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

Model Number	3545650
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Seroma (2069); Deformity/ Disfigurement (2360); Breast Mass (2439)
Date of Event	04/01/2021
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: rupture, late onset of seroma, breast mass.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 42(b)(6) female patient who underwent breast implant surgery with mentor medical devices (siltex uhp 650cc, date of implant (b)(6) 2016) developed late-onset seroma in both breasts and also has experienced asymmetry and swelling of the left breast.During explantation on (b)(6) 2021 hcp found bilaterally ruptured implants, along with growths/tumors on ribs, a biopsy of growths was performed and sent to pathology.Per the provided pathology result, no tumor was confirmed, histiocytic reaction to hydrophobic foreign material, and nonspecific chronic inflammation was reported.Should additional information become available, this case will be re-assessed and notes will be updated.This report relates to the left prosthesis.
Additional Manufacturer Narrative
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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation completed on may 30, 2021: visual analysis of the returned sample determined that the siltex uhp 650cc breast implant was found to be ruptured.A microscopic examination was performed, and the cause of the tear could not be identified.Asymmetry may be attributed to one or more of the following: contracture of the fibrous capsule, seroma or hematoma, development of postoperative breast dysplasia, unilateral discrepancy in muscle development, deflation of the implant, incorrect choice of implant shape or size, and surgical technique.Asymmetry is a known complication associated with these devices and is referenced in our current product insert data sheet.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.You should consider the possibility of bia-alcl when a patient presents with late onset, persistent peri-implant seroma.In some cases, patients presented with capsular contracture or masses adjacent to the breast implant.When testing for bia-alcl, collect fresh seroma fluid and representative portions of the capsule, and sent to a laboratory with appropriate expertise for pathology test to rule out alcl, including immunohistochemistry testing for cd30 and alk (anaplastic lymphoma kinase).If your patient is diagnosed with peri-implant bia-alcl, develop an individualized treatment plan in coordination with a multidisciplinary care team.The national comprehensive cancer network (nccn) recommends surgical treatment that includes implant removal and complete capsulectomy ipsilaterally as well as contralaterally, where applicable.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
• MDR Report Key: 11842996
• Report Number: 1645337-2021-05516
• Device Sequence Number: 14611090
• Product Code: FTR
• UDI-Device Identifier: 00081317007203
• UDI-Public: 00081317007203
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• 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): 04/27/2021

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: 09/14/2020
• Device Model Number: 3545650
• Device Catalogue Number: 3545650
• Device Lot Number: 6974342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 05/20/2021; 05/30/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 05/25/2021; 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR