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

Catalog Number	3507225BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/09/2024
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.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: capsular contracture.D4: udi: as the catalog/model number was not provided, the (01)gtin is not available.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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient who underwent a primary breast augmentation procedure with an unspecified mentor gel breast prosthesis developed capsular contracture (baker grade unknown) in her right breast post implantation.The capsular contracture was diagnosed during an office visit.As a result, the patient underwent explantation with no replacement breast prostheses on (b)(6) 2024.During explant surgery, it was observed that the removed right breast prosthesis had ruptured.
Additional Manufacturer Narrative
On 06-nov-2024, the mentor failure analysis lab received the device for evaluation.Mentor became aware that the suspect medical device is a mentor memorygel breast implant 225cc gel breast prosthesis, catalog #3507225, lot #5704368, pma #p030053.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.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.On 12-nov-2024, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient experienced a rupture in the breast implant and developed capsular contracture.The product was returned to mentor for evaluation.Mentor then conducted a visual inspection, leak testing, and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the breast implant was found to have a tear (a) on the anterior view, measuring approximately 0.7 cm.Leak testing was performed, according to mentor procedure, and it identified a tear (b) measuring approximately 0.1 cm within shell abrasion on the posterior view.Microscopic examination was performed on the edges of the tear (a), and parallel striations were found in the whole area of the tear (a).Parallel striations are consistent with markings made by a sharp object perforating the implant shell.Based on the information currently available, the microscopic examination of the tear (a) indicates that the implant could have been damaged during or subsequent to implantation.The product insert data sheet cautions to not allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps, or scissors to contact the device during the implantation or other surgical procedures.The evaluation determined that the possible cause of the tear (b) 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.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, capsule, and effusion to pathology for examination.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Capa activity was not required.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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
• 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: 20423517
• Report Number: 1645337-2024-11922
• Device Sequence Number: 12888298
• Product Code: FTR
• UDI-Device Identifier: 00081317000068
• UDI-Public: 00081317000068
• 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: 2009
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2011
• Device Catalogue Number: 3507225BC
• Device Lot Number: 5704368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2006
• 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: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic