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

Model Number	MX-410410
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2018
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: rupture.
Event or Problem Description
Patient reported acute appendicitis, gallstone, brain fog, sinus and ear infections, fevers, abdominal pain, cyst in abdominal area, pain, bladder infection, uti, right side rupture, right side swelling, feels cold fluid on right side, right side has dropped, right side feels warmer, right side redness and exchange from textured to smooth breast implants due to the patient¿s concern with the product.Device remains implanted.
Additional Manufacturer Narrative
In response to fda report number: mw5110001.
Event or Problem Description
Patient reported acute appendicitis, gallstone, brain fog, sinus and ear infections, fevers, abdominal pain, cyst in abdominal area, pain, bladder infection, uti, right side rupture, right side swelling, feels cold fluid on right side, right side has dropped, right side feels warmer, right side redness and exchange from textured to smooth breast implants due to the patient¿s concern with the product.Device remains implanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified the device was broken shell, yellow particles material was found on the shell and flat creases.A weight test of the device was verified and the device underweight.A microscopic analysis was performed which identified broken striated.Based on the device analysis the final assessment is: - a striated edge broken in the side anterior assessed as surgical damage.
Event or Problem Description
Patient reported right side rupture, "feels cold fluid on right side", "pain", "right side swelling¿, ¿right side feels warmer¿, ¿right side redness¿, "right side has dropped", and exchange from textured to smooth breast implants due to the patient¿s concern with the product.Patient later reported "unusual rashes would appear across my chest, the entire right side of my face (but not the other)".Healthcare professional later reported right side "intracapsular rupture." patient additionally reported the following events, which are not device-related: "acute appendicitis, gallstone, brain fog, sinus and ear infections, fevers, abdominal pain, cyst in abdominal area, bladder infection, and uti".Later, patient reported, "their hair is starting to fall out," which is not device-related.Patient also reported the following events, which are not device-related: "depression, very frequent headaches and migraines, nose bleeds, i became increasingly overly fatigued, frequent fevers that would sometimes last for several days, frequent fevers between 100-102 degrees, inability to control my body temperature, persistant joint and muscle pain, respiratory difficulties which then required an inhaler and flonase, chronic dry mouth and eyes (although always highly hydrated), poor memory/concentration, insomnia.Sweats around the clock".The device has been explanted.
Event or Problem Description
Patient reported right side rupture, "feels cold fluid on right side", "pain", "right side swelling¿, ¿right side feels warmer¿, ¿right side redness¿, "right side has dropped", and exchange from textured to smooth breast implants due to the patient¿s concern with the product.Patient later reported "unusual rashes would appear across my chest, the entire right side of my face (but not the other)".Healthcare professional later reported right side "intracapsular rupture." patient additionally reported the following events, which are not device-related: "acute appendicitis, gallstone, brain fog, sinus and ear infections, fevers, abdominal pain, cyst in abdominal area, bladder infection, and uti".Later, patient reported, "their hair is starting to fall out," which is not device-related.Patient also reported the following events, which are not device-related: "depression, very frequent headaches and migraines, nose bleeds, i became increasingly overly fatigued, frequent fevers that would sometimes last for several days, frequent fevers between 100-102 degrees, inability to control my body temperature, persistant joint and muscle pain, respiratory difficulties which then required an inhaler and flonase, chronic dry mouth and eyes (although always highly hydrated), poor memory/concentration, insomnia.Sweats around the clock".The device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data.
Event or Problem Description
Patient reported right side rupture, "feels cold fluid on right side", "pain", "right side swelling¿, ¿right side feels warmer¿, ¿right side redness¿, "right side has dropped", and exchange from textured to smooth breast implants due to the patient¿s concern with the product.Patient later reported "unusual rashes would appear across my chest, the entire right side of my face (but not the other)".Healthcare professional later reported right side "intracapsular rupture." patient additionally reported the following events, which are not device-related: "acute appendicitis, gallstone, brain fog, sinus and ear infections, fevers, abdominal pain, cyst in abdominal area, bladder infection, and uti".Later, patient reported, "their hair is starting to fall out," which is not device-related.Patient also reported the following events, which are not device-related: "depression, very frequent headaches and migraines, nose bleeds, i became increasingly overly fatigued, frequent fevers that would sometimes last for several days, frequent fevers between 100-102 degrees, inability to control my body temperature, persistant joint and muscle pain, respiratory difficulties which then required an inhaler and flonase, chronic dry mouth and eyes (although always highly hydrated), poor memory/concentration, insomnia.Sweats around the clock".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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 14581332
• Report Number: 9617229-2022-09107
• Device Sequence Number: 5492194
• Product Code: FTR
• UDI-Device Identifier: 10888628003743
• UDI-Public: 10888628003743
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/02/2022

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: 07/18/2020
• Device Model Number: MX-410410
• Device Catalogue Number: MX-410410
• Device Lot Number: 2791255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 06/14/2022; 07/20/2022; 08/17/2022; 10/06/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 07/12/2022; 08/17/2022; 09/08/2022; 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2015
• 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: 32 YR
• Patient Sex: Female
• Patient Weight: 61 KG