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

Catalog Number	TCM-445
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported a left exchange from textured to smooth implants due to the patients concerns with the product with "anxiety, changes in how they feel and how they look, left is larger than the other, had a couple of spots looks like precancerous spots on my chest above my breast.I had them burned off 6 months ago and getting more burned off in june, pain underneath them in the tissue around them, mainly the left, scared because i already had cancer once and don't want to get it again".The event of ¿had a couple of spots looks like precancerous spots on my chest above my breast¿ is not device related.Patient also reported bilateral rashes, redness, extreme swelling, pain, and is very stressed about the textured implants she has.Healthcare professional later reported capsular contracture, baker grade iii.The device has been explanted.
Additional Manufacturer Narrative
Continued: h.6.F2201.A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: based on the device analysis grid, the assessments of the complaint are: anxiety¿product/procedure: unable to observe since it is not related to the device.Pain: unable to observe since it is not related to the device.Visibility/palpability: unable to observe since it is not related to the device.Other-medical-ndr: unable to observe since it is not related to the device.Inflammation/irritation: unable to observe since it is not related to the device.Skin rash/dermatitis: unable to observe since it is not related to the device.Capsular contracture: unable to observe since it is not related to the device.No additional observations are performed.No further actions are required since no issue in the manufacturing of the device is observed.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 iii.

• Brand Name: INSPIRA TEXTURE COHESIVE 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18324250
• Report Number: 9617229-2023-19879
• Device Sequence Number: 20713015
• Product Code: FTR
• UDI-Device Identifier: 10888628030930
• UDI-Public: 10888628030930
• 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
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2023

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: 02/17/2022
• Device Catalogue Number: TCM-445
• Device Lot Number: 3033319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2017
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 59 KG