Persons with breast implants have a minimally increased risk of developing lymphoma
Since 2014, the Danish Medicines Agency has registered few Danish cases of breast implant associated anaplastic large cell lymphoma (BIA-ALCL). This is an extremely rare form of cancer, and the Danish Medicines Agency is keeping up-to-date with the issue both in Denmark and abroad.
It is important that doctors inform patients about the risks associated with the surgical procedure, but also about the risks related to the implant itself – including BIA-ALCL – to ensure their informed consent.
What is the risk of developing BIA-ALCL?
The diagnosis is rare. Currently, it is estimated that one in about 3,000 to 30,000 persons with breast implants develops the disease. The risk dependends, among others, on the type of breast implant used.
Significance of breast implant surface structure
The development of BIA-ALCL is observed in persons, who have undergone surgery involving textured breast implants with a particularly rough surface. The greatest number of cases is seen among persons with textured breast implants manufactured by Allergan. Consequently, this type of implant has been recalled and is no longer used.
How is BIA-ALCL treated?
Treatment for BIA-ALCL is often effective and consists of removing the breast implant and the surrounding fibrous capsule. This cures the disease in most cases. A few patients also receive chemotherapy, while very few may need additional radiotherapy or immunotherapy.
Which symptoms should you be aware of?
The most important symptom is persistent swelling of the breast, caused by the formation of fluid around the implant. More rarely, tumour formation can occur close to the implant. Persons with breast implants who experience persistent, unexplained swelling and pain occurring more than six months after surgery may be exhibiting symptoms of BIA-ALCL. Persons who experience the described symptoms should consult their general practitioner.
How is BIA-ALCL diagnosed?
In case some of the symptoms described above are present, the general practitioner will refer the patient to a mammography and an ultrasound examination at which fluid will often be aspirated, or a biopsy be performed, to confirm or reject the diagnosis.
The Danish Medicines Agency closely follows up on BIA-ALCL nationally and internationally
The scientific study of BIA-ALCL is a continuous process that must be based on valid data and evidence. Research has yet to provide a definitive answer to how BIA-ALCL develops, and several plausible theories are currently being explored. The Danish Medicines Agency keeps well-informed of the latest knowledge on BIA-ALCL.
Should breast implants be removed in healthy persons?
Based on the very low risk of developing BIA-ALCL, it is not recommended to remove implants in healthy persons. This is partly because of the risks associated with the surgical procedure itself, and partly because it is not known if it will actually reduce the risk of developing the disease.
Reporting of BIA-ALCL cases to the Danish Medicines Agency
Manufacturers and healthcare professionals are obliged to report every suspected and verified case of BIA-ALCL as an incident with medical devices to the Danish Medicines Agency. Find information concerning reporting incidents here. Patients and relatives may also report via the above link.