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

Catalog Number	3505160BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Pain (1994); Scarring (2061); Impaired Healing (2378); No Code Available (3191)
Date of Event	04/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.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: rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a breast augmentation revision with mentor memorygel breast implants 160cc and experienced bilateral issues including open wounds, pain, capsular contracture baker grade unknown, and rupture.As a result, the patient underwent removal and replacement with unspecified mentor gel breast implants on (b)(6) 2019.This report is for the right side.
Additional Manufacturer Narrative
Device evaluation summary: during analysis of the sample a rupture was observed on the anterior view, measuring approximately 3.9 cm.No other anomalies were observed.Since the authorization for return and examination of medical device form was not signed and/or returned, mentor product analysis lab was precluded from further evaluating the device.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 normal, daily routines including customary and purposeful trauma to the breast.Most women undergoing augmentation or reconstruction with a mammary prosthesis will experience some breast and/or chest 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 the compression of nerves, hematoma, migration, infection, surgical technique, improper size, placement or 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 condition has also been associated with device deflation/ rupture, wrinkling and/or displacement of the prosthesis.Capsular contracture may be more common following infection, hematoma, and seroma, and the chance of it happening may increase over time.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.The reported complaint was confirmed.It should be noted that as part of our quality process, each device is visually inspected and functionally tested 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.Complaint information will be included in complaint trending that is reviewed and monitor by quality assurance on a regular basis to determine if further action is necessary.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on (b)(6) 2019 indicated the patient experienced bilateral keloid scarring.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: 8641820
• Report Number: 1645337-2019-12647
• Device Sequence Number: 11324441
• Product Code: FTR
• UDI-Device Identifier: 00081317006855
• UDI-Public: 00081317006855
• 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: 2017
• 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): 04/24/2019

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: 06/30/2017
• Device Catalogue Number: 3505160BC
• Device Lot Number: 6604664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 06/18/2019; 08/28/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 06/21/2019; 09/27/2019
• 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: 42 YR