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

Catalog Number	3544475
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Granuloma (1876); Breast Mass (2439); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On june 07, 2024, 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).
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.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.Reason for device explant and/or reoperation: rupture, granuloma date of explantation: (b)(6) 2024 manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a primary breast augmentation surgery with implantation of a 475cc mentor memorygel breast implant prosthesis.Post-operatively, the patient was diagnosed with bilaterally ruptured breast implants using magnetic resonance imaging.Subsequently, a lymph node biopsy was performed and the patient was diagnosed with granulomas of the breasts.As a result, the patient is scheduled for bilateral breast implant removal and replacement on (b)(6) 2024.This report is for the left breast prosthesis.Refer to manufacturing report number 645337-2024-04265 for the contralateral event.
Additional Manufacturer Narrative
On may 16, 2024, mentor received the following additional information.It was reported that the granuloma was only present in the right axillae per ultrasound imaging and the biopsy was only performed on the right breast.Additionally, per magnetic resonance imaging, there was implant site fluid collection both breasts and a left breast mass.The patient underwent bilateral replacement with 500cc mentor memorygel breast implants during the removal surgery.As this report is for the left breast, surgical intervention and granuloma are no longer applicable.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 26, 2024, mentor completed an evaluation on the returned device.Mentor conducted a visual inspection and microscopic examination of the device.Visual analysis of the returned sample revealed that the breast implant was found to have a tear at the junction between the shell and patch.A microscopic examination was performed, and the cause of the tear could not be identified.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: rupture can occur after implantation but is more likely to occur the more prolonged the implant is implanted.The following may cause the implant to rupture: stressing the implant during implantation and weakening it; folding or wrinkling of the implant shell; excessive force to the chest (e.G.During closed capsulotomy); trauma; compression during mammographic imaging; and severe capsular contracture.Breast implants may also wear out over time.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: 19074521
• Report Number: 1645337-2024-04266
• Device Sequence Number: 19997821
• Product Code: FTR
• UDI-Device Identifier: 00081317003946
• UDI-Public: 00081317003946
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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: 01/21/2021
• Device Catalogue Number: 3544475
• Device Lot Number: 7282508
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 06/07/2024; 06/26/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 06/01/2024; 06/21/2024; 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2016
• 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: 53 YR
• Patient Sex: Female