Breast implants

Learn about breast implants and the risks involved with the related surgery. If you decide to get breast implants, you should know what questions to ask your surgeon.

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About breast implants

Breast implants are medical devices. They can be filled with silicone gel or saline.

What you need to know about breast implants

Breast implants licensed for sale in Canada have shells made from silicone with either a smooth or a textured surface. They are intended for:

  • increasing breast size (augmentation)
  • replacing a previous implant
  • correcting breast unevenness or appearance
  • reconstructing breasts following surgery, such as a mastectomy (the removal of 1 or both breasts due to breast cancer)

Breast implants are not lifetime devices. You will likely need additional surgeries and visits to your surgeon over time. At some point, your implants will probably need to be removed. You will then have to decide if you want to replace them.

Like all medical devices, breast implants have both benefits and risks.

The risks associated with breast implants

Breast implants sold in Canada are not 100% free of risks. Health Canada’s licensing means that the risks have been reduced as much as possible.

While the risks associated with breast implants are explained in the manufacturer's labelling, common risks include:   

  • swelling
  • bleeding
  • nipple sensitivity
  • infection (mild to serious)
  • a tightening or hardening of the scar tissue (also called capsular contracture)

Sometimes, additional surgery is needed due to:

  • rupturing (the implant shell breaks or tears)
  • dissatisfaction with the size or shape of the implants
  • disfigurement (unwanted changes in appearance, potentially because of the tightening or hardening of the scar tissue around the breast implant)

You should also know that:

  • many changes to the shape of the breast cannot be reversed 
  • you should check your breasts every month for unusual changes, such as swelling
  • if you have your breast implants removed later your breasts may look different due to:
    • loose skin
    • thinning of your natural tissue
    • natural aging changes associated with gravity, time and genetics, including:
      • dimpling
      • wrinkling
      • puckering

Breast implant-associated anaplastic large cell lymphoma

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare type of non-Hodgkin lymphoma that can develop next to the implant. Non-Hodgkin lymphoma is a cancer that affects your immune system (the system that fights infections).

Women with breast implants have a low but increased risk of developing BIA-ALCL. Currently, the exact incidence of BIA-ALCL is unknown and varies widely in the literature. Available data in Canada and internationally suggest that BIA-ALCL is more often reported with implants with a textured surface rather than a smooth surface. It is unknown what causes BIA-ALCL but areas of ongoing research include:

  • surface texture
  • trauma to the breast
  • chronic inflammation
  • bacterial contamination and
  • hardening of scar tissue that can form around breast implants

BIA-ALCL is not a cancer of the breast tissue. There is no evidence that breast implants cause breast cancer.

BIA-ALCL most often presents as a sudden swelling or enlargement of the breast. This may develop many months or years following an initial breast implant procedure. It is called a delayed seroma. Cases of BIA-ALCL may also present with these symptoms:

  • a lump/mass in the breast
  • capsular contracture
  • skin changes
  • other symptoms developing months to years following an initial implant surgery

Patients with breast implants should monitor their breasts for changes. Patients with any signs or symptoms should discuss them with a healthcare professional who can rule out any other health problems.

Reported treatments for BIA-ALCL vary from complete implant and capsule (scar tissue around the implant) removal to chemotherapy and/or radiation. In rare cases, deaths have also been reported.

Other concerns about risk

There is no evidence that breast implants cause:

  • connective tissue disease
  • increased illness in children of women with breast implants

Unlicensed breast implant test kits

The materials found in breast implants that are sold in Canada have been tested for toxins. Be aware of companies that market breast implant test kits to measure platinum levels in silicone implants. These kits are not licensed for sale in Canada because there is no evidence they work.

What you should ask the surgeon

Before you decide to have breast implants, you should ask the surgeon the following important questions:

  • cost of the surgery (including the removal or replacement of an implant)
    • this is a factor if you are interested in cosmetic surgery to increase your breast size
    • this may be a factor if you want reconstructive surgery after a trauma like a mastectomy due to cancer
  • number of times the surgeon has done this operation
  • chance of experiencing a tightening of the scar tissue
  • reason the surgeon recommends a particular type of implant
  • advantages and disadvantages of the different types of breast implants
  • number of times the surgeon has seen breast implants rupture, including:
    • how to tell if a rupture has happened
    • what actions are taken after a rupture
  • times when a replacement surgery may be required, such as when an implant ruptures

It is also a good idea to ask about the risks involved, including:

  • placement of the implant
  • location and appearance of the scar
  • difficulty producing milk for breastfeeding
  • time needed to recover from the operation
  • longer-term cosmetic effects, such as wrinkles
  • possible side effects after the operation, such as:
    • pain
    • swelling
    • bruising
    • bleeding
    • infection
    • nipple sensitivity
  • the surface type of the implant (smooth or textured)
    • this may determine the amount of tightening or hardening of the scar tissue around the breast implant
  • how breast implants affect your health care provider’s ability to screen for breast cancer
  • BIA-ALCL

After consulting with your surgeon, you should consider taking your time before making a decision. If you decide to have the surgery, you and your surgeon should sign an informed consent document. Keep a copy for your records in case there is ever a product advisory or recall. You will be able to find out if you or your implants are affected.

You should ask the surgeon to send a letter about the operation details to your family doctor or health care provider. This is so they know that future changes to your health could be related to the surgery. They will know of what signs and symptoms to look for if you experience any health issues.

Post-operation follow-up

After the operation, you should see your surgeon if you:

  • have concerns
  • develop complications

The government of Canada's role in regulating medical devices

The government of Canada regulates medical devices such as breast implants. All makes and models of breast implants sold in Canada must have a medical device licence from the government.

Before any medical device like a breast implant is licensed for sale in Canada, the government:

  • reviews the device
  • assesses its safety, effectiveness and quality

Once the device is on the market, we verify if it is compliant by monitoring recalls and investigating complaints.

You can report problems related to breast implants or other medical devices by contacting us online or at 1-800-267-9675.

For general questions, please e-mail us.

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