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

Catalog Number	3544475
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On june 14, 2024, mentor received additional information indicating that the patient's implants were intact upon removal.The patient as diagnosed with ptosis and asymmetry.In addition, the patient's race and ethnicity were also provided.
Additional Manufacturer Narrative
On june 3, 2024, the mentor failure analysis lab received the device for evaluation.On june 10, 2024, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the siltex hpg, 475cc breast implant was found to be ruptured.Microscopic examination was performed and the cause of the tear could not be identified.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Although no conclusion could be reach on the cause of the reported event, the instructions for use contain the following caution: rupture can occur at any time after implantation but is more likely to occur the longer the implant is implanted.The following may cause 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 simply wear out over time.A second product was received (lot-6824182).No adverse events were reported for this concomitant (contralateral) device, therefore no further analysis is required.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No corrective and preventive action (capa) is required now.
Additional Manufacturer Narrative
On july 3, 2024, the product investigation was updated.Investigation summary was updated with the addition of the following statements: asymmetry may be attributed to one or more of the following: contracture of the fibrous capsule, seroma or hematoma, development of postoperative breast dysplasia, unilateral discrepancy in muscle development, deflation of the implant, incorrect choice of implant shape or size, and surgical technique.Asymmetry is a known complication associated with these devices and is referenced in our current product insert data sheet.Some breast ptosis is a normal component of the mature breast.Ptosis becomes undesirable when the breast parenchyma predominates below the areola, droops considerably below the inframammary fold and the nipple points downward.Augmentation alone, without consideration of the ptosis can produce a less than desirable cosmetic result known as a "rock in sock" deformity or an increased ptotic appearance.Ptosis is a known complication associated with these devices and is referenced in our current product insert data sheet.
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: material 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 or Problem Description
It was reported that a patient underwent primary breast augmentation with two 475cc mentor memorygel breast implants.Post-operatively, the patient was diagnosed, via physical examination, with left breast implant rupture.As a result, the patient underwent bilateral breast implant removal and replacement surgery on may 7, 2024.The replacement devices were: (left) 585cc mentor memorygel boost breast implant catalog: shpb585 lot: 9987091 sn: (b)(6) and (right) 585cc mentor memorygel boost breast implant catalog: shpb585 lot: 9987091 sn:(b)(6).

• 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: 19361587
• Report Number: 1645337-2024-06062
• Device Sequence Number: 11704749
• Product Code: FTR
• UDI-Device Identifier: 00081317003946
• UDI-Public: 00081317003946
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• 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: 04/30/2019
• Device Catalogue Number: 3544475
• Device Lot Number: 6816208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 06/03/2024; 06/14/2024; 07/03/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/11/2024; 06/27/2024; 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2014
• 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: 34 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American, Asian