Breast Implants

This page is for the public, patients, and healthcare professionals.

It provides information on complications associated with breast implants.

Breast implants are medical devices used in breast reconstruction and cosmetic surgery. 

How do I report a problem about a breast implant?

You should report any problem about a breast implant to your implanting surgeon, doctor or GP immediately for advice on what to do.

We encourage the public, patients and healthcare professionals to also report problems to us. For more information, please see our reporting webpage.

What is breast implant associated anaplastic large cell lymphoma (BIA-ALCL)?

BIA-ALCL is a rare form of cancer that can occur in people with breast implants. BIA-ALCL may develop several years after surgery.

What are the symptoms of BIA-ALCL?

Common symptoms of BIA-ALCL are:

  • a new collection of fluid (seroma) next to a breast implant,
  • a lump beside the implant,
  • breast pain and swelling,
  • local skin changes,
  • nearby swollen lymph nodes.

Typically, these symptoms occur 10 years after surgery but can occur as early as 1 year after surgery.

What should I do if I notice symptoms of BIA-ALCL?

If you have a symptom of BIA-ALCL, contact your implanting surgeon, doctor or GP at once.

You can also report safety issues to us by going to our reporting webpage.

Further guidance is available on the HSE website.

How is BIA-ALCL treated?

In most cases, the prognosis for BIA-ALCL is very good and can be managed with surgery alone if detected and treated early.

National clinical guidance for healthcare professionals is being developed by the HSE on the management of BIA-ALCL.

What should I know if I am considering breast implant surgery?

If you are considering breast implant surgery, you should discuss the following with your surgeon or healthcare professional:

  • The risks and benefits of breast implants, including the rare risk of BIA-ALCL.
  • Breast implant safety and alternatives to surgery.
  • How to check for signs of breast implant associated complications, including BIA-ALCL, after surgery.

For more guidance, please refer to the HSE website.

How common is BIA-ALCL, and which implants are affected?

BIA-ALCL is rare. Worldwide, around 1,200 cases have been reported.

  • The risk of BIA-ALCL may vary depending on how rough the surface of the breast implant is:
  • smooth,
  • micro-textured (low surface roughness),
  • macro-textured (medium to high surface roughness).

BIA-ALCL is mainly associated with macro-textured implants.

Information for healthcare professionals

BIA-ALCL is a rare but important risk associated with breast implants, especially macro-textured implants.

The estimated incidence rate of BIA-ALCL varies but has been most strongly associated with the Allergan BIOCELL implant, which was removed from the global market in 2019 and has not been in use in Ireland since 2018. In the UK, the MHRA have estimated the overall incidence of BIA-ALCL at 1 in 16,500. Higher rates of approximately 1 in 3,000 have been reported with Allergan Biocell Implants in international studies.

Clinical guidance on the management of BIA-ALCL is being developed by the HSE. The potential risk of BIA-ALCL should be discussed with patients as part of the pre-implant consent process, as well as information on how to check for signs of breast implant associated complications, including BIA-ALCL, after surgery.

Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC)

What is BIA-SCC?

BIA-SCC is a very rare group of cancers that have been reported in some people in the scar tissue or capsule that forms around breast implants.

What are the symptoms of BIA-SCC?

Symptoms of BIA-SCC include:

  • Swelling or pain in the breast,
  • lumps near the implant, and
  • local skin discoloration.

In some reported cases, these symptoms have occurred many years after surgery.

What should I do if notice symptoms of BIA-SCC?

If you have a symptom of BIA-SCC, contact your doctor, GP or implanting surgeon at once.

You can also report safety issues to us by going to our reporting webpage.

How common is BIA-SCC, and what are the risks?

Only a small number of BIA-SCC cases have been identified worldwide.

The precise cause, frequency, and risks of these cancers is unclear at present.

It is not known if BIA-SCC is linked with any implant. Regulators worldwide will continue to monitor any emerging information on BIA-SCC. We encourage healthcare professionals to report any suspected or confirmed cases of BIA-SCC

What should I know if I am considering breast implant surgery?

If you are considering breast implant surgery, you should discuss the following with your surgeon or healthcare professional:

  • The risks and benefits of breast implants.
  • Breast implant safety and alternatives to surgery.
  • How to check for signs of breast implant associated complications after surgery.

For more guidance, please refer to the HSE website.

Other complications associated with breast implants

What other complications may be associated with breast implants?

Breast implants may be associated with other problems such as:

  • Breast implant illness (BII),
  • Capsular contracture,
  • Implant rupture and deflation,
  • Breast asymmetry,
  • Implant malposition,
  • Surgical complications including wound infection and scarring,
  • Additional procedures or surgical revision.

What is breast implant illness and what are the symptoms?

BII refers to a wide variety of systemic or non-specific symptoms that may affect different parts of the body, that people may experience after breast implant surgery.

BII is not a form of cancer.

BII symptoms may be reported after any type of breast implant. Symptoms have been reported shortly after surgery or several years later.

Much is unclear about BII and any potential link with breast implants, and researchers in this field have highlighted the need for further research to understand the causes and underlying mechanisms of BII.

What should I do if I notice symptoms of BII or other conditions?

If you have a symptom of BII or any other condition, contact your doctor, GP or implanting surgeon at once.

You can also report safety issues to us by going to our reporting webpage.

What should I know if I am considering breast implant surgery?

If you are considering breast implant surgery, you should discuss the following with your surgeon or healthcare professional:

  • The risks and benefits of breast implants.
  • Breast implant safety and alternatives to surgery.
  • How to check for signs of breast implant associated complications after surgery.

For more guidance, please refer to the HSE website.