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

Model Number	3545430
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Autoimmune Reaction (1733); Capsular Contracture (1761); Unspecified Infection (1930); Seroma (2069); No Code Available (3191)
Date of Event	06/26/2014
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, infection, capsular contracture, autoimmune reaction.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 (b)(6) year-old caucasian female who underwent breast augmentation revision with a 430cc mentor memorygel breast implant (left) and a 480cc mentor memorygel breast implant (right) experienced several health issues post procedure.Bilateral capsular contracture, bilateral seroma, infection, and autoimmune disorders were all noted.After a mammogram identified an issue, an ultrasound was recommended.The ultrasound was performed at the end of (b)(6) 2020 and revealed that seromas and effusions were surrounding the implants.The capsular contracture was identified by a physician examination.The physician indicated the degree of capsular contracture was likely baker grade iv by stating that the contracture was the highest severity.The patient was diagnosed with raynaud¿s and was experiencing pins and needle sensations in her hands.Additionally, the patient had rashes over her body, insomnia, her lymph system was unable to drain, chronic fatigue, red eyes, and sickly appearance.The patient was unable to work due to these issues.No device issue such as rupture was reported.The devices were explanted without replacement and the patient reported an improvement in her symptoms since explant.See 1645337-2020-05676 for contralateral prosthesis report.

• 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
• MDR Report Key: 9963881
• Report Number: 1645337-2020-05677
• Device Sequence Number: 2750312
• Product Code: FTR
• UDI-Device Identifier: 00081317007159
• UDI-Public: 00081317007159
• 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: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2017
• Device Model Number: 3545430
• Device Catalogue Number: 3545430
• Device Lot Number: 6632089
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR