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

Catalog Number 3543001

Device Problems Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 03/18/2024

Event Type  Injury  

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: 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.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).

Event Description

It was reported that a patient implanted with a 300cc (left), 250cc (right), mentor memorygel breast implant experienced bilateral ruptures and capsular contracture baker grade 4 on the right side post-operatively.As a result, the patient underwent explantation on (b)(6) 2024.This report is for the left side device.

Manufacturer Narrative

Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the sx mpp gel 300cc breast implant.Leak testing was performed, in accordance with mentor procedures, and no areas of gel exposure were detected during the analysis.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: rupture status identified by mri evaluation includes both suspected ruptures, which are those ruptures identified by mri but not confirmed by explantation and examination of the device, and confirmed ruptures, which are those ruptures that are confirmed by evaluation of the explanted devices.The event described could not be confirmed as the breast implant was returned without detectable gel exposure.Although no product defect 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 to approved specifications.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).

Manufacturer Narrative

Mentor became aware the patient did not experience any rupture.Coding has been updated.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Type of Device: 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: 19082007
• MDR Text Key: 339845215
• Report Number: 1645337-2024-04346
• Device Sequence Number: 1
• Product Code: FTR
• UDI-Device Identifier: 00081317000860
• UDI-Public: 00081317000860
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• 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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 3543001
• Device Lot Number: 6401064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/24/2024; Not provided
• Supplement Dates FDA Received: 04/29/2024; 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female