MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 110 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	110-420
Medical Device Problem Codes	Gel Leak (1267); Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.A review of the device history record has been completed.No deviations or non-conformances noted.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: gel bleed.
Event or Problem Description
Patient reported experiencing ¿pain that comes and goes¿, ¿lumps underneath breast and armpit, feels like nodules¿, ¿fibrocystic breast¿, ¿rippling¿ and ¿exchange from textured to smooth breast implants due to the their concern¿ with the product.Additionally, healthcare professional reported "a small amount of silicone bleed¿.Device has been explanted.This record is for the right side.
Event or Problem Description
Healthcare professional later reported right side rupture.Patient representative reported "significantly increased risk for developing bia-alcl.".
Additional Manufacturer Narrative
Continued h.6 health effect - impact code: f2203.Device evaluation: visual analysis of the returned device identified, the weight the device within specification, crease flat, deformation and voids.After autoclave cycle was observed: cloudy color in the gel.Based on the device analysis the final assessment is no issues found related with the manufacturing process and wrinkles (creases) are observed but have no relationship with manufacturing.

• Brand Name: STYLE 110 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 9991920
• Report Number: 9617229-2020-05709
• Device Sequence Number: 14412082
• Product Code: FTR
• UDI-Device Identifier: 10888628002265
• UDI-Public: 10888628002265
• Combination Product (Y/N): N
• Initial Reporter State: LA
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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: 12/21/2019
• Device Model Number: 110-420
• Device Catalogue Number: 110-420
• Device Lot Number: 2697685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female