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

Catalog Number	3507550BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint device has been discarded.  as a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.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. 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 surgery with implantation of a 550cc mentor memorygel breast implant prosthesis.Post-operatively, the patient was diagnosed with a ruptured breast implant of an unspecified side using mammogram imaging.As a result, the patient underwent bilateral removal and replacement with 550cc mentor memorygel breast implants on (b)(6) 2010.However, during the surgery, both implants were found to be ruptured.There were no reported procedural delays or patient consequences due to the discovery.This report is for the left breast prosthesis.
Additional Manufacturer Narrative
On october 28, 2024, mentor was notified by the patient that she had bilaterally ruptured breast implant confirmed using mammogram imaging and after explantation.Additionally, the patient began to experience symptoms in 2009 that included; fatigue, brain fog, hair loss, insomnia, dry eyes, estrogen dominance, easy bruising, throat clearing, shortness of breath, asthma, reflux, ringing in ears, leaky gut, gastrointestinal issues, achy joints, frequent urination, heart palpitations, yeast infections, headaches, hypothyroid, thyroid nodules, and depression.As an approximate event date was provided the date of event was updated.Date of event: january 01, 2009.H6 health effect - clinical code e2402: generalized illness.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: 20470870
• Report Number: 1645337-2024-12199
• Device Sequence Number: 7236308
• Product Code: FTR
• UDI-Device Identifier: 00081317000167
• UDI-Public: (01)00081317000167(17)080930(10)266713
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2010
• 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: 09/30/2008
• Device Catalogue Number: 3507550BC
• Device Lot Number: 266713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2003
• 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: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White