MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND MODERATE PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3501680
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On march 24, 2026, mentor was provided with a scheduled explantation date.Date of explantation: on (b)(6) 2026.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 475cc mentor smooth round moderate profile saline breast implant prosthesis.Post-operatively, the patient was diagnosed with a deflated right implant during a physical exam which was suspected to have deflated during mammogram imaging.As a result, the patient was scheduled for implant removal on (b)(6) 2026.The date of implantation was provided to mentor as a best estimate.Mentor became aware that a discrepancy was observed when the information reported included a date of implantation that occurred prior to the manufacturing date of the breast implant.Follow-ups are being conducted.If more information becomes available, mentor will submit a supplemental report accordingly.
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: deflation date of explantation: (b)(6) 2026.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).
Additional Manufacturer Narrative
On march 04, 2026, mentor was notified that the patient surgery was cancelled and not rescheduled.Reason for device explant and/or reoperation: the patient has not undergone explantation or reoperation at this time.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.On march 23, 2026, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On april 28, 2026, mentor became aware that a duplicate file was reported under manufacturer¿s report number 1645337-2026-01725.All information has been transferred to this report and no further reports will be made in association with the duplicate.Updates: an updated explant date was provided.Date of explantation: (b)(6) 2026.(b)(6) 2026, mentor was notified that the patient underwent bilateral exchange with mentor gel implants during the revision surgery.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 01, 2026, the mentor analysis lab received the suspect medical device for evaluation.On june 09, 2026, mentor completed an evaluation on the returned device.Device evaluation: a thorough investigation was conducted.Visual analysis of the returned device revealed that the breast implant was found to have a tear on the anterior view, measuring approximately 0.3 cm.Leak testing was performed, in accordance with mentor procedures, and no additional leak sites were detected during the analysis.Microscopic examination was performed and instrument damage was not found.Therefore, a thickness measurement was conducted on the shell at the tear, and the thickness was within manufacturing specifications.The evaluation determined that the possible cause of the deflation is the trauma experienced.Deflation can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.Trauma is a known inherent risk of saline-filled mammary prosthesis.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.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND MODERATE PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• 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: 24398054
• Report Number: 1645337-2026-01823
• Device Sequence Number: 8158827
• Product Code: FWM
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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: 11/22/2008
• Device Catalogue Number: 3501680
• Device Lot Number: 5570564
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 03/04/2026; 03/24/2026; 04/28/2026; 06/01/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/24/2026; 03/26/2026; 05/22/2026; 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2004
• 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: 60 YR
• Patient Sex: Female
• Patient Race: White