Breast implants: Common risks
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The risks associated with breast implants
Like all medical devices, breast implants have benefits and risks. Licensing of a medical device means:
- the benefits outweigh the risks associated with the use of the device
- the risks have been reduced as much as possible by the manufacturer
There can be important new information about a device's safety, effectiveness or quality after licensing. For this reason, we continue to monitor the benefits and risks of products while they are marketed in Canada.
If you are considering breast implants, discuss the risks and benefits with your health care provider. Carefully review any information provided to you by your health care provider.
Learn more:
You are also encouraged to review information about the risks of specific breast implants. For example, you can:
- find Canadian recalls and safety alerts associated with breast implants
- ask your doctor for the patient brochure, patient labelling and instructions for use
- review our fact sheet on breast implants
You can also find more information about each manufacturer's breast implants in:
- our summary basis of decisions
- the manufacturer's product label
Once you have breast implants, you can stay informed by subscribing to Health Canada updates on authorized breast implants:
Common risks and adverse events
There are many complications and risks associated with breast implants. These risks are explained in the product labelling, which should be available from your surgeon.
Common risks immediately following surgery include:
- pain
- swelling
- bleeding
- mild to serious infection
- changes in nipple and breast sensation
In some cases, more surgery may be required:
- due to dissatisfaction with the size or shape of the implant(s)
- to treat an adverse event following the initial procedure
Some of the adverse events that can occur with breast implants include:
- incorrect positioning of the implant
- rupturing (the implant shell breaks or tears), when
- saline-filled implants deflate
- silicone gel-filled implants silently rupture
- tightening or hardening of scar tissue around the implant (called capsular contracture)
- breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin's lymphoma (cancer of the immune system) that can develop next to the implant
- in rare cases, BIA-ALCL has resulted in death
You are encouraged to:
- review the information provided by your health care provider to understand these and other potential adverse events
- report a medical device problem related to the use of breast implants