Regarding the Latest News on Natural Cycles
Welcome! You’re probably here in light of the recent media coverage about Natural Cycles, and that’s great. Our hope is to provide as many answers as possible to the questions or concerns you may have. On this page you will find our official statement and frequently asked questions about the recent events.
Hospitals in Sweden reported unintended pregnancies that can be linked to Natural Cycles.
Natural Cycles is 93% effective with typical use, which means that 7 out of 100 women become pregnant in one year.
Natural Cycles has reviewed the reports from the hospitals. We have been in contact with the Medical Products Agency (Läkemedelsverket) and responded to each individual report.
The original individual reports regarding unintended pregnancies to the Medical Products Agency have been closed. The investigation continues and the MPA has requested additional information regarding clinical evaluation, risk management, and post-market surveillance.
Frequently Asked Questions
What is Natural Cycles?
Why does Natural Cycles exist?
Natural Cycles is an effective, non-invasive, hormone-free method of digital contraception. It uses a sophisticated algorithm to analyze a user’s basal body temperature (which is entered into a mobile app in the morning) to calculate her fertile and non-fertile days. On fertile days (red days), the user must use protection (e.g. condoms) or abstain from sex. On non-fertile days (green days), the user does not have to use protection during sex. It takes one to three cycles for the app to adapt to a user’s unique cycle, that means a possibility for more red days in the beginning.
Natural Cycles is:
We believe in increasing contraceptive choice. Every woman is unique, and every cycle is unique and by providing another option to choose from we are giving women not only an effective and natural contraceptive, but also a tool to get to know their bodies and cycles. We are passionate about women's health and with years of research and conducting clinical studies, we are striving to lead the way for the future of contraception.
Is Natural Cycles effective if women are getting pregnant using it?
Natural Cycles is NOT:
Yes! Studies have repeatedly shown that Natural Cycles is effective. Natural Cycles is less effective than for example the IUD, but comparable to other methods that require a daily routine.
Natural Cycles is 93% effective with typical use. This means that 7 out of 100 women become pregnant during one year due to all possible reasons (e.g. having intercourse without protection on red days, condom breaking etc). At perfect use, Natural Cycles is 99% effective. This means that 1 woman out of 100 become pregnant despite having no unprotected intercourse on red days.
Why did reports on Natural Cycles get sent to the Swedish Medical Products Agency?
Why is Natural Cycles considered a method of contraception?
The Medical Products Agency (MPA, Läkemedelsverket) is a Swedish governmental authority that is responsible for the approval and supervision of pharmaceuticals, as well as the supervision of cosmetics and medical devices.
For medical devices, the MPA’s function is to ensure that public safety is maintained and that every product released on the market fulfills the demands required by Swedish law. The MPA is not a certifying body for medical devices, this is done by a EU notified body. TÜV SÜD is the EU notified body that is responsible for auditing Natural Cycles’ quality system and product.
It is advisable that hospitals and users submit reports to the Medical Products Agency on incidents related to medical devices. Natural Cycles is a new contraceptive on the market. The number of users has grown significantly, and as a consequence, so has the number of unintended pregnancies attributable to us (since Natural Cycles is 93% effective with typical use). This is a statistical truth and applies in different ways for all types of contraception.
Hospitals and individual users have sent reports to the Medical Products Agency, which, as said, is desirable to create transparency on clinical use. We are continuously evaluating the information we receive from the reports and incorporating it into our central database. This information is reported to the authorities and our notified body.
Quality research, compliance audits and the implementation of processes in line with regulatory requirements have led to Natural Cycles becoming the only app to be CE marked as a contraceptive device.
The CE marking means that Natural Cycles is classified as a IIb medical device intended for contraceptive use in the EU, the same classification as the male condom. It also means we are allowed to market ourselves as a contraception. The certification requires us to follow and maintain international standards for quality assurance and product development processes. This means that just like any other medical device, we get yearly and unannounced audits. The latest unannounced audit that was conducted and passed was in December 2017.
Learn more about the certification here.
Efficacy Rates of Contraceptive Methods:
💜 Been using Natural Cycles for some time now and never had any problems. You put your basal temperature into the app each day and it gets to know your unique cycle. I believe that if used correctly it is fool proof. Just like any contraceptive it isn’t 100% as I know people who have got pregnant on the pill and with IUD etc ultimately it’s a personal choice what you choose to use, do your own research and decide what is best for you!
We want to take this moment to say how thankful we are for all our users continuous love and support throughout the recent events. You are the most important part of Natural Cycles and the reason why we strive to do better in every way.
Don't take it from us...
💜 I love NC and cycling life so much! Thanks for being an awesome organisation and helping women everywhere to get control of their fertility and enjoy natural contraception! Behind you 100%! 😊 😊 😊
💜 NC has been incredible in allowing me to follow my cycle through treatment for PCOS. I've been able to see my cycle go from highly irregular to irregular to REGULAR in just a few months. Without this app I would not have seen the changes so clearly. It is so much more than a bc app. Keep up the good work.
Feel free to reach out if you have any questions or concerns.
Still have questions?