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

Model Number	3546001
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: the patient has not undergone explantation or reoperation at this time.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old caucasian female patient who underwent a breast augmentation revision with a 600cc textured mentor memorygel breast implant has experienced postoperative left-sided breast pain, along with rupture of left implant, and right-sided capsular contracture, baker grade unknown.Rupture was confirmed by ultrasound.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch report is for the left-sided implant.
Additional Manufacturer Narrative
Mentor received additional event information that the patient is scheduled to undergo explantation on (b)(6) 2020.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.Reason for device explant and/or reoperation: rupture, breast pain.H6 patient code 3191: medical device removal.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The mentor failure analysis lab has received and completed the evaluation of the suspect medical device.Device evaluation summary: during the visual inspection, the sample was found to be ruptured.Additionally, shell wear was observed in the edge of the tear.The evaluation determined that the loss of shell integrity is consistent with a rupture caused by wear.Shell wear suggests in-vivo folding or creasing of the device.This may be the result of the following factors: continuous and sustained stresses to the device such as too small breast pocket and folding or wrinkling of the shell in the breast pocket.In some cases, the breast implants may also wear out over time.Most women undergoing augmentation or reconstruction with a mammary prosthesis will experience some pain postoperatively.While pain normally subsides in most women as they heal from surgery, it can become a chronic problem in other women.Chronic pain can be associated with a variety of factors.Surgeons should instruct their patients to inform them if there is significant pain or if pain persists.Pain is a known complication associated with these devices and is referenced in our current product insert data sheet.As part of our quality process, the manufacturing records of this lot-serial number were reviewed and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Rupture and pain complaint information is consistently analyzed and monitored by mentor quality assurance to determine when further action is necessary.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Mentor received additional event information that the patient underwent replacement with non-mentor breast implants on (b)(6) 2020.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: 9774084
• Report Number: 1645337-2020-03365
• Device Sequence Number: 2495846
• Product Code: FTR
• UDI-Device Identifier: 00081317000945
• UDI-Public: 00081317000945
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/05/2020

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: 11/21/2009
• Device Model Number: 3546001
• Device Catalogue Number: 3546001
• Device Lot Number: 5567343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 09/10/2020; 10/20/2020; 11/05/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 09/22/2020; 11/02/2020; 11/19/2020
• 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: Other; Required Intervention
• Patient Age: 52 YR