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

Catalog Number N-TSF295

Device Problems Device Appears to Trigger Rejection (1524); No Apparent Adverse Event (3189)

Patient Problems Capsular Contracture (1761); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2023

Event Type  Injury  

Manufacturer Narrative

A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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 fibrosis" (unknown baker grade).

Event Description

Patient reporting " capsular fibrosis" (unknown baker grade) due to allergan implant.Device has been explanted and replaced with non-allergan device.This relates to the left device.

Event Description

Previous medwatch submission noted capsular contracture, baker grade unknown.Patient later reported baker grade ii.Upon further information, abbvie has determined that the event of capsular contracture, baker grade ii is non serious and not reportable.

Manufacturer Narrative

Photo analysis: visual analysis of the photographs identified: capsular contracture : unable to observe as it is a medical event that is not related to the device.No additional observations.No further actions are required since no issue in the manufacturing of the device is observed.

• Brand Name: INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
• Type of Device: 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 ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18284961
• MDR Text Key: 329960983
• Report Number: 9617229-2023-31731
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P020056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2019
• Device Catalogue Number: N-TSF295
• Device Lot Number: 2609149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 01/04/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 67 KG