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

Model Number	3341454
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is part of a batch of late reports resulting from internally identified data inconsistencies between a postmarket study and our complaint handling databases.Additional information about this event was made available on (b)(6) 2022 via postmarket study data, but was not transferred to our complaint handling database at that time.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: as of now there is no information regarding the explant or reoperation.(b)(4).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.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number (b)(4).
Event or Problem Description
This event is associated with the mnt-men-15-003 clinical trial, participant (b)(4).It was reported that a black or african american female patient underwent revision breast reconstruction surgery with 755cc mentor memoryshape breast implant (mentor glow study gel devices) on both sides on (b)(6) 2018, newly diagnosed right breast cancer (right implant serial number (b)(4)).On (b)(6) 2021, the patient reported newly diagnosed right breast cancer.The patient was hospitalized for one (1) day and was treated with a capsulotomy.On (b)(6) 2021 the patient underwent right-sided capsulotomy, scar revision surgery, and pocket adjustment due to capsular contracture baker grade iii and necrosis.The right-side device was not explanted, and a new device was not implanted.On the same day, the patient underwent left-sided capsulotomy, pocket adjustment, and skin adjustment due to capsular contracture baker grade iii and asymmetry.The left-side device was not explanted, and a new device was not implanted.During the patient¿s first (1) year follow-up visit was performed on (b)(6) 2020, the second (2) year follow-up visit was performed on (b)(6) 2020, the third (3) year follow-up was performed on (b)(6) 2021 and the fourth (4) year follow-up visit performed on (b)(6) 2022, the patient reported post-op rheumatology signs and symptoms, and generalized illness symptoms including joint stiffness, pain, joint swelling, sleep disorders, difficulty with balance, fatigue, muscle cramps, change in coloration of fingers, numbness in fingers, change in temperature of fingers, dry eyes, dry mouth, paresthesia, cognitive issues, difficulty walking, muscle weakness, asymmetry, soft tissue necrosis.Additional information was received on (b)(6) 2022.The following is a summary of the information provided: during the patient¿s fourth (4) year follow-up (entered in the post-op cancer details form), the patient reported having surgery to remove the right breast implant and replacement with a tissue expander at an unknown date.At the time of this report, mentor has received no information regarding explantation or an expected explantation date regarding the left side device.This medwatch report is for the patient¿s left-sided device.
Additional Manufacturer Narrative
Additional information received on november 9, 2022 was reviewed by the clinician and per review, per review, the date of explant for the right side should be updated (b)(6), 2021.Also, the patient has a history of breast cancer, but the side is not specified.Further clarification is needed on whether the right-sided breast cancer is newly diagnosed or has a recurrence.There is contradicting information entered into the crf.Supplemental report will be submitted when additional information or clarification is received.This supplemental medwatch report is for the patient¿s left-sided device.Manufacturer¿s reference number (b)(4).
Additional Manufacturer Narrative
Per clinician's review of additional information received on january 15, 2024, the following information has been updated: adverse event #3 and #5: baker iii capsular contracture (right implant serial number (b)(6); left implant serial number (b)(6)).On (b)(6) 2021, the patient reported bilateral baker grade iii capsular contracture.The principal investigator assessed these events as moderate in severity, serious, and definitely related to the device.Both events were resolved with a capsulotomy on (b)(6) 2021.Adverse event #4: necrosis (right implant serial number (b)(6)).On (b)(6) 2018, the patient reported right-sided necrosis.The principal investigator assessed this event as moderate in severity, and serious, but it¿s unknown if this is event is related to the device.This event was resolved with a scar revision surgery on (b)(6) 2021.Adverse event #6: asymmetry (left implant serial number (b)(6)).On (b)(6) 2018, the patient reported right-sided asymmetry.The principal investigator assessed this event as moderate in severity, not serious, and possibly related to the device.This event was resolved with pocket adjustment surgery on (b)(6) 2021.This supplemental medwatch report is for the patient¿s left-sided device.Manufacturer¿s reference number (b)(4).
Additional Manufacturer Narrative
Per secondary review of the file performed by the clinician, following updates have been made: - bilateral medical device removal was performed on (b)(6) 2021.- health effect impact code "device explantation" has been added to field h6.D6b explantation date: (b)(6) 2021.This supplemental medwatch report is for the patient¿s left-sided device.Manufacturer¿s reference number (b)(4).
Additional Manufacturer Narrative
On february 19, 2026, mentor became aware that the patient had right-sided breast cancer diagnosed sometime in 2018 and recurrence occurred around 2021.Per the information provided, the patient has a new diagnosis of cancer, but this seems more like metastasis from initial breast cancer.Adverse event #7: cancer [new diagnosis other than breast] specify body location, stage iv bone marrow cancer in the thoracic cavity.On an unknown date, the patient was diagnosed with stage iv bone marrow cancer in the thoracic cavity.At the time of this review, the principal investigator¿s assessment was not entered in the crf.This supplemental medwatch report is for the patient¿s left-sided device.Manufacturer¿s reference number (b)(4)_.

• Brand Name: MENTOR MEMORYSHAPE 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 ; 646591-7981
• MDR Report Key: 15607804
• Report Number: 1645337-2022-11110
• Device Sequence Number: 19415307
• Product Code: FTR
• UDI-Device Identifier: 00081317024279
• UDI-Public: 00081317024279
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• 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: 06/10/2023
• Device Model Number: 3341454
• Device Catalogue Number: 3341454
• Device Lot Number: 7585155
• 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: 07/19/2022
• Supplement Date Received by Manufacturer: 11/09/2022; 01/15/2024; 08/25/2025; 02/19/2026
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 11/26/2022; 02/03/2024; 09/02/2025; 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2018
• 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 Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American