- Natural Cycles is a popular contraceptive app which tells women which days they can have unprotected sex by tracking their temperature.
- The app is under fire in Sweden after a hospital reported 37 women who had been using the app to avoid pregnancy became pregnant, according to local news agency SVT.
- The hospital reported its findings to Sweden’s medical devices regulator, which has reportedly launched a probe.
- Natural Cycles said more unwanted pregnancies were to be expected as its app becomes more popular.
Birth control app Natural Cycles is under fire in its native Sweden after 37 women reported they got pregnant, despite using the app as contraception.
According to Swedish news agency SVT, a major hospital in Sweden has logged a report with the local medical device regulator after finding 37 of its 668 female patients who sought an abortion between September and December 2017 had been using Natural Cycles.
A midwife at the Södersjukhuset hospital in Stockholm, Carina Montin, told the news agency: “It’s a new method and we see a number of unwanted pregnancies, so we are reporting this to the Medical Products Agency.”
Sweden’s Medical Products Agency has launched a probe. A spokeswoman told Business Insider the investigation was still in the early stages.
Natural Cycles describes its app as an “effective method of contraception.” The app tracks women’s temperature to gauge their hormone cycle and tells them accordingly whether they can have unprotected sex or not on particular days. The app has become a popular alternative to the pill and other hormone-based contraception because it doesn’t involve taking any medicines, inserting devices, or hormone patches.
A spokesman said Natural Cycles was comparable to other forms of contraception, and that no method was “100% effective.”
“Natural Cycles has a Pearl Index of 7, which means it is 93% effective at typical use, which we also communicate,” he said. “Our studies have repeatedly shown that our app provides a high level of effectiveness similar to other methods.”
Natural Cycles said it hadn’t spoken to the hospital but that it was in touch with Sweden’s regulator about individual cases. The firm has also conducted an internal investigation, and said the numbers were not surprising given the popularity of its app.
“As our user base increases, so will the amount of unintended pregnancies coming from Natural Cycles app users, which is an inevitable reality,” the spokesman said.
Södersjukhuset hospital didn’t specify how old its patients were, nor whether they had been using the app correctly. Natural Cycles said it was aimed at women over 18 who have a regular cycle, with the average user around 30 years old. Younger users, the firm said, should consider other methods of contraception.
The app is also used by hundreds of thousands of British women, according to statistics from Google Play. The app launched in the UK in September last year after gaining a CE mark, which means it meets EU standards for medical devices. The mark is a legal requirement for anyone wanting to sell medical devices within the union.
At this point, it doesn’t look likely that Natural Cycles will be banned in Europe. The original CE mark was given by the German body TÜV SÜD, overseen by the German medical devices regulator. Should Sweden escalate its complaint to Germany, or should German users complain, it’s possible the regulator could withdraw Natural Cycles’ CE mark — but that’s in the most extreme case. Sweden’s regulator said it didn’t know if it would escalate a complaint just yet.
What is more likely is that the Swedish regulator might force Natural Cycles to add more warnings about unwanted pregnancies to its app.
When contacted by Business Insider, the UK’s medical devices regulator, the MHRA, said it hadn’t received complaints about the app.
Source: telegraph. Co.uk