In October the TGA took action in relation to all breast implants and tissue expanders sold in Australia, with some breast implant devices suspended for six months.
Action was taken due to the risk of breast implant-associated anaplastic large lymphoma (BIA-ALCL). Allergan elected to recall all of their un-implanted macro-textured breast implants and tissue expanders.
Although patients are likely to contact their surgeon with any queries, as there has been media coverage, GPs may have patients coming to them to discuss the matter.
We have been working with surgical societies on a common approach on how to manage concerns from patients. To assist you with patient queries the key elements are summarised below.
The most common symptom is swelling of a breast caused by fluid build-up around the implant, but in some cases it may appear as a lump in the breast or armpit.
Patients may consult with you because they are concerned about the possibility of BIA-ALCL or they may have symptoms and require a referral for the recommended investigations and a specialist consult.
This TGA factsheet provides further information about BIA-ALCL its diagnosis, management and Medicare billings.
Symptomatic patient referral
The patient should be referred to the implanting surgeon or to a different breast surgeon if the original surgeon is not available. We suggest you liaise with the surgeon and arrange for diagnostic imaging scans and blood tests to be performed, so results are available at the time of the patient’s appointment with the surgeon.
Services for investigation and treatment of BIA-ALCL are eligible for Medicare payment, even if the original surgery did not attract a benefit. This includes removal of the implants where it is clinically required. The costs associated with replacing the implants are only covered by Medicare if the original implants were required in the context of cancer treatment or developmental abnormality.
We recommend follow up to ensure the patient had the investigations recommended and attended specialist consultation.
It is not recommended to remove breast implants if the patient does not have symptoms of BIA-ALCL. There is also no current evidence to support regular review or ultrasound screening of asymptomatic patients. However, patients should continue to visit their surgeon for standard reviews and to discuss any concerns. If patients notice any changes around their implant, such as new swelling or a lump, they should be referred to a specialist.
Document clear and contemporaneous notes of the discussions with the patient to facilitate continuity of care.
TGA information for patients:
Information for health professionals