MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	TSF-605
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) (4549)
Date of Event	10/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Article citation: theodor mares, radu ionescu, daniel dima, michail sorotos, fabio santanelli di pompeo, cristian radu jecan, breast implant-associated anaplastic large cell lymphoma in romania: first case series of all documented cases, journal of plastic reconstructive & aesthetic surgery 99, 21jun2024, 602-607.The reported events are physiological complications and analysis of the device generally does not assist abbvie in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: seroma and bia-alcl.
Event or Problem Description
Through journal article breast implant-associated anaplastic large cell lymphoma in romania: first case series of all documented cases, healthcare professional reported right side bia-alcl, and seroma.Histopathological markers are reported and specific cd30 positive and alk negative.The device has been explanted.Treatment involved en-bloc explanation and adjuvant therapies.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b7, d6a clarification to d6a: partial implant date reported as 2014.
Event or Problem Description
Through journal article breast implant-associated anaplastic large cell lymphoma in romania: first case series of all documented cases, healthcare professional reported right side bia-alcl, and seroma.Histopathological markers are reported and specific (cd30 positive and alk negative.The device has been explanted.Treatment involved en-bloc explanation and adjuvant therapies.
Additional Manufacturer Narrative
Through review of additional information this report has been determined to be a duplicate of mrn 9617229-2021-00261.This report will be closed and all new information captured under the aforementioned mrn.
Event or Problem Description
Through review of additional information this report has been determined to be a duplicate of mrn 9617229-2021-00261.This report will be closed and all new information captured under the aforementioned mrn.
Additional Manufacturer Narrative
The 2nd supplemental medwatch may be disregarded, as this complaint is not a duplicate and is reportable.Article citation: theodor mares, radu ionescu, daniel dima, michail sorotos, fabio santanelli di pompeo, cristian radu jecan, breast implant-associated anaplastic large cell lymphoma in romania: first case series of all documented cases, journal of plastic reconstructive & aesthetic surgery 99, 21jun2024, 602-607.The reported events are physiological complications and analysis of the device generally does not assist abbvie in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: "seroma to the right breast, with no history of previous replacements, followed by a fine needle aspiration (fna) confirming the diagnosis via immunohistochemical analysis with cd30+ and alk staining." clarification to d6a: partial implant date reported as 2014.
Event or Problem Description
Through journal article breast implant-associated anaplastic large cell lymphoma in romania: first case series of all documented cases, healthcare professional reported right side bia-alcl, and seroma.Histopathological markers are reported and specific (cd30 positive and alk negative).The device has been explanted.Treatment involved en-bloc explanation and adjuvant therapies.The 2nd supplemental medwatch may be disregarded, as this complaint is not a duplicate and is reportable.

• Brand Name: INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 20871708
• Report Number: 9617229-2024-25728
• Device Sequence Number: 8838569
• Product Code: FTR
• UDI-Device Identifier: 10888628034211
• UDI-Public: 10888628034211
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: TSF-605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 01/14/2025; 03/13/2025; 03/26/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/05/2025; 03/14/2025; 04/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2011068-7/2/19-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female