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

Model Number	3544457MC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	07/23/2019
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: left-sided rupture.Concomitant products: 445cc mentor memorygel breast implant (catalog number: 3544457mc; serial number: (b)(4)).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a breast augmentation revision with a 445cc mentor memorygel breast implant and experienced postoperative left-sided rupture.The diagnosis was confirmed by physician upon physical examination.As a result, the patient¿s impacted device was explanted on (b)(6) 2019.
Additional Manufacturer Narrative
On 10/3/2019, the mentor failure analysis lab received the device for evaluation.On (b)(6) 2019, additional information was received indicating the patient experienced bilateral capsular contracture baker grade unknown.The patient underwent removal and replacement with mentor memorygel breast implant 445cc, catalog number 3507445mc, serial number (b)(4) (r) and serial number (b)(4) (l) on (b)(6) 2019.This report is for the left side.Device evaluation summary: during evaluation of the sample a parallel lines of shell wear were observed on the posterior aspect.Within the shell wear a tear was observed measuring approximately 1.0 cm.No additional anomalies were observed.Shell wear suggesting in-vivo folding or creasing of the device may be the result of the continuous and sustained stresses to the device caused by the capsular contracture.Postoperative formation of a fibrous tissue capsule around a mammary prosthesis is a normal physiologic response to the implantation of a foreign object and occurs in all patients in varying degrees.In some cases, contracture of the fibrous capsule may occur.This phenomenon is referred to as capsular contracture.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The device evaluation summary was updated: during the visual evaluation of the product, parallel lines of shell wear were observed on the posterior aspect.Within the wear, a tear was observed measuring approximately 0.1 cm.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, breast implants may also wear out over time.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.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: 8918971
• Report Number: 1645337-2019-17614
• Device Sequence Number: 18961279
• Product Code: FTR
• UDI-Device Identifier: 00081317004462
• UDI-Public: 00081317004462
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2019

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: 07/31/2017
• Device Model Number: 3544457MC
• Device Catalogue Number: 3544457MC
• Device Lot Number: 6613119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 10/03/2019; 07/08/2020
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 11/01/2019; 07/09/2020
• 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: 72 YR