All cases were in-patients with textured implants. Roughly 95 per cent of cases were detected within three to 14 years of breast implantation.
But the FDA found cases of ALCL in women with smooth surface implants. The agency received close to 460 reports of ALCL linked to breast implants, including nine deaths as of September 2018.
Two-thirds involved implants with textured surfaces and five per cent were smooth surface implants. The rest of the reports did not specify the type of implant.
The FDA urged doctors to consider ALCL in breast implant patients, particularly those who present with new swelling, lumps or pain around the implants.
ALCL is rare and the overall risk of developing the cancer is very low. Prevalence estimates range from one in 30,000 to one in 3800 women with breast implants.
ALCL is not breast cancer but cancer of the immune system that develops in the fluid and scar tissue around breast implants.
The most common symptom is swelling caused by fluid build-up after the initial swelling immediately after surgery has subsided, and in some cases lumps in the breast or armpit.
ALCL is not detectable on mammograms and is diagnosed from samples of fluid taken from around the implant.
In November, an investigation by ABC’s Background Briefing and the International Consortium of Investigative Journalists revealed there were 81 cases of breast implant-linked ALCL in Australia and New Zealand, including four deaths.
The TGA’s incomplete adverse events database for breast implant-linked ACLC prompted calls for doctors to be forced to report all adverse events associated with medical devices and any financial ties with manufacturers.
Doctors do not routinely report adverse events and mandatory reporting only applies to manufacturers.
The TGA and FDA both recommended that doctors refer patients with these symptoms for further testing by an expert multidisciplinary team.
In most cases, treatment involves removing the implants and the scar tissue around the implants. Patients whose cancer has spread will likely need further treatment. Both agencies recommended against removing implants in patients with no symptoms.
Kate Aubusson is Health Editor of The Sydney Morning Herald.