FDA Approves Controversial Birth Control App

Health News

Apppregnancy

There’s an app for everything these days, including not getting pregnant.

This month, the Food and Drug Administration (FDA) announced its approval of Natural Cycles, the first-ever digital birth control for women age 18 and older, which charts a patient’s fertility so that she knows which days to avoid intercourse.

Created by a women’s health tech company based out of Stockholm, Sweden, the app has been approved for contraceptive use in Europe since 2017.

Natural Cycles requires the patient to take her basal body temperature — that is, her temperature at rest — each morning upon waking, as well as track her menstrual cycle, and input that data into the app.

Relying on her self-reported information, Natural Cycles analyzes the data and warns the user to “use protection” (red days) when she is fertile, and lets her know she is “not fertile” (green days) the rest of the time.

Available in the App Store, Natural Cycles comes with a 30-day free trial, after which the service is available for $79.99 per year, with a basal thermometer included; or for $9.99 per month but without a basal thermometer, which would need to be purchased separately.

Digital birth control seems to have taken the premise of fertility apps — that is, ovulation-tracking apps that assist women with getting pregnant — “and reversed it,” said Dr. N. Edward Dourron, a reproductive endocrinologist and fertility specialist at Southern Fertility and Surgery Services in Chamblee, Georgia.

We typically view apps as making things more simple — press a couple buttons, and dinner is delivered to our front door.

To that end, Dourron said he understands the appeal of a birth control app from a “practical standpoint.” It’s more “user friendly” than what we might call old-school family planning (mapping out one’s basal body temperature and menstrual cycle on charts).

This method that has been around on paper forever has now gone high-tech. But it still has pros and cons to weigh.

‘Labor intensive’ birth control

Dr. Alisa Goldberg, MPH, associate professor of obstetrics/gynecology at Harvard Medical School, Brigham and Women’s Hospital, Department of Obstetrics and Gynecology, and director of their Family Planning Fellowship, concurred that Natural Cycles is “a reasonable option” — but with some caveats.

In particular, digital birth control could be embraced by women who have had negative side effects with hormonal birth control such as the vaginal ring (NuvaRing), the patch, or birth control pills.

But she warned that Natural Cycles may be more “labor intensive” as birth control than users might expect from an app.

In addition to taking her temperature and tracking her period, a woman needs to consistently use a backup method, such as condoms, on her fertile days, Goldberg explained.

Some experts believe that attempting to predict future ovulation dates based on past basal temperature data in order to prevent pregnancy may be risky.

“Patients can have a variation in their ovulation date,” said Dourron. “If a patient was consistently ovulating on day 14 and now her ovulation is delayed to day 16 or 17, and the app is using previous cycle data to get the green light for intercourse, it could open patients up to a pregnancy.”

Dourron warned that not all women may be good candidates for Natural Cycles, despite the fact that it’s so accessible. Irregular ovulation could also throw off the efficacy of the app.

For example, the majority of women with polycystic ovary syndrome (PCOS) — a condition that causes irregular periods — have not been diagnosed. Therefore, it’s possible that women who don’t realize they’re ovulating dysfunctionally could “have too much faith in this method,” said Dr. Dourron.

Effectiveness is based on ‘perfect use’

Based on a study of 22,785 women, Natural Cycles claims a 93 percent efficacy with “typical use” and a 99 percent efficacy with perfect use (that is, never having unprotected sex on red — or fertile — days).

Those statistics seem promising, but the OB-GYNs with whom Healthline spoke warned that human error has a way of bungling even the best of reproductive intentions.

“When you look at the chart of the best [forms of] contraception it really comes down to the one where you do not involve the patient in any way,” said Dourron.

Implants, IUDs, and tubal ligation are harder to mess up — like, say, forgetting to take the pill — because a person “doesn’t have to remember to do anything,” he explained.

Nevertheless, some women are willing to take on the higher risk of pregnancy associated with natural family planning because they really want to avoid hormonal birth control or invasive implants.

“If … [patients] truly understand what they’re signing up for, then I think it’s okay,” said Goldberg. “But what I worry about is people having unrealistic expectations of what their risk really is.”

Finding the right birth control

Ultimately, choosing birth control is a highly personalized decision for both an individual and a couple. In a statement to Healthline, Ame Wadler, a spokesperson from Natural Cycles, said contraceptive choice is key.

“There is no ‘one size fits all’ when it comes to birth control — every woman has different needs and priorities,” Wadler said in a statement. “This is why contraceptive choice is so important. We believe that by increasing the options available, more women will be able to find a contraceptive that is right for them.

This thought was echoed by Goldberg, who said, “In general, the more options that are available for women and for families, the more likely it is that everybody is going to be able to find something that works for them.

That said, Goldberg continued, “I worry about people forsaking highly effective methods of contraception for something that they think is going to be more effective than it actually shakes out to be in real practice — in real life.”

Dourron also voiced his skepticism. Consumers may have a “false sense of security” about an app’s ability to prevent pregnancy, he warned.

“The FDA, in their desire to offer contraceptive options to patients, is going to err on the side of giving another option,” he explained. “Consumers in general view the FDA as kind of a watchdog that’s only going to approve apps, devices, [and] medications that have been rigorously studied and have proven efficacy.”

While Natural Cycles is a method for avoiding pregnancy, “it should not be used by patients that really don’t want a pregnancy, period,” he continued. “If they’re not prepared to accept a pregnancy as a potential issue that comes up with this app, then they’re really not good candidates to use it.”

The best way to think of the Natural Cycles app may be as a tool to make natural family planning a little bit easier. And while natural family planning is “not very effective at all at preventing pregnancy,” he noted, “it’s better than just doing the withdrawal method.”