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

Catalog Number	3541208
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Deformity/ Disfigurement (2360)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
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: insufficient information.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 underwent a primary breast augmentation surgery with implantation of a 280cc mentor memoryshape breast implant prosthesis.Post-operatively, the patient underwent bilateral implant removal without replacement on (b)(6) 2025, for an undisclosed reason.However, during the surgery, a ruptured right implant was discovered.There were no reported procedural delays or patient consequences due to the finding.Follow-ups have been conducted, and no additional information has been received.If more information becomes available, mentor will submit a supplemental report accordingly.
Additional Manufacturer Narrative
On october 08, 2025, mentor was notified that the patient had presented with firm breasts and a ruptured right implant.She was diagnosed with bilateral capsular contracture (baker grade ratings were not provided).Reason for device explant and/or reoperation: rupture, capsular contracture as an event for the contralateral side was indicated, another file was generated to document the event.This report is for the right breast prosthesis.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On september 18, 2025, the mentor analysis lab received the suspect medical device for evaluation.On september 26, 2025, mentor completed an evaluation on the returned device.Device evaluation: mentor conducted a visual inspection of the device.Visual analysis of the returned device revealed that the breast implant was found to have a tear on the anterior view extending to the posterior view, measuring approximately 9.7 cm.As the authorization form for examination was not received, the product evaluation lab could not reach a conclusion regarding the specific nature of the ruptures.The evaluation was limited to non-destructive testing.Although no conclusion could be reach on the cause of the reported event, the instructions for use contain the following caution: rupture can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.The following things may cause implant to rupture: damage by surgical instruments; stressing the implant during implantation and weakening it; folding or wrinkling of the implant shell; excessive force to the chest (e.G.During closed capsulotomy); trauma; compression during mammographic imaging; and severe capsular contracture.Breast implants may also simply wear out over time.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 24, 2025, mentor completed an evaluation on the returned device.Device evaluation: as the authorization form for examination was received, mentor conducted a microscopic examination and mechanical testing of the device.A microscopic examination was performed, and the cause of the tear could not be identified.Mechanical testing was conducted on complaint sample including tension set to evaluate the residual elongation, joint strength to examine the ability of the shell/patch bond to withstand stress while the shell material adjacent to the bond is elongated, and tensile/elongation to measure the inherent material behavior.All testing results met or exceeded international standards.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.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: henry boden ; 3041 skyway circle north; irving, TX 75038 ; 9497882078
• MDR Report Key: 23067049
• Report Number: 1645337-2025-10250
• Device Sequence Number: 9681057
• Product Code: FTR
• UDI-Device Identifier: 00081317005452
• UDI-Public: (01)00081317005452(17)190331(10)6811933
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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

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: 03/31/2019
• Device Catalogue Number: 3541208
• Device Lot Number: 6811933
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 09/18/2025; 10/08/2025; 11/24/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/02/2025; 10/23/2025; 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2014
• 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: 27 YR
• Patient Sex: Female