MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number N-27-FF140-535

Device Problems Material Rupture (1546); Patient-Device Incompatibility (2682)

Patient Problems Wound Dehiscence (1154); Foreign Body Reaction (1868); Unspecified Infection (1930)

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 events of infection, wound dehiscence, and exposure 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/will be requested.No additional information is available at this time.Reason for reoperation: ¿infectious and inflammatory process¿, ¿bacteria that were generating a considerable infectious process¿; ¿dehiscence¿; ¿exposure of the implant¿.

Event Description

Patient representative reported patient experiencing pain in the left breast, ¿causeless allergies¿ (not device related), ¿chronic fatigue¿ (not device related), ¿hair loss¿ (not device related), ¿terrible pain¿, ¿dizzying pain in the patient¿s body¿, ¿severe pain¿, ¿local pain¿, ¿reddish spots began to appear in the region of the prosthesis¿, ¿hyperemia¿, ¿pain and suffering that the patient went through had no end, taking away even [their] joy in living¿, ¿infectious and inflammatory process¿, ¿bacteria that were generating a considerable infectious process¿, ¿inflammatory process¿, ¿chronic inflammatory process¿, ¿dehiscence¿, and ¿exposure of the implant¿.Affected side is left.The device has been explanted.

Manufacturer Narrative

Reason for reoperation: rupture.

Event Description

Additionally reported was "possible rupture.".

• Brand Name: STYLE 410 COHESIVE 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: 19080952
• MDR Text Key: 339836870
• Report Number: 9617229-2024-06205
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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: 03/05/2018
• Device Catalogue Number: N-27-FF140-535
• Device Lot Number: 2426685
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/05/2013
• 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