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).Device evaluation: device photograph(s) for the device related to the reported event capsular contracture was requested on (b)(6) 2023.It is not possible to determine the lot number or catalog number through the photos provided.Visual analysis of the photographs identified: capsular contracture: unable to observe as it is not related to the device.No additional observations are performed.No further actions are required as no manufacturing issues are observed.

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 right device.

Event Description

It has been determined that the event associated with this device is not reportable, as healthcare professional reported baker grade ii.This record is no longer reportable to the fda and will be unreported.

• 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: 18285296
• MDR Text Key: 329963398
• Report Number: 9617229-2023-31732
• 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,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2023
• 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 Sex: Female