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

Catalog Number	3501690
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Deformity/ Disfigurement (2360)
Date of Event	02/24/2025
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: 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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 49-year-old caucasian female patient underwent a breast augmentation revision with a 575cc mentor smooth round moderate profile saline breast prosthesis and experienced a deflation on the left side post-operatively, which was diagnosed with a physical exam.As a result, the patient underwent explantation on (b)(6) 2025.
Additional Manufacturer Narrative
On march 31, 2025, the mentor failure analysis lab has received the device for evaluation.On april 07, 2025, the evaluation for the device was completed.Device evaluation summary: visual analysis of the returned device revealed a crease/fold on the posterior view of the sal smooth rnd diap 575cc breast implant.Leak testing was performed, in accordance with mentor procedures, and no leak sites were detected during the analysis.The event described could not be confirmed as the breast implant was returned without detectable leaks sites.Although no leakage 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.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).
Additional Manufacturer Narrative
On april 21, 2025, mentor received additional information regarding the event.The patient's healthcare provider a copy of the patient's mammogram which reported that the patient also had a few benign round calcifications present.Code e230901 has been added in section h6-health effect - clinical code to document this additional information.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On july 01, 2025, a re-evaluation for the device was completed.Device re-evaluation summary: visual analysis of the returned device revealed a crease/fold on the posterior view of the sal smooth rnd diap 575cc breast implant.Leak testing was performed, in accordance with mentor procedures, and no leak sites were detected during the analysis.The event described could not be confirmed as the breast implant was returned without detectable leaks sites.Although no leakage 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.Calcification and breast imaging calcification of a biomaterial occurs when calcium salts are deposited in the tissue capsule surrounding the implanted device.Calcification occurs in association with a wide variety of implanted prostheses, including breast implants, heart valves, vascular grafts, and soft contact lenses, as well as in the mature breast tissue of women that have not undergone breast surgery.Calcification of the fibrous capsule that may occur following implantation of breast prostheses is generally not of clinical significance, although it may exacerbate symptoms of capsular contracture.Concern has been raised, however; that calcification may interfere with tumor detection, because microcalcifications are considered a halfmark of malignant breast disease.Although clinicians have recommended pre- and post-surgical mammograms for augmentation patients to assist in distinguishing post-operative findings from calcification associated with malignancy, benign calcification resulting from surgery is generally considered distinguishable from malignant-type calcification.Further, no published reports were identified that document any actual occurrences of missed or delayed diagnoses attributable to capsular calcification.Calcification is not a phenomenon unique to breast implants.It occurs in 11 to 53 percent of women who underwent breast reduction procedures (abboud et aj.1995, m&nick et al.1990, brown et al.1987).In the breasts of women who have not undergone any breast surgery, the prevalence of benign calcifications increases progressively with age from 8 percent in women 25 to 29 years old up to 86 percent in women 75 to 79 years old (stomper et al.1996).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 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 21627593
• Report Number: 1645337-2025-02828
• Device Sequence Number: 8266376
• Product Code: FWM
• UDI-Device Identifier: 00081317001317
• UDI-Public: (01)00081317001317(17)210613(10)7479536
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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: 06/13/2021
• Device Catalogue Number: 3501690
• Device Lot Number: 7479536
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 03/31/2025; 04/21/2025; 07/01/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/08/2025; 05/13/2025; 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2017
• 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: 49 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White