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

Catalog Number	SSX-800
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
Company representative reported on behalf of physician, "had trouble getting these two implants out of their packaging." device was not implanted.
Additional Manufacturer Narrative
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.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: difficult to open or remove packaging material.
Event or Problem Description
Company representative reported on behalf of physician, "had trouble getting these two implants out of their packaging." device was not implanted.
Additional Manufacturer Narrative
Visual analysis of the photographs identified: tyvek or thermoform sticking: observed thermoform sticking.No further actions are required since no issue in the manufacturing of the device is observed.Device evaluation: based on the device analysis grid, the assessments of the complaint are: tyvek or thermoform sticking: observed delamination in the inner and outer lid.Additional observations: observed deformation on the device.A further investigation is required to analyze the event of lid delamination.
Event or Problem Description
Company representative reported on behalf of physician, "had trouble getting these two implants out of their packaging." device was not implanted.
Additional Manufacturer Narrative
Corrected data: h.1 in previous medwatches should have been listed as malfunction.
Event or Problem Description
Company representative reported on behalf of physician, "had trouble getting these two implants out of their packaging." device was not implanted.
Additional Manufacturer Narrative
Correction to g.3.Aware date of supplemental medwatch #2.Aware date should have been listed as 17may2024.
Event or Problem Description
Company representative reported on behalf of physician, "had trouble getting these two implants out of their packaging." device was not implanted.
Event or Problem Description
Company representative reported on behalf of physician, "had trouble getting these two implants out of their packaging." device was not implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: h11.Fi summary: the review of the documentation associated to the manufacturing process indicates that all devices with lot number (b)(4) were released in accordance with abbvie¿s procedures and were no defects/problems/issues found in the documents or in the personnel training related to the reported event.Additionally, no er/ ncr(s) were identified during the investigation associated with this lot and the complaint.According to the device analysis performed in the laboratory delamination was observed on the inner and outer lid.This event is not categorized as workmanship, but this further investigation was opened to analyze the event.A review of the current risk documents afmea-bi family rev.5.0 and dfmea-bi pkg and lblg rev.4.0 was performed, and the event of difficult to open packaging (lid delamination) is a known event, for which current process controls and inspections are established to reduce the incidence of this defect.Also, pra (b)(4) was opened to preventively analyze this event.During the trend review of all lid delamination complaints for gel breast implant for the period of (b)(6) 2022 through (b)(6) 2024, was noted 1 outlier in (b)(6) 2022.The additional analysis performed shows all that results met the acceptance criteria and no issues, deviations or non-conformances were found which could be associated to the lid delamination event, so, no additional actions are deemed required at this time.The issue with lid delamination will continue to be monitored and corrective action taken in the future if deemed appropriate.

• 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: 19139918
• Report Number: 9617229-2024-06740
• Device Sequence Number: 18251195
• Product Code: FTR
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/25/2026

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 Catalogue Number: SSX-800
• Device Lot Number: 1203472
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/03/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 04/24/2024; 03/27/2024; 02/07/2025; 09/09/2024; 08/07/2026
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/15/2024; 06/08/2024; 02/07/2025; 04/16/2025; 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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 Sex: Female