Birth control app remains under investigation by regulators, despite company’s claims to be ‘all clear’

Birth control app remains under investigation by regulators, despite company’s claims to be ‘all clear’

Sweden’s medical regulator says it is continuing to investigate the contraceptive app Natural Cycles over 37 unintended pregnancies, despite claims from Natural Cycles that the company is “all clear” following the investigation. The Medical Products Agency (MPA) says reports that the investigation has closed are incorrect.

Natural Cycles, the contraceptive app that is certified in the EU as a form of birth control, was hit with a complaint earlier this month after Södersjukhuset hospital in Stockholm reported the app to the MPA. Thirty-seven women had visited the hospital for abortions after becoming pregnant while using the app.

Earlier today, Natural Cycles put out a statement saying it was “all clear” after the closure of investigations into each pregnancy. “This proves that we have acted according to regulations regarding contraception, both when it comes to the actual product, but also the way we market it,” said co-founder and CEO Raoul Scherwitzl in the statement.

But the regulator says while it’s closed the first part of the investigation, it’s now moving on to the next step.

The MPA’s manager, Ewa-Lena Hartman, said the investigation of Natural Cycles is ongoing. “The MPA has decided to escalate the ongoing market surveillance investigation to review parts of the documentation that was compiled as a justification for the CE mark certification issued by a third party,” Hartman said in an emailed statement to The Verge.

The MPA said it had completed the first phase of the investigation and will collect more information and ask Natural Cycles for its clinical data, risk analysis, and aftermarket control. That information will be used to determine any shortcomings in the product, or how the manufacturer can follow up the product’s information and use.

“The result of our investigation will form a base for a decision if further action is needed related to the contraception app placed on the EU market,” Hartman said.

In an email to The Verge, Natural Cycles said it did not claim the investigation had ended:

Yes, we agree with the MPA, we have not claimed otherwise.

The Medical Products Agency has decided that all reports concerning Natural Cycles will be transitioned to trend reporting, in order to continuously monitor and report any unintentional pregnancies given the spread of the popular contraception app. Natural Cycles welcomes further data from the public to strengthen our clinical studies and aftermarket follow-up, [sic] why our open case at the Medical Products Agency is important to us.

Natural Cycles’ original statement implied that no investigation was continuing.

Natural Cycles says its app is 93 percent effective at typical use. The company also states that as more people start to use a contraceptive, more unplanned pregnancies would be linked to that contraceptive. Natural Cycles says it’s experienced a boom in users in the last year, with the number of UK women using the app soaring from 5,000 to 125,000. The company has over 600,000 users worldwide.

Moving forward, Natural Cycles said it will work together with the MPA on trend reporting to monitor rates of unintended pregnancies.

 

Source by theverge…

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