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

Model Number	3545295
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2020
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: breast asymmetry.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a breast augmentation revision with 295cc mentor memorygel breast implants and experienced postoperative right-sided breast lump.On (b)(6) 2020, the patient was diagnosed with right-sided rupture via mammogram and ultrasound.Tissue from the patient's right and left capsules were tested, and the findings identified inflamed tissue with no malignancy.As a result, the patient underwent bilateral explantation on (b)(6) 2020 and did not receive replacement devices.This report is for the patient's left-sided device.
Additional Manufacturer Narrative
On 4/21/2020, mentor became aware that incorrect due date of 5/1/2020 was inadvertently reported under previous submission.The correct due date for the follow up 1 report is 5/20/2020.This supplemental report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
After clinical/secondary review of this file performed on 4/20/2020, it was decided to remove breast mass code and add granuloma and capsular contracture codes to the right side and also remove anisomastia from the left side and add breast implant prophylactic removal code to more accurately capture the reported event.Event description has also been updated under field b5 after clinician's review.This supplemental report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported from the us that a 56-year-old female patient of an unknown ethnicity who underwent breast augmentation revision implant surgery with mentor medical devices (siltex uhp 295cc, date of implant (b)(6) 2013 has experienced right breast implant rupture, capsular contracture, and granuloma.An ultrasound that was performed displayed 9 separate silicone granulomas of the right breast extending from the axillary tail down along the lateral chest wall with the lowest and largest at 1 and 8 o¿clock corresponding to the mass felt by the patient.As a result, the patient underwent explanation of the devices on (b)(6) 2020.The left breast implant was removed prophylactically because the doctor had a suspicion that the patient had bia-alcl.As per the operative report, the doctor reports that the right-side capsule was thickened and abnormal looking.He stated that he feared that the patient might have bia-alcl and therefore did a bilateral total capsulectomy.Both capsules were sent to the lab and results showed inflamed tissue with no malignancy.
Additional Manufacturer Narrative
This supplemental report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
After clinical/secondary review of this file performed on july 20, 2023, it was decided to remove "medical device removal" and "new patient code", and add "no adverse event"to more accurately capture the reported event.Per the information provided, the left breast implant was removed prophylactically due to fear of bia-alcl, but there was no issue with the left breast.Manufacturer¿s reference number: (b)(4) coding corrections made under section h per clinician's review.
Additional Manufacturer Narrative
Per clinician's review, medical device problem code has been correctly updated under field h6 to "adverse event without identified device or use problem" to more accurately capture the reported event.This supplemental report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).Corrected device problem code under h6.

• 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 ; 949789-8687
• MDR Report Key: 9970047
• Report Number: 1645337-2020-05415
• Device Sequence Number: 2077250
• Product Code: FTR
• UDI-Device Identifier: 00081317007104
• UDI-Public: 00081317007104
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/01/2020

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: 09/12/2017
• Device Model Number: 3545295
• Device Catalogue Number: 3545295
• Device Lot Number: 6633486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 04/21/2020; 04/21/2020; 07/20/2023; 07/25/2023; 07/27/2023
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 04/21/2020; 04/21/2020; 07/25/2023; 07/25/2023; 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2012
• 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: 56 YR
• Patient Sex: Female