MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SILTEX CONTOUR PROFILE SPECTRUM; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3542512
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
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.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: capsular contracture.Date of explantation: (b)(6) 2022.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a breast augmentation revision surgery with implantation of an unknown saline breast implant prosthesis.Post-operatively, the patient was diagnosed with baker grade iv capsular contracture of the right breast.As a result, the patient will undergo removal and a planned replacement with mentor gel implants on (b)(6) 2022.This report is for the right breast implant.Refer to manufacturing report number 1645337-2022-02670, for the contralateral event.
Additional Manufacturer Narrative
On april 13, 2022, the mentor failure analysis lab has received the suspect medical device for evaluation.The received device contained a blue solution.Upon review of additional information that was provided, the surgeon explained this was an intention use of methylene blue as it used to be used to aid in the detection of deflations.Per the instructions for use, mentor saline-filled breast implants are not intended to be filled with anything other than sterile, pyrogen free sodium chloride u.S.P.Solution for injection, and thus this device is used in a manner inconsistent with the ifu.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.On april 14, 2022, mentor received additional information indicating the patient had vague symptoms that could not be explained.With the limited information, it is being reported the patient has an unspecified generalized illness.At the present time, there is no sufficient evidence to show an association between breast implants and generalized illness (assessing the risks of breast implants and fda¿s vision for the national breast implant registry).Additionally, the patient underwent replacement with 325cc mentor smooth round moderate plus profile saline breast implants.On april 21, 2022, mentor received additional information that provided the identity of the device.Device name: 350cc mentor siltex contour profile spectrum.Catalog: 3542512.Lot: 229002.With the provided lot number, 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: generalized illness.H6 health effect - clinical code e2303: generalized illness.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On may 30, 2022, mentor completed an evaluation on the returned device.Mentor conducted a visual inspection of the device.Visual analysis of the returned sample revealed that the breast implant was found to have a tear on the anterior view, measuring approximately 1.3 cm.In addition, the shell of the product was colored blue.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.At the present time, there is no sufficient evidence to show an association between breast implants and generalized illness.(assessing the risks of breast implants and fda¿s vision for the national breast implant registry).As stated in the product insert data sheet, is contraindicated to place drugs or substances inside the implants other than sterile saline for injection since this could compromise the product integrity.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX CONTOUR PROFILE SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 13726949
• Report Number: 1645337-2022-02669
• Device Sequence Number: 5986003
• Product Code: FWM
• UDI-Device Identifier: 00081317002147
• UDI-Public: 00081317002147
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2005
• Device Model Number: 3542512
• Device Catalogue Number: 3542512
• Device Lot Number: 229002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 04/13/2022; 05/30/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 05/12/2022; 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2001
• 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: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White