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

Catalog Number	3546001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	10/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report contains supplemental information for mentor psr reference number (b)(4).This device report is being submitted late as a result of the exemption transition period following the revocation of mentor¿s psr exemption #e2007003.Device evaluation summary: background: 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.The severity of this condition varies with each individual.Capsular contracture can make the breast harder and firmer than desirable which may result in breast asymmetry, discomfort or pain.This condition has also been associated with device deflation, 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.Device evaluation and investigation findings: upon receipt by mentor, the gel contained in the device appears clear.No foreign material was observed within the device.Gel was observed on the shell surface.Mentor product analysis lab discovered an area of missing material measuring approximately 2.2 cm x 2.1 cm located on the anterior aspect.Parallel lines of shell wear were also observed on the anterior aspect, suggesting in-vivo folding or creasing of the device.No other anomalies were discovered.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.Potential cause: capsular contracture is the result of the body¿s individual physiological response to the implantation of a foreign object in soft tissue.The severity level for this complaint code was determined to be a s3, which is defined as: necessitates intrusive medical or surgical intervention.Corrective action: because mentor product analysis lab was unable to confirm any unusual failure mode, no corrective action will be taken at this time.Conclusion statement: the patient¿s breast prosthesis was submitted with a complaint of capsular contracture.Mentor product analysis lab discovered an area of missing material measuring approximately 2.2 cm x 2.1 cm located on the anterior aspect.Parallel lines of shell wear were also observed on the anterior aspect, suggesting in-vivo folding or creasing of the device.No other anomalies were discovered.Mentor product analysis lab concluded the reported complaint of 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.Reason for device explant and/or reoperation: capsular contracture baker grade 3.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) female patient underwent a breast augmentation primary with a 600cc mentor memorygel breast implant and experienced postoperative right-sided grade 3 capsular contracture.The patient experienced pain and tightness, and capsular contracture was confirmed by a physician.As a result, the patient underwent removal and replacement with 600cc mentor memorygel breast implant, catalog # 3546001, serial # (b)(4) on (b)(6) 2018.

• 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: 9170309
• Report Number: 1645337-2019-20904
• Device Sequence Number: 2424983
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2021
• Device Catalogue Number: 3546001
• Device Lot Number: 7292949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 10/09/2019
• 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: 34 YR