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

Model Number	TRM-345
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	12/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The event of "seroma-late" 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: seroma-late and rupture.
Event or Problem Description
Healthcare professional reported a right side exchange from textured to smooth breast implants due to the patient¿s concern with the product and also stated that the patient does have signs of late seroma which will be tested for alcl during surgery.Device remains implanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified underweight, broken shell, missing.A microscopic analysis was performed which identify sharp edge opening assessed as unidentified tear opening.A dimension measurement in the shell was performed which identify the thickness within specification.Based on the device analysis the final assessment is: a sharp broken on posterior assessed as an unidentified (tear) opening.A piece of the shell is missing the assessment is inconclusive.Additional data: b.5, d.7, d.10, g.3, h.3, h.6.
Event or Problem Description
Healthcare professional additionally reported a right side rupture.Device has been explanted.
Event or Problem Description
Patient representative reported " removal of implants due to fear of alcl, to reduce risk of alcl, and due to symptoms consistent with alcl and fear of alcl: mental anguish and fear of alcl, increased risk of alcl, evaluation for alcl, revision, tissue damage, scarring, disfigurement, swelling, pain, asymmetry, seroma.Patient has not been diagnosed with bia-alcl".Also reported "anxiety, significant weight gain; aggravation of underlying conditions; and other physical and emotional manifestations that are severe and ongoing" which are not related to the device.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data.Correct reason for reoperation: "exchange from textured to smooth breast implants due to the patient¿s concern with the product" and "late seroma".
Event or Problem Description
Healthcare professional reported a right side exchange from textured to smooth breast implants due to the patient¿s concern with the product and also stated that the patient does have signs of late seroma which will be tested for alcl during surgery.Healthcare professional also reported "rupture".Patient representative reported " removal of implants due to fear of alcl, to reduce risk of alcl, and due to symptoms consistent with alcl and fear of alcl: mental anguish and fear of alcl, increased risk of alcl, evaluation for alcl, revision, tissue damage, scarring, disfigurement, capsulectomy, removal of implants, swelling, pain, asymmetry, seroma, anxiety, significant weight gain; aggravation of underlying conditions; and other physical and emotional manifestations that are severe and ongoing.At this time it is unclear if plaintiff was enrolled in any of defendant¿s clinical trials or studies.Patient has not been diagnosed with bia-alcl" device has been explanted and replaced.

• 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; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 9968720
• Report Number: 9617229-2020-06347
• Device Sequence Number: 11911594
• Product Code: FTR
• UDI-Device Identifier: 10888628008106
• UDI-Public: 10888628008106
• Combination Product (Y/N): N
• Initial Reporter State: UT
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/15/2022

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: 03/01/2021
• Device Model Number: TRM-345
• Device Catalogue Number: TRM-345
• Device Lot Number: 2895813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 05/25/2020; 01/28/2021; 05/19/2022; 06/22/2022
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 06/24/2020; 05/03/2022; 06/15/2022; 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2016
• 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 Age: 38 YR
• Patient Sex: Female
• Patient Weight: 75 KG