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

Catalog Number	3507150MC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/01/2024
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, capsular contracture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a breast reconstruction revision surgery with implantation of a 150cc mentor memorygel breast implant prosthesis.Post-operatively, the patient was diagnosed with a ruptured right breast implant using magnetic resonance imaging and right-breast baker grade iii capsular contracture during an in office visit with a medical professional.As a result, the patient underwent breast implant removal on (b)(6) 2024.The date of event was provided to mentor as a best estimate.Follow-ups are being conducted.If more information becomes available, mentor will submit a supplemental report accordingly.
Additional Manufacturer Narrative
On october 18, 2024, mentor was notified that the patient underwent bilateral removal and replacement with a left-sided 350cc mentor memorygel breast implant during the revision surgery.The right breast implant was not replaced.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On august 01, 2024, the mentor analysis lab received the suspect medical device for evaluation.With the return of the device, an updated date of explantation was provided.Date of explantation: july 11, 2024 on august 08, 2024, mentor completed an evaluation on the returned device.Mentor conducted a visual inspection of the device.Visual analysis of the returned sample revealed that the breast implant was found to be ruptured and received incomplete.Additionally, shell abrasion was observed on the edges of the rupture.The evaluation determined that the possible cause of the rupture was consistent with normal wear.Shell abrasion suggests in-vivo folding or creasing of the device.This may be the result of the following factors: continuous and sustained stresses to the device such as too small breast pocket and folding or wrinkling of the shell in the breast pocket.In some cases, the breast implants may also wear out over time.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body's individual physiological response to the implantation of a foreign object in soft tissue.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, capsules, and effusion to pathology for examination.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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 19567188
• Report Number: 1645337-2024-07360
• Device Sequence Number: 6140542
• Product Code: FTR
• UDI-Device Identifier: 00081317004073
• UDI-Public: (01)00081317004073(11)180202(17)230131(10)7546195(21)7546195-053
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• 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: 01/31/2023
• Device Catalogue Number: 3507150MC
• Device Lot Number: 7546195
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 08/01/2024; 10/17/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/12/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2018
• 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
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White