Recent allegations claim that Health Canada, the Canadian health regulator, hasn’t been transparent in warning consumers about Essure side effects.

Essure was approved for use in Canada in 2001. Health Canada reportedly maintains a registry of complications associated with devices but only requires reports when they involve “adverse events”.

Even when adverse events are reported to Health Canada, they are not made public. This means that, regardless of complications associated with the permanent birth control device, the public may not have been warned about Essure side effects.

An investigation by CBC News and Fifth Estate reported that the lack of information about Essure side effects may have contributed to Canadian women pursuing the potentially harmful device.

Over the course of two years, CBC News obtained raw data from Health Canada through access to information requests. The data showed that Health Canada received one report within the first 12 years of Essure being licensed. However, since 2013, the regulatory body has received 84 reports regarding Essure side effects. Sixty-four of those reports were submitted by Bayer, the device’s manufacturer, and the rest were submitted privately by doctors and patients.

However, these numbers may not accurately reflect the number of Canadian women affected by Essure side effects. Because manufacturers are only required to report complications which qualify as adverse events, there is no way to know how many reports Bayer has received.

There are around 10,000 women in Canada who have had Essure implanted. Three thousand of these women have had the procedure done at the Regina General Hospital Women’s Health Centre in Saskatchewan. Dr. John Thiel was one of the first doctors to bring the device to Canada.

The doctor, who serves as the provincial head of the obstetrics, gynecology, and reproductive sciences for the College of Medicine at the University of Saskatchewan, has performed around 2,000 procedures to implant the device and has trained other doctors how to insert the device. Thiel sits on the medical advisory board for Bayer and has been listed as Bayer’s consultant for two of his nine articles published regarding Essure.

“It’s safer, it’s more reliable,” Thiel told CBC News in 2007. “There are fewer failures associated with it.”

The doctor reportedly said that when patients return to his office after having Essure implanted, the staff didn’t immediately link the issues with Essure. Since the device’s release in 2002, Thiel has made no reports to Health Canada about Essure side effects.

“As far as I know, I never, we never submitted anything to Health Canada on any adverse event,” said Thiel, according to CBC News. “There was never a requirement. There was never a reason to.”

In the United States, around 18,000 women have taken legal action against Bayer for allegedly failing to design a safe product and warn about Essure side effects. Bayer announced this year that they would no longer be selling Essure in America in 2019.

Although she declined an interview with The Fifth Estate, Health Minister Ginette Petipas Taylor recently issued an order for stronger medical device regulations and improvements to reporting and pre-marketing studies.

“We also want to make sure that institutions will have to report to Health Canada if there’s any side-effects or any issues related to medical devices,” Petipas Taylor said in a statement to CBC News. “We want to expand that and we want to make sure that hospitals will have to report that information to Health Canada. And also I want to create a process that patients will also be able to make that report to Health Canada.”