Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
The below extracts, written by Dr Farhadieh, are from the Breast Augmentation chapter of the international reference Plastic Surgery textbook; Plastic Reconstructive Surgery. Dr Farhadieh is also the textbook's current chief editor.
The first reported case of a patient with anaplastic T-cell lymphoma was by Keech in 1997. The Food and Drug Administration (FDA) has been notified by the American Society of Plastic Surgeons (ASPS) of 414 cases of BIA-ALCL. The current risk based on cited cases of BIA-ALCL with textured implants is a range of 1:3,817 to 1:30,000, therefore, the FDA does not recommend any changes in medical care and follow-up in asymptomatic patients. Initially in Australia, spanning over a 5 year period, there were 55 recorded cases of BIA-ALCL involving textured implants. There have been 4 related cases of death. Eleven patients had complications of either rupture, contracture or infection. The incidence in reported cases has recently risen to 81 with the majority of cases being related to grade 4 implants (polyurethane, rough).
More recent studies suggest a BIA-ALCL incidence of 1 in 6,920 women who have breast augmentation.
Almost all implants implicated in BIA-ALCL formation are textured.
Only 4 cases of patients had smooth implants where they had previously had textured permanent implants and in one case textured tissue expander.
Patients may present with asymmetry secondary to effusion or masses, capsular contracture or lymphadenopathy. Lymphadenopathy has been reported in 35% of cases. Those with proven lymphoma should undergo removal of implants and capsulectomy in both disease affected and normal sides. Cases of confirmed disease with lymphocytic hyperplasia in the capsule should then be discussed at a multi-disciplinary meeting for consideration of postoperative chemo-radiotherapy. There may also be a role for preoperative neoadjuvant chemoradiotherapy or bone marrow transplant in advanced disease. The ability to perform capsulectomy for a lymphoma is beneficial for disease control, owing to the fact that BIA-ALCL behaves more like a solitary tumour. The margin recommendations of normal breast cancer surgery are not indicated in these cases. Standard follow-up should include appropriate surveillance every 3-6 months with interval imaging with CT staging and PET every 6 months for 2 years.
There is insufficient data to establish a time course for morbidity and mortality of BIA-ALCL. Presumably early intervention and treatment alters the time course of the disease favourably. There have been recorded deaths from metastatic disease, sepsis, complications post bone marrow transplantation and obstructive respiratory failure.
Currently, BIA-ALCL remains a rare disease but the risks should be discussed nonetheless. Clinicians should give patients the breast implant manufacturer’s labelling and educational material prior to implantation. The risks associated with textured implants should be outlined. The Plastic Surgery Foundation or National Comprehensive Cancer Network can aid in developing individualised treatment plans.
The TGA has announced a proposed ban on a large number of silicone implants. This was not unexpected from Dr Farhadieh’s perspective, as the clinical and basic science research has been pointing to this for some time. The textured implants have been implicated in development of a rare T-cell lymphoma.
The first reported case of a patient with anaplastic T-cell lymphoma was by Keech in 1997. In America, The Food and Drug Administration (FDA) has been notified by the American Society of Plastic Surgeons (ASPS) of 414 device reports of BIA-ALCL, estimate to be under 1000 world wide. The current risk according to the FDA based on cited cases of BIA-ALCL with textured implants is a range of 1:3,817 to 1:30,000 and with this risk in mind the FDA does not recommend any changes in medical care and follow-up, particularly in asymptomatic patients. A recent systematic review by Leberfinger and colleagues identified 115 articles on BIA-ALCL involving 93 reported cases which have been identified in the literature. In Australia, spanning a 5 year period, there were 55 recorded cases of BIA-ALCL involving textured implants. There have been 4 related cases of death. Explantations (removal of the implant and capsule) included higher surface area of implants. Eleven patients had complications of either rupture, contracture or infection. All patients underwent total capsulectomy and resection of capsule. The most significant point here is that they were all textured implants and this seems to be the reason for Allergan’s withdraw of all textured implants and tissue expanders. The current recommendation involves analysing any new seromas for possibility of this.
Julie Luezzi was only 49 years old when she was diagnosed with breast-implant associated large cell lymphoma (ALCL) in April 2013. Julie is one of five women in Australia and New Zealand who have died of breast implant-associated (BIA) ALCL. A total of 107 Australian women have been diagnosed with the rare cancer of the immune system that develops in the fluid and scar tissue surrounding the implants. Her implants – Allergen ‘Biocell’ – are one of the highly textured implants the TGA has proposed banning.
A MESSAGE FROM DR FARHADIEH:
WHAT SHOULD YOU DO?
1) Find out what implant type you have.
2) Contact your surgeon; we routinely follow up our patients and contact them in any cases of notification. We do not use Allergan implants.
3) If you are considering implant surgery, do your research and make sure that you find a qualified specialist plastic surgeon and ask questions.
Please contact us today if you would like more information.
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Dr Rostam D Farhadieh
BSc(Med)Hons, MBBS, MD, EBOPRASF, FRACS(Plast), FRCS(Plast)
Plastic & Reconstructive Surgeon
Clinical Senior Lecturer
University of Sydney Medical School
Australian National University Medical School