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

Model Number	SMPX645
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 57-year old caucasian female patient underwent primary breast augmentation with a 645cc mentor memorygel breast implant on the right breast, suffered right breast that has gotten larger, firmer and sore, post-operatively.The patient was given an unspecified medication.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: n/a 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
On september 29, 2022, mentor received additional information indicating that the patient's capsular contracture is baker grade iv.On september 30, 2022, mentor received additional information indicating that the patient has been scheduled for breast implant removal surgery on (b)(6) 2022.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.Reason for device explant and/or reoperation: capsular contracture.
Additional Manufacturer Narrative
On december 21, 2022, mentor received additional information indicating that the patient's right breast also suffered from malposition and dog ear deformity.During the revision surgery on (b)(6) 2022, the patient underwent capsulectomy, dog ear excision, and breast implant exchange with a 645cc mentor silicone implant.On january 3, 2023, the mentor failure analysis lab 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.
Additional Manufacturer Narrative
On january 17, 2023, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted visual inspection of the returned device.During visual evaluation, no apparent damage or visual anomalies were observed on the smooth mod + prof xtra 645cc returned device.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.

• 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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 15432363
• Report Number: 1645337-2022-10875
• Device Sequence Number: 14871066
• Product Code: FTR
• UDI-Device Identifier: 00081317025153
• UDI-Public: 00081317025153
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2026
• Device Model Number: SMPX645
• Device Catalogue Number: SMPX645
• Device Lot Number: 9589085
• 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: 08/24/2022
• Supplement Date Received by Manufacturer: 09/29/2022; 12/21/2022; 01/17/2023
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/06/2022; 01/12/2023; 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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: Other; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White