Breast implants: Risks

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.
You are also encouraged to review information about the risks of specific breast implants. For example, you can:

visit our website for safety information
search for Canadian recalls and safety alerts associated with breast implants
ask your doctor for the patient brochure, patient labelling and instructions for use

You can also find more information about each manufacturer's breast implants in:

our summary basis of decisions
the manufacturer's product label

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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

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare type of non-Hodgkin lymphoma that can develop next to the implant.

BIA-ALCL is not a cancer of the breast tissue, but a rare and serious cancer of the immune system (the system that fights infections). BIA-ALCL in Canada currently meets the World Health Organization's (WHO) definition of "rare". WHO uses the following terms when describing how often an adverse event occurs:

uncommon: between 1 in 100 people and 1 in 1,000 people
rare: between 1 in 1,000 people and 1 in 10,000 people
very rare: fewer than 1 in 10,000 people

In Canada, the rate of BIA-ALCL is significantly higher in patients who have highly textured (macro-textured) breast implants. In 2019, Health Canada completed a review of BIA-ALCL. As a result of the findings, we suspended the licences for Allergan's Biocell breast implants. These were the only macro-textured implants available in Canada.

Allergan has recalled all unused Biocell devices from the Canadian market. Allergan also issued a worldwide recall on all Biocell breast implants and tissue expanders.

You can find current information about the number of reported cases of BIA-ALCL in Canada on our BIA-ALCL Canadian surveillance data blog. You can also find current information on recalls, advisories and safety alerts.

Symptoms

Symptoms of BIA-ALCL can develop months or years after the implant surgery and may include:

pain and/or redness
asymmetry of the breasts
a lump or mass in the breast
skin changes around the implant
tightening or hardening of scar tissue around the implant (capsular contracture)
sudden swelling or enlargement of the breast known as delayed seroma (accumulation of liquid around the implant)
- this is the most common symptom

You should check your breasts regularly for any unusual changes, such as:

sudden swelling or a lump
redness, soreness or a rash
dimpling, puckering or bulging of the skin
a nipple that has changed position or an inverted nipple (pushed inward)

Discuss any signs or symptoms with your health care provider.

Diagnosis and treatment

Removing breast implants isn't recommended if there are no signs or symptoms suggesting BIA-ALCL. You should discuss the risks and benefits of removal with your health care provider.

If BIA-ALCL is suspected, samples of the following are collected and sent for analysis:

scar tissue (capsule)
any fluid (seroma) found around the implant
any mass found within or around the implant

Please refer to the guidelines on the diagnosis and treatment of BIA-ALCL.

The recommended treatment for suspected or confirmed BIA-ALCL is to surgically remove both:

the breast implant
all the scar tissue (capsule) around the implant

Some women may need follow-up chemotherapy and/or radiation to treat the disease.

In rare cases, BIA-ALCL has resulted in death.

Other types of cancer near a breast implant

The United States Food and Drug Administration recently published information about other types of cancer found in the scar tissue that can form around a breast implant. The U.S. reports were found with both smooth and textured breast implants, and those filled with saline or silicone.

These cancers are different from BIA-ALCL. They include different types of lymphomas and squamous cell carcinoma.

As of June 2022, squamous cell carcinoma and different types of lymphomas have been reported in the literature and directly to Health Canada through incident reporting. We continue to review the reports of these other types of cancers and are actively monitoring this issue. We will inform Canadians as required.

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If you are considering breast implants or have breast implants, our recommendations remain the same:

If you are considering breast implants
- Get information about the risks and benefits of breast implants.
- Discuss the risks and benefits with a health care provider.
If you have breast implants
- Check your breasts regularly for any unusual changes.
- Discuss any signs or symptoms with your health care provider.
If you are a health care provider
- Report cases of any type of cancer found in tissue near a breast implant.

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