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

Model Number	TSM-375
Medical Device Problem Codes	Material Rupture (1546); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Swollen Lymph Nodes/Glands (4432)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event of lymphadenopathy is a physiological complication 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.Reason for reoperation: rupture, silicone migration and lymphadenopathy.
Event or Problem Description
Physician reported right side "extracapsular rupture, silicomatosic adenopathies and also intracapsular rupture" confirmed by mri.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d4, d9, h3, h4, h6.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Device photo evaluation: visual analysis of the photographs identified: device patch with lot (or catalog) number catalog number: unk mammary implant (it is not possible to see the batch number and catalog of the device due to the quality of the photos).Red biological tissue on the shell.An opening extended is observed in the radius of the device.Device analysis performed through photographs, due to the impossibility to perform microscopic analysis it is not possible to determine the most likely failure mode.Device evaluation: visual analysis of the returned device identified: white calcification in shell(10%), curved opening, weight within specification.A microscopic analysis was performed which identified: a curved striated opening on radius side assessed as surgical damage.Based on the device analysis the final assessment is: - a curved striated opening assessed as surgical damage consist in the use of some surgical tool.
Event or Problem Description
Physician reported right side "extracapsular rupture, silicomatosic adenophaties and also intracapsular rupture" confirmed by mri.Device has been explanted.
Event or Problem Description
Physician reported right side "extracapsular rupture, silicomatosic adenophaties and also intracapsular rupture" confirmed by mri.Device has been explanted.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 11657082
• Report Number: 9617229-2021-05615
• Device Sequence Number: 3495651
• Product Code: FTR
• UDI-Device Identifier: 10888628033955
• UDI-Public: 10888628033955
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2021

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 Expiration Date: 07/16/2012
• Device Model Number: TSM-375
• Device Catalogue Number: TSM375
• Device Lot Number: 1462343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 04/22/2021; 03/18/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/20/2021; 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2007
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female