If you are looking into breast implant safety Canada guidance, you deserve clear answers. Health Canada assesses breast implants as medical devices and authorizes their sale.
This page summarises what government sources say. The wider context of services and coverage is in the hub on breast reconstruction in Canada.
| Topic | What the source says |
|---|---|
| Who oversees implants | Health Canada assesses safety, efficacy and quality, and authorizes sale. |
| Device class | Regulated as class IV, the highest risk class of medical devices. |
| Shell and filling | Smooth or textured silicone shell; silicone gel or saline filling. |
| BIA-ALCL | A serious but rare lymphoma that may develop months or years later. |
| Biocell licences | On May 27, 2019, Health Canada notified Allergan of the suspension. |
These details come from the Government of Québec and Health Canada’s safety review. Information can change, so please check the sources for the latest.
How breast implants are regulated
The Government of Québec describes Health Canada as the agency responsible for assessing the safety, efficacy and quality of medical devices such as breast implants, and for authorizing their sale in Canada. Health Canada’s safety review explains that breast implants are regulated in Canada as class IV medical devices, the highest risk class of medical devices.
The review says breast implants are licensed to increase breast size, correct or improve the results of a previous implant surgery, correct breast unevenness, or rebuild breast tissue following surgery. It adds that implants marketed in Canada have a smooth or textured silicone shell and are filled with silicone gel or sterile salt water, called saline.
What BIA-ALCL is
Most safety attention has focused on breast implant-associated anaplastic large cell lymphoma, usually shortened to BIA-ALCL. Health Canada describes it as a serious but rare type of non-Hodgkin lymphoma, a cancer that affects the immune system, that may develop many months or years after a breast implant procedure. It states that this is not a cancer of the breast tissue, and that the cause is not fully understood but is likely the result of multiple factors.
The United States Food and Drug Administration similarly says that BIA-ALCL is found in the scar tissue and fluid near the implant, that an individual’s risk is considered to be low, and that the cancer is serious and can lead to death, especially if not treated promptly. It says that in most patients it is treated successfully with surgery to remove the implant and surrounding scar tissue.
The 2019 Health Canada review and licence suspension
Health Canada completed an update to its 2017 safety review, which was triggered by newly reported Canadian cases and by new literature and information from international regulators. The summary issued in 2019 says the evidence strongly suggests an increased risk of BIA-ALCL with highly textured, or macro-textured, implants compared with less textured or smooth ones. It states that on May 27, 2019, Health Canada notified Allergan of the suspension of the licences for Biocell breast implants, which were the only macro-textured implants available in Canada.
The Government of Québec confirms that in 2019 Health Canada suspended the licences for Allergan’s Biocell breast implants and that, since then, it has kept watch on all new and confirmed cases of BIA-ALCL in Canada. It says Health Canada requires any new cases to be reported.
The review records that Health Canada determined the manufacturer’s response did not give enough evidence that the benefits of Biocell implants continued to outweigh the risks, and that suspension means they will no longer be marketed in Canada. Health Canada also committed to work with manufacturers to strengthen the instructions for use of all breast implants and to continue to actively monitor their safety.
Risk estimates and how they have changed
Figures differ by date and by implant type. In its 2019 summary, Health Canada estimated the rate of BIA-ALCL at 1 in 3,565 for Allergan Biocell macro-textured implants and 1 in 16,703 for Mentor Siltex micro-textured implants. At that time it reported no Canadian cases of BIA-ALCL associated with smooth implants and no deaths in Canada, and it warned that the number of cases and estimated disease rate were evolving.
The Government of Québec gives a later set of figures. It states that as of December 31, 2022, Health Canada estimated the risk of developing BIA-ALCL in patients with macro-textured breast implants at 1 in 1,475, considered rare, and for micro-textured implants at 1 in 19,412, considered very rare. It adds that as of December 2022 there were no confirmed cases of BIA-ALCL in people with smooth breast implants.
Because the estimates come from different dates and from case and sales data that change over time, they should not be compared as if they described the same period.
Symptoms and what the guidance says about removal
The Government of Québec says complications can occur several years after surgery and that BIA-ALCL symptoms generally appear around 8 to 10 years after surgery. It lists swelling or enlargement of the breast with or without pain, tightening or hardening of the breast, a mass in the breast or underarm, and skin rash or a change in breast skin colour, and says anyone with implants who notices these should talk to their surgeon, oncologist or family doctor.
The FDA lists the main symptoms as persistent swelling, a mass or pain in the area of the breast implant, which may occur well after the incision has healed. It says an evaluation typically involves a physical exam, imaging and assessment of fluid or tissue around the implant, and that a confirmed diagnosis may change the type of operation that should be performed.
On removal, Health Canada’s review states that preventive removal of breast implants is not recommended in the absence of signs or symptoms suggestive of BIA-ALCL, and that patients with concerns should discuss the risks and benefits of removal with their healthcare professional.
Implants are not lifetime devices
Safety is not only about BIA-ALCL. The FDA states that breast implants are not considered lifetime devices, that the longer people have them the greater the chances are that they will develop complications, and that some complications will require more surgery. It adds that a person may need one or more reoperations over the course of their life.
The FDA lists reoperation procedures that can include implant removal with or without replacement, removal of the scar capsule, scar or wound revision, drainage of a hematoma and repositioning of the implant. It says that anyone considering removal should discuss with their surgeon which method suits their situation.
People who want to understand what kind of support is available when facing these decisions can read the guide to breast cancer support Canada, and those looking for information on early detection can read about breast cancer screening Canada.
Finding out which implant you have
The Government of Québec notes that a person who is unsure whether they have textured implants can find the information in their medical record, by contacting the institution or private clinic where surgery took place. It also describes how, in 2019, public institutions in Québec reviewed patient records and contacted patients with textured breast implants as a preventive measure.
Decisions about implants, symptoms, monitoring and removal belong with the reader’s own surgeon and care team, who know the type of implant and the history of the surgery. The information on this page summarises published government material and is not a substitute for an individual assessment.
Frequently asked questions
Who regulates breast implants in Canada?
Show answer
Health Canada assesses their safety, efficacy and quality and authorises their sale, according to the Government of Québec.
Were textured implants banned?
Show answer
Health Canada suspended the licences for Allergan’s Biocell macro-textured implants in 2019, so they are no longer marketed in Canada, according to its safety review.
Does Health Canada recommend removing implants without symptoms?
Show answer
Its review states that preventive removal is not recommended in the absence of signs or symptoms suggestive of BIA-ALCL.
Do implants last a lifetime?
Show answer
The FDA says they are not considered lifetime devices and that complications can become more likely the longer they are in place.
