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

Catalog Number SRM-640

Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682)

Patient Problems Wound Dehiscence (1154); Capsular Contracture (1761); Foreign Body Reaction (1868)

Event Date 12/25/2023

Event Type  Injury  

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.The events of capsular contracture, wound dehiscence are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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 and later also reported "exposed implant", "hurting so much" and "mechanical issue with the pectoralis major pushing on incision breaking it enough for it to open".

Event Description

Healthcare professional reported a left side capsular contracture baker grade iv and later also reported "exposed implant", "hurting so much" and "mechanical issue with the pectoralis major pushing on incision breaking it enough for it to open".Device has been explanted.

• Brand Name: INSPIRA SMOOTH 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 ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 18904864
• MDR Text Key: 337675282
• Report Number: 9617229-2024-04355
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

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 Catalogue Number: SRM-640
• Device Lot Number: 3494109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/14/2024
• 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: 35 YR
• Patient Sex: Female
• Patient Weight: 106 KG