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

Catalog Number	3544800
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	04/02/2025
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, seroma.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a breast augmentation primary with mentor memorygel breast implants 800cc was diagnosed with ¿suspected¿ right-sided breast implant-associated anaplastic large cell lymphoma (bia-alcl).Per the information provided, the patient experienced a ¿possible breast infection or seroma or bia-alcl¿ on the right breast.The treatment plan involved removing the breast implants, letting the pocket heal for three months and then re-implanting at a later time.Imaging was performed, which showed fluid around the right breast implant, but due to the amount of fluid and swelling a rupture cannot be excluded.The patient mentioned they ¿woke up in the middle of the night with pain, redness, swelling and fever¿.Breast implant removal surgery was performed where samples of the fluid were collected and sent for further testing (results pending).Summary of the information provided in the operative note: breast implant removal surgery was performed on 24-apr-2025.A total of 300 cc of straw-colored seroma fluid was drained from the right periprosthetic space.The right breast implant was ruptured, but the left implant was intact.Both were mentor 800 cc high profile implants.No growth or white blood cells were seen in the culture of the seroma fluid from the right breast.The right and left breast capsule came back negative for cd30, benign appearing reactive lymphocytes and no evidence of malignancy.The final diagnosis was as follows: a.Left breast capsule: benign fibrous capsule with foreign body giant cell reaction and granulomatous inflammation.Negative for fungal organisms and acid-fast bacilli.B.Right breast capsule: benign fibrous capsule with foreign body giant cell reaction and granulomatous inflammation.Negative for fungal organisms and acid-fast bacilli.Based on the report source (i.E.Operative note and post-operative report), this case is no longer classified as a case of ¿suspected¿ bia-alcl.Per the information provided, testing came back negative for bia-alcl.The clinical information provided supports that this case is not consistent with a bia-alcl diagnosis.
Additional Manufacturer Narrative
On may 19, 2025, the mentor failure analysis lab received the device for evaluation.Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted visual inspection of the returned device.Visual analysis of the returned device revealed that the siltex hpg, 800cc breast implant was found to have an area of siltex cracking on the posterior view.In addition, a tear was noted within the siltex cracking measuring approximately 9.6 cm.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 seroma is a build-up of fluid around the implant.Symptoms from a seroma may include swelling, pain, and bruising.A seroma may occur soon after surgery, or any time later on, which would be referred to as a late seroma.While the body may absorb seromas, some may require surgery for drainage.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 MEMORYGEL 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: 21986386
• Report Number: 1645337-2025-04997
• Device Sequence Number: 17297771
• Product Code: FTR
• UDI-Device Identifier: 00081317001164
• UDI-Public: (01)00081317001164(17)191206(10)6885117
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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

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: 12/06/2019
• Device Catalogue Number: 3544800
• Device Lot Number: 6885117
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2014
• 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: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White