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

Catalog Number	SRM-640
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is a follow up report to a medwatch submitted under manufacture report number 9617229-2023-18321.A review of the device history record has been completed.No deviations or non-conformance's noted.Device evaluation: the device related to the reported events of rupture and capsular contracture was received on january 11, 2024, with lot number: 3185095.Per the investigation procedure, the device is analyzed through visual inspection microscopic inspection if openings are observed and a weight verification.Per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: rupture: observed an opening through microscopic inspection assessed as fold flaw opening.No further actions are required as it is not related to the manufacturing process.Capsular contracture: unable to observe through visual inspection as it is a physiological phenomenon.None of the other observations performed during the device analysis (creases, non-penetrating nicks and wear abrasion) are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.The event of "capsular contracture" 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 and capsular contracture, baker grade iv.
Event or Problem Description
Patient reported exchange with no complaint against the device.Later healthcare professional reported capsular contracture baker grade unknown.Later healthcare professional reported "rupture".Later healthcare professional reported the capsular contracture is baker grade iv.Device has been explanted.

• 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: 24987207
• Report Number: 9617229-2026-07530
• Device Sequence Number: 9698606
• Product Code: FTR
• UDI-Device Identifier: 10888628007192
• UDI-Public: (01)10888628007192(10)3185095(11)180327(17)230227
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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: 02/27/2023
• Device Catalogue Number: SRM-640
• Device Lot Number: 3185095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/24/2026
• Date Device Manufactured: 03/27/2018
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Hispanic