MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
|
Back to Search Results |
|
Catalog Number 3544001 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
|
Patient Problems
Capsular Contracture (1761); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 06/11/2017 |
Event Type
Injury
|
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.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: generalized illness.H6 health effect - clinical code e2402: generalized illness.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.Manufacturer¿s reference number: (b)(4).
|
|
Event Description
|
It was reported via mw5152198 that a patient implanted with two 400cc mentor memorygel breast implant experienced symptoms including breast implant illness, debilitating health issues, vision issues, fatigue, brain fog, high prolactin, low thyroid function, low hormones, high rheumatoid factor post-operatively.As a result, the patient underwent explantation on (b)(6) 2024.This report is for the first of two devices.
|
|
Manufacturer Narrative
|
Mentor received a confirmed serial number for the device.In addition, an updated date of implant was received, and it was confirmed the patient experienced capsular contracture on the left side.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.Manufacturer¿s reference number: (b)(4).
|
|
Search Alerts/Recalls
|
|
|