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

Model Number	3545251
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Granuloma (1876); Seroma (2069); No Code Available (3191); Cancer (3262); Lymphoma (3263)
Date of Event	08/06/2019
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.Reason for device explant and/or reoperation: capsular contracture baker grade 4, granuloma, late onset seroma, neoplasm malignant.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient with a history of chronic lymphocytic leukemia diagnosed in 2003 who underwent breast augmentation revision with 525cc mentor memorygel breast implant presented to physician's office stating that she began running a fever, right breast was painful, breasts began hardening, and it felt like her right breast got much larger.Upon examination of the right breast, it was noted to be tender, large, swollen, mildly warmer than left with slight erythema in dependent portions.The patient was assessed as having baker grade iv capsular contracture of the right breast and baker grade iii capsular contracture of the left breast.The patient had a pet scan on (b)(6) 2019 that showed fluid in the right breast.The patient underwent bilateral removal of the implants, bilateral removal of capsules, and bilateral replacement with smooth silicone unknown brand breast implants on (b)(6) 2019.Upon explantation, it was noted via gross examination that the right implant was ruptured and the left implant was intact.Both the left and right side capsules showed chronic lymphocytic leukemia/sll, silicone granuloma, and fibrosis.This medwatch report is for the right-sided implant.
Additional Manufacturer Narrative
Upon review of the file, the following statement from clinician's review is to be included: "the patient had a right axilla lymph node excisional biopsy that showed cd5 positive diffuse large b cell lymphoma and silicone granuloma lymphadenitis.Lmmunohistochemical stains showed lymphoma cells are positive for cd 20, bcl 2 and cd5, and lymphoma cells are negative for bcl 1, cd3, cd138, cd30, cd10, bcl6, mum1 and sox11; ki-67 shows proliferation index of 70% in lymphoma cells.Cd 21 highlights residual of replaced germinal centers.Flow cytometry showed monoclonal cd5 positive 8-cells; majority of monoclonal 6-cells are medium to large size by forward scattered and side scattered characteristics.It appears there was cytology testing of right breast fluid was completed, but those results along with 2 wound cultures were not provided in the paperwork.In conclusion, the patient with a history of chronic lymphocytic consistent with richter transformation presented with an axillary lymph node biopsy showing a cd5 positive diffuse large 8-cell lymphoma.The patient has ancillary studies pending to exclude a double hit lymphoma.Fibroadipose tissue from left breast and right breast also shows involvement by chronic lymphocytic leukemia/sll: however, it is negative for high-grade b-cell lymphoma.Those results were not provided.Should additional information become available, this case will be re-assessed and notes will be updated." on 24-sep-2019, mentor received the suspect medical device.On 17-oct-2019, mentor completed the investigation on the suspect medical device.Device evaluation summary: according with the information reported the patient developed late onset seroma, granuloma, capsular contracture and neoplasm malignant also, experienced a rupture in the breast implant.During evaluation of the device a line of shell wear was observed in posterior view also, a rupture within the shell wear was noted, measuring approximately 1 cm.No additional anomalies were observed.A shell wear/ fold failure may be the result of the continuous and sustained stresses to the device caused by the capsular contracture, which resulting in a tear at a later date.Postoperative formation of a fibrous tissue capsule around a mammary prosthesis is a normal physiologic response to the implantation of a foreign object and occurs in all patients in varying degrees.In some cases, contracture of the fibrous capsule may occur.This phenomenon is referred to as capsular contracture.Excessive postoperative accumulation and/or transient reaccumulation of fluid around an implant most likely occur soon after surgery; however, it can occur at any time.Symptoms from seroma may include swelling, pain, and bruising.While the body absorbs small hematomas and seromas, some will require surgery.Seromas presenting after the immediate post-operative period may require additional work-up by the surgeon.Seroma is a known complication associated with this surgery and is referenced in our current product insert data sheet.Granulomas are noncancerous nodules that are a common tissue reaction to the presence of a variety of foreign materials, such as silicone.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Complaint information will be included in complaint trending that is reviewed and monitor by quality assurance on a regular basis to determine if further action is necessary.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 09, 2022, mentor updated the file to provide more specific coding related to the adverse event.Lymphoma code replaced neoplasm malignant to more accurately depict the event.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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 949789-8687
• MDR Report Key: 9101367
• Report Number: 1645337-2019-19652
• Device Sequence Number: 16853422
• Product Code: FTR
• UDI-Device Identifier: 00081317003908
• UDI-Public: 00081317003908
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2019

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: 03/31/2019
• Device Model Number: 3545251
• Device Catalogue Number: 3545251
• Device Lot Number: 6807299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 09/24/2019; 11/09/2022
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 10/21/2019; 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2014
• 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: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White