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

Catalog Number	SHPX415
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Capsular Contracture (1761); Emotional Changes (1831); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/01/2021
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, emotional changes.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 underwent a breast surgery with implantation of a 415cc mentor memorygel xtra breast implant prosthesis.Post-operatively, the patient experienced pain, anxiety, and discomfort.During a consultation with a medical professional, she was diagnosed with bilateral baker grade iii capsular contracture.As a result, the patient underwent bilateral implant removal without replacements on (b)(6) 2025.
Additional Manufacturer Narrative
On december 17, 2025, the mentor analysis lab received the suspect medical device for evaluation.On december 29, 2025, mentor completed an evaluation on the returned device.Device evaluation: mentor conducted a visual inspection of the device.During visual evaluation no apparent damage or visual anomalies were observed on the returned device.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).
Additional Manufacturer Narrative
On december 30, 2025, mentor received the following additional information: the patient was reported to have also experienced breast implant illness, fatigue, brain fog, muscle aches, weakness, soreness, hair loss, dry skin, dry eyes, temperature intolerance, low libido, autoimmune issues, night sweats, estrogen/progesterone imbalance, muscle twitching, photosensitivity, edema around the eyes, premature aging, thyroid problems, declined changes in vision, slow muscle recovery after activity, gastrointestinal digestive issues, chemical sensitivities, persistent infections, chronic inflammation, recurring sinus, urinary tract infections, panic attacks, mood swings, emotional instability, and ringing in the ears.During the physical exam she was also noted to have bottoming out and lateralization of both implants with associated breast asymmetry.Reason for device explant and/or reoperation: generalized illness, migration.H6.Health effect - clinical code e2402: generalized illness.On january 02, 2026, mentor updated the evaluation per the new information received.Updated device evaluation: implant displacement/migration may occur from improper implant sizing and/or placement, i.E., when the implant is too large or the pocket too small or when there has been inadequate preoperative assessment of stresses causing movement of the prosthesis.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL XTRA 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: 23658452
• Report Number: 1645337-2025-13203
• Device Sequence Number: 9962093
• Product Code: FTR
• UDI-Device Identifier: 00081317025276
• UDI-Public: (01)00081317025276(17)250325(10)9451519
• 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: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,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 Expiration Date: 03/25/2025
• Device Catalogue Number: SHPX415
• Device Lot Number: 9451519
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 12/17/2025; 12/30/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/30/2025; 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2020
• 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: 27 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White