Breast implants: Update on TGA monitoring of anaplastic large cell lymphoma

Consumers and health professionals are advised that the TGA has continued to monitor the association between anaplastic large cell lymphoma (ALCL) and breast implants since we published a safety communication regarding this issue on 27 January 2011.

Overall, the TGA continues to support the advice provided in the 2011 web statement. The current rate of ALCL associated with breast implants remains very low. Women with breast implants should continue to routinely monitor their breast implants and consult their implanting surgeon if they have any concerns.

The TGA has received 23 reports of breast implant-associated ALCL since 2011.

At this time, the TGA does not recommend preventative breast implant removal in patients without symptoms or other abnormality.

Ongoing activities conducted by the TGA since 2011 have included:

• monitoring of reports made to the TGA and rates of ALCL associated with breast implants
• review of published literature in peer-reviewed journals
• communication with specialist groups, including a review by the Advisory Committee on the Safety of Medical Devices
• monitoring of developments overseas, including:
  • statements made by international regulators
  • monitoring developments both nationally and internationally to set up breast implant registers
  • seeking involvement in international working groups.

Review by the Advisory Committee on the Safety of Medical Devices

The Advisory Committee on the Safety of Medical Devices met in April 2015 to discuss the issue of ALCL associated with breast implants. This discussion included two key publications that appeared in early 2015.

Overall, the committee did not suggest any further investigations or actions apart from the ongoing monitoring activities undertaken by the TGA (as listed above).

The committee said the apparent relationship between breast implants and ALCL was very small, and the committee offered no suggestions on how to further reduce this risk.

The committee said the TGA's current advice that ALCL is a very rare complication of breast implants should be maintained.

Information for consumers

If you or someone you provide care for has breast implants, please be aware of this issue, but note that the apparent risk of developing ALCL is very small.

There is no need to change your planned medical care or follow-up if you have not noticed any changes or symptoms that concern you.

Consumers are encouraged to seek medical attention if they have any concerns or notice any changes, abnormalities or symptoms within the breast.

Please report any suspected or confirmed cases of ALCL to the TGA.

Information for health professionals

If you are treating a patient who has breast implants, please be alerted to this issue.

ALCL is a very rare condition that is most frequently identified in patients undergoing implant revision for late onset persistent seroma.

As stated by the FDA (see the 'Additional information' section below), consider the possibility of ALCL when you have a patient with late onset, persistent seroma, capsular contracture or masses adjacent to the breast implant.

When ALCL is suspected or when testing for ALCL, consult an anatomical pathologist for appropriate further analysis to establish this diagnosis, which may include cytological examination of seroma fluid and immunohistochemistry testing.

Report any suspected and confirmed cases of ALCL in women with breast implants to the TGA.

Additional information

• United States Food and Drug Administration (FDA) statement on ALCL
• French National Institute of Cancer (INCa) (pdf,328kb)
• Health Canada, Summary Basis of Decision (SBD), 17 January 2014
• United Kingdom Medicines and Healthcare products Regulatory Agency, Breast implants – report cases of anaplastic large cell lymphoma, 10 July 2014

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.