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

Catalog Number	SSL-320
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Dhr trend summary: the review of all potential trend evaluations for breast implants closed during the past 12 months indicates that no confirmed complaint trends have been observed for the event a0412 material rupture and a010402 migration.The event of "capsular contracture, baker grade iii" 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: capsular contracture, baker grade iii and device rupture.
Event or Problem Description
Healthcare professional reported "capsular contracture baker grade iii".Healthcare professional later reported "#1 history of bilateral augmentation mammoplasty, #2 capsular contracture with implant displacement bilaterally, #3 ptosis bilateral breast.Healthcare professional later reported "obvious displacement with suspected capsular contracture generating that implant displacement palpable and visible particularly in the superior poles bilaterally with an appropriate need for removal and replacement and considerations for conversion either whole or in part into a new pocket of muscular space.She has had and in fact has had suggestions for mastopexy in the past as well as recently and elected to proceed with the after mentioned procedure to rectal capsular contracture as well as ascertain the need for removal and replacement given the obvious implant displacement and suspected incipient implant rupture with crease fold failure of the implant generated by capsular tissue." capsular contracture baker grade iii confirmed via mammogram.This record is for left side.Device was explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d.9, h.3, h.6.Device evaluation: based on the product analysis performed, the assessments of the complaints are: ¿ capsular contracture: unable to observe as it is not related to the manufacturing process.¿ rupture: not observed openings during the analysis.¿ malposition: unable to observe as it is not related to the manufacturing process.¿ crease/folding of implant: observed.As per the investigation procedures wear abrasion was completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.
Event or Problem Description
Healthcare professional reported "capsular contracture baker grade iii".Healthcare professional later reported "#1 history of bilateral augmentation mammoplasty, #2 capsular contracture with implant displacement bilaterally, #3 ptosis bilateral breast.Healthcare professional later reported "obvious displacement with suspected capsular contracture generating that implant displacement palpable and visible particularly in the superior poles bilaterally with an appropriate need for removal and replacement and considerations for conversion either whole or in part into a new pocket of muscular space.She has had and in fact has had suggestions for mastopexy in the past as well as recently and elected to proceed with the after mentioned procedure to rectal capsular contracture as well as ascertain the need for removal and replacement given the obvious implant displacement and suspected incipient implant rupture with crease fold failure of the implant generated by capsular tissue." capsular contracture baker grade iii confirmed via mammogram.This record is for left side.Device was explanted and replaced.

• Brand Name: INSPIRA SMOOTH 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: 22057263
• Report Number: 9617229-2025-08344
• Device Sequence Number: 12715844
• Product Code: FTR
• UDI-Device Identifier: 10888628032552
• UDI-Public: (01)10888628032552(10)3539380(11)210806(17)260706
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2026
• Device Catalogue Number: SSL-320
• Device Lot Number: 3539380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White