MAUDE Adverse Event Report: Establishment Labs S.A. MOTIVA IMPLANTS; Ergonomix Round SilkSurface

Catalog Number	ERSD-265
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Usa.It was alleged that a patient who underwent breast revision surgery in (b)(6) 2025 developed baker grade iii capsular contracture, implant flipping, bottoming out, and rippling of the left breast.Revision surgery was performed, during which a gel fracture was observed.The investigation is ongoing.
Additional Manufacturer Narrative
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: capsular contracture: ¿capsular contracture occurs when the capsule tightens and squeezes the implant.This can cause the implant to turn rigid (from slightly firm to quite hard) and the firmest ones can cause varying degrees of discomfort, pain, and palpability.In addition to the firmness, capsular contracture can result in a deformed breast, visible surface wrinkling and/or displacement of the implant.Detection of breast cancer by mammography may also be a more difficult.Capsular contracture may be more common following infection, hematoma, and seroma, and the chance of it happening may increase over time.Capsular contracture is a risk factor for implant rupture, and it is the most common reason for reoperation in augmentation and reconstruction patients.Patients should also be advised that additional surgery might be needed in cases where pain and/or firmness are severe (baker grades iii or iv) and that capsular contracture may happen again after additional surgeries."correction of capsular contracture may require surgical removal or release of the capsule, or removal and possible replacement of the implant itself¿.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 a simple sub¿mammary fixation to the use of additional supporting materials".Rippling: rippling is the cutaneous manifestation, visible or palpable, of the implant ripples and edge that are typically most apparent when the patient bends forward.In situations where the implant's soft tissue coverage is insufficient, these harmful effects become more apparent.Risk factors for rippling are related to the breast-tissue quality and low cohesivity of the implanted gel.Adequate coverage over the implant ripples is a mandatory element in preventing rippling or implant edge visibility.Flipping: anterior/posterior rotation, also called flipping, has been observed more frequently with cohesive gel implants.The flat base of the implant is positioned anteriorly, deforming the breast of the patient.Proper placement and pocket dissection reduce the risk of occurrence.Flipping can be treated with bimanual manipulation in the surgeon's office and can be done repeatedly in recurrent cases.However, in some cases, revision surgery may be necessary to reduce pocket dimensions.Gel fracture: gel fracture is defined as a fissure or cracks in the implant¿s gel when excessive intrinsic forces forcibly separate the silicone gel filling.As a result, the implant¿s shape is irrevocably lost, leading to the need for implant replacement.It can occur with cohesive silicone gel and most frequently due to exposing the implant to excessive compression forces applied to a small shell area during implant insertion.Gel fracture can also occur due to the development of capsular contracture and may result in device distortion.

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: Ergonomix Round SilkSurface
• Manufacturer (Section D): Establishment Labs S.A.; building b-25, coyol free zone; alajuela,alajuela 20113 ; CS 20113
• Manufacturer (Section G): Establishment Labs S.A.; building b-25, coyol free zone; alajuela,alajuela 20113 ; CS 20113
• Manufacturer Contact: susana hidalgo ; building b-25, coyol free zone; alajuela,alajuela 20113 ; CS 20113 ; +1(800)355-4164
• MDR Report Key: 50726422
• Report Number: 3012883202-2026-02918
• Device Sequence Number: 10620895
• Product Code: FTR
• UDI-Device Identifier: 07445161010544
• UDI-Public: (01)07445161010544(11)250204(17)300204
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 09/10/2026

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-265
• Device Lot Number: 25020051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2025
• 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: Unknown