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 health care providers.

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About breast implants

Breast implants are medical devices made of a smooth or textured silicone shell filled with either silicone gel or saline.

What you need to know about breast implants

Breast implants licensed for sale in Canada are intended for:

  • increasing breast size (augmentation);
  • replacing a previous implant;
  • correcting breast unevenness or appearance; or
  • breast reconstruction following surgery, such as a mastectomy (the removal of 1 or both breasts).

Breast implants are not lifetime devices and usually need to be replaced at some point in time.

The risks associated with breast implants

Like all medical devices, breast implants have benefits and risks.  Health Canada's licensing means that the risks have been reduced as much as possible and that in general, the benefits outweigh the potential risks of the use of the device.

Potential risks associated with breast implants are outlined in the manufacturer's labelling. Common risks include:

  • swelling;
  • bleeding;
  • nipple sensitivity;
  • infection (mild to serious); and/or
  • 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; and/or
  • disfigurement (unwanted changes in appearance, potentially because of the tightening or hardening of the scar tissue around the breast implant).

You should also be aware that:

  • some changes to the shape of the breast resulting from getting breast implants cannot be reversed;
  • you should check your breasts every month for unusual changes, such as swelling; and
  • 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; and/or
      • 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).

People with breast implants have a low but increased risk of developing BIA-ALCL. The exact incidence of BIA-ALCL is unknown and varies widely in the literature. Available data in Canada and internationally suggest that the risk of BIA-ALCL is higher with implants having a textured surface, especially those with a more highly textured surface rather than the one with a less textured or a smooth surface.

On May 27, 2019, following a safety review on BIA-ALCL, Health Canada suspended the licences for Allergan’s Biocell breast implants (the only macro-textured implants available in Canada) based on an unacceptable level of risk of BIA-ALCL with macro-textured breast implants. Allergan has agreed to voluntarily recall unused Biocell devices from the Canadian market.

It is unknown what causes BIA-ALCL but areas of ongoing research include:

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

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; and/or
  • other symptoms developing months to years following an initial implant surgery.

Patients with breast implants should regularly examine their breasts for changes. Patients with any signs or symptoms should discuss them with a health care provider.

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 (though none have been reported in Canada to date). Preventive removal of breast implants is not recommended in the absence of signs or symptoms suggestive of BIA-ALCL. Patients should discuss the risks and benefits of implant removal with their healthcare professional if they have concerns.

Other concerns about risk

There is currently insufficient evidence to show that breast implants cause:

  • connective tissue disease; and/or
  • 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 your health care provider

Before you decide to have breast implants, you should ask your health care provider to provide you with the patient brochure for the product you are considering having implanted and all documentation (i.e. labelling containing safety information) available about the breast implant of interest. You should also ask the surgeon performing your surgery the following important questions:

  • cost of the surgery (including the removal or replacement of an implant)
  • 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
  • any other risks associated with breast implants

After consulting with your surgeon and reviewing all documentation available regarding the implant and the surgical procedure, 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 or other health care provider if you have concerns or 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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