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Allergan macro-textured breast implants and tissue expanders

Hazard alert – risk of breast implant-associated anaplastic large cell lymphoma in rare cases

2 August 2019

Consumers and health professionals are advised that Allergan has elected to recall all of their un-implanted macro-textured breast implants and tissue expanders due to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in rare cases.

Micro textured and smooth breast implants are not affected by this hazard alert and sponsor initiated recall.

The TGA has been advised that removal or replacement of macro-textured breast implants or tissue expanders in asymptomatic patients is not recommended.

BIA-ALCL usually involves a swelling of the breast, typically on an average of 8 years after the operation to insert the breast implant. This swelling is usually due to an accumulation of fluid around the implant. Less commonly, BIA-ALCL can take the form of a lump in the breast or a lump in the armpit. It is a rare condition, with experts estimating the published risk of BIA-ALCL at between 1-in-1000 and 1-in-10,000.

Although fatalities have been recorded, the vast majority of BIA-ALCL cases are cured by removal of the implant and the capsule surrounding the implant.

The TGA has published a range of detailed information about this issue, and others associated with breast implants, in the Breast implant hub on its website. The TGA also recently published the preliminary outcomes of a review into all textured breast implants on the Australian market.

Information for consumers

If you have breast implants and notice swelling or a lump in your breast or armpit, or you have any other concerns with your implants, you should seek medical attention.

Because BIA-ALCL is rare, experts do not recommend removal of breast implants where there are no problems with the implant.

Visit the TGA's Breast implant associated cancer (BIA-ALCL): Information for consumers webpage for more information.

Information for health professionals

All patients with breast implants should be advised to become familiar with the usual features of their breasts and conduct regular self-examination as they would for routine breast cancer awareness.

People with breast implants should be made aware of the common presenting symptoms including asymmetry, pain, delayed effusion or seroma, or, less commonly, a mass or lymphadenopathy. They should be encouraged to present for immediate clinical assessment should there be any change in size, shape or symptoms related to the breast and/or implant, as surgery as a result of early diagnosis can be curative. Disease which has spread through the capsule, forms a mass or spreads to local lymph nodes carries a worse prognosis.

Visit the BIA-ALCL: Information for health professionals webpage for more information.

Information for implanting surgeons

Allergan has advised implanting surgeons to be alert to this issue and requested they review the relevant literature in the context of their particular patients on a case-by-case basis.

The hazard alert and voluntary recall relate to macro-textured breast implants and tissue expanders. They do not affect smooth or BRST Microcell breast implant products.

The affected products are:

Product Name

ARTG Number

Natrelle Inspira Truform 1 Gel, Textured, Single Lumen

175422

Natrelle Inspira Truform 2 Gel, Textured Single Lumen

175425

Natrelle Truform 3 Gel, Textured Single Lumen

171512

Natrelle Soft Touch, Truform 2 Gel, Textured, Single Lumen

171475

Natrelle Truform Dual Gel, Textured Single Lumen

171387

Natrelle Double Lumen Gel/Saline

169956

Natrelle Tissue Expanders – Skin Expander

175797

Natrelle Truform 1 Gel, Textured, Single Lumen*

175420

Natrelle Saline-Filled, Textured*

171388

* These two products were not marketed in Australia.

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.