Health Canada is rarely tracking the sex of patients who have experienced adverse incidents involving medical devices such as insulin pumps, breast implants and pacemakers despite committing to do so two years ago, reveal documents obtained by The Globe and Mail.
Experts say tracking sex in these cases is vital to understanding who is being harmed, and to identifying when a device may be failing a particular group. Health Canada itself acknowledged 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 sex and gender-considerations are systematically integrated in 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 with the potential for death or injury. However, documents obtained under access to information legislation reveal that in the first year and a half of data collection, sex was not recorded in 95 per cent of incidents.
Health Canada never made it compulsory for hospitals, health care providers, consumers and industry players to report the sex of patients, even though it had the power to make it mandatory. The rationale for optional disclosure was that issues with the devices are not unique to the individual harmed by them, according to a statement from Health Canada.
“The majority of incidents relate to issues with the device itself and not with a specific interaction with and/or the physiological makeup of an individual,” media relations adviser André Gagnon said in an e-mail.
The Scientific Advisory Committee on Health Products for Women, which advises Health Canada, is calling on the department to make the collection of sex in medical device incident reports obligatory. The chair of the committee, Lorraine Greaves, a medical sociologist, said the sex of the people harmed is a critical piece of information.
Unless these data are collected, “we don’t know what we need to investigate in terms of unintended consequences or impact on one particular group of people,” Ms. Greaves said.
According to Mr. Gagnon, the changes to incident reporting, such as providing the option to include sex 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 sex can play an important role in how a medical device functions. “Sex as a biological variable affects, for instance, our heart rhythm or our heart size, so there have been recalls on cardiac stents that have been made one size fits all.”
Cumulative bias and disregard for the importance of sex-related factors has permeated medicine, she said. “If you look in a medical textbook, I think 70 per cent of the pictures are based on the male body. It’s just the historical default.”
The Implant Files, a 2018 investigation by the International Consortium of Investigative Journalists, found millions of patients around the world have been harmed by medical devices. In the United States, the group discovered that in cases where sex could be identified, 67 per cent of people who died or were injured in incidents relating to medical devices were women.
A similar analysis has not been possible in Canada, since Health Canada did not provide the option to track sex in these incidents until February, 2020. The limited data collected through optional reporting since then means such analysis is still not possible.
The approval process for devices in the United States and Canada is fairly similar, Dr. Tannenbaum said. “If this information is coming out of the U.S., Canada has a responsibility to see what our statistics here are.”
Cynthia Gagné had a urinary incontinence sling implanted in 2015. She said prior to the procedure she wasn’t 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 who faced similar issues.
If a medical device is affecting one sex more than another there should be a record of it, “to allow medicine to continue to evolve without repeating the same mistakes,” Ms. Gagné said
According to Mr. Gagnon, the department recognizes that women have experienced uniquely challenging issues when it comes to medical devices. “We acknowledge that more can be done on this issue and we are committed to better understanding the sex 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 part of medical device incident reporting in 2022.
A spreadsheet of incident data obtained through access to information showed seemingly (but not always) obvious cases where biological sex could have been included and wasn’t. For example, in a February, 2020, incident involving a tampon where there was potential for death or injury, and in numerous incidents where people were injured by breast implants.
Ms. Greaves said reports are often filled out by health providers and hospital staff who may not understand the importance of including sex information because it seems self-evident.
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