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22 Cases of Breast Implant-Associated ALCL: Awareness and Outcome Tracking from the Italian Ministry of Health.

Abstract To date, 359 cases of anaplastic large cell lymphoma (ALCL) in women with breast implants (breast implant-associated ALCL [BIA-ALCL]) worldwide have been reported among more than 10 million patients who have received implants, but health care authorities suspect this is a possible underestimation, and the limited number of cases makes it difficult to clarify its cause. The General Directorate of Medical Devices and Pharmaceutical Services of the Italian Ministry of Health has examined and studied the Italian BIA-ALCL cases.
PMID
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22 Cases of BIA-ALCL: Awareness and Outcome Tracking from the Italian Ministry of Health.

Authors

Mayor MeshTerms

Breast Implantation

Postoperative Complications

Keywords
Journal Title plastic and reconstructive surgery
Publication Year Start




PMID- 29280858
OWN - NLM
STAT- MEDLINE
DCOM- 20180112
LR  - 20180112
IS  - 1529-4242 (Electronic)
IS  - 0032-1052 (Linking)
VI  - 141
IP  - 1
DP  - 2018 Jan
TI  - 22 Cases of Breast Implant-Associated ALCL: Awareness and Outcome Tracking from
      the Italian Ministry of Health.
PG  - 11e-19e
LID - 10.1097/PRS.0000000000003916 [doi]
AB  - BACKGROUND: To date, 359 cases of anaplastic large cell lymphoma (ALCL) in women 
      with breast implants (breast implant-associated ALCL [BIA-ALCL]) worldwide have
      been reported among more than 10 million patients who have received implants, but
      health care authorities suspect this is a possible underestimation, and the
      limited number of cases makes it difficult to clarify its cause. The General
      Directorate of Medical Devices and Pharmaceutical Services of the Italian
      Ministry of Health has examined and studied the Italian BIA-ALCL cases. METHODS: 
      An official document has been diffused to all medical associations, aiming at
      encouraging all physicians to notify each BIA-ALCL case. A retrospective study
      has been performed on the notified BIA-ALCL cases collected in the database named
      Dispovigilance. RESULTS: Research on Dispovigilance returns a list of 22 BIA-ALCL
      cases. The mean patient age was 49.6 years (range, 30 to 71 years). The average
      time to the onset of the symptoms was 6.8 years (range, 1 to 22 years). The
      average time to diagnosis was 7.8 years (range, 4 to 22 years). The estimated
      incidence of the Italian BIA-ALCL cases related to 2015 is 2.8 per 100,000
      patients. CONCLUSIONS: The pathogenesis of BIA-ALCL remains unknown. The
      establishment of a national breast implant registry is needed to better
      understand some aspects of this disease. Future genetic studies on the population
      affected could clarify why only some patients with implants develop this disease.
FAU - Campanale, Antonella
AU  - Campanale A
AD  - Rome, Italy From the General Directorate of Medical Devices and Pharmaceutical
      Services, Medical Device Vigilance System and Inspections, Italian Ministry of
      Health.
FAU - Boldrini, Rosaria
AU  - Boldrini R
FAU - Marletta, Marcella
AU  - Marletta M
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Plast Reconstr Surg
JT  - Plastic and reconstructive surgery
JID - 1306050
SB  - AIM
SB  - IM
MH  - Adult
MH  - Aged
MH  - *Breast Implantation
MH  - Databases, Factual
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Incidence
MH  - Italy
MH  - Lymphoma, Large-Cell, Anaplastic/diagnosis/epidemiology/*etiology
MH  - Middle Aged
MH  - *Postoperative Complications/diagnosis/epidemiology
MH  - Retrospective Studies
EDAT- 2017/12/28 06:00
MHDA- 2018/01/13 06:00
CRDT- 2017/12/28 06:00
PHST- 2017/12/28 06:00 [entrez]
PHST- 2017/12/28 06:00 [pubmed]
PHST- 2018/01/13 06:00 [medline]
AID - 10.1097/PRS.0000000000003916 [doi]
AID - 00006534-201801000-00006 [pii]
PST - ppublish
SO  - Plast Reconstr Surg. 2018 Jan;141(1):11e-19e. doi: 10.1097/PRS.0000000000003916.