MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3543007MC
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Breast Mass (2439); Breast Discomfort/Pain (4504)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: na.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that an (b)(6) caucasian female patient who underwent a breast augmentation revision with mentor memorygel, 300cc breast implant has experienced bilateral symptomatic ruptures and breast pain postoperatively.The patient reported bilateral rupture & shooting pain through the breasts.The issue was confirmed through ultrasound & mri examination.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report relates to the left prosthesis.
Additional Manufacturer Narrative
Additional information received on july 19, 2022 indicated that the patient scheduled for explantation on (b)(6) 2022.Reason for device explant and/or reoperation: rupture, breast pain.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on september 27, 2022 indicated that the date of removal has been cancelled.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on february 10, 2023 indicated that the postoperative diagnosis revealed that both implants were intact.Therefore pec coding was updated from rupture symptomatic (post-implant) to adverse event on both sides.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on january 25, 2023 indicated that the date of removal was updated to (b)(6) 2023.Patient experienced bilateral capsular contracture:(unknown grade), and breast mass, therefore pc coding was updated.Serious injury and breast pain were removed, and breast mass, medical device removal and capsular contracture associated with breast implant were added.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation completed on march 10 , 2023: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.During visual evaluation no apparent damage or visual anomalies were observed on the sx mod classic gel, 300cc returned device.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.It should be noted that as part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Since no malfunction was observed during the investigation, capa activity was not required.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.Date of removal updated to feb 7, 2023.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 6465917981
• MDR Report Key: 14057903
• Report Number: 1645337-2022-03957
• Device Sequence Number: 4603715
• Product Code: FTR
• UDI-Device Identifier: 00081317004394
• UDI-Public: 00081317004394
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: 3543007MC
• Device Catalogue Number: 3543007MC
• Device Lot Number: 7369895
• 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: 03/22/2022
• Supplement Date Received by Manufacturer: 07/19/2022; 09/27/2022; 01/25/2023; 02/10/2023; 02/22/2023; 03/10/2023
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 07/25/2022; 10/10/2022; 02/01/2023; 02/13/2023; 02/27/2023; 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2016
• 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: Other; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White