December 14, 2018

An FDA-Approved Digital Contraceptive is Stirring Controversy

“In August, the F.D.A. announced that it had allowed a new form of contraception on the market: a mobile app called Natural Cycles. The app, which was designed by a Swedish particle physicist, asks its users to record their temperature with a Natural Cycles-branded thermometer each morning, and to log when they have their periods. Using a proprietary algorithm, the app informs its users which days they are infertile (green days—as in, go ahead, have fun) and which they are fertile (red days—proceed with caution), so that they can either abstain or use a backup method of birth control. In clearing the app as a medical device, the F.D.A. inaugurated “software application for contraception” as a new category of birth control under which similar products can now apply to be classified. The F.D.A.’s press release quotes Terri Cornelison, a doctor in its Center for Devices and Radiological Health, who said, “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.”

In the past several years, dozens of apps that track a woman’s fertility have been introduced. Most are marketed as a tool for women who are trying to become pregnant, or for those who just want to know more about their bodies. Natural Cycles is the first to be certified, in Europe, and cleared for marketing, in the United States, as a form of contraception. Many women say that doctors reflexively prescribe birth control as soon as a woman becomes sexually active, often eliding what for some can be significant side effects or neglecting to teach patients how fertility works. As a way to avoid synthetic hormones and unpleasant side effects, and to understand one’s body, Natural Cycles ticks all the boxes.

Natural Cycles’ F.D.A. market authorization, though, followed a kerfuffle in Sweden about the app’s efficacy. In January, a single hospital in Stockholm alerted authorities that thirty-seven women who had sought abortions in a four-month period had all become pregnant while using Natural Cycles as their primary form of contraception. The Swedish Medical Products Agency agreed to investigate. Three weeks ago, that agency concluded that the number of unwanted pregnancies was consistent with the “typical use” failure rate of the app, which they found to be 6.9 per cent. During the six-month investigation, six hundred and seventy-six additional Natural Cycle users in Sweden reported unintended pregnancies, a number that only includes the unwanted pregnancies disclosed directly to the company. There’s no available data on how many people actively use Natural Cycles, but if all of the people who have registered with the company were to use it as their contraceptive method “typical use” would result in more than sixty-two thousand unintended pregnancies.”

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