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

Model Number	3544457MC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Granuloma (1876); Deformity/ Disfigurement (2360)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explantation date: (b)(6) 2023.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 47-year old caucasian female patient underwent breast augmentation revision with a 445cc mentor memorygel breast implant on the right breast.Post-operatively, the patient was diagnosed, via physical examination, with right breast implant rupture.As a result, the patient has been scheduled for breast implant removal surgery on (b)(6) 2023.
Additional Manufacturer Narrative
On july 10, 2023, mentor received additional information indicating that the patient was also diagnosed with two enlarged lymph nodes in the right axilla, and right breast capsular contracture (baker grade iv).The right breast was palpable, has visible deformity, and pain.In addition, the patient was also diagnosed with left breast cyst, lymphadenopathy, and left breast implant gel bleed.The patient's implants were replaced bilaterally with two 650cc mentor silicone implants.On july 21, 2023, the mentor failure analysis lab received the device for evaluation.On july 26, 2023, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the sx mod classic gel, 445cc breast implant had an area of siltex cracking on the posterior view.In addition, a tear was noted within the siltex cracking measuring approximately 1.8 cm.The evaluation determined that the cause of the rupture is consistent with normal wear.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Siltex cracking is ultimately a result of high stresses.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, capsules, and effusion to pathology for examination.Granulomas are noncancerous nodules that are a common tissue reaction to the presence of a variety of foreign materials, such as silicone.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Capa activity was not required.This medwatch form is for the right breast prosthesis.Complications on the left breast will be reported under mrn: 1645337-2023-08941.

• 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: 16955975
• Report Number: 1645337-2023-05918
• Device Sequence Number: 3466134
• Product Code: FTR
• UDI-Device Identifier: 00081317004462
• UDI-Public: 00081317004462
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 04/30/2016
• Device Model Number: 3544457MC
• Device Catalogue Number: 3544457MC
• Device Lot Number: 6462503
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2011
• 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: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White