A mobile contraceptive app used by more than 500,000 women is being criticized after reportedly causing 37 unwanted pregnancies.
Stockholm's Södersjukhuset hospital has now reported the Natural Cycles app to the Swedish Medical Products Agency (the government body tasked with the regulation of medical devices) according to news outlet SVT.
The app scans body temperature during the menstrual cycle to notify women when it is safe to have unprotected sex. Days when it's okay are marked as green on its calendar, but if it shows red couples are advised to use an extra form of protection. It's own research suggests Natural Cycles is more effective than the contraceptive pill when used correctly.
The 37 unwanted pregnancy cases stem from a study of over 600 women who sought abortions at Södersjukhuset hospital from September 2017 until the end of the year. "We have a duty to report all side effects, such as pregnancies, to the Medical Products Agency," midwife Carina Montin told Siren news agency. The findings could come as a blow to Natural Cycles' plans to pursue FDA approval.
In a statement, Natural Cycles said: "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."
In February 2018 Natural Cycles became the first app to be certified for contraceptive use, following approval by the German regulatory body Tuv Sud, after which its UK users spiked from 5,000 to 125,000. In November, the app, founded by husband and wife duo Dr. Raoul Scherwitzl and Dr. Elina Berglund, snagged US$ 30 mIllion in funding.
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