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

Catalog Number 3503751BC

Device Problems Material Rupture (1546); Appropriate Term/Code Not Available (3191)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 08/01/2022

Event Type  Injury  

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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: rupture mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a patient implanted with a 350cc (left), 375cc (right) mentor memorygel breast implant experienced bilateral ruptures post-operatively.As a result, the patient underwent explantation on (b)(6) 2024.This report is for the right side device.

Manufacturer Narrative

Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted visual inspection of the returned device.Visual analysis of the returned sample revealed that the sm mpp gel 375cc breast implant was found to be ruptured.Additionally, an area of shell abrasion was found at the edge of the rupture.The evaluation determined that the possible cause of the rupture is 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 stresses to the device such as too small breast pocket and folding or wrinkling of the shell in the breast pocket.In some cases, the breast implants may also wear out over time.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Type of Device: 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 19014535
• MDR Text Key: 339051164
• Report Number: 1645337-2024-03967
• Device Sequence Number: 1
• Product Code: FTR
• UDI-Device Identifier: 00081317000310
• UDI-Public: 00081317000310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2014
• Device Catalogue Number: 3503751BC
• Device Lot Number: 5924101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White