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

Catalog Number	3502375
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Deformity/ Disfigurement (2360)
Date of Event	08/12/2025
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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent primary breast augmentation with two 375cc mentor smooth round moderate plus profile saline breast prostheses.Post-operatively, the patient was diagnosed, via physical examination, with left breast implant deflation.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On september 17, 2025, mentor received additional information indicating that the patient has been scheduled for breast implant removal surgery on (b)(6) 2025.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.Reason for device explant and/or reoperation: material rupture.
Additional Manufacturer Narrative
On october 10, 2025, mentor received additional information indicating that the patient's implants were replaced bilaterally with two mentor saline implants.On october 16, 2025, mentor also received additional information indicating that the patient was also diagnosed with left breast capsular contracture (baker grade iii).Reason for device explant and/or reoperation: material rupture, capsular contracture.
Additional Manufacturer Narrative
On december 5, 2025, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection, leak testing, and microscopic examination 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 a tear was noted on the anterior view measuring approximately 0.1 cm.In addition, no more leak sites were noted after leak testing.Microscopic examination was performed and the cause of the deflation could not be identified.As the authorization form for examination was not received, the shell thickness could not be measured.The evaluation was limited to non-destructive testing.Mentor also performed a manufacturing record evaluation related to the reported complaint for the finished device lot number.No manufacturing non-conformance's were identified as part of this evaluation.Although no conclusion could be reach on the cause of the reported event, the instructions for use contain the following caution: causes of deflation of saline implants include but are not limited to the following events: crease fold failure, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma such as that which can occur during vigorous exercise, athletics, etc.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 contralateral device was also received (lot number 6409110).The patient did not report any issue with this device.Therefore, no further analysis of the contralateral device is required.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 Manufacturer Narrative
On november 6, 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.

• Brand Name: MENTOR SMOOTH ROUND MODERATE PLUS 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: 22983592
• Report Number: 1645337-2025-09845
• Device Sequence Number: 9256846
• Product Code: FWM
• UDI-Device Identifier: 00081317001423
• UDI-Public: (01)00081317001423(17)140930(10)6413476
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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: 09/30/2014
• Device Catalogue Number: 3502375
• Device Lot Number: 6413476
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 10/10/2025; 11/06/2025; 12/05/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/05/2025; 10/24/2025; 11/26/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2010
• 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; Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native