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

Model Number	3542512
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that (b)(6) old caucasian female patient underwent a breast augmentation revision surgery with implantation of a 350cc mentor siltex contour profile spectrum saline breast implant prosthesis.Post-operatively, the patient was diagnosed with a ruptured left breast implant.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 left breast implant.Refer to manufacturing report number 1645337-2022-02669 for the contralateral event.
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: deflation date of explantation: (b)(6) 2022.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On april 13, 2022, the mentor failure analysis lab has received the suspect medical device for evaluation.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 may 05, 2022, mentor completed an evaluation on the retuned device.Mentor then conducted a visual inspection and microscopic examination of the device.Visual analysis of the returned sample determined that two tears (a and b) were found on the posterior aspect of the breast implant, tear (a) was found within the patch, and tear (b) was found between the union of the shell and patch.Microscopic examination was performed on the edges of the rupture (a), and parallel striations were found in the whole area of the tear (a).Parallel striations are consistent with markings made by a sharp object perforating the implant shell.The microscopic examination was performed and the cause of rupture (b) could not be identified.Based on the information currently available, microscopic examination of the rupture (a) indicates that the implant could have been damaged during or subsequent to implantation.The product insert data sheet cautions to not allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps, or scissors to contact the device during the implantation or other surgical procedures.Although no conclusion could be reached on the cause of the ruptured (b), the instructions for use contain the following caution: causes of deflation of saline implants include but are not limited to the following events: crease fold failure, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma such as that which can occur during vigorous exercise, athletics, etc.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).Reason for device explant and/or reoperation: generalized illness h6 health effect - clinical code e2303: generalized illness.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: 13727029
• Report Number: 1645337-2022-02670
• Device Sequence Number: 6055160
• 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: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• 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: 03/19/2020
• Device Model Number: 3542512
• Device Catalogue Number: 3542512
• Device Lot Number: 7305444
• 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
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2016
• 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