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Contraceptive App In Hot Water For Leading To Unwanted Pregnancies
By Yoon Sann Wong, 17 Jan 2018
Contraceptive app ‘Natural Cycles’ has come under fire after allegedly causing 37 unwanted pregnancies.
Södersjukhuset hospital, Stockholm, reported the app to the Swedish Medical Products Agency, which manages the regulation of medical devices.
These 37 cases are part of a study involving over 600 women, who sought abortions at Södersjukhuset hospital between September 2017 and the end of the year.
‘Natural Cycles’—yet to attain FDA approval—was founded by husband-wife team Dr Raoul Scherwitzl and Dr Elina Berglund. It scans the body’s temperature during the menstrual cycle to identify if it is safe for the female user to engage in unprotected sex.
Days that are safe are marked in green on the app’s calendar. Otherwise, a red color warns the user to use protection. Last year, Engadget reported that a study conducted by the app revealed, “After testing 22,785 women throughout 224,563 menstrual cycles, the startup found the app provided 99 percent contraceptive effectiveness if used perfectly. If used ‘typically’, the app was 93 percent effective. The contraceptive pill, meanwhile, is 91 percent effective.”
The app was certified for contraceptive use last February after gaining approval from German supervisory body TUV SUD. The app’s UK users subsequently rose from 5,000 to 125,000.
‘Natural Cycles’ has responded to the complaint saying, “No contraception is 100 per cent and unwanted pregnancies is an unfortunate risk with any contraception.”
“To have 37 unwanted pregnancies out of the 668 mentioned in this study at Södersjukhuset means that 5.5 per cent of women who stated they used Natural Cycles also had an unwanted pregnancy. This is in line with what we communicate as the risk of unwanted pregnancy with typical use, and which is comparable to other types of contraception.”
Following this, Engadget shared an updated statement from the team behind the app, addressing the situation:
“Natural Cycles has a Pearl Index of 7, which means it is 93% effective at typical use, which we also communicate. Our studies have repeatedly shown that our app provides a high level of effectiveness similar to other methods.”
“Natural Cycles has not yet received any information from SÖS, so we cannot comment on specifics. We are however in touch with the Medical Product Agency (MPA) and are responding to each individual reported case. At first sight, the numbers mentioned in the media are not surprising given the popularity of the app and in line with our efficacy rates. We have initiated an internal investigation with our clinical department in order to confirm this.”
“As our user base increases, so will the amount of unintended pregnancies coming from Natural Cycles app users, which is an inevitable reality.”
“We agree with what Carina Montin says, ‘Perhaps young people should use another form of contraception.’ You have to be over 18 to use Natural Cycles. The average Natural Cycles user is 30 years and less than 1% are under 20.”
“Today there is a big trend for women to move away from hormonal contraception, and Natural Cycles can provide a helpful option for these women. We therefore expect, in fact, overall to decrease the unwanted pregnancy rates because we’re increasing contraceptive choice, and see that many of our users are women that have not used any type of contraception before.”
“We’d like to reassure the medical community and the public that Natural Cycles is an effective, clinically proven, form of contraception, which hundreds of thousands of women worldwide trust as their birth control to prevent or plan a pregnancy.”
“Our goal is to increase contraceptive choice so that all women find a suitable method of contraception.”
[via Engadget and SVT, image via naturalcycles]
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