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

Catalog Number	SHPX755
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Skin Inflammation/ Irritation (4545)
Date of Event	10/22/2024
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 35-year-old female patient underwent a primary breast augmentation with a 755cc mentor memorygel xtra breast implant and experienced capsular contracture (baker grade 3) on the right side post-operatively.The breast was getting more firm and higher.As a result, the patient underwent explantation on (b)(6) 2025, and replaced with a 755cc mentor memorygel xtra breast implant (catalog number shpx755) with serial number (b)(6).It was reported that the patient had a prior surgical intervention on the right side.The patient had a capsulorrhaphy with a mesh.The patient went from being too loose to too tight more than expected.The patient had a palpable nodule of the mesh which was bugging her.
Additional Manufacturer Narrative
On march 25, 2025, the mentor failure analysis lab has received the device for evaluation.On march 31, 2025, the evaluation for the device was completed.Device evaluation summary: during the visual evaluation, no apparent damage or visual anomalies were observed on the smooth high profile xtra 755c 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.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).
Additional Manufacturer Narrative
On july 27, 2025, a re-evaluation for the device was completed.Device re-evaluation summary: during the 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.A skin reaction is a noticeable change in the texture and/ or color of the skin.This can include bumps, scales, pustules or redness that can be inflamed, irritated, painful, or itchy.This can be due to a variety of factors such as infections, heat, allergens or immune system disorders.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).
Additional Manufacturer Narrative
On july 02, 2025, mentor received additional information regarding the patient's event.It was reported that prior to the patient's explantation, the patient had experienced a skin reaction on her breast.The patient had some redness near her incision site in the inferior portion of the breast.The patient also had minor discoloration in the inferolateral aspect of her breast.This could have been due to slight bruising or possible reaction to the patient's breast mesh.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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 21669566
• Report Number: 1645337-2025-03076
• Device Sequence Number: 8175886
• Product Code: FTR
• UDI-Device Identifier: 00081317025368
• UDI-Public: (01)00081317025368(17)261116(10)9660647
• 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: 2024
• 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,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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SHPX755
• Device Lot Number: 9660647
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 03/25/2025; 07/02/2025; 07/27/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/04/2025; 07/25/2025; 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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: 36 YR
• Patient Sex: Female