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

Catalog Number	3544600
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Seroma (2069); Deformity/ Disfigurement (2360)
Date of Event	08/26/2025
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: no information regarding explantation or an expected explantation date has been received.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 implanted with two 600cc mentor memorygel breast implant experienced swollen lymph nodes and implant site fluid collection on the left side, and bilateral ruptures post-operatively.The patient required surgical intervention to treat the left side via drainage.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
Mentor received a confirmed date of explant and additional information indicating the patient experienced bilateral seroma.Coding and relevant fields have been updated.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted visual inspection of the returned device.Visual analysis of the returned device did not reveal any apparent damage in the breast implant leak testing was performed, in accordance with mentor procedures, and it identified a tear in the anterior aspect, measuring approximately 0.1 cm.Additionally, it was within an area of siltex cracking.These findings are consistent with normal wear of the device.Shell abrasion suggests in-vivo folding or creasing of the device, which may be caused by continuous and sustained stresses to the device, such as an excessively small breast pocket or the folding or wrinkling of the shell within the breast pocket.In some cases, breast implants may also experience normal wear over time.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.You should consider the possibility of bia-alcl when a patient presents with late onset, persistent peri-implant seroma.In some cases, patients presented with capsular contracture or masses adjacent to the breast implant.When testing for bia-alcl, collect fresh seroma fluid and representative portions of the capsule, and sent to a laboratory with appropriate expertise for pathology test to rule out alcl, including immunohistochemistry testing for cd30 and alk (anaplastic lymphoma kinase).If your patient is diagnosed with peri-implant bia-alcl, develop an individualized treatment plan in coordination with a multidisciplinary care team.The national comprehensive cancer network (nccn) recommends surgical treatment that includes implant removal and complete capsulectomy ipsilaterally as well as contralaterally, where applicable.Report all confirmed cases of bia-alcl to the fda (https://www.Fda.Gov/safety/medwatch).Fda also recommends reporting cases of bia-alcl to the profile registry (https://www.Thepsf.Org/research/clinical-impact/profile.Htm) where you can submit more comprehensive data.Lastly, please notify mentor, because as the device manufacturer, we are collecting data on these cases as well.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, and that normal wear may have caused the observed defect.No corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals will be 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: henry boden ; 3041 skyway circle north; irving, TX 75038 ; 9497882078
• MDR Report Key: 23076626
• Report Number: 1645337-2025-10319
• Device Sequence Number: 13260973
• Product Code: FTR
• UDI-Device Identifier: 00081317001133
• UDI-Public: (01)00081317001133(17)161231(10)6533745
• 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: 2012
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 3544600
• Device Lot Number: 6533745
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 02/05/2026; 02/27/2026; 04/17/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 02/23/2026; 03/26/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2012
• 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: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White