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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What are breast implants?

Breast implants are medical devices. They can be filled with silicone gel, saline or another type of filler.

What do I need to know about breast implants?

Breast implants licensed for sale in Canada have shells made from silicone. They are intended for:

  • increasing breast size (augmentation)
  • replacing a failed implant
  • correcting natural 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.

What are the risks associated with breast implants?

Breast implants sold in Canada are not 100% free of risks. Our licensing only means the risks have been reduced as much as possible.

While all risks are explained in the manufacturer's labelling, common breast implant risks include:   

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

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 will have to 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

Anaplastic large-cell lymphoma (ALCL)

Anaplastic large-cell lymphoma (ALCL) is a rare type of non-Hodgkin lymphoma. Non-Hodgkin lymphoma is a cancer that affects your immune system (ability to fight infections).

Women with breast implants have a low but increased risk of developing breast implant-associated ALCL. It has been found in the scar tissue surrounding breast implants in some women. It is not a cancer of the breast tissue.

It is estimated that 3 out of 100 million women are diagnosed with ALCL next to an implant each year. Research into this association is ongoing.

There is no evidence that breast implants cause breast cancer or immune system illnesses.

Other concerns about risk

There is also 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 since there is no evidence they work.

What should I 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

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

What is 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 at Info@hc-sc.gc.ca. 

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