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| Image Credit: Natural Cycles |
The fertility tracking application, Natural Cycles, has recently announced that it has garnered approval from the U.S. Food and Drug Administration (FDA) for seamless integration into the Apple Watch—a device donned by an estimated 100 million individuals across the globe. Notably, Natural Cycles achieved historical recognition in 2018 when it became the inaugural digital contraceptive method to receive the FDA's imprimatur. Its modus operandi entails the amalgamation of user-inputted temperature data with a sophisticated algorithm, enabling the determination of fertile and non-fertile days within the menstrual cycle. This revolutionary application is now poised for integration into one of the world's most favored smartwatches.
The plea for inclusion in the Apple Watch, renowned for its body temperature-based ovulation tracking since the 2022 release of its Series 8 iteration, ranks as the most sought-after feature among Natural Cycles' three million-strong user base. This, according to the company, follows a successful year of deployment on the Oura Ring, subsequent to securing FDA clearance in 2021.
Yet, in light of this development, a pivotal query arises: Can the fertility awareness method endorsed by Natural Cycles be deemed a secure contraceptive for Apple Watch users? To elucidate, one must delve into the mechanics of Natural Cycles.
While Natural Cycles may have ushered in a new era of contraception, it did not emerge unscathed from controversy. It is predicated on the fertility awareness method, a rebranded version of natural family planning that entails vigilant monitoring of physiological changes to discern fertile and non-fertile days each month. As a non-hormonal alternative, it has found favor among those concerned about the safety and potential side effects of hormonal contraceptive methods.
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| Image Credit: Natural Cycles |
The core premise underlying the fertility awareness method posits that a woman's fertile window spans a mere six days within her menstrual cycle: the day of ovulation and the preceding five days, during which sperm may endure and fertilize the released egg cell. Natural Cycles leverages temperature data to ascertain the day of ovulation and the subsequent fertile days, guiding users on when unprotected intercourse is safe and when it is not. Until now, users have been required to diligently input this data each morning upon awakening, relying on thermometers to gauge their basal temperature.
Natural Cycles boasts an impressive 98 percent efficacy rate when adhered to meticulously and correctly, akin to several contraceptive methods. However, when examining "typical use," this figure dwindles to 93 percent. In comparison, combined and progestin contraceptive pills exhibit a similar efficacy disparity between perfect and typical use, with effectiveness diminishing in instances of missed doses.
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| Image Credit: Natural Cycles |
The accuracy of Natural Cycles' temperature-based approach can be significantly influenced by imperfect use, often due to factors beyond the user's control. Consistency in measurement time is essential, a potential challenge more pronounced with manual thermometer usage than with wearable technology. Dr. Shazia Malik, a consultant obstetrician and gynecologist in the UK, raises concerns that "wearing a watch isn't a panacea for the factors that may compromise temperature readings."
Her enumeration of potential variables is extensive: "Consumption of alcohol the preceding night, overnight battery depletion, movement during sleep, inadequate rest, temperature elevation due to illness, and irregular menstrual cycles."
Consequently, Natural Cycles has faced criticism in various markets for not providing more forthright information regarding typical use. In 2018, a Swedish hospital reported that 37 of 668 women seeking abortion had relied solely on Natural Cycles as their contraceptive method. An investigation by the Swedish Medical Products Agency concluded that while the number of pregnancies was consistent with Natural Cycles' failure rate, the company was urged to "clarify the risk of unintended pregnancies" in its instructions, which it duly addressed.
During the same year, the UK's Advertising Standards Agency censured a Natural Cycles Facebook advertisement for inaccurately portraying the method as "highly accurate." The company was cautioned against overstating the efficacy of its contraceptive method.
Elina Berglund, CEO and co-founder of Natural Cycles contended that the algorithm's likelihood of causing unintended pregnancies was "exceedingly low." She added that users in the approximately 30-year-old demographic might exhibit riskier behaviors, presumably owing to greater life stability and reduced apprehension regarding pregnancy. Dr. Malik concurred, emphasizing that fertility awareness methods should only be considered when an unintended pregnancy would not be catastrophic.
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| Elina Berglund, CEO and co-founder of Natural Cycles. Credit: Natural Cycles |
However, can integration into wearable technology enhance the practicality of this "typical" usage? Berglund acknowledged that Apple Watch's existing period tracking data had surreptitiously been utilized by owners as a fertility awareness tool. She stated, "We remain the sole app endorsed and authorized by the FDA for contraceptive purposes. We have conducted more than four studies on contraceptive efficacy alone, and efficacy is not the sole consideration; ease of use and alignment with women's lifestyles also hold significance." With Apple Watch integration, she expressed optimism that dropout rates would decrease.
In a post-Roe era, intimate access to sensitive health data via fertility tracking applications has prompted concerns about privacy. Natural Cycles assuages these concerns by operating on a subscription-based model. Berglund affirmed, "We have no incentive to commodify user data, and we never will. Natural Cycles will never trade user data, a commitment validated through audits, given its status as a medical contraceptive device."
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