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

Catalog Number	3544500
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Granuloma (1876); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported (via mw5162816 & mw5162817) that a patient who had 500cc mentor memorygel breast implants placed experienced bilateral rupture, granuloma formation and several unexplained systemic symptoms post procedure.The granulomas were noted in the form of a lump and the sternum and silicone noted withing the lymph nodes.X-ray, magnetic resonance imaging, and mammography were used to identify device rupture.Pain, brain fog, low white blood cells, abnormal red blood cells, elevated estrogen, headaches, constipation, and anxiety were the unexplained systemic symptoms noted.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.
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.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: n/a.H6 health effect - clinical code e2402: generalized illness.D4: udi: as the catalog/model number was not provided, the (01) gtin is not available.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on february 28, 2025.The implant date was clarified to be (b)(6) 2015.Mastopexy and explant was performed on (b)(6) 2025.The right sided device, originally reported as ruptured, was found intact upon explant.Rupture and granuloma are no longer applicable to the right side.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.Reason for device explant and/or reoperation: generalized illness, rupture, granuloma.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the photograph provided was completed by the failure analysis lab on april 19, 2025.Device evaluation summary: upon visual evaluation of the image provided in the complaint no apparent damage or visual anomalies were observed.As the product involved in this complaint was not received, the device could not be analyzed according to our procedures.As part of mentor's quality process, all devices are manufactured, inspected, and released according to approved specifications.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria: since no malfunction was observed during the investigation.No corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 21048969
• Report Number: 1645337-2024-15200
• Device Sequence Number: 3409650
• Product Code: FTR
• UDI-Device Identifier: 00081317001119
• UDI-Public: 00081317001119
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,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 Catalogue Number: 3544500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 02/28/2025; 04/19/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 03/19/2025; 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 32 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White