variety of pregnancies was consistent with Pure Cycles’ failure price, the corporate was advised to “make clear the danger of undesirable pregnancies” in its directions, which it did. 

Throughout the identical yr, the UK’s Promoting Requirements Company discovered a Pure Cycles Fb advert’s self-description of being a “extremely correct” methodology was deceptive, and so they had been warned about exaggerating the efficacy of Pure Cycles’ methodology as a type of contraception. 

Elina Berglund, CEO and co-founder of Pure Cycles, advised Mashable that the probability of getting an unintended being pregnant due to the algorithm was “actually low”, and added that customers in cohorts round 30 years of age can develop into riskier of their behaviours, presumably as a result of they’re extra prone to be settled of their lives and fewer frightened about getting pregnant. Malik echoed this, saying, “You must solely use [fertility awareness methods] if getting pregnant isn’t going to be a catastrophe.”

Elina Berglund, CEO and co-founder of Pure Cycles.
Credit score: Pure Cycles

However can the mixing into wearable expertise enhance this ‘typical’ use? Berglund added that she was conscious that the Apple Watch’s present interval monitoring knowledge was already being utilized by watch house owners below the radar as a fertility consciousness methodology. “We’re nonetheless the one app that’s FDA accepted and cleared to be used as contraception. We’ve printed greater than 4 research simply on contraceptive effectiveness, and it’s not simply effectiveness that’s essential — it’s the benefit of use and the way it matches in with girls’s lives.” With the Apple Watch integration, she mentioned, “We imagine the drop off charges will likely be decrease.”

Defending consumer knowledge in a post-Roe world

Within the post-Roe local weather, intimate entry to delicate well being data via fertility monitoring apps has raised privateness considerations. Pure Cycles’ reassurance that the corporate protects customers’ knowledge lies in its subscription mannequin; Berglund mentioned, “We’re not incentivised to monetise folks’s knowledge and we by no means would. Pure Cycles would by no means promote a consumer’s knowledge and as a medical machine for contraception that is one thing we’ve been audited in opposition to.” 

Jen Catilder, program director of *Privateness Not Included on the Mozilla Basis, advised Mashable, “Based mostly on our analysis, Pure Cycles is among the higher reproductive well being apps relating to privateness.”

“They don’t promote knowledge. Whereas they do share some knowledge for focused promoting, it’s restricted,” she mentioned. “They restrict how knowledge could be shared with legislation enforcement in ways in which look good to us. They’ve a good monitor file at defending their consumer’s private data. That is all good.”

Catilder warned, nevertheless, that not all reproductive well being apps had been created equal, and that others in the marketplace are “really terrible.” 

It is essential to know the place your knowledge could possibly be going.
Credit score: Vicky Leta / Mashable

Within the UK, which is Pure Cycles’ second-biggest market, demand in strategies like Pure Cycles is rising in line with Alice Pelton at The Lowdown, the world’s first contraceptive assessment platform. “Hundreds of thousands of girls are determined for higher non-hormonal strategies of contraception,” Pelton advised Mashable. “Why? As a result of innovation and funding into new contraceptive strategies has been massively missing for years.” 

Pelton is aware of the criticisms round digital contraceptives, however added that they “are positively not proper for everyone however work rather well for some people. It’s good to be engaged, proactive and disciplined to make use of these apps.” Lowdown opinions, she provides, have instructed that many customers have discovered the morning temperature checks for Pure Cycles “annoying to recollect, and don’t just like the beeping sound the thermometer makes once they use it. [The Apple Watch integration] is a good step ahead, and means girls with an Apple Watch don’t want to purchase one other machine.” 

“Hundreds of thousands of girls are determined for higher non-hormonal strategies of contraception. Why? As a result of innovation and funding into new contraceptive strategies has been massively missing for years.”

MSI Reproductive Selections’ medical director Dr. Dhammika Perera advised Mashable that he was general very optimistic about wearable tech in well being, and {that a} fertility monitoring app “has positively bought worth for some.” In relation to unintended pregnancies, Perera was way more involved about misinformation on social media than he was about apps selling the fertility consciousness methodology.

However Perera famous that the three million customers already subscribed to Pure Cycles was not numerous customers in his view, and that he nonetheless wouldn’t advocate utilizing a way like Pure Cycles to any individual near him. “I’d say to strive one thing with a better efficacy price first — probably the most efficacious methodology, even for youthful generations, are the lengthy performing reversible contraceptives (LARCs).”