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

Catalog Number	3341259
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/12/2017
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.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.H6 health effect - clinical code e2402: generalized illness.Reason for device explant and/or reoperation: generalized illness.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a primary breast augmentation surgery with implantation of a 395cc mentor memoryshape breast implant prosthesis.Post-operatively, the patient was reported to have experienced autoimmune-like symptoms, fatigue, joint disease, muscle aches, back pain, breast pain, weight gain, and possible systemic inflammation.The patient also had concerns of breast implant illness.Many tests were performed regarding her symptoms, but no diagnoses were made.Mammogram and ultrasound imaging were performed and no significant findings were indicated.She was evaluated by a plastic surgeon and diagnosed with bilateral breast ptosis.As a result, the patient underwent bilateral breast implant removal without replacements on (b)(6) 2024.However, during the surgery, bilaterally ruptured breast implants were discovered.There were no reported procedural delays or patient consequences due to the discovery.This report is for the right breast prosthesis.
Additional Manufacturer Narrative
On february 20, 2025, the mentor analysis lab received the suspect medical device for evaluation.On february 26, 2025, mentor completed an evaluation on the returned device.Mentor conducted a visual inspection and microscopic examination of the device.Visual analysis of the returned device revealed that the breast implant had a tear on the posterior view, between the union of the shell and patch.The patch was completely separated from the shell.A microscopic examination was performed, and the cause of the tear could not be identified.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: rupture can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.The following things may cause the implant to rupture: damage by surgical instruments; stressing the implant during implantation and weakening it; folding or wrinkling of the implant shell; excessive force to the chest (e.G.During closed capsulotomy); trauma; compression during mammographic imaging; and severe capsular contracture.Breast implants may also simply wear out over time.At present, there is no sufficient evidence to show an association between breast implants and generalized illness.(assessing the risks of breast implants and fda¿s vision for the national breast implant registry).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: 21172995
• Report Number: 1645337-2025-00478
• Device Sequence Number: 14516040
• Product Code: FTR
• UDI-Device Identifier: 00081317005087
• UDI-Public: (01)00081317005087(17)211006(10)7384680
• 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: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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: 10/06/2021
• Device Catalogue Number: 3341259
• Device Lot Number: 7384680
• 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: 01/03/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2016
• 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: 29 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White