MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 115 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	115-469
Medical Device Problem Codes	Material Rupture (1546); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Seroma (2069); Swollen Lymph Nodes (2093)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional 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.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: rupture and silicone migration.
Event or Problem Description
Patient reported right side rupture and breast "doubled in size, is hard, and silicone in lymph node." device has been explanted.
Event or Problem Description
Additionally, healthcare professional reported a patient experienced the events of ¿significant increase in the size of the right breast overnight¿, ultrasound showed ¿bilateral silicone implant rupture", "silicone uptake was noted within a couple of lymph nodes within the right axilla".Mri showed ¿intracapsular rupture of the silicone implant on the right and a copious amount of fluid surrounding the implant, silicone uptake was also noted in one axillary lymph node on the right and an internal mammary lymph node on the right¿, ¿ruptured breast implant with right axilla lymphadenopathy¿, ¿found to have 2 abnormal lymph nodes in the right axilla¿.
Additional Manufacturer Narrative
The events of seroma (late) and lymphadenopathy are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified to be underweight, a broken shell, a flat crease and yellow particles.A microscopic analysis was performed which identified a sharp edge opening assessed as an unidentified tear opening.A dimension measurement in the shell was performed which identified the thickness was within specification.Based on the device analysis the final assessment is: a sharp opening on posterior assessed as an unidentified (tear) opening.
Event or Problem Description
Patient reported right side rupture and breast "doubled in size, is hard, and silicone in lymph node." device has been explanted.

• Brand Name: STYLE 115 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; CS
• MDR Report Key: 9711481
• Report Number: 9617229-2020-01547
• Device Sequence Number: 16981975
• Product Code: FTR
• UDI-Device Identifier: 10888628002432
• UDI-Public: 10888628002432
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2020

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: 01/13/2020
• Device Model Number: 115-469
• Device Catalogue Number: 115-469
• Device Lot Number: 2705518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 02/21/2020; 02/06/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/20/2020; 04/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR