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

Catalog Number	3542680
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Breast Discomfort/Pain (4504)
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 is in progress.Once completed, a supplemental report will be submitted.D4: udi: product made prior to udi compliance date.Udi not required.Reason for device explant and/or reoperation: breast discomfort/pain, deflation 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 underwent a breast augmentation surgery with implantation of a 475cc mentor siltex round moderate profile saline breast implant prosthesis.Post-operatively, the patient experienced left breast pain and discomfort in addition to a deflated left implant.As a result, the patient underwent breast implant removal without replacement on (b)(6) 2025.
Additional Manufacturer Narrative
On september 29, 2025, mentor completed an evaluation on the returned device.Device evaluation: mentor conducted visual inspection of the device.Visual analysis of the returned device revealed that the breast implant had a line of shell wear on the anterior view.In addition, a tear was noted within the shell wear measuring approximately 0.2 cm.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 continuous and sustained stresses to the device.Most women undergoing augmentation or reconstruction with a mammary prosthesis will experience some pain postoperatively.While pain normally subsides in most women as they heal from surgery, it can become a chronic problem in other women.Chronic pain can be associated with a variety of factors.Surgeons should instruct their patients to inform them if there is significant pain or if pain persists.Pain is a known complication associated with these devices and is referenced in our current product insert data sheet.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 august 05, 2025, the mentor failure analysis lab has 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).

• Brand Name: MENTOR SILTEX 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: 22677297
• Report Number: 1645337-2025-08375
• Device Sequence Number: 15740630
• Product Code: FWM
• UDI-Device Identifier: 00081317001836
• UDI-Public: 00081317001836
• 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: 1997
• 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

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: 07/31/2005
• Device Catalogue Number: 3542680
• Device Lot Number: 162395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 09/29/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/19/2025; 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/1997
• 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 Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White