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

Catalog Number	3545700
Medical Device Problem Codes	Off-Label Use (1494); Migration (4003)
Health Effect - Clinical Codes	Capsular Contracture (1761); Neurological Deficit/Dysfunction (1982); Breast Mass (2439); No Code Available (3191)
Date of Event	05/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: capsular contracture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female who underwent primary breast augmentation post procedure with 700cc mentor memorygel breast implants began experiencing problems shortly following the procedure.She stated that when she would flex her left sided muscle the muscle would move upwards, but the implant would stay in place.On (b)(6) 2012 a capsulectomy was performed and the same implant was re-used.The explanting surgeon stated there was an unspecified deformity.The re-use of these implants is off label use.After the capsulectomy the implant had ripped through the breast wall (not skin), caused extreme rippling, and dent / lumps where the implant is bottoming out.Also, pain and burning in the left breast described as an electricity sensation was present.Imaging was performed and did not show a rupture, however, did indicate the presence of slight tumors.The patient has stated that she suspects breast implant illness.However, the root cause of the patient¿s symptoms is unclear.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report relates to the left prosthesis.See 1645337-2019-22636 for contralateral prosthesis report.
Additional Manufacturer Narrative
Additional information was received on september 6, 2024.An additional and separate rupture event occurred with this device occurred several years following the initial event reported.The connecting report information has been attached in h10.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 ; 949789-8687
• MDR Report Key: 9245363
• Report Number: 1645337-2019-22635
• Device Sequence Number: 13565113
• Product Code: FTR
• UDI-Device Identifier: 00081317007210
• UDI-Public: 00081317007210
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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: 07/18/2020
• Device Catalogue Number: 3545700
• Device Lot Number: 6953385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2015
• 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: 26 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White