MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) UNK GEL BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	UNK GEL BREAST IMPLANT
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
Event or Problem Description
Physician reported left side capsular contracture, baker grade iv.Patient also reported, ¿pain and abnormalities in my breasts¿, ¿increasing pain¿ and ¿hardening in my breasts¿, ¿feeling fatigued¿, ¿light headed¿ and ¿at times generally unwell¿, ¿found a lump in my breast¿ and ¿these faulty implants¿, ¿due to the fact there have been so many issues with these specific implants that they have had to be recalled¿.The device has been explanted with a complete capsulectomy and replaced with another manufacturer's device.
Additional Manufacturer Narrative
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 iv.Visual analysis: visual analysis of the photographs identified: lump/nodule: unable to observe since it is not related to the device.Fatigue: unable to observe since it is not related to the device.Dizziness: unable to observe since it is not related to the device.Capsular contracture: unable to observe since it is not related to the device.Anxiety-product/procedure: unable to observe since it is not related to the device.No additional observations are performed.No further actions are required as no manufacturing issues are observed.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.6, d.6b, h.6.
Event or Problem Description
Physician reported left side capsular contracture, baker grade iv.Patient also reported, ¿pain and abnormalities in my breasts¿, ¿increasing pain¿ and ¿hardening in my breasts¿, ¿feeling fatigued¿, ¿light headed¿ and ¿at times generally unwell¿, ¿found a lump in my breast¿ and ¿these faulty implants¿, ¿due to the fact there have been so many issues with these specific implants that they have had to be recalled¿.The device has been explanted with a complete capsulectomy and replaced with another manufacturer's device.
Event or Problem Description
Physician reported left side capsular contracture, baker grade iv.Patient also reported, ¿pain and abnormalities in my breasts¿, ¿increasing pain¿ and ¿hardening in my breasts¿, ¿feeling fatigued¿, ¿light headed¿ and ¿at times generally unwell¿, ¿found a lump in my breast¿ and ¿these faulty implants¿, ¿due to the fact there have been so many issues with these specific implants that they have had to be recalled¿.The device has been explanted with a complete capsulectomy and replaced with another manufacturer's device.
Additional Manufacturer Narrative
Correction to g.3.Aware date of supplemental medwatch #1.Aware date should have been listed as 05/30/2024.

• Brand Name: UNK GEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): SANTA BARBARA; 900 parkway global park zona f; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 19311989
• Report Number: 9617229-2024-08270
• Device Sequence Number: 15204540
• Product Code: FTR
• UDI-Device Identifier: 10888628008519
• UDI-Public: 10888628008519
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2025

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: UNK GEL BREAST IMPLANT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 04/25/2024; 09/09/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/28/2024; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 31 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White