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

Model Number	3544800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/28/2014
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.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, infection.Date of explantation: (b)(6) 2021.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old mixed-race (caucasian, african american, indian, hispanic/latino) female patient underwent a primary breast reconstruction with two 800cc mentor memorygel breast implant prostheses and suffered several unexplained systemic symptoms postoperatively.The symptoms are breast pain, memory loss, headaches, tissue tenderness, sleep disturbance, burning sensation, mental distress, inflammation, difficulty concentrating, necrosis and infection (twice), hypothyroidism, skin rash, left implant is visibly moved and wrinkled on side, scarring, fatigue, hot by touch, discomfort wearing clothes, and sensitive skin.No device issue was reported.The root cause of the patient¿s symptoms is unclear.As a result, the patient is scheduled to undergo explantation on (b)(6) 2021.The event date was estimated as (b)(6) 2014 based on available information.This report is for the right-sided prosthesis.
Additional Manufacturer Narrative
On 15-oct-2021, mentor received additional information regarding the patient¿s symptoms.The patient experienced left-sided rupture.The patient stated that ct scan and sonogram performed on (b)(6) 2021 indicated left-sided rupture.In addition, the patient suspects that her left kidney is having an issue (unspecified) due to this rupture.The root cause of the patient¿s left kidney issue is unclear.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 12-nov-2021, mentor received additional information regarding the patient¿s symptoms and revision surgery.The patient experienced bilateral capsular contracture (grade unknown) and breast pain.The patient underwent bilateral removal without replacement on 1-nov-2021.The relevant field has been updated.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 7-feb-2021, mentor received additional information regarding the event, the patient¿s information, and the reporting status to the fda.Manufacture report number 1645337-2021-13365 has been identified as a duplicate of this report, 1645337-2021-11494.Final regulatory reporting will be performed through manufacturing report number 1645337-2021-11494.The patient¿s middle name is (b)(6).The patient¿s addresses is (b)(6).The patient reported the event to the fda on (b)(6) 2021.The relevant fields have been updated.On 18-feb-2022, the suspected medical device was returned for evaluation.On 3-feb-2022 or 2-feb-2022, the investigation on the suspected medical device was completed.Investigation summary: mentor conducted a visual inspection of the returned device.During visual evaluation, no apparent damage or visual anomalies were observed on the 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.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 the 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.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 part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer's reference number: (b)(4).

• 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 12637327
• Report Number: 1645337-2021-11494
• Device Sequence Number: 11892675
• Product Code: FTR
• UDI-Device Identifier: 00081317001164
• UDI-Public: 00081317001164
• 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: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/21/2021

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: 10/08/2019
• Device Model Number: 3544800
• Device Catalogue Number: 3544800
• Device Lot Number: 6867593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 10/15/2021; 11/12/2021; 02/07/2022
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/08/2021; 12/06/2021; 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2014
• 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: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: Black Or African American, White