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

Catalog Number	SRL-290
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	03/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "capsular contracture" baker grade iii.Patient later reported "intracapsular breast implant rupture", "folded over", "bubbled", "real thin in some parts", "i am so sick", "memory issues", "extreme limited mobility"," can't lift my arm above my shoulder", "migrated up kind of towards the armpit", "the sharp corner where it's folded kind of sticks out and protrudes, you can visibly see it", "it's grade iv", "pocket degradation", "not in the pocket anymore where it's supposed to be", "extreme pain", "it's like a bowling ball, it's like a rock" and "they don't know if the implant's capsule is adhesion to my lungs until they get in there".Patient also reported "extreme fatigue", "numbness and tingling in my fingers", "i am so sick", "memory issues", "extreme limited mobility"," can't lift my arm above my shoulder" and "shortness of breath" which are not device related.This record is for the left side.Device remains implanted.
Additional Manufacturer Narrative
This is a follow-up report to a medwatch submitted under manufacture report number 9617229-2019-08033, submitted on 1/jul/2019.A review of the device history record has been completed.No deviations or non-conformances noted.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: rupture, extrusion and capsular contracture, baker grade iv.

• 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: 50721159
• Report Number: 9617229-2026-17297
• Device Sequence Number: 10166791
• Product Code: FTR
• UDI-Device Identifier: 10888628006713
• UDI-Public: (01)10888628006713(17)201115
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 11/15/2020
• Device Catalogue Number: SRL-290
• Device Lot Number: 2842594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 12/15/2015
• 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: Other
• Patient Age: 46 YR
• Patient Sex: Female