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

Model Number	3341105
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Capsular Contracture (1761); Wrinkling (2613); Breast Discomfort/Pain (4504)
Date of Event	08/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: n/a 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 36-year-old hispanic female patient who underwent a primary breast augmentation procedure with a mentor memoryshape breast implant 255cc gel breast prosthesis (left device) and a mentor memoryshape breast implant 270cc gel breast prosthesis (right device) developed capsular contracture (baker grade unknown) in her left breast post implantation.Additionally, it was reported that the patient¿s right breast prosthesis rotated.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch report is for the patient¿s left breast prosthesis.
Additional Manufacturer Narrative
On 27-jun-2023, mentor received additional information about the event.It was reported that the patient didn¿t develop capsular contracture in her left breast post implantation.It was reported that the patient¿s left breast prosthesis probably rotated and that she developed breast atrophy after nursing.This medwatch report is for the patient¿s left breast prosthesis.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Correction: mentor inadvertently did not report that the patient developed breast pain post implantation.It was not specified which breast developed pain (left, right, or bilateral).If clarification is received, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).H6 health effect - clinical code breast discomfort/pain (e1402) was added.
Additional Manufacturer Narrative
On 30-mar-2025, mentor received additional information about the event.The patient developed rippling (wrinkling) on both breast post implantation.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 25-mar-2026, mentor received additional information about the event.The patient underwent bilateral explantation and replacement with unspecified mentor breast prostheses on an unknown date.Reason for device explant and/or reoperation: breast pain, device migration, wrinkling on breasts.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Mentor received additional information about the event.The patient underwent bilateral explantation and replacement with unspecified mentor saline breast prostheses on (b)(6) 2025.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE 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: 16717908
• Report Number: 1645337-2023-04253
• Device Sequence Number: 7237354
• Product Code: FTR
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup,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 Expiration Date: 08/30/2023
• Device Model Number: 3341105
• Device Catalogue Number: 3341105
• Device Lot Number: 7619408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 06/27/2023; 05/06/2024; 03/30/2025; 03/25/2026; 06/22/2026
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 07/18/2023; 05/28/2024; 04/22/2025; 04/15/2026; 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2018
• 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; Other
• Patient Age: 35 YR
• Patient Sex: Female