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

Catalog Number	3503310
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Deformity/ Disfigurement (2360)
Date of Event	06/04/2025
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.Since no lot number was provided, no manufacturing record evaluation could be performed.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.D4: udi: as the catalog/model number was not provided, the (01) gtin is not available.Reason for device explant and/or reoperation: rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient with unspecified mentor gel breast implants and experienced rupture on the left side post-operatively, which was confirmed during a physical exam.As a result, the patient underwent device removal and replacement.
Additional Manufacturer Narrative
On july 22, 2025, the mentor failure analysis lab received the device for evaluation.Per device received, and review performed, the following fields have been updated on this form: field d1 for brand name has been updated to "mentor smooth round high profile" field d2a for common device name has been updated to "prosthesis, breast, inflatable, internal, saline." field d2b for procode has been updated to "fwm" field d4 for catalog number has been updated to "3503310" field d4 for lot number has been updated to "6584639" field d4 for unique identifier( udi) has been updated to "(b)(4)." d4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.Field g4 for pma/ 510(k) has been updated to "p990075" clinical code " implant site calcification" has been added under field h6 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.Mentor is aware that the date of implant is before the manufacture date of lot 6584639.If any clarification or information is received in the future, a supplemental report will be submitted.Reason for device explant and/or reoperation: left deflation, and implant site calcification.On august 1, 2025, device evaluation was completed as follows: mentor conducted visual inspection and leak testing of the returned device.Visual analysis of the returned device revealed that the breast implant had a crease/fold on the anterior view.Leak testing was performed, according to mentor procedure, and it identified a tear within the crease/fold measuring approximately 0.6 cm on the anterior view.The evaluation determined that the possible cause of the rupture is consistent with normal wear.Deflation can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.Creating wrinkles or folds should be avoided during implantation or other procedures as it can result in a deflation in a later time.Breast implants may also simply wear out over time.The contralateral device was also received (lot number 6476020).The patient did not report any issue with this device.Therefore, no further analysis of the contralateral device is required.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, and that normal wear may have caused the observed defect.No corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND HIGH 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: 22383160
• Report Number: 1645337-2025-07251
• Device Sequence Number: 12526131
• Product Code: FWM
• UDI-Device Identifier: 00081317001638
• UDI-Public: 00081317001638
• 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: 2012
• 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

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: 04/30/2016
• Device Catalogue Number: 3503310
• Device Lot Number: 6584639
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2012
• 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: 45 YR
• Patient Sex: Female