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

Model Number	SSL-290
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Erosion (1750); Capsular Contracture (1761); Sepsis (2067)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported right side gel implant "capsular contracture grade iv" and pain.Healthcare professional later reported right side rupture.Device has been explanted.
Additional Manufacturer Narrative
Email: (b)(6).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 "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: capsular contracture baker grade iv and rupture.
Additional Manufacturer Narrative
Device evaluation: "based on the device analysis grid, the assessments of the complaint are: rupture: observed two openings striated on anterior side assessed as surgical damage.Capsular contracture: unable to confirm as it is a medical event not related to the device.Additional observations: white particles on the surface of the shell.No further actions are required as the device was implanted." additional, changed, and/or corrected data: d.9, h.3, h.6.
Event or Problem Description
Patient reported right side gel implant "capsular contracture grade iv" and pain.Healthcare professional later reported right side rupture.Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the product analysis performed, the assessments of the complaints are: ¿ rupture: observed two openings striated assessed as surgical damage.¿ extrusion: unable to observe since it is not related to the device.¿ capsular contracture: unable to observe since it is not related to the device.¿ rupture: unable to observe since it is not related to the device.¿ infection (early onset): unable to observe since it is not related to the device.¿ cyst - ndr: unable to observe since it is not related to the device.¿ depression - ndr: unable to observe since it is not related to the device.¿ other medical: unable to observe since it is not related to the device.¿ anxiety/product/procedure: unable to observe since it is not related to the device.¿ capsular contracture: unable to observe since it is not related to the device.As per the investigation procedure was completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.The reported events of extrusion and infection (early onset) are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Reason for reoperation: extrusion and infection (early onset).
Event or Problem Description
Patient later reported ¿went septic after surgery¿, ¿infection was after surgery.¿healthcare professional later reported ¿that the implant was sticking out through the patients skin.¿ 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 2525 dupont drive; building 3; irvine, CA 92612 ; 8479366324
• MDR Report Key: 15577856
• Report Number: 9617229-2022-17949
• Device Sequence Number: 17959963
• Product Code: FTR
• UDI-Device Identifier: 10888628032545
• UDI-Public: 10888628032545
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2025
• Device Model Number: SSL-290
• Device Catalogue Number: SSL-290
• Device Lot Number: 3450927
• 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: 09/15/2022
• Supplement Date Received by Manufacturer: 11/07/2022; 02/17/2025
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 12/01/2022; 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2020
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 92 KG