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

Catalog Number	3544475
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069); Fluid Discharge (2686); Swollen Lymph Nodes/Glands (4432)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Correction: after clinical/secondary review of this file, it was decided to add codes surgical intervention (f19) and seroma (e0307) to more accurately capture the reported event.Code e0307 represents the 40cc of serous fluid drained from the left breast and the code replaces code e2315 that was used in the initial report.On 21-may-2025, mentor received additional information about the event: - patient¿s race and ethnicity were provided.- the patient was scheduled to undergo bilateral explantation on (b)(6) 2025.Reason for device explant and/or reoperation: bilateral capsular contracture, left breast seroma.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 02-jul-2025, the mentor failure analysis lab 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.Device evaluation summary: (b)(4).
Event or Problem Description
It was reported that a patient underwent a breast augmentation procedure with mentor memorygel breast implant 475cc gel breast prostheses developed baker grade ii capsular contracture in both breasts post implantation.Additionally, mri results indicated minimal fluid in right breast and small to moderate fluid in the left breast.Results also indicated mild left axillary lymphadenopathy with numerous borderline enlarged lymph nodes.On (b)(6) 2025, patient underwent a ultrasound-guided left breast fluid collection aspiration procedure.Approximately 40cc of serous fluid was drained from the space around the left breast implant.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
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.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).
Additional Manufacturer Narrative
Device evaluation summary: 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 returned device.A seroma is a build-up of fluid around the implant.Symptoms from a seroma may include swelling, pain, and bruising.A seroma may occur soon after surgery, or any time later on, which would be referred to as a late seroma.While the body may absorb seromas, some may require surgery for drainage.Regarding the reported capsular contracture condition, there are not enough details to determine the factors that may have caused this condition.Capsular contracture in the patient¿s breast might be the result of the body¿s individual physiological response to the implantation of a foreign object in soft tissue.Further, capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.Lymphadenopathy or palpable lymph nodes may be the result of bacterial or viral infection, neoplasm (primary or metastatic), or as the result of an idiopathic inflammatory process or foreign body reaction.There have been reports regarding movements of silicone gel material to lymph nodes even with or without evident of rupture leading to lymphadenopathy.A number of epidemiology studies have evaluated large populations of women with breast implants from a variety of manufacturers and implant models.The studies do not, taken together, support an association of breast implants and a diagnosed rheumatic disease.Other than one study, these studies do not distinguish whether the women had ruptured or intact implants.Because there were no supporting pathology reports or physician consultation summaries forwarded to product evaluation, we are unable to confirm the presence of or the possible etiology of the reported lymphadenopathy.Lymphadenopathy is a known complication associated with this surgery and is referenced in our current product insert data sheet.As part of mentor's quality process, all devices are manufactured, inspected, and released according to approved specifications.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria.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: henry boden ; 3041 skyway circle north; irving, TX 75038 ; 9497882078
• MDR Report Key: 21895226
• Report Number: 1645337-2025-04331
• Device Sequence Number: 8162138
• Product Code: FTR
• UDI-Device Identifier: 00081317003946
• UDI-Public: (01)00081317003946(17)210812(10)7351338
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 08/12/2021
• Device Catalogue Number: 3544475
• Device Lot Number: 7351338
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 05/21/2025; 07/02/2025; 07/29/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/12/2025; 07/18/2025; 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2016
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White