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

Model Number	3507175BC
Medical Device Problem Codes	Material Discolored (1170); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Deformity/ Disfigurement (2360)
Date of Event	04/01/2020
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: right side breast implant rupture and discoloration.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent revision breast augmentation with a 175cc mentor memorygel breast implant and experienced right side breast implant rupture and discoloration postoperatively.The issue was diagnosed via physical exam.As a result, the device was explanted on (b)(6) 2021.The customer reported the device appeared discolored post explantation.This is not the primary reason for explantation.The potential that this issue could cause or contribute to a death or serious injury, or other significant adverse event, is remote.This complaint is being reported primarily due to the breast implant rupture.
Additional Manufacturer Narrative
On (b)(6) 2021, device evaluation was completed.Device evaluation summary: mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that the gel mod-rnd 175cc breast implant had a crease/fold on the anterior view.Also the device doesn't look discolored.Leak testing was performed, according to mentor procedure, and it identified a tear within the crease/fold measuring approximately 0.1 cm.The evaluation determined that the cause of the rupture is consistent with normal wear.The instructions for use state that ruptures can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.The following may cause implants to rupture: stressing the implant during implantation or other procedures and weakening it; folding or wrinkling of the implant shell.Breast implants may also wear 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.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsules, and effusions to pathology for examination.A second product was received (lot-6435440).No adverse events were reported for this concomitant (contralateral) device, therefore no further analysis is required.It should be noted that as part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On february 10, 2021, mentor became aware that patient also experienced right side capsular contracture; baker grade iv.Clinical code capsular contracture has been added to field h6 on this form.On february 11, 2021, the mentor failure analysis lab 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.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: 11267214
• Report Number: 1645337-2021-00975
• Device Sequence Number: 11083601
• Product Code: FTR
• UDI-Device Identifier: 00081317000044
• UDI-Public: 00081317000044
• 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: 2011
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2021

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: 12/31/2015
• Device Model Number: 3507175BC
• Device Catalogue Number: 3507175BC
• Device Lot Number: 6435440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 02/10/2021; 03/05/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 02/16/2021; 03/07/2021
• 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