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

Catalog Number	3541408
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Cyst(s) (1800); Deformity/ Disfigurement (2360); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
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.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.Reason for device explant and/or reoperation: rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a breast augmentation revision with mentor memoryshape breast implants 440cc and experienced bilateral rupture post-operatively, which was confirmed via mri.As a result, the patient is scheduled for removal on (b)(6) 2025.This report is for the left breast prosthesis.
Additional Manufacturer Narrative
On feb 13, 2025, additional information was received indicating the patient also experienced bilateral implant site fluid collection along with a breast cyst on the left side.On feb 20, 2025, additional information was received indicating the replacement devices were mentor gel breast implants (serial numbers (b)(6).Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On mar 5, 2025, the mentor failure analysis lab received the device for evaluation.On mar 12, 2025, it was noticed the following information was erroneously omitted from the previous report: the patient experienced breast cysts bilaterally.Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.Visual analysis of the returned device revealed that the mentor memoryshape¿ mm 440cc breast implant was found to be ruptured, received in two (2) parts.Additionally, an area of silex cracking was observed on the edges of the rupture.The evaluation determined that the possible cause of the rupture is consistent with normal wear.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Siltex cracking is ultimately a result of high stresses.A breast cyst is a fluid-filled sac within the breast.One breast can have one or more breast cysts.They are often described as round or oval lumps with distinct edges.Breast cysts are usually and typically do not require treatment, but they can be drained using fine needle aspiration if the cyst is large or uncomfortable.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, and that normal wear may have caused the observed defect.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: 21294561
• Report Number: 1645337-2025-00990
• Device Sequence Number: 7746690
• Product Code: FTR
• UDI-Device Identifier: 00081317005490
• UDI-Public: (01)00081317005490(17)181031(10)6763428
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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: 10/31/2018
• Device Catalogue Number: 3541408
• Device Lot Number: 6763428
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 02/13/2025; 03/05/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 03/05/2025; 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2013
• 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: 50 YR
• Patient Sex: Female