Thousands of suspected breast implant-related injuries revealed in manufacturer’s data dump, CBC analysis finds
Health Canada has been left in the dark for years about thousands of alleged breast implant injuries and complications – including multiple mentions of rare cancer – that manufacturers have failed to report, CBC News has learned .
The 5,990 incidents were submitted en masse by breast implant makers Allergan and the Johnson & Johnson Mentor subsidiary on three dates in 2019: January 14, June 26 and November 7, according to CBC analysis Health Canada Medical Device Incident Database.
This is 10 times more than the 594 breast implant reports submitted in 2018.
More than half of the new reports are suspected injuries, while the rest are categorized as potentially causing injury or death if the offense recurs, also known as near misses. The oldest injury cited dates back to 1994.
The data suggests that the manufacturers received reports as early as 2000, but they were not submitted to Health Canada’s database until almost two decades later.
Federal reporting requirements say companies must report deaths, injuries and near misses involving a device to Health Canada within 10 to 30 days – but they also say it is up to manufacturers to determine whether an incident is reportable or not.
“A breach of trust”
A patient rights advocate and plastic surgeon say the new revelations have shaken their confidence in manufacturers and suggest Health Canada’s reporting system is down.
“It should be clear what events are to report,” said BC plastic surgeon Dr. Peter Lennox, who viewed CBC’s data analysis, including the nature of the problems and the type of named implants.
He says beyond the sheer volume of reports what is more alarming is the age of some incidents.
“The fact that [this reporting] hasn’t been done for 19 years is of real concern, and I think a lot of surgeons would want an explanation for this. ”
While patients, physicians and hospitals can report incidents to Health Canada, Lennox says most surgeons report directly to manufacturers and are confident they will comply with mandatory reporting requirements.
“It’s a bit of a breach of trust,” he said. “I use these devices in the hope that if I report an implant rupture to a manufacturer, that manufacturer will report it to Health Canada. Finding out this information is not good for the relationship between surgeons and implant manufacturers. “
“I’m shocked, but I’m not surprised,” said Terri McGregor, an Ontarian who was diagnosed with rare cancer associated with textured breast implants in 2015.
She has since become a patient advocate for others.
“How not to look at this dump of manufacturers’ data, up to 20 years later, and not see that the lives of patients mattered less than the profitability of a breast implant? “
Unclear reporting requirements: plastic surgeon
CBC’s analysis found that the majority of the devices named in this data dump were smooth saline-filled implants with recurring issues related to leaks, ruptures, and pain that led to revision or revision surgeries. withdrawal.
Lennox says most surgeons probably wouldn’t view deflated saline implants and revision procedures as injuries, as these are well-known complications that patients are made aware of before surgery and “shouldn’t have a significant impact on the patients”.
“There is nothing in this data that worries me more for patients, there are no new risks here,” said Lennox, who has practiced in British Columbia for over 20 years.
The former president of the Canadian Society of Plastic Surgeons believes this data dump suggests that the reporting requirements may not be clear to manufacturers.
“Just having these broad categories that are not useful for making political decisions just implies that the system is not functional. It does not protect patients and does not give physicians information useful for providing advice to patients. “
In its response to CBC News, Health Canada mentioned that “breast implants have been approved with conditions, including collecting data on the incidence of ruptures.”
CBC finds 2015 patient report in data dump
CBC News also identified 26 reports in the landfill with a mention of anaplastic large cell lymphoma associated with breast implants (BIA-ALCL) – a rare cancer linked to textured breast implants – submitted to Allergan between 2009 and 2019.
The data does not say whether the cases mentioned are confirmed or suspected.
CBC News found McGregor’s medical device incident report in the landfill.
She says her doctor filed the report with manufacturer Allergan in June 2015. CBC research suggests the same report was submitted to Health Canada’s database in November 2019.
How do you hold these people accountable? We need an objective third party. We need an objective review on this, and we thought it was Health Canada.– Terri McGregor, Patient Advocate
“How do we hold these people accountable? We need an objective third party. We need an objective review on this, and we thought it was Health Canada,” said McGregor, who is suing Allergan for not l ” have warned of the risks associated with their implant.
In an affidavit filed in the Court of Queen’s Bench in Alberta, Allergan’s senior director of regulatory affairs, Glen Tam, said the company’s documentation for patients over the years has included “the disclosure of information on possible associations between NATRELLE textured implants and various types of cancer. – including, most recently – ALCL. “
Similar data dumps reported in the United States
CBC also shared its findings with Madris Kinard, a former U.S. Food and Drug Administration (FDA) data analyst and now CEO of DeviceEvents, a web-based tool that searches for medical device reports submitted in the United States.
“A lot of them were breakups,” Kinard said. “Just because the patient didn’t have to go to the emergency room doesn’t mean it wasn’t of a serious nature. All of this should have been reported at 10 or 30 days. no doubt. “
In 2018, Kinard drew international attention to a dramatic increase in suspected incidents of breast implants submitted to the FDA, which included thousands of injuries treated as routine occurrences and not publicly disclosed by the manufacturers until years later.
She said she saw a lot of similarities between this situation and Canada’s data dump.
“It shouldn’t depend on the manufacturer [to report] because they have a fiduciary interest in it, so there’s no reason they want to self-report, ”Kinard said.
Under-reporting discovered in 2017: Health Canada
Health Canada told CBC News it found an initial red flag after reviewing Allergan’s 2017 annual report, which mentioned incidents of breast implants that were not showing up in its database.
The federal agency explained that a thorough analysis of medical device incidents related to breast implants later revealed that “the reporting volume was very low”, suggesting “potential underreporting.” This led Health Canada to inspect the Allergan and Johnson & Johnson subsidiary, Mentor.
“The inspections identified a significant number of medical device incidents ranging from approximately 1999 to 2018 that were required to be reported to Health Canada under the Medical Devices Regulations, but were not submitted. The majority of these retroactive reports were submitted to Health Canada, in bulk in 2019, “a spokesperson for Health Canada confirmed in an email.
When asked by CBC News to provide more context on this underreporting and Health Canada’s inspection, Allergan declined to comment.
Johnson & Johnson’s subsidiary, Mentor, says it “has been and remains transparent and fully complies with Health Canada regulations in its reporting. The reports to which you refer were submitted following a proactive internal review by Mentor and with the support of Health Canada.
Health Canada says the information provided in what it calls the bulk reports “has been key to the risk assessments currently underway” and that it plans to release an update on the risks associated with breast implants early on. from 2022.
METHODOLOGY: How did CBC analyze medical device incidents in Canada?
The statistics included in this story were obtained by analyzing the Complete extract from Health Canada’s Medical Device Incident (MDI) database available online which was last updated on November 28, 2021 (based on file metadata). The excerpt contains six inter-relational data tables that were joined by CBC News using the unique identifier code assigned to each incident by Health Canada (Incident_id). Incidents that did not occur in Canada were excluded from this analysis. The dates when incidents occurred were not available for 30% of the reports in the three data dumps we analyzed. For reporting delays, we calculated the difference between the date the company learned of the incident and the date the report was first received by Health Canada.
CBC News has isolated all reports related to breast implants using alphanumeric codes assigned to breast implant products by Health Canada. Reports related to devices such as breast implant sizers, breast tissue expanders, and devices inaccurately cataloged as breast implants were excluded. Reports classified as “recalls”, “no device license” and “no establishment license” were excluded.
Data Analysis: Valérie Ouellet, Senior Data Reporter, CBC News (Jan 2022)