Also see Update - TGA Monitoring, 27 September 2016
On 26 January 2011, the US Food and Drug Administration (FDA) announced a safety communication to warn about an association between breast implants and anaplastic large cell lymphoma. The risk of a patient developing this type of lymphoma is very low.
The Therapeutic Goods Administration (TGA) has been monitoring the situation and has been in communication with the FDA and specialist groups over the past year on the issue. The Australian Society of Plastic Surgeons posted guidance for patients on this issue in March 2010.
Women with breast implants should continue to routinely monitor their breast implants and consult their implanting surgeon if they have any concerns.
At this time, TGA does not recommend prophylactic breast implant removal in patients without symptoms or other abnormality.
Additional information
- Anaplastic large cell lymphoma (ALCL) is a rare cancer of the immune system that can occur anywhere in the body. According to the Surveillance, Epidemiology, and End Results Program of the U.S. National Cancer Institute, an estimated 1 in 500,000 women per year in the United States is diagnosed with ALCL.
- ALCL in the breast is even more rare; approximately 3 in 100 million women per year in the United States are diagnosed with ALCL in the breast.
- Although there are no equivalent data for Australia, the rate of ALCL is likely to be the same in Australia as in the US.
- An FDA review of the scientific literature published from 1997 through May 2010 identified 34 unique cases of ALCL in women with breast implants throughout the world. Four of these cases are from Australia.
- The 34 cases of ALCL in women with breast implants identified by the FDA is extremely small compared to the estimated 5 to 10 million women who have received breast implants worldwide.
- Nevertheless, based on these data, it is possible that women with breast implants may have a very small but increased risk of ALCL.
- Because the risk of ALCL appears very small, TGA believes that the totality of the evidence presently available continues to support a reasonable assurance that approved breast implants are safe and effective when used as labelled.
- In total, FDA is aware of approximately 60 case reports of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature and duplications may exist in the reporting.
- Patients with breast implants should continue to routinely monitor their implants in accordance with advice given to them by their implanting surgeon. If they notice any changes, they should contact their implanting surgeon to discuss their concerns.
- The FDA and the TGA will continue to evaluate the available information to understand the nature and possible factors contributing to ALCL in women with breast implants.