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

Catalog Number	SSLP-220
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported " "bubbles" on the top and bottom of the right-side breast", "looked like a freak", and looked "elongated and twisted".Later, reported "have you been diagnosed with implant rupture, capsular contracture or other devise malfunction? yes".This relates to the right side.Device was explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The reported events are physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: visibility/palpability, rupture and capsular contracture baker grade unknown.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b1; h6.
Event or Problem Description
Patient reported " "bubbles" on the top and bottom of the right side breast", "looked like a freak", and looked "elongated and twisted".Later, reported "have you been diagnosed with implant rupture, capsular contracture or other devise malfunction? yes".This relates to the right side.Device was explanted.
Event or Problem Description
Patient reported " "bubbles" on the top and bottom of the right side breast", "looked like a freak", and looked "elongated and twisted".Later, reported "diagnosed with implant rupture, capsular contracture and other devise malfunction", "painful", "asymmetric, capsuled, deformed".This relates to the right side.Device was explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, b7, h6.

• 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: 22685026
• Report Number: 9617229-2025-12976
• Device Sequence Number: 8892326
• Product Code: FTR
• UDI-Device Identifier: 10888628032682
• UDI-Public: (01)10888628032682(10)3512479(11)210422(17)260322
• 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: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2025

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: 03/22/2026
• Device Catalogue Number: SSLP-220
• Device Lot Number: 3512479
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 08/01/2025; 10/05/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/21/2025; 10/24/2025
• Date Device Manufactured: 04/22/2021
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White