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

Catalog Number	SRM-600
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Date of Event	12/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "nipple discharge", "breast feels soft when squeezed", "capsular contracture baker grade unknown", "so much fluid".Later healthcare professional reported "rupture".This record is for the left side.The device remains implanted.Patient received an unknown treatment.
Event or Problem Description
Patient reported "nipple discharge", "breast feels soft when squeezed", "capsular contracture baker grade unknown", "so much fluid".Later healthcare professional reported "rupture".Later healthcare professional reported "not ruptured".This record is for the left side.The device was explanted.Patient received an unknown treatment.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of "seroma-late and 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: rupture, seroma-late and capsular contracture, baker grade unknown.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b1, b2, b5, h6, h11.Information contained in this report was previously submitted through psr on 23/july/2018 and 15/oct/2018.Un-report a0412 (rupture).

• 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: 50808940
• Report Number: 9617229-2026-17752
• Device Sequence Number: 15616683
• Product Code: FTR
• UDI-Device Identifier: 10888628007185
• 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
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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 Expiration Date: 10/02/2021
• Device Catalogue Number: SRM-600
• Device Lot Number: 2981613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 11/02/2016
• 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; Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 111 LB
• Patient Race: White