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

Model Number	3546007
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Swollen Lymph Nodes/Glands (4432)
Date of Event	09/22/2021
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: rupture, swollen lymph nodes.Date of explantation: (b)(6) 2022.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a breast augmentation revision surgery with implantation of a 600cc mentor memorygel breast implant prosthesis.Post-operatively, during a physical exam, the patient was observed to have a ruptured left breast prosthesis and multiple large left axillary lymph nodes.Mammogram and ultrasound imaging were performed on the patient.As a result, the patient will undergo removal and replacement on (b)(6) 2022.This report is for the left breast prosthesis.Refer to manufacturing report number 1645337-2022-00722 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: rupture, swollen lymph nodes.Date of explantation: (b)(6) 2022.(b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a breast augmentation revision surgery with implantation of a 600cc mentor memorygel breast implant prosthesis.Post-operatively, during a physical exam, the patient was observed to have a ruptured left breast prosthesis and multiple large left axillary lymph nodes.Mammogram and ultrasound imaging were performed on the patient.As a result, the patient will undergo removal and replacement on (b)(6) 2022.This report is for the left breast prosthesis.Refer to manufacturing report number 1645337-2022-00722 for the contralateral event.
Additional Manufacturer Narrative
On march 15, 2022, mentor became aware that information was not reported inadvertently in the initial report.The lot number should have been populated as 223438.Additionally, the replacement device used was a 300cc mentor smooth round moderate profile saline breast implant.Manufacturer¿s reference number: (b)(4) in the initial, d4.Lot: 223438 should have been populated.
Additional Manufacturer Narrative
On march 21, 2022, the mentor failure analysis lab has received the suspect medical device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On april 19, 2022, mentor completed a device evaluation on the returned device.Mentor conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed an area of delamination at the union between the patch and shell, causing gel leakage on the breast implant.Although potential causes of patch delamination are unknown, stresses and forces on the implant in-vivo or exposure to betadine at insertion could result in delamination and ruptures.Per the current product insert data sheet (pids), rupture is a known complication associated with these devices and can occur at any time during or after implantation.Lymphadenopathy or palpable lymph nodes may be the result of bacterial or viral infection, neoplasm (primary or metastatic), or the result of an idiopathic inflammatory process or foreign body reaction.There have been reports regarding movements of silicone gel material to lymph nodes even with or without evidence of rupture leading to lymphadenopathy.A number of epidemiology studies have evaluated large populations of women with breast implants from a variety of manufacturers and implant models.The studies do not taken together, support an association between breast implants and a diagnosed rheumatic disease.Other than one study, these studies do not distinguish whether the women had ruptured or intact implants.Because there were no supporting pathology reports or physician consultation summaries forwarded to product evaluation, we are unable to confirm the presence of or the possible etiology of the reported lymphadenopathy.Lymphadenopathy is a known complication associated with this surgery and is referenced in our current product insert data sheet.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: 13350126
• Report Number: 1645337-2022-00723
• Device Sequence Number: 11178229
• Product Code: FTR
• UDI-Device Identifier: 00081317000754
• UDI-Public: 00081317000754
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• 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

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: 02/28/2006
• Device Model Number: 3546007
• Device Catalogue Number: 3546007
• Device Lot Number: 223438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 03/15/2022; 03/21/2022; 04/19/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 03/15/2022; 04/14/2022; 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2001
• 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: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White