MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BOOST BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	SHPB325
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/16/2025
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: silent rupture 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
A female patient who underwent breast augmentation revision with mentor memorygel, boost 325cc silicone prosthesis experienced a left-sided silent rupture and right-sided device malposition post-operation.Consequently, she had a left-sided replacement with catalog number shpb325 and serial number (b)(6) , along with a right-sided revision that included the application of tigr mesh and an autogenous fat graft from her trochanters to her breasts on (b)(6) 2025.This report relates to the left side.
Additional Manufacturer Narrative
Suspect device received on june 17, 2025.Device evaluation completed on june 24, 2025: the product was returned to mentor for evaluation.Mentor conducted a visual inspection, and microscopic examination of the returned device.Visual analysis of the returned device revealed that the smo ro high pro boost gel325cc breast implant was found to be ruptured.Microscopic examination was performed on the edges of the rupture, and parallel striations measuring approximately 0.3 cm were found in an area of the tear on the anterior aspect.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.The cause of the rupture in the remaining area of the tear could not be identified.Mentor also performed a manufacturing record evaluation related to the reported complaint for the finished device lot number.No manufacturing non-conformances were identified as part of this evaluation.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.The manufacturing record evaluation (mre) was reviewed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.Correction: on july 8, 2025, the mentor became aware that the initial report section b5, mistakenly reported date of removal as (b)(6) 2025.The correct date of removal is (b)(6) 2025.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BOOST BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: 22190929
• Report Number: 1645337-2025-06446
• Device Sequence Number: 20972964
• Product Code: FTR
• UDI-Device Identifier: 10081317030659
• UDI-Public: (01)10081317030659(11)240401(17)290331(10)9988464
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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 Catalogue Number: SHPB325
• Device Lot Number: 9988464
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White