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

Catalog Number	3501251BC
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Autoimmune Disorder (1732); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 50-year-old caucasian female patient underwent a breast augmentation revision with two 125cc mentor memorygel breast implant and experienced a rupture on the left side post-operatively.It was also reported that the patient experienced generalized illness symptoms including being tired, lethargic, having unspecified sickness, and having unspecified autoimmune issues.As a result, the patient is to undergo bilateral device explantation on (b)(6) 2024.This report is for the left side device.
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.Reason for device explant and/or reoperation: generalized illness and rupture.H6 health effect - clinical code e2402: generalized illness.Section d6b.Explantation date: (b)(6) 2024.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On may 01, 2024, mentor received additional information regarding the patient's diagnosis.It was reported in the patient's operative report that the patient's left breast prosthesis was found to be intact.The patient had a ultrasound which showed a rupture, however, was not confirmed during the explantation surgery.Only the patient's left side breast prosthesis was removed and replaced with a 150cc mentor memorygel breast implant (catalog number 3501501bc) with serial number (b)(6).Code a24 has been added in section h6-medical device problem code to reflect this additional information.On may 16, 2024, the mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.It was also reported by the patient that on (b)(6) 2024 she got tested once again and was diagnosed with raynaud's.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2024, after clinical review, mentor determined that since the patient reporting having raynaud's syndrome, the health effect - clinical code in section h6 has been updated to e0401-autoimmune disorder to better capture this information more accurately.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On may 24, 2024, the evaluation for the device was completed.Device evaluation summary: during visual evaluation no apparent damage or visual anomalies were observed on the sm mpp gel 125cc returned device.The lay community, the popular press and medical literature has raised the possibility that there may be an association between certain immunological-based diseases and silicone implants.The diseases most commonly mentioned include scleroderma, rheumatoid arthritis and syndromes which mimic systemic lupus erythematosus.Available information does not permit precise quantification of risk.Neurological problems have been reported in a small number of breast implant patients who also exhibit immunological symptoms.Mentor has completed extensive biocompatibility studies on the polymer materials used in manufacture and finished devices.None of these studies have shown any indication of inducing immune responses.Studies on carcinogenicity, mutagenicity, hemolysis, dna transfers, responses to particulate formation, etc.Have all shown these materials to be safe.Evidence suggests that such diseases or conditions are no more common in women with breast implants than in women without implants.Concern over the association of breast implants to the development of autoimmune or connective tissue diseases, such as lupus, scleroderma, or rheumatoid arthritis, was raised because of cases reported in literature with small numbers of women with implants.Scientific expert panels and literature reports have found no evidence of a consistent pattern of signs and symptoms associated with these diseases in women with breast implants.Additionally, having rheumatological signs and symptoms does not necessarily mean a patient has a connective tissue disorder or autoimmune disease.Per the fda¿s ¿update on the safety of silicone gel-filled breast implants¿ published in june 2011, ¿there is no apparent association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems.¿ furthermore, the institute of medicine (iom) of the national academy of science released a final report stating ¿a review of seventeen epidemiological reports of connective tissue disease in women with breast implants was remarkable for its consistency in finding no elevated risks or odds ratio for an association of implants with disease¿there is no evidence that silicone implants are responsible for any major diseases of the whole body.Women are exposed to silicone constantly in their daily lives.There is no plausible evidence of a novel autoimmune disease caused by implants.¿ based on these reports, product evaluation (pe) is unable to confirm that the reported complaints are device related; however, mentor continues to include extensive discussions on alleged silicone responses in its product insert data sheets so that the patient and physician are fully informed of any potential risks.Mentor believes its current controls are adequate.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Since no malfunction was observed during the investigation, no corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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: 19160500
• Report Number: 1645337-2024-04780
• Device Sequence Number: 7349618
• Product Code: FTR
• UDI-Device Identifier: 00081317000211
• UDI-Public: 00081317000211
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 06/08/2024
• Device Catalogue Number: 3501251BC
• Device Lot Number: 7737693
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 05/01/2024; 05/21/2024; 05/24/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 05/20/2024; 05/21/2024; 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2019
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: White