MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) Inspira Smooth Silicone Gel Filled Breast Implant; prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	SSM-445
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Cellulitis (1768); Foreign Body Reaction (1868); Impaired Healing (2378)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "infection, swelling and exposure on the new device", "hospitalized for 3 days and was on iv antibiotics, prescribed levofloxacin", "infection tested positive for acute cellulitis".Later healthcare professional reported " acute cellulitis, tenderness, swelling, fever, redness, patient was then sent to hospital for iv antibiotics".This record is for the record is for the right side.Device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of cellulitis 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: cellulitis.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d4, h6.The event of delayed healing is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.
Event or Problem Description
Later patient reported "right side is not healing".
Event or Problem Description
Patient reported "infection, swelling and exposure on the new device", "hospitalized for 3 days and was on iv antibiotics, prescribed levofloxacin", "infection tested positive for acute cellulitis".Later healthcare professional reported " acute cellulitis, tenderness, swelling, fever, redness, patient was then sent to hospital for iv antibiotics".This record is for the record is for the right side.Device remains implanted.
Event or Problem Description
Patient reported "infection, swelling and exposure on the new device", "hospitalized for 3 days and was on iv antibiotics, prescribed levofloxacin", "infection tested positive for acute cellulitis".Later healthcare professional reported " acute cellulitis, tenderness, swelling, fever, redness, patient was then sent to hospital for iv antibiotics".Later patient reported "hospitalized with an infection and the incisions would not heal".This record is for the record is for the right side.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h.6.
Additional Manufacturer Narrative
Correction/clarification to h6 adverse event problem: un-reporting e1707 impaired healing, submitted in supplemental medwatch #1, as the reported event of ¿incisions would not heal¿ is more accurately captured by e2340 wound dehiscence.The events of "cellulitis" and "wound dehiscence" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Reason for reoperation: "acute cellulitis"; "incisions would not heal" additional, changed, and/or corrected data: b5, b6, b7, d6b, g2, 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 ; +1(847)936-6324
• MDR Report Key: 25259008
• Report Number: 9617229-2026-09593
• Device Sequence Number: 12117027
• Product Code: FTR
• UDI-Device Identifier: 10888628032972
• UDI-Public: (01)10888628032972(17)300819
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/16/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SSM-445
• Device Lot Number: 1342469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/27/2026
• Supplement Date Received by Manufacturer: 06/01/2026; Not provided; 09/03/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 06/23/2026; 09/03/2026; 09/16/2026
• Date Device Manufactured: 09/19/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 115 LB
• Patient Race: White