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FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy

The U.S. Food and Drug Administration today permitted marketing of the first mobile medical application (app) that can be used as a method of contraception to prevent pregnancy. The app, called Natural Cycles, contains an algorithm that calculates the days of the month a woman is likely to be fertile based on daily body temperature readings and menstrual cycle information, a method of contraception called fertility awareness. Designed for mobile devices, it is intended for use in pre-menopausal women aged 18 and older.

Clinical studies to evaluate the effectiveness of Natural Cycles for use in contraception involved 15,570 women who used the app for an average of eight months. The app had a “perfect use” failure rate of 1.8 percent, which means 1.8 in 100 women who use the app for one year will become pregnant because they had sexual intercourse on a day when the app predicted they would not be fertile or because their contraceptive method failed when they had intercourse on a fertile day. The app had a "typical use" failure rate of 6.5 percent, which accounted for women sometimes not using the app correctly by, for example, having unprotected intercourse on fertile days.

If I'm understanding this right, the FDA just gave the thumbs up to the rythm method as a proper birth control method.

https://www.androidpolice.com/2018/08/14/fda-okays-digital-birth-control-app/

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616511.htm

Many of the app's early adopters would probably agree. Numerous media reports have highlighted horror stories of unwanted pregnancies after users were seduced by the idea of a hormone and latex-free contraceptive. Swedish media reported earlier this year that a hospital in Stockholm filed a complaint against Natural Cycles with the Swedish Medical Products Agency. The hospital identified 37 women who sought abortions after relying on the app for contraception. Those women were among 668 seeking abortions at the hospital between September 2017 and the end of the year.

The Swedish MPA, with help from the Swedish Medicines Agency, is now investigating the app. The agency told VICE news that they expect to wrap up investigation in September.

At the same time, the UK’s Advertising Standards Authority (ASA) is also investigating the app and some of its advertising that appeared on Facebook. The ASA told The Guardian that it had received three complaints about the Facebook ads, which described Natural Cycles as highly accurate.

“We would require robust substantiation from any company to support such a claim,” an ASA spokesperson told the newspaper.



https://arstechnica.com/science/201...ed-by-unwanted-pregnancies-gets-fda-approval/


This is ridic.
 

eddie4

Genuinely Generous
If only there was an easier way other than having to input all this information into an app...... if only.......hmmm.......
 
Rhythm method is a useful part of female reproductive education. I know it's a dogwhistle for people worried about abortion or sex-ed being banned (or something equally ridiculous) but if you are trying to get pregnant or trying not to get pregnant, knowing your cycle seems like pretty basic knowledge.

Let me put it this way: would you rather have kids assuming that the condom (even if improperly applied) solves everything, or would you like them to be aware of additional pieces of knowledge that they can do in addition to contraceptives (i.e. abstaining from sex during their "fertile" days, if they choose)?
 

diablos991

Can’t stump the diablos
I think this app would be fantastic if one was trying to get pregnant but should absolutely never be relied on for preventing pregnancy.
 

RubxQub

φίλω ἐξεχέγλουτον καί ψευδολόγον οὖκ εἰπόν
I mean, a 93.5% success rate under "typical use" is pretty darn great. I wouldn't necessarily depend on this method exclusively...but if you pair this method with something like...pulling out or condoms...the success rate has to skyrocket to something like 99.99% I'd imagine.

It's just kind of strange that it's going to be considered a contraceptive, though.

If I hadn't had a vasectomy, I wouldn't really trust this app unless I was in a committed relationship. Some chick you randomly meet and she says "oh don't worry about it, I'm using this app and it says I'm good to go"...yeah, not going to take that at face value.
 
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