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

Catalog Number	SRX-650
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: capsular contracture, baker grade unknown.
Event or Problem Description
Patient reported "capsular contracture, baker grade unknown" and "severe food intolerances, widespread connective tissue pain, triggers points, chronic tension headaches, memory fog, loss of muscle strength, hair loss and fatigue".This record is for the left side.The device remains implanted.
Event or Problem Description
Patient reported "capsular contracture" baker grade unknown.Patient also reported the following events, which are all not device-related: "severe food intolerances, wide spread connective tissue pain, triggers points, chronic tension headaches, memory fog, loss of muscle strength, hair loss and fatigue", ¿stomach issues¿, ¿lost 30lbs in 6 months¿, ¿couldn't eat without severe stomach issues¿, ¿diagnosed with ibs (irritable bowel syndrome)¿, ¿started having widespread muscle/connective tissue pain¿, ¿chronic tension headaches¿, and ¿diagnosed with fibromyalgia¿.Patient was prescribed the following medications, which "only partially help": acetaminophen, flexoril, gabapentin, ibuprofen, simethicone, wellbutrin and zeolite.This record is for the left side.The device was explanted.
Additional Manufacturer Narrative
In response to fda report numbers: mw5187587, mw5187588, mw5187589, mw5187590.Clarification to b3 date of event: partial date 2020.

• 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 ; 8479366324
• MDR Report Key: 22458429
• Report Number: 9617229-2025-11418
• Device Sequence Number: 8315702
• Product Code: FTR
• UDI-Device Identifier: 10888628007604
• UDI-Public: (01)10888628007604(10)2865503(11)160203(17)210103
• 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: 2019
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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 Expiration Date: 01/03/2021
• Device Catalogue Number: SRX-650
• Device Lot Number: 2865503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 06/12/2026
• Date Device Manufactured: 02/03/2016
• 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
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White