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

Catalog Number	3545557MC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Seroma (2069); No Code Available (3191)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device report is being submitted late as a result of the exemption transition period following the revocation of mentor¿s psr exemption # e2007003.On 08/20/2019, mentor became aware that patient also suffered generalized illness.Upon receipt by mentor, the gel contained in the device appears clear.Yellow material was observed within the device and on the shell surface.Mentor product analysis lab discovered a rent measuring approximately 6.3 cm within parallel lines of shell wear running from the posterior aspect to the anterior aspect, suggesting in-vivo folding or creasing of the device.The complaint was confirmed since a rupture was found on the device.However, at this point it is not possible to determine the root cause of such damage or the etiology of the yellow material found on the device.All the implants are 100% inspected before leaving the facility.There is no evidence that the issue is related with manufacturing.Rupture, as indicated in the product insert data sheet (pids), is a known complication associated with mentor mammary prostheses.Causes of rupture of gel-filled implants include, but are not limited to the following events: damage from surgical instruments, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during daily routines such as vigorous exercise, athletics, routine manual massage and intimate physical contact, mechanical damage prior to or during surgery, closed capsulotomy, capsular contracture and origins which are simply unknown.Excessive postoperative accumulation and/or transient reaccumulation of fluid around an implant most likely occur soon after surgery; however, it can occur at any time.Symptoms from seroma may include swelling, pain, and bruising.While the body absorbs small hematomas and seromas, some will require surgery.Seromas presenting after the immediate post-operative period may require additional work-up by the surgeon.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: bilateral rupture, seroma, generalized illness.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
This report contains supplemental information for mentor psr reference number (b)(4).It was reported that a (b)(6) year-old caucasian female patient underwent revision breast augmentation revision with 555cc mentor memorygel breast implants on (b)(6) 2014 developed bilateral rupture that was observed on (b)(6) 2018.Seroma and generalized illness were also reported.The patient underwent bilateral removal and replacement with catalog number: 3545557mc; serial number: (b)(4) on the right side and with catalog number: (b)(4); serial number: (b)(4) on the left side on (b)(6) 2018.This report is for the patient¿s right-sided device.
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.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
• MDR Report Key: 9098078
• Report Number: 1645337-2019-19760
• Device Sequence Number: 16786200
• Product Code: FTR
• UDI-Device Identifier: 00081317004509
• UDI-Public: 00081317004509
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: 11/30/2017
• Device Catalogue Number: 3545557MC
• Device Lot Number: 6640822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 11/12/2019
• 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: 62 YR