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

Catalog Number	3545501
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Hematoma (1884); Deformity/ Disfigurement (2360); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2018
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: 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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a breast augmentation revision surgery with implantation of a 550cc mentor memorygel breast implant prosthesis.Post-operatively, the patient was diagnosed with a ruptured left implant during a physical exam and confirmed using magnetic resonance imaging.As a result, the patient underwent bilateral exchange with mentor gel implants on (b)(6) 2025.
Additional Manufacturer Narrative
On december 16, 2025, mentor received the following additional information: post-implantation of the suspect device, the patient was diagnosed with a left breast hematoma which caused a firm and black/blue colored breast.No intervention was reported but the event was monitored.Date of event: 6/19/2018.At a later time, the patient experienced right breast pain and resultantly, magnetic resonance imaging was performed.Imaging results indicated a ruptured left implant, intact right implant, and minimal bilateral peri-implant fluid.During a physical exam the patient was observed to have a firm and high left breast and a little right breast ptosis.She was also diagnosed with left breast baker grade iii capsular contracture in addition to the rupture.Reason for device explant and/or reoperation: capsular contracture.H6 health effect - clinical code e2402: implant site fluid collection.As an event for the contralateral side was indicated, another file was generated to document the event.This report is for the left breast prosthesis.On january 08, 2026, the mentor analysis lab received the suspect medical device for evaluation.On january 09, 2026, mentor completed an evaluation on the returned device.Device evaluation: mentor conducted visual inspection and microscopic examination of the device.Visual analysis of the returned device revealed that the breast implant was found to have a tear in the posterior aspect extending to the anterior aspect, measuring approximately 13.3cm.Additionally, it had parallel lines of shell wear on the anterior aspect in the edges of the tear.Microscopic examination was performed, and no instrument damage was identified.The evaluation determined that the possible cause of the rupture is consistent with normal wear.Shell wear 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.Hematoma is a collection of blood within the space around the implant.Symptoms from hematoma may include swelling, pain, and bruising.If a hematoma occurs, it will most likely occur soon after surgery; however, it can occur at anytime, such as after an injury to the breast.Small hematomas may be absorbed by the body, while others may require surgery for drainage.Hematoma is a known complication associated with this procedure and is referenced in our product insert data sheet.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.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: henry boden ; 3041 skyway circle north; irving, TX 75038 ; 9497882078
• MDR Report Key: 23785188
• Report Number: 1645337-2025-13814
• Device Sequence Number: 5081528
• Product Code: FTR
• UDI-Device Identifier: 00081317000938
• UDI-Public: (01)00081317000938(17)201204(10)7003828
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• 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: 12/04/2020
• Device Catalogue Number: 3545501
• Device Lot Number: 7003828
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2015
• 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: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White