Health Canada rarely tracks patient gender in medical device adverse incidents, data shows

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Health Canada rarely tracks the gender of patients who have suffered adverse incidents involving medical devices such as insulin pumps, breast implants and pacemakers despite pledging to do so two years ago, documents obtained by The Globe and Mail.

Experts say gender tracking in these cases is key to understanding who is hurt and identifying when a device may be failing for a particular group. Health Canada itself recognized the importance of collecting such information when it launched a sex and gender action plan in 2020 that aimed to establish the federal agency “as an organization where gender considerations and gender are systematically integrated into all our research, legislation, policies, regulations, programs and services.

Between February 2020 and July 2021, more than 18,000 adverse incidents involving medical devices were reported to Health Canada, including 71 deaths, 453 injuries and 2,337 cases involving death or injury. However, documents obtained under freedom of information legislation reveal that in the first year and a half of data collection, gender was not recorded in 95% of incidents.

Health Canada has never made it mandatory for hospitals, healthcare providers, consumers and industry players declare the sex of patients, even if he had the power to make it compulsory. According to a statement from Health Canada, the rationale for voluntary disclosure was that problems with devices are not unique to the person experiencing them.

“The majority of incidents are related to issues with the device itself and not with any specific interaction with and/or an individual’s physiological makeup,” media relations adviser André Gagnon said in an email. .

The Scientific Advisory Committee on Women’s Health Products, which advises Health Canada, is calling on the department to make it mandatory to collect sex in medical device incident reports. The chair of the committee, Lorraine Greaves, a medical sociologist, said the gender of those injured is essential information.

Unless that data is collected, “we don’t know what we need to investigate in terms of unintended consequences or impact on a particular group of people,” Ms Greaves said.

According to Gagnon, the changes to incident reporting, such as the ability to include gender data, were made to “improve monitoring and reduce the recurrence of incidents.”

Dr. Cara Tannenbaum, a women’s health researcher and professor at the University of Montreal, said gender can play a big role in how a medical device works. “Sex as a biological variable affects, for example, our heart rate or the size of our heart, so there have been reminders about heart periods that have been made one-size-fits-all.”

Cumulative biases and disregard for the importance of gender factors have permeated medicine, she said. “If you look in a medical textbook, I think 70% of the images are based on the male body. It’s just the historical flaw.

The Implant Files, a 2018 survey by the International Consortium of Investigative Journalists, found that millions of patients worldwide have been injured by medical devices. In the United States, the group found that in cases where gender could be identified, 67% of people killed or injured in medical device incidents were female.

A similar analysis was not possible in Canada, as Health Canada did not provide the option to track gender in these incidents until February 2020. The limited data collected through voluntary reporting since then means that such an analysis is still not possible.

The device approval process in the United States and Canada is quite similar, Dr. Tannenbaum said. “If this information comes from the United States, Canada has a responsibility to see what our statistics are here.”

Cynthia Gagné had a urinary incontinence sling implanted in 2015. She said before the procedure she was not properly informed of the risks. After the implantation, she experienced extreme pain, loss of strength in her leg, and an inability to play sports or have sex. She founded a support group for women facing similar issues.

If a medical device affects one gender more than another, there should be registration, “to allow medicine to continue to evolve without repeating the same mistakes,” Gagné said.

According to Mr. Gagnon, the department recognizes that women have experienced particularly difficult problems when it comes to medical devices. “We recognize that more can be done on this issue and are committed to better understanding the sexual and gender implications of medical devices,” he said.

Health Canada told The Globe and Mail it will be consulting on the potential addition of sex as a mandatory component of medical device incident reporting in 2022.

A spreadsheet of incident data obtained through Access to Information showed seemingly (but not always) obvious instances where biological sex could have been included and was not. For example, in a February 2020 incident involving a tampon where there was a risk of death or injury, and in numerous incidents where people were injured by breast implants.

Ms Greaves said the reports are often filled out by healthcare providers and hospital staff who may not understand the importance of including gender information, as it seems self-evident.

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