DR. MARTIN J. GIUFFRE (B.MS., MD., F.R.C.S.(C))

Research

BIA-ALCL

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Much of the information found herein is derived from a webinar on November 4, 2019, that was organized by the Association of Specialists in Plastic and Aesthetic Surgery of Quebec with Dr. Mark Clemens as guest lecturer. 

Dr. Clemens is a plastic surgeon affiliated with MD Anderson Cancer Centre in Texas, and is a world expert on BIA-ALCL. He provided the latest information about BIA-ALCL, including the guidelines from the NCCN (National Comprehensive Cancer Network) as well as the information from the First World Conference on BIA-ALCL held in Rome, Italy on October 6, 2019. Dr. Clemens was the co-chair of this conference.

Ottawa Hospital Research Institute

http://www.ohri.ca/profile/mclemons

Findings:

Current known cases of BIA-ALCL (statistics as of August 2019):

There are 18 clusters around the world associated with BIA-ALCL. The cause of these clusters is not known.

USA 164 cases

Canada 31 cases

Remaining world 511 cases

BIA-ALCL cases causing death:

Canada 1 death

World 33 deaths

Incidence by implant texture type:

Macro textured implants (including Biocell) - all companies worldwide incidence is approximately 1:2200

Incidence by implant company in Canada:

Allergan Biocell incidence is approximately 1:3345

Ratio of incidence in Canada:

Biocell : Siltex is 25 : 1

To-date, there has never been a case of BIA-ALCL in a patient that has only ever had a pure smooth implant(s).

To-date, there is no association between BIA-ALCL and surgical technique at the time of implantation or an infectious cause.

To-date, there is no distinct microbiome associated with BIA-ALCL.

At present, no plastic surgery professional society in North America (CSPS / CSAPS / ASAPS) or ISAPS and no government

agency (Health Canada / FDA) is suggesting or recommending the prophylactic removal of macro textured breast implants.

Presentation of BIA-ALCL:

BIA-ALCL may present as an effusion, mass, skin rash or ulcer in a patient who has had textured implants for greater than one year (peak incidence is 8 to 10 years). There is a bell curve distribution in the occurrence of BIA-ALCL ranging from 2 to 22 years post implantation with a peak at 8-10 years post-implantation.

It is normal in all breast implant patients to have 10 to 15 cc of fluid around all breast implants. In cases of BIA-ALCL there is usually 100 to 1000 ml of fluid around the implant.

Ultrasound seems an appropriate first test to evaluate the implant, the capsule, the chest wall and the adjacent lymph node basin. In addition, the contra-lateral breast implant should be assessed by ultrasound. If ultrasound detects any abnormality, MRI is the most appropriate follow-up investigation.

If fluid is present, a fine needle aspiration should be done under ultrasound control. The fluid should be sent for cytology, flow cytometry for T cell clones and, if available, IHC for CD30 and possible additional markers to differentiate further, if the aspirate is CD30 positive. When possible, aspirate 50 cc or more to increase the accuracy of the cytology. Availability of these tests may differ by regional differences in provinces and territories, as well as the presence of radiologic expertise.

If a mass is present, an incisional biopsy or core needle biopsy is indicated.

Treatment:

Patients with biopsy proven BIA-ALCL require a multidisciplinary approach including an oncologist (lymphoma specialist), surgical oncologist, plastic surgeon and an oncologic haematologist.

Surgical treatment:

All cases require surgical intervention including en-bloc resection of the implant, capsule and surrounding tumour that extends beyond the capsule. Surgical treatment includes lymph node biopsy and / or removal.

In 85% of cases, the surgery will be definitive treatment.

It is currently acceptable to use a smooth implant at the time of reconstruction after treatment of BIA-ALCL.

Prophylactic removal of Biocell textured implants and the surrounding capsules:

There are currently no Plastic Surgery professional societies or government agencies (Health Canada / FDA) in North America that recommend the prophylactic removal of Biocell implants and the surrounding capsules.

At present, it is believed that an exchange of a patient’s textured implants for smooth implants with or without partial or complete capsulectomy does not eliminate the risk of a patient developing BIA-ALCL. There have been two patients who underwent total capsulectomy and removal of their textured implants who developed BIA-ALCL at a later date (remote from the explantation and capsulectomy).

Prophylactic removal of textured implants for patient anxiety / fear / concern and not for established BIA-ALC has been associated with significant morbidity. Complications have included - but are not limited to - pneumothorax, exposure of the pericardium and damage to the subclavian vessels with significant intra-operative bleeding. The prophylactic removal of a submuscular grade I capsule is near impossible to do “en-bloc”. When planning a prophylactic removal, we advise to discuss these risks with patients and, in particular, patients should be aware that a complete capsulectomy does not necessarily impart a “guarantee” that they will not develop BIA-ALCL at a later date.

LINKS & JOURNALS

2019 NCCN Consensus Guidelines on the Diagnosis and Treatment of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)