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

Catalog Number	SMHB500
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Pocket Erosion (2013); Deformity/ Disfigurement (2360); Post Operative Wound Infection (2446)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 29-year-old caucasian female patient underwent a breast augmentation revision with a 500cc mentor memorygel boost breast implant and experienced a rupture on the right side post-operatively, which was diagnosed during surgery.As a result, the patient underwent explantation on (b)(6) 2024.
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.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On february 28, 2024, mentor received additional information regarding the patient's diagnosis.It was reported that the patient also experienced a wound infection and device extrusion.The patient was seen in a follow-up after reporting a new onset right breast erythema, induration and seropurulent drainage.The patient experienced non-healing right t point dehiscence prompting and a large amount of seropurulent fluid was encountered within the breast.On march 06, 2024, the evaluation for the device was completed.Device evaluation summary: visual analysis of the returned sample revealed that the smooth mod high boost, 500 cc breast implant was found to have a tear on the anterior view measuring approximately 7.9 cm.A microscopic examination was performed, and the cause of the tear could not be identified.Therefore a thickness measurement was conducted on the shell at the tear, and the thickness was within manufacturing specifications.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were 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 at any time after implantation, but it is more likely to occur the longer the implant is implanted.The following things may cause the implant to rupture: damage by surgical instruments; 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.  implant displacement/migration may occur from improper implant sizing and/or placement, i.E., when the implant is too large or the pocket too small or when there has been inadequate preoperative assessment of stresses causing movement of the prosthesis.Implant displacement/migration is a known complication associated with these devices and is referenced in our current product insert data sheet.Infection, manifested by swelling, tenderness, pain and fever, may appear in the immediate postoperative period or at any time after insertion of the implant.In the absence of classic symptoms, subacute or chronic infections may be difficult to diagnose.If infection does not subside promptly with the appropriate treatment, removal of the implant is indicated.Infection is a known complication associated with any surgery.Per a database query, this is the only reported complaint of infection against this lot number.The mentor microbiology department has provided information on the sterility lot for the implanted device indicating that it met all sterilization parameters required to provide a 10e-6 sterility assurance level prior to release for distribution.Product evaluation concluded the reported infection occurred from a source other than the device.Infection is a known complication associated with any surgery and is referenced in our current product insert data sheet.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 complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 13, 2024, mentor received information by the healthcare provider that the patient will be having her replacement implanted on (b)(6) 2024.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BOOST 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: 18794166
• Report Number: 1645337-2024-02445
• Device Sequence Number: 7248472
• Product Code: FTR
• UDI-Device Identifier: 10081317031144
• UDI-Public: 10081317031144
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: 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: SMHB500
• Device Lot Number: 9979379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/28/2024; 06/13/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 03/15/2024; 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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: 29 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White