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

Catalog Number	SRL-140
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported right side "implant protruded the lower side of the breast", "lump in the upper right breast", "implant was still protruding from the bottom of the breast" and "may have ruptured".Patient stated imaging at the time "did not show a rupture" and the patient "chose not to remove the contracted implants".Patient later reported right side "rupture" via calcium scan and "history of contracture" baker grade unknown.Device remains implanted.
Additional Manufacturer Narrative
This is a follow-up report to a medwatch submitted under manufacturer report number 9617229-2021-46921.Clarification to b3 date of event: partial date (b)(6) 2021.A review of the device history record has been completed.No deviations or non-conformances noted.The event of "capsular contracture" is a physiological complication and analysis of the device generally does not assist abbvie 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; capsular contracture, baker grade unknown.
Additional Manufacturer Narrative
The event of rupture is no longer reportable to the fda and has been removed.The record remains reportable for capsular contracture.Additional, corrected and/or changed data: b.5, b.6.
Event or Problem Description
The event of rupture has been removed and is no longer reportable to the fda.Patient reported the "mri with contrast shows the implant(s) folding, but no sign of rupture".Device remains implanted.

• 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: 22075167
• Report Number: 9617229-2025-08582
• Device Sequence Number: 8703087
• Product Code: FTR
• UDI-Device Identifier: 10888628006669
• UDI-Public: (01)10888628006669(10)2846005(11)160105(17)201205
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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: 12/05/2020
• Device Catalogue Number: SRL-140
• Device Lot Number: 2846005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/24/2025
• Date Device Manufactured: 01/05/2016
• 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: 66 YR
• Patient Sex: Female