Thousands of suspected injuries tied to breast implants revealed in manufacturer data dump, CBC analysis finds

Health Canada was left in the dark for years about thousands of suspected injuries and complications related to breast implants — including multiple mentions of a rare cancer — that manufacturers failed to report, CBC News has learned.

The 5,990 incidents were submitted in bulk by breast implant makers Allergan and Johnson & Johnson's affiliate Mentor on three dates in 2019: Jan. 14, June 26 and Nov. 7, according to CBC's analysis of Health Canada's medical device incidents database.

That's 10 times more than the 594 breast implant-related reports submitted in 2018.

More than half of the new reports are suspected injuries, while the rest are classified as having the potential for injury or death should they reoccur, also called near misses. The oldest injury cited occurred in 1994.

The data suggests manufacturers received some reports as early as 2000, but they weren't submitted to Health Canada's database until nearly two decades later. 

Federal reporting requirements state that companies must report deaths, injuries and near misses involving a device to Health Canada within 10 to 30 days — but they also say it's up to manufacturers to determine if an incident is reportable or not.

A patient advocate and a plastic surgeon say these new revelations have shaken their trust in manufacturers and suggest Health Canada's reporting system is broken.

"It should be crystal clear what events are reportable," said B.C. plastic surgeon Dr. Peter Lennox, who has consulted CBC's data analysis, including the nature of problems and the type of implants named. 

He says beyond the sheer volume of reports, what's more alarming is how old some incidents appear to be.

"The fact that [this reporting] has not been done for 19 years is really concerning, and I think a lot of surgeons would want an explanation for that." 

Although patients, physicians and hospitals can report incidents to Health Canada, Lennox says most surgeons report directly to manufacturers and trust that they will comply with mandatory reporting requirements. 

"It's a bit of a violation of trust," he said. "I use those devices with the expectation that, if I report a ruptured implant to a manufacturer, that manufacturer would report that to Health Canada. Finding out this information is not great for the relationship between surgeons and implant manufacturers."

"I'm shocked, but I'm not surprised," said Terri McGregor, an Ontario woman who was diagnosed with a rare cancer associated with textured breast implants in 2015.