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

Catalog Number	3544350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pocket Erosion (2013); Seroma (2069); Post Operative Wound Infection (2446)
Date of Event	01/01/2024
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: seroma, device extrusion, infection 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).
Event or Problem Description
It was reported that a female who underwent a breast augmentation primary with a mentor memorygel breast implant, 350cc silicone prosthesis experienced right-sided wound infection, early onset of seroma, and device extrusion post-operation.The report stated that the seroma started after a month of implantation.As a result, patient underwent bilateral prosthesis removal on (b)(6) 2024.
Additional Manufacturer Narrative
Per additional information on may 27, 2024: translation of pdf inside attachment "external fwd mentor breast implant follow up pc-001611862": microbiology gram coloration sample no.1: sample: right breast secretion leukocyte reaction: abundant gram positive cocci: ++++.Cultivation of common germs sample no.1 ¿ right breast discharge straphylococcus aureus: abundant growth.Antibiogram | cmi (here are the results for each substance, where the correlated translation is: interpretacion predictiva resistente = robust predictive interpretation | sensible = sensitive | resistente = resistant) gram coloration sample no.2 sample: left breast secretion leukocyte reaction: abundant gram positive cocci: ++++ cultivation of common germs sample no.2 ¿ left sinus discharge staphylococcus aureus: abundant growth.Antibiogram | cmi (here are the results for each substance, where the correlated translation is: interpretacion predictiva resistente = robust predictive interpretation | sensible = sensitive | resistente = resistant) manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation completed on july 23, 2024: during visual evaluation no apparent damage or visual anomalies were observed on the siltex hpg, 350cc returned device.Extrusion may occur when the wound has not closed or when tissue covering the implants weakens.The incidence of extrusion has been shown to increase when undue pressure is applied on the tissue located over the device, trauma to surrounding tissues may lead to thrombosis, delayed wound healing, improper size, placement, larger sized implants, use of steroids in the surgical pocket and microwave diathermy.Radiation therapy has been reported to increase the likelihood of extrusion.Extrusion may require additional surgery and possible removal of the implant, which may result in additional scarring and/or loss of breast tissue.Infection, manifested by swelling, tenderness, pain and fever, may appear in the immediate postoperative period or at any time after insertion of the implant.In the absence of classic symptoms, subacute or chronic infections may be difficult to diagnose.If infection does not subside promptly with the appropriate treatment, removal of the implant is indicated.Infection is a known complication associated with any surgery.Per a database query, this is the only reported complaint of infection against this lot number.The mentor microbiology department has provided information on the sterility lot for the implanted device indicating that it met all sterilization parameters required to provide a 10e-6 sterility assurance level prior to release for distribution.Product evaluation concluded the reported infection occurred from a source other than the device.Infection is a known complication associated with any surgery and is referenced in our current product insert data sheet.A seroma is a build-up of fluid around the implant.Symptoms from a seroma may include swelling, pain, and bruising.A seroma may occur soon after surgery, or any time later on, which would be referred to as a late seroma.While the body may absorb seromas, some may require surgery for drainage.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The mentor failure analysis lab has received the 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).

• 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: 19454703
• Report Number: 1645337-2024-06613
• Device Sequence Number: 15226174
• Product Code: FTR
• UDI-Device Identifier: 00081317001065
• UDI-Public: 00081317001065
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 3544350
• Device Lot Number: 9951827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 05/27/2024; 07/15/2024; 07/23/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/13/2024; 07/16/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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: 27 YR
• Patient Sex: Female