STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2024-07271
- Event Type
- Injury
- Date Received
- April 26, 2024
- Report Date
- May 30, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P040046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B2, D6A.
JOURNAL ARTICLE CITATION: DAVANZO, V.; FALDA, A.; FOGAR, P.; LUDWIG, K.; ZUIN, J.; TOFFANIN, M.C.; PIZZI, M.; DEI TOS, A.P.; BASSO, D. FLOW CYTOMETRY ANALYSIS IN BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA: THREE CASE REPORTS. INT. J. MOL. SCI. 2024, 25, 3518. HTTPS://DOI.ORG/10.3390/IJMS25063518 ACADEMIC EDITORS: CLAUDIO ORTOLANI, JOSÉ-ENRIQUE O¿CONNOR AND MONIA LENZI. RECEIVED: 19 FEBRUARY 2024, REVISED: 16 MARCH 2024, ACCEPTED: 18 MARCH 2024, PUBLISHED: 20 MARCH 2024. CONTRIBUTING AUTHORS: VERONICA DAVANZO LABORATORY MEDICINE UNIT, BIOMEDICAL SCIENCES DEPARTMENT¿DSB, UNIVERSITY OF PADOVA, 35128 PADOVA, ITALY. ALESSANDRA FALDA: AUTHOR FOR CORRESPONDENCE; EMAIL: [email protected] LABORATORY MEDICINE UNIT, INTEGRATED DIAGNOSTIC SERVICES¿DIDAS, PADOVA UNIVERSITY HOSPITAL, 35128 PADOVA, ITALY. PAOLA FOGAR LABORATORY MEDICINE UNIT, INTEGRATED DIAGNOSTIC SERVICES¿DIDAS, PADOVA UNIVERSITY HOSPITAL, 35128 PADOVA, ITALY. KATHRIN LUDWIG SURGICAL PATHOLOGY AND CYTOPATHOLOGY UNIT, DEPARTMENT OF MEDICINE¿DIMED, PADOVA UNIVERSITY HOSPITAL, 35128 PADOVA, ITALY. JENNY ZUIN LABORATORY MEDICINE UNIT, INTEGRATED DIAGNOSTIC SERVICES¿DIDAS, PADOVA UNIVERSITY HOSPITAL, 35128 PADOVA, ITALY. MARIA CRISTINA TOFFANIN DEPARTMENT OF BREAST SURGERY, VENETO INSTITUTE OF ONCOLOGY IOV IRCCS, 35128 PADOVA, ITALY. MARCO PIZZI SURGICAL PATHOLOGY AND CYTOPATHOLOGY UNIT, DEPARTMENT OF MEDICINE¿DIMED, PADOVA UNIVERSITY HOSPITAL, 35128 PADOVA, ITALY SURGICAL PATHOLOGY AND CYTOPATHOLOGY UNIT, DEPARTMENT OF MEDICINE¿DIMED, UNIVERSITY OF PADOVA, 35128 PADOVA, ITALY. ANGELO PAOLO DEI TOS SURGICAL PATHOLOGY AND CYTOPATHOLOGY UNIT, DEPARTMENT OF MEDICINE¿DIMED, PADOVA UNIVERSITY HOSPITAL, 35128 PADOVA, ITALY SURGICAL PATHOLOGY AND CYTOPATHOLOGY UNIT, DEPARTMENT OF MEDICINE¿DIMED, UNIVERSITY OF PADOVA, 35128 PADOVA, ITALY. DANIELA BASSO LABORATORY MEDICINE UNIT, INTEGRATED DIAGNOSTIC SERVICES¿DIDAS, PADOVA UNIVERSITY HOSPITAL, 35128 PADOVA, ITALY LABORATORY MEDICINE UNIT, DEPARTMENT OF MEDICINE¿DIMED, UNIVERSITY OF PADOVA, 35128 PADOVA, ITALY. THE EVENTS OF SEROMA-LATE AND LYMPHOMA-ALCL ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION: RUPTURE, SEROMA-LATE, LYMPHOMA-ALCL.
A LITERATURE REVIEW TITLED "FLOW CYTOMETRY ANALYSIS IN BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA: THREE CASE REPORTS" REPORTED: CASE 2 FOR LEFT SIDE DEVICE - PERIPROSTHETIC EFFUSION, RUPTURE OF THE LEFT IMPLANT; LEFT BREAST WAS DEFORMED BY A NOT VERY COMPRESSIBLE COLLECTION, WITHOUT SIGNS OF INFLAMMATION, MASS, LYMPHADENOPATHY, OR ANY OTHER LESIONS. HISTOPATHOLOGICAL MARKERS OF CD30+ AND ALK- HAVE BEEN PROVIDED. THE DEVICE HAS BEEN EXPLANTED. MANUFACTURER OF THE DEVICE IS UNKNOWN.
A LITERATURE REVIEW TITLED "FLOW CYTOMETRY ANALYSIS IN BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA: THREE CASE REPORTS" REPORTED: CASE 2 FOR LEFT SIDE DEVICE - PERIPROSTHETIC EFFUSION, RUPTURE OF THE LEFT IMPLANT; LEFT BREAST WAS DEFORMED BY A NOT VERY COMPRESSIBLE COLLECTION, WITHOUT SIGNS OF INFLAMMATION, MASS, LYMPHADENOPATHY, OR ANY OTHER LESIONS. HISTOPATHOLOGICAL MARKERS OF CD30+ AND ALK- HAVE BEEN PROVIDED. THE DEVICE HAS BEEN EXPLANTED. MANUFACTURER OF THE DEVICE IS UNKNOWN.
A LITERATURE REVIEW TITLED "FLOW CYTOMETRY ANALYSIS IN BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA: THREE CASE REPORTS" REPORTED: CASE 2 FOR LEFT SIDE DEVICE - PERIPROSTHETIC EFFUSION, RUPTURE OF THE LEFT IMPLANT; LEFT BREAST WAS DEFORMED BY A NOT VERY COMPRESSIBLE COLLECTION, WITHOUT SIGNS OF INFLAMMATION, MASS, LYMPHADENOPATHY, OR ANY OTHER LESIONS. HISTOPATHOLOGICAL MARKERS OF CD30+ AND ALK- HAVE BEEN PROVIDED. THE DEVICE HAS BEEN EXPLANTED. MANUFACTURER OF THE DEVICE IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 886180 | STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Female | Required Intervention| L |