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

Model Number	3547007
Medical Device Problem Codes	Material Rupture (1546); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was returned to mentor for evaluation.Mentor conducted visual inspection.Visual analysis of the returned sample revealed that the breast implant had an area of siltex cracking on the posterior view.The siltex cracking area has a tear measuring approximately 3 cm.The evaluation determined that the cause of the rupture was consistent with normal wear.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Siltex cracking is ultimately a result of high stress.Mentor concluded that the capsular contracture in the patients breast was the result of the bodys 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, capsule, and effusion to pathology for examination.It should be noted that as part of mentors quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device 210562 number, and no non-conformances were identified.Reason for device explant and/or reoperation: capsular contracture/rupture.Manufacturers reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female who underwent breast augmentation revision with 700cc mentor memorygel breast implants experienced spontaneous right bilateral rupture accompanied by a deformed nipple post procedure.Additionally baker grade iv capsular contracture was present.The rupture was diagnosed through a physical examination and ultrasound.As a result, explant and replacement with mentor gel was performed on (b)(6) 2021.The right sided rupture was reported initially under 1645337-2021-07418 on june 30, 2021.On august 24, 2021 mentor received additional information and initial awareness of bilateral issues.This report relates to the left prosthesis.

• 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: 12492835
• Report Number: 1645337-2021-09670
• Device Sequence Number: 5088083
• Product Code: FTR
• UDI-Device Identifier: 00081317000761
• UDI-Public: 00081317000761
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: No Information
• Device Expiration Date: 04/30/2005
• Device Model Number: 3547007
• Device Catalogue Number: 3547007
• Device Lot Number: 210562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/17/2021
• 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: 54 YR