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

Catalog Number	3341257
Medical Device Problem Codes	Gel Leak (1267); Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	03/22/2024
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.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
It was reported that a patient who underwent a primary breast augmentation procedure with a mentor memoryshape breast implant 330cc gel breast prosthesis developed capsular contracture (baker grade unknown) in her right breast post implantation.The capsular contracture was diagnosed during an office visit.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On 15-apr-2024, mentor received additional information about the event.It was reported that there is possible bilateral rupture of the patient¿s breast prostheses due to ¿physical abuse trauma¿.This medwatch report is for the patient¿s right breast prosthesis.Refer to manufacturer report number 1645337-2024-05190 for the report for the patient¿s left breast prosthesis.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 05-sep-2025, mentor received additional information about the event: the patient developed baker grade iv capsular contracture.The patient was scheduled to undergo explantation on (b)(6) 2025.Reason for device explant and/or reoperation: capsular contracture, possible breast prosthesis rupture.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 23-sep-2025, mentor received additional information about the event: the patient¿s explanted breast prostheses were replaced with mentor memorygel boost breast implant 390cc gel breast prostheses.The baker grade iv capsular contracture was reported to be in the patient¿s right breast only.Both breast prostheses were removed intact.However, there was a moderate amount of gel bleed on both, more on the right versus the left.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 07-oct-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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 05-nov-2025, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient experienced a rupture in the breast implant after physical abuse, but the implant was removed intact.However, there was a moderate amount of gel bleed on the implant.Additionally, the patient developed capsular contracture.The product was returned to mentor for evaluation.Mentor conducted visual inspection and leak testing of the returned device.Visual analysis of the returned device revealed that no damage or anomalies were observed on the breast implant.Leak testing was performed, in accordance with mentor procedures, and no areas of gel exposure or gel bleed were detected during the analysis.The event described could not be confirmed as the breast implant was returned without detectable gel exposure or gel leaks.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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.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: 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 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 19074479
• Report Number: 1645337-2024-04267
• Device Sequence Number: 20539586
• Product Code: FTR
• UDI-Device Identifier: 00081317004943
• UDI-Public: 00081317004943
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• 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,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: 01/25/2021
• Device Catalogue Number: 3341257
• Device Lot Number: 7285965
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: 04/15/2024; 09/05/2025; 09/23/2025; 10/07/2025; 11/05/2025
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/01/2024; 09/22/2025; 10/06/2025; 10/23/2025; 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2016
• 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: Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White