MAUDE Adverse Event Report: ESTABLISHMENT LABS S.A. MOTIVA IMPLANTS; SILKSURFACE PLUS WITH QID

Catalog Number	RSF-425+Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Impaired Healing (2378)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Extrusion represents potential complications associated with the use of breast implants, it involves the implant coming through the skin, normally through the incision where it¿s been placed.Extrusion can happen for several reasons, such as the skin over the implant thinned too much leaving too little coverage for the implant, the implant used is too large, the incision did not heal well and broke open.Implant exposure due to poor tissue coverage frequently obligates the surgeon to remove the breast implant and begin anew (gargano, ciminello & de santis; 2009).Early seroma formation is defined as periprosthetic fluid accumulation within the first postoperative year, whereas the late form is any moment beyond that time (sforza, et al.2017).Per our directions for use, each patient must receive the establishment labs s.A.¿motiva implants®: information for the patient¿ during her surgical consultation, it is the surgeons´ responsibility to ensure that the patient completely understands the information regarding the risks, benefits, and recommendations associated with silicone gel-filled breast implant surgery, as well as the complications typical of any type of surgery.This document is available in motiva® website: ifu.Motiva.Health.The instructions for use in the directions for use were reviewed, to determinate if there are indications that ensure the prevention and good handling of the product.For this event, it is considered that the information is suitable for the section of surgical precautions as follows: seroma: "seroma is an accumulation of fluid that results from tissue inflammation.The etiology of seroma is known in breast surgery and is connected to a hypovascular milieu or trauma following the surgery.Often, seromas are reabsorbed by the body over several weeks, but needle drainage is sometimes needed to remove the fluid.While seromas do not increase breast cancer risk, they sometimes heal with scar tissue or calcifications that can raise a concern about mammograms in the future.Seroma symptoms most often appear a week to 10 days after surgery; the area may feel tender and swollen, with a discrete lump and redness arising within a day or two.Early seroma formation is defined as periprosthetic fluid accumulation within the first postoperative year, whereas the late form is any moment beyond that time.In addition to causing pain, a seroma increases the risk of developing an infection in the breast.Depending on the location, it may also increase pressure over the surgical site and sometimes cause wound dehiscence".Extrusion: "breast implant extrusion, or breast implant exposure, occurs when the breast skin and tissues that are holding the implant fail, causing the implant to protrude through the skin and become exposed.It happens in less than 2% of patients; it is shortly after breast augmentation or down the road.Breast-implant extrusion can occur for various reasons, such as improper wound healing due to an infection, trauma, too little soft-tissue coverage, oversized implant coupled with too little tissue coverage, or lack of blood supply.Breast-implant extrusion calls for surgery and removal of the implant".Establishment labs will continue to monitor for similar complaints/trends.As part of the post market surveillance process, monitoring of the primary endpoints reported is performed to determine unfavorable trends.Per our current complaint data report, no unfavorable trends were detected on this product.No further actions are required.
Event or Problem Description
México.Allegedly, a patient who underwent a breast augmentation surgery presented with breast implant exposure following spontaneous seroma drainage confirmed by ultrasound five weeks post-op (sn: (b)(6).No patient demographics, such as weight, or ethnicity, were provided by the reporter.Efforts to gather additional information are ongoing, and the investigation remains in progress.

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: SILKSURFACE PLUS WITH QID
• Manufacturer (Section D): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela 20113
• Manufacturer (Section G): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela 20113
• Manufacturer Contact: susana hidalgo ; building b-25, coyol free zone; alajuela,alajuela 20113 ; 8003554164
• MDR Report Key: 23559671
• Report Number: 3012883202-2025-01458
• Device Sequence Number: 9858763
• Product Code: FTR
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: RSF-425+Q
• Device Lot Number: 23022561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2023
• 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: 22 YR
• Patient Sex: Female