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

Catalog Number	3505320BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Pocket Erosion (2013)
Date of Event	09/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female who underwent a breast reconstruction primary with mentor memorygel, 320cc silicone prosthesis experienced right-sided symptomatic rupture, and device extrusion postoperative.The patient comes to consultation with an open wound from which a gel appears.An ultrasound is performed, and a rupture is observed.As a result, patient underwent removal on (b)(6) 2024.
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: symptomatic rupture, device extrusion 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).
Additional Manufacturer Narrative
Device evaluation completed on feb.04, 2025: the product was returned to mentor for evaluation. mentor then 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 smooth uhp 320cc breast implant.Leak testing was performed, in accordance with mentor procedures, and two tears (a and b) were noted on the anterior view measuring approximately 0.8 cm and 0.2 cm respectively.Microscopic examination was performed on the edges of tears a and b.Parallel striations measuring less than 0.1 cm were found in an area of tear a.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 ]tear a could not be identified, and parallel striations were found in the whole area of tear b.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.  based on the information currently available, a microscopic examination of tear b indicates that the implant could have been damaged during or subsequent to implantation.The product insert data sheet cautions not to allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps or scissors to contact the device during the implantation or other surgical procedures.Extrusion may occur when the wound has not closed or when the tissue covering the implants weakens.The incidence of extrusion has been shown to increase when undue pressure is applied on the tissue located over the device, trauma to surrounding tissues may lead to thrombosis, delayed wound healing, improper size, placement, larger sized implants, use of steroids in the surgical pocket and microwave diathermy.Radiation therapy has been reported to increase the likelihood of extrusion.Extrusion may require additional surgery and possible removal of the implant, which may result in additional scarring and/or loss of breast tissue.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
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 MEMORYGEL 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 20569707
• Report Number: 1645337-2024-12761
• Device Sequence Number: 7988538
• Product Code: FTR
• UDI-Device Identifier: 00081317006916
• UDI-Public: (01)00081317006916(11)230801(17)280729(10)9942934
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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 Catalogue Number: 3505320BC
• Device Lot Number: 9942934
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: 01/28/2025; 02/04/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 01/29/2025; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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: 47 YR
• Patient Sex: Female