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

Model Number	115-435
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Failure of Implant (1924); Seroma (2069); Swollen Lymph Nodes/Glands (4432)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: exchange from textured to smooth implants due to the patient's concern with the product and possible rupture.
Event or Problem Description
Healthcare professional reported exchange from textured to smooth implants due to the patient's concern with the product and possible rupture.Patient also reported "sore throat and losing weight" - these are not device related.Device remains implanted.This record is for the right side.
Additional Manufacturer Narrative
In response to fda report number: mw5103458.
Event or Problem Description
Healthcare professional reported for right side "exchange from textured to smooth implants due to the patient's concern with the product" and "possible rupture".Patient also reported "sore throat and losing weight" - these are not device related.Patient reported via voluntary mw "breast tenderness, pain, pain in chest", "increased anxiety, "chronic anxiety", "implants were recalled and known to cause a rare form of cancer", "pockets of fluid", "lymph nodes were inflamed", "leaking silicone and had lost volume".Also reported the following events deemed not related to the device "stomach problems, excessive weight gain, estrogen levels of 997", massive night sweats, memory lapses, excessive cold limbs, insomnia, skyrocketing blood pressure, "began to drop weight", "thyroid was attacking itself", diagnosed with hashimotos like illness¿,"ringing in ears", "excessive brain fog", "metal taste in mouth", "bleeding gums", "depression", "diagnosed with raynaud's started a new medication for twitching", "ultrasound showed a mass", "multiple utis", "constant infections", "pain in throat and joints', "excessive exhaustion".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
• 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: 12010024
• Report Number: 9617229-2021-07405
• Device Sequence Number: 4440108
• Product Code: FTR
• UDI-Device Identifier: 10888628002425
• UDI-Public: 10888628002425
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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: 11/16/2020
• Device Model Number: 115-435
• Device Catalogue Number: 115-435
• Device Lot Number: 2848028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2015
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 56 KG