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

Model Number	3501001BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	09/03/2021
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: cap con iv, rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female who underwent a breast augmentation primary with a mentor memorygel, 100cc breast implant experienced right-sided capsular contracture grade iv, and rupture post procedure.The patient stated that she is experiencing pain as well.The matter was diagnosed through physical examination.As a result, patient underwent bilateral removal without replacements on (b)(6) 2021.
Additional Manufacturer Narrative
Device evaluation completed on november 03, 2021: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the sm mpp gel 100cc breast implant had a tear of 4 cm approximately in the posterior view where an area of shell abrasion was identified within the tear.The evaluation determined that the cause of the rupture was consistent with normal wear.Shell abrasion suggests in-vivo folding or creasing of the device.This may be the result of the following factors: continuous and sustained stress 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.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implant capsules and effusion to pathology for examination.It should be noted that as part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Manufacturer report 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
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 12704814
• Report Number: 1645337-2021-11956
• Device Sequence Number: 16510835
• Product Code: FTR
• UDI-Device Identifier: 00081317000204
• UDI-Public: 00081317000204
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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
• Report Date (Section B): 10/07/2021

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: 10/22/2019
• Device Model Number: 3501001BC
• Device Catalogue Number: 3501001BC
• Device Lot Number: 6875679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White