Breast Implants


There have been reports in the media recently regarding a rare cancer associated with breast implants called Anaplastic Large-Cell Lymphoma (ALCL). ALCL is not cancer of the breast tissue, it is a kind of lymphoma (a tumour arising from any of the cellular elements of lymph nodes), but how does it relate to breast implants?

When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle. Over time, a fibrous scar called a capsule develops around the implant, separating it from the rest of the breast. In women with breast implants who developed ALCL, the tumour was generally found adjacent to the implant itself and contained within the fibrous capsule.


The expert advisory panel at the TGA has provided the following Q&A’s for consumers:

What is breast implant-associated ALCL?

  • Breast implant-associated ALCL is a rare type of cancer.
  • It usually involves a swelling of the breast, typically 3 to 14 years after the operation to insert the breast implant. This swelling is due to an accumulation of fluid. Breast implant-associated ALCL has been known to occur as soon as 1 year after the operation and as late as 37 years after the operation.
  • Less commonly, breast implant-associated ALCL can take the form of a lump in the breast or a lump in the armpit.
  • If you notice any of these problems (swelling or a lump), or have any other concerns with your implants, you should seek medical attention.
  • Most cases of breast implant-associated ALCL are cured by removal of the implant and the capsule surrounding the implant.

What is the risk?

  • Based on the currently available data, it is not possible to provide an accurate estimate of risk. Current expert opinion puts the risk of ALCL at between 1-in-1,000 and 1-in-10,000. Based on currently available data, most (95%) of cases of breast implant-associated ALCL occur between 3 and 14 years after the implant (median: 8 years; range: 1-37 years).
  • It can be difficult to express this risk in a concrete way, such that you can make a fully informed decision about whether or not to have a breast implant. Some different ways of expressing the risk are given below:
    • One woman will be diagnosed with breast implant-associated ALCL for every 1000 to 10,000 women with breast implants.
    • Suppose we took 1-in-5000 women, the middle of the experts’ range, as the best estimate of risk of ALCL in women who have breast implants. This would mean that, of 5000 women with implants, one woman will develop ALCL over a period of about 3-14 years following an implant; the other 4999 women will not develop ALCL.

Should implants be removed, just in case?

  • Because breast implant-associated ALCL is rare, experts do not recommend removal of breast implants for women who have no problems with the implant.
  • If you are concerned you should discuss your options with your doctor.
  • Generally, breast implants are not lifetime devices regardless of breast implant-associated ALCL. Typically, they are removed after 10-15 years. The longer you have the implant, the more likely it will need to be removed. Common reasons for removal are contracture (hard or painful implants) or movement of the implant.

How is breast implant-associated ALCL diagnosed?

  • If you develop swelling of an implanted breast your doctor will send you for an ultrasound scan to see if this is due to a fluid collection. If fluid is present it will be removed and sent to the laboratory for analysis. Most fluid collections are not ALCL, but the laboratory test will be able to tell for sure.
  • Mammograms are not helpful for diagnosing ALCL.
  • Other investigations such as MRI and CT-scans would typically be done if the laboratory analysis of the fluid confirms a diagnosis of ALCL.

Should women with implants be screened for ALCL?

  • Based on external expert clinical advice received by the TGA, regular screening is not recommended at this time.
  • If you notice enlargement or swelling of one or both breasts, or a lump, you should seek medical advice as soon as possible.

Are some women more at risk of breast implant-associated ALCL than others?

  • Breast implant-associated ALCL can develop regardless of whether the implant is inserted for cosmetic reasons or for reconstruction of the breast following breast cancer.
  • It can occur with both saline and silicone gel filled implants.
  • To date:
    • No Australian cases have been reported in women who have only had smooth implants.
    • All Australian cases have occurred in women who have had textured or polyurethane implants.
  • Based on the currently available data:
    • It is uncertain whether textured (either micro or macro) and polyurethane implants carry different risks.
    • It is uncertain whether different brands of textured and polyurethane implants carry different risks.
    • It is not possible to predict which women with textured or polyurethane implants will develop breast implant-associated ALCL.

What is the prognosis and treatment of breast implant-associated ALCL?

  • Most cases are cured by removal of the implant and capsule surrounding the implant. Usually your doctor will remove both implants, even if breast implant-associated ALCL has only occurred in one breast. This is because there is a small but real risk that breast implant-associated ALCL can develop in the opposite breast.
  • Sometimes there is a solid lump (not just fluid). In these cases, chemotherapy or radiotherapy may be required.
  • Over the last 10 years, three Australian women have died from breast implant-associated ALCL.
  • The management of breast implant-associated-ALCL is multidisciplinary with all patients requiring a referral to a surgeon experienced with breast implants and the involvement of a haematologist who specialises in lymphoma, for initial and ongoing investigations and management.

If you have breast implants and have any concerns, please see your GP and/or breast surgeon for further advice.

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