2015-03-20 EURAPS Central Office

The BIA-ALCL       – SUMMARY in Swedish at the end –

Since the FDA advisory regarding Breast Implant Associated – Anaplastic
Large Cell Lymphoma (BIA-ALCL) in 2011, I’ve established a collaboration
between the Italian Ministry of Health and the Chair of Plastic Surgery,
‘Sapienza’ University of Rome, Faculty of Medicine and Psychology, Plastic
Surgery Unit, Azienda Ospedaliera Sant’Andrea, starting a research project
aiming at:
tracking the effects of BIA-ALCL;
stimulation of scientific research on clinical, pathologic, and
molecular aspects;
setting of guidelines to aid diagnosis and therapy of BIA-ALCL;
institution of the Azienda Ospedaliera Sant’Andrea as the Italian
reference centre.

The project group, led by myself and including Prof. Maria Rosaria
Giovagnoli (cytopathologist), Dr. Maria Christina Cox (onco-haematologist)
and Dr. Arianna di Napoli (anatomopathologist), investigated 4 new cases
of BIA-ALCL, 3 due to post-oncologic mammary reconstruction, and 1 due to
aesthetic breast augmentation. Results will be published by Plastic and
Reconstructive Surgery journal on the August 2015 issue.

As a consequence, as Secretary General of EURAPS I was invited with the
group by the Italian Ministry of Health, to present the Italian and
European experience on this topic, to the executives of the Scientific
Societies involved in the project, which led to the issue of the
ministerial advisory dated 12 March 2015.

The matter will be dealt with in more depth in occasion of the 4th
International Breast Surgery Workshop taking place 17-18 April 2015, at
the Italian Ministry of Health, in via G. Ribotta 5.

The current scientific knowledge does not significantly demonstrate causal
between ALCL onset and mammary prosthesis;
between ALCL onset and a specific type of mammary prosthesis;
between ALCL onset and mammary reconstruction following tumor or aesthetic
breast augmentation.

Therefore, the EU Ministries of Health still consider mammary prosthesis
secure, without any risk for women’s health. However, the need to continue
the study of this emerging pathology in order to identify its real
frequency, causes, clinical aspects, development, prognosis and treatment
is of utmost importance.

Data collection
Since long a European task force has been established between the
Ministries of Health on this topic, aiming at collecting useful data for
further statistical investigation. Soon will be promoted a common data
base to collect and share all official data within the EU member states,
possibly comparable to FDA.

At the moment, these are the number of cases officially communicated to
Ministries of Health in Europe:
France 18
Italy 4 (+2 unofficial)
UK 3
Denmark 2
Sweden 2
Swiss 1
Holland 1
It is reasonable to believe that other cases have been detected but not
communicated to the authorities, in case you have any information of
further cases please inform me and provide an official communication to
your Ministry of Health.

How to investigate and behave
Any patient with breast prosthesis presenting with a “late, cold seroma”
i.e. at least 6 months post-op, not related to any trauma or infection,
should undergo to ultrasound guided needle aspiration and cytology
analysis of the serum (al least 20cc). Sample should be centrifuged, drag
and stained with Giemsa and Papanicolaou, and in case of positive or
possible cellular anomalies, patients should be addressed to a
Haemopathology unit for cytology confirmation of BIA-ALCL.
In case of diagnosis confirmation, implant removal including all capsula
is suggested together with a multidisciplinary follow up.
Thank you for your time and future effort.

Sincerely yours

Fabio Santanelli di Pompeo, MD, PhD
EURAPS Secretary General


Summary In Swedish:

Hur man undersöker och handlägger Bröstimplantat Associerat – Anaplastiskt
Stor cellslymfom (BIA-ALCL).
Varje patient med bröstprotes som uppvisar ett ”sent, kallt seroma”
dvs minst 6 månader efter op, inte relaterat till något trauma eller infektion,
bör genomgå ultraljud-guidad nål-aspiration och cytologi med
analys av serum (al minst 20cc). Provet skall centrifugeras, dra
och färgades med Giemsa och Papanicolaou, och i händelse av en positiv eller
möjliga cellulära avvikelser bör patienter remitteras till en
Haematopathologi enhet för cytologi bekräftelse av BIA-ALCL.
Vid diagnosbekräftelse, avlägsnas implantatet inklusive all kapsel
och rekommenderas en multidisciplinär uppföljning.
Tack för din tid och framtida insatser.

Med vänlig hälsning

Fabio Santanelli di Pompeo, MD, PhD
EURAPS generalsekreterarersig