MAUDE Adverse Event Report: ESTABLISHMENT LABS S.A. MOTIVA IMPLANTS; ERGONOMIX ROUND SMOOTHSILK

Catalog Number	ERSD-425
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930); Ptosis (2620)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The alleged event is a risk associated with breast surgery and there is no evidence to suggest a link between this particular implant and/or its manufacturing process and a higher risk of occurrence.A complete review of the dhr for lot involved was carried out, no deviation was found in the manufacturing process.Additionally, there were no indications of abnormalities in raw materials or manufacturing processes which may have affected this particular batch.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: infection: "signs of acute infection reported in association with breast implants include edema, erythema, tenderness, pain, and fever.As with other invasive surgeries, toxic shock syndrome (tss), a life-threatening condition, has been reported in rare instances following breast implant surgery.Symptoms of tss occur suddenly and can include high fever (102°f (38.8°c) or higher), vomiting, diarrhea, sunburn-like rash, red eyes, dizziness, lightheadedness, muscle aches, and drops in blood pressure, which may cause fainting.Patients should immediately contact their physician for diagnosis and treatment if any of these symptoms occur." 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.Bottoming out - this refers to the inferior displacement of a breast implant that increases the distance between the nipple-areolar complex and the inframammary fold (imf) after breast-implant surgery.Risk factors reported in the literature are, but not limited to, the lack of quality of pre-existing breast tissue (i.E., thin subcutaneous tissue, defective dermal elements and breast tuberosity), characteristics of the selected breast implant (such as being overly large), imf dissection, and the type of implant placement during surgery (i.E., submuscular and subglandular planes).The clinical symptoms resulting from a bottomed-out implant include asymmetry, upward-pointing nipples, sagging, palpability, etc.Appropriate surgical planning can mitigate the possible causes of bottoming out.Recommendations include a careful and individual assessment of mammary tissues, careful implant selection, application of risk-minimizing surgical techniques, and adequate breast support after surgery.Treatments may vary depending on the severity of the complication and range from simple submammary fixation to the use of additional supporting materials.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.As stated in the literature: the human breast is not a sterile anatomic structure; it contains endogenous flora, derived from the nipple ducts, that is essentially similar to that found in normal skin.Multiple breast ducts provide a passage from the skin surface to deep within the breast tissue (pittet et al, 2005).Symptoms of infection usually manifest during the first 2 postoperative weeks, but delayed infections may occur months or even years after the operation (skandalakis, 2009).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).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
Usa.Allegedly, a patient presented with bilateral fluid leaking through the points and wounds (signs of infection), additionally, bottoming out, and visibility of the left breast implant through the t-point wound.During surgery, purulence was observed in both breast pockets; a culture was performed, but the results are not ready yet (r: (b)(6), l: (b)(6)).

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: ERGONOMIX ROUND SMOOTHSILK
• 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: 24562716
• Report Number: 3012883202-2026-02058
• Device Sequence Number: 15835641
• 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: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2026

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: ERSD-425
• Device Lot Number: 25050374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 06/03/2026; 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2025
• 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 Sex: Female