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

Catalog Number	3543251
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Hematoma (1884)
Date of Event	12/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On march 7, 2025, mentor became aware that the patient underwent left side surgical intervention for evacuation of hematoma, and also experienced right side malposition of the breast implants.Coding has been added under section h accordingly on this form.Reason for device explant and/or reoperation: left rupture, and capsular contracture; baker grade iii, and implant site hematoma.This supplemental medwatch report is for the patient¿s left-sided device.Right side complication is being reported separately.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On april 11, 2025, photo evaluation was completed as follows: upon visual evaluation of the image provided in the complaint, the implant was observed ruptured.As the product involved in this complaint was not returned, the device could not be analyzed according to our procedures.Mentor also performed a manufacturing record evaluation related to the reported complaint for the finished device lot number.No manufacturing non-conformances were identified as part of this evaluation.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 the american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.Hematoma is a collection of blood within the space around the implant.Symptoms from hematoma may include swelling, pain, and bruising.If a hematoma occurs, it will most likely occur soon after surgery; however, it can occur at anytime, such as after an injury to the breast.Small hematomas may be absorbed by the body, while others may require surgery for drainage.Hematoma is a known complication associated with this procedure and is referenced in our 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: 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.This supplemental medwatch report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Since the device has not been returned for analysis, 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: left rupture, and capsular contracture; baker grade iii.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 40-year-old asian female patient underwent primary breast augmentation with 325cc mentor memorygel breast implant and experienced breast implant rupture, and capsular contracture; baker grade iii on her left side postoperatively; diagnosed after physical exam.The patient has consulted with the healthcare professional.As a result, the patient underwent bilateral replacement surgery with catalog number 3502751bc; serial number (b)(6) on the left side, and catalog number 3502751bc; serial number (b)(6) on the right side on (b)(6) 2024.
Additional Manufacturer Narrative
On may 21, 2025, the mentor failure analysis lab received the device for evaluation.On may 28, 2025, device evaluation was completed as follows: mentor conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned device revealed that the sx mpp gel 325cc breast implant had parallel lines of shell wear on the posterior view extending to the anterior view.In addition, a tear was noted on the posterior view extending to the anterior view within the shell wear measuring approximately 6.9 cm.A microscopic examination was performed and instrument damage was not found on the area of the tear.The evaluation determined that the possible cause of the rupture is consistent with normal wear.Shell wear suggests in-vivo folding or creasing of the device.This may be the result of the following factors: continuous and sustained stresses to the device such as too small breast pocket and folding or wrinkling of the shell in the breast pocket.In some cases, the breast implants may also wear out over time.Hematoma is a collection of blood within the space around the implant.Symptoms from hematoma may include swelling, pain, and bruising.If a hematoma occurs, it will most likely occur soon after surgery; however, it can occur at anytime, such as after an injury to the breast.Small hematomas may be absorbed by the body, while others may require surgery for drainage.Hematoma is a known complication associated with this procedure and is referenced in our 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, 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.This supplemental medwatch report is for the patient¿s left-sided device.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: 21509832
• Report Number: 1645337-2025-01898
• Device Sequence Number: 7962321
• Product Code: FTR
• UDI-Device Identifier: 00081317000877
• UDI-Public: (01)00081317000877(17)220308(10)7439782
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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: 03/08/2022
• Device Catalogue Number: 3543251
• Device Lot Number: 7439782
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 03/07/2025; 04/11/2025; 05/21/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/20/2025; 04/21/2025; 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2017
• 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 Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian