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

Model Number	FX-410450
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
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.(b)(4).Device evaluation: visual analysis of the returned device identified the device was broken shell, missing shell and fold creases.A weight test of the device was verified and the device underweight.A microscopic analysis was performed which identified sharp edge broken in the shell with stress marks, partial delamination of orientation dot and wear abrasion.A dimension measurement in the shell was performed which identify the thickness within specification.Based on the device analysis the final assessment is: a sharp edge broken in the shell with nick in the side posterior assessed as surgical impact opening.Partial delamination of orientation dot assessed as adhesive failure.Missing shell assessed as inconclusive.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: "having experienced autoimmune issues such as skin reactions, illnesses and infections.".
Event or Problem Description
Patient reported "having experienced autoimmune issues such as skin reactions, illnesses and infections".Patient reported additional events of ¿multiple health problems leading to higher and higher thyroid meds, currently taking the max amount of hormones for that (considering i still have my thyroid).I am on a dose that replaces one all together and blood tests have been stumping my doctor.¿, ¿debilitating migraines¿, ¿sinus infections¿, ¿yeast in gut and throat¿, ¿anxiety attacks, skin rashes and blisters¿, ¿really bad gastrointestinal problems causing irregular weight gain and urinary problems with urgency and frequency¿, and ¿insomnia¿.The aforementioned events are not related to the device.Healthcare professional reported right side rupture.The device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data.In response to fda report number: mw5093908.
Event or Problem Description
Patient reported "having experienced autoimmune issues such as skin reactions, illnesses and infections".Patient reported additional events of ¿multiple health problems leading to higher and higher thyroid meds, currently taking the max amount of hormones for that (considering i still have my thyroid).I am on a dose that replaces one all together and blood tests have been stumping my doctor.¿, ¿debilitating migraines¿, ¿sinus infections¿, ¿yeast in gut and throat¿, ¿anxiety attacks, skin rashes and blisters¿, ¿really bad gastrointestinal problems causing irregular weight gain and urinary problems with urgency and frequency¿, and ¿insomnia¿.The aforementioned events are not related to the device.Healthcare professional reported right side rupture.The device has been explanted.

• Brand Name: STYLE 410 COHESIVE 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 12156981
• Report Number: 9617229-2021-46449
• Device Sequence Number: 14597569
• Product Code: FTR
• UDI-Device Identifier: 10888628002999
• UDI-Public: 10888628002999
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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: 10/13/2020
• Device Model Number: FX-410450
• Device Catalogue Number: FX-410450
• Device Lot Number: 2830309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2015
• 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 Age: 41 YR
• Patient Sex: Female
• Patient Weight: 59 KG