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

Catalog Number	3544457MC
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Codes	Cyst(s) (1800); Swollen Lymph Nodes/Glands (4432)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 47-year old caucasian female patient underwent breast augmentation revision with two 445cc mentor memorygel breast implants.Post-operatively, the patient was diagnosed with right breast implant rupture, two enlarged lymph nodes in the right axilla, and right breast capsular contracture (baker grade iv).The right breast was palpable, has visible deformity, and pain.In addition, the patient was also diagnosed with left breast cyst and lymphadenopathy.As a result, the patient underwent bilateral breast implant removal and replacement surgery on (b)(6) 2023.The left breast implant was identified to have a gel bleed.The patient's implants were replaced bilaterally with two 650cc mentor silicone implants.This medwatch form is for the left breast prosthesis.Complications on the right breast have been reported under mrn: 1645337-2023-05918.
Additional Manufacturer Narrative
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.Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the sx mod classic gel, 445cc breast implant.Leak testing was performed, in accordance with mentor procedures, and no leak sites were detected during the analysis.The event described could not be confirmed as the breast implant was returned without a detectable gel bleed.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A breast cyst is a fluid-filled sac within the breast.One breast can have one or more breast cysts.They are often described as round or oval lumps with distinct edges.Breast cysts usually and typically do not require treatment, but they can be drained using fine needle aspiration if the cyst is large or uncomfortable.Lymphadenopathy or palpable lymph nodes may be the result of bacterial or viral infection, neoplasm (primary or metastatic), or as 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.It should be noted that as part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Since no malfunction was observed during the investigation, capa activity was not required.Reason for device explant and/or reoperation: breast cyst, lymphadenopathy, gel bleed.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).

• 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: 17431783
• Report Number: 1645337-2023-08941
• Device Sequence Number: 8898526
• Product Code: FTR
• UDI-Device Identifier: 00081317004462
• UDI-Public: 00081317004462
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 04/30/2016
• Device Catalogue Number: 3544457MC
• Device Lot Number: 6462503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2011
• 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: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White