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

Catalog Number	SMPB480
Medical Device Problem Codes	Material Discolored (1170); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	11/18/2024
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.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: capsular contracture.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 or Problem Description
It was reported that a patient who underwent a breast augmentation revision procedure with a mentor memorygel boost breast implant 480 cc gel breast prosthesis developed baker grade iii-iv capsular contracture in her left breast post implantation.The capsular contracture was diagnosed via a physical exam.As a result, the patient underwent explantation on (b)(6) 2024.
Additional Manufacturer Narrative
On 06-jan-2025, the mentor failure analysis lab received the device for evaluation.On 10-jan-2025, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient developed capsular contracture.The product was returned to mentor for evaluation.Mentor then conducted a visual inspection and leak test of the returned device.Visual analysis of the returned sample revealed that the breast implant had some bubbles within the gel.Leak testing was performed, in accordance with mentor procedures, and no areas of gel exposure were detected during the analysis.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.Bubbles in the gel can be originated with changes in pressure and temperature which can affect volume.The shell wall is permeable to air, therefore trapped air can form bubbles with changes in pressure or temperature.When left by themselves with no changes in temperature or pressure, bubbles usually dissipate over time, unless trapped by cured gel.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.H6 investigation findings c22: cosmetic defect.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 07-feb-2025, mentor received additional information about the event.- the patient had only the left breast prosthesis explanted and it was replaced with a mentor memorygel boost breast implant 480cc gel breast prosthesis.- during explant surgery, it was noted that there was staining on the device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 31-mar-2025, mentor re-evaluated the suspect medical device.Device evaluation summary: according to the information received, the patient developed capsular contracture.During explant surgery, it was reported that there was staining on the device.The product was returned to mentor for evaluation.Mentor conducted a visual inspection and leak testing of the returned device.During visual evaluation, no apparent damage or visual color anomalies were observed on the gel or shell of the returned device.Leak testing was performed, in accordance with mentor procedures, and no areas of gel exposure were detected during the analysis.The event described could not be confirmed as the breast implant was returned without detectable stain on gel/shell anomalies.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Regarding the reported capsular contracture condition, there are not enough details to determine the factors that may have caused this condition.Capsular contracture in the patient¿s breast might be the result of the body¿s individual physiological response to the implantation of a foreign object in soft tissue.Further, 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 according to approved specifications.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria: since no malfunction was observed during the investigation.No corrective and preventive action (capa) is required now.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 BOOST 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: 20867148
• Report Number: 1645337-2024-14327
• Device Sequence Number: 18314799
• Product Code: FTR
• UDI-Device Identifier: 00081317026914
• UDI-Public: (01)00081317026914(17)290102(10)9982766
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup,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 Catalogue Number: SMPB480
• Device Lot Number: 9982766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 01/06/2025; 02/07/2025; 03/31/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/13/2025; 02/26/2025; 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• 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: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White