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

Catalog Number	ERSM-185
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Usa.Allegedly, a patient who underwent a breast revision augmentation surgery on (b)(6) 2025, developed a bilateral capsular contracture baker grade iii, she presented asymmetry and pain due the capsular contracture.During the explant surgery, a late seroma was found.The investigation is ongoing.
Additional Manufacturer Narrative
As stated in literature: the most common overall indication for reoperation is capsular contracture.(handel, 2006).Breast prostheses are no different from any foreign material implanted into the human body in the sense of triggering a protective immune reaction from the host.This ¿foreign body response¿ (fbr) is universal and ideally removes or otherwise surrounds the ¿irritant material¿ with fibrous tissue to prevent unwanted immune sequelae.A capsule around a breast implant is, therefore, a necessary mechanism of body defense, but if excessive it can lead to pain and deformity of the breast (steiert, et al., 2013).¿it is imperative that careful planning and exacting surgical technique are used to reduce iatrogenic damage of implants during primary placement and subsequent reoperations.¿ (handel, garcía and winxtrom, 2013).¿seroma can present both early and late, with the latter being recently linked with malignant growths and prolonged onset.¿ (sforza, et al.2017).Per our directions for use, each patient must receive the establishment labs s.A.¿motiva implants®: 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¿time9.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".¿ 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¿.

• 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 ; 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: 50570059
• Report Number: 3012883202-2026-02849
• Device Sequence Number: 10533387
• Product Code: FTR
• UDI-Device Identifier: 07445161010322
• UDI-Public: (01)07445161010322(11)250402(17)300402
• 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
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: ERSM-185
• Device Lot Number: 25033132
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• 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