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

Catalog Number	3545455
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2023
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: n/a.H6 health effect - clinical code e2402: generalized illness.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a breast augmentation revision procedure with mentor memorygel breast implant 455cc gel breast prostheses and suffered several unexplained systemic symptoms, including inflammation from the arm to the knees, to the feet, then to the hands.Blood test results indicated increased ama levels.No device issue such as rupture was reported.The root cause of the patient¿s symptoms is unclear.Additionally, the patient developed asymmetry post implantation.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch report is for the patient¿s left breast prosthesis.
Additional Manufacturer Narrative
On 09-apr-2024, mentor received additional information about the event: the patient developed baker grade iii capsular contracture in her right breast post implantation.The patient underwent bilateral explantation on (b)(6) 2023.Reason for device explant and/or reoperation: generalized illness, right breast capsular contracture.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 03-oct-2024, mentor received additional information about the event.The patient is scheduled to undergo a bilateral replacement surgery with unspecified breast prostheses on (b)(6) 2024.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
This complaint has been identified as a duplicate of manufacturer report number: 1645337-2023-11998.This file has been updated to contain all of the most current and correct information, and final reporting/documentation of this event will take place in this pc.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Correction: follow up report #3 contained a statement about a duplicate report submitted to the us fda for this event, but an incorrect report number was referenced.This report number and manufacturer report number 1645337-2024-12797 were identified as duplicates.All follow-up reports for this event will take place in this report (manufacturer report number 1645337-2023-11999).On 07-nov-2024, mentor received additional information about the event.The suspect medical device was discarded following explant surgery.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 29-nov-2024, mentor completed the investigation on the suspect medical device.The investigation was completed on a photo of the suspect medical device because the physical device has not been received by mentor.Device evaluation summary: according to the information reported, the patient developed unexplained systemic symptoms.Upon visual evaluation of the image provided in the complaint, no apparent damage or visual anomalies were observed.At the present, there is no sufficient evidence to show an association between breast implants and generalized illness (assessing the risks of breast implants and fda¿s vision for the national breast implant registry).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, no corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 17902330
• Report Number: 1645337-2023-11999
• Device Sequence Number: 8224949
• Product Code: FTR
• UDI-Device Identifier: 00081317007166
• UDI-Public: (01)00081317007166(17)210911(10)7374907(21)7374907-001
• 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: 2020
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2021
• Device Catalogue Number: 3545455
• Device Lot Number: 7374907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2023
• Supplement Date Received by Manufacturer: 04/09/2024; 10/03/2024; 11/06/2024; 11/07/2024; 11/29/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 04/22/2024; 10/17/2024; 11/12/2024; 11/22/2024; 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2016
• 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: Required Intervention; Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White