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

Catalog Number	ERSD-475
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Wrinkling (2613); Ptosis (2620)
Date of Event	12/05/2025
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.The cause of capsular contracture is multifactorial, and we cannot conclude that the reported event was caused by the manufacturing process and/or the product itself.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: capsular contracture: "a capsular contracture pertains to hypertrophic scar tissue investing in a foreign body or surgically implanted device, compromising the aesthetic outcome, resulting in pain, breast deformity, and often necessitating further operations4.Detection of breast cancer by mammography may also be challenging.Capsular contracture may be more common following infection, hematoma and seroma, and the chance of it happening may increase over time.Capsular contracture occurs more commonly in patients undergoing revision surgery than in patients undergoing primary implantation surgery.Capsular contracture is the most common complication following implant- based breast surgery and is one of the most common reasons for reoperation".Symmastia ¿ this is a relatively rare implant-displacement problem that occurs when the skin and muscle between the breasts over the sternum (breastbone) detaches, and the two pockets of tissue that hold the breast implants come together to form one pocket.This allows the implants to come together in the middle, creating the appearance of a ¿uniboob¿ and sometimes causing discomfort or pain.It¿s often difficult to correct symmastia and it may require more than one surgery.In most cases, surgery will involve removing the implants and replacing them with new (usually smaller) implants.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 most common overall indication for reoperation is capsular contracture (handel, 2006).Capsular contracture produces asymmetry between both breasts either in bilateral (when the degree of affectation is different) or unilateral cases.The patient may present discomfort in the contracting breasts, such as coldness and pain (f.J.Escudero et al., 2005).Capsular contracture occurs approximately five times more frequently with smooth surface implants compared with textured surface implants (barnsley, et al.2006).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 developed a bilateral capsular contracture baker grade iii, and a revision surgery was required.On the physical examination, it was observed that the left breast was firmer than the right and a bilateral symmastia.The patient also reported rippling in her left breast (sns (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.
Additional Manufacturer Narrative
General conclusion device involvement: a causal relationship between the reported event and the device has been established.Event characterization: the event was classified as capsular contracture, symmastia.Clinical confirmation upon thorough evaluation of the submitted clinical documentation and supporting evidence, capsular contracture, symmastia were confirmed, however rippling was not confirmed.Root cause analysis this event is a well-documented complication inherent to breast implant surgery.Based on the analysis of the available data, including clinical findings and product traceability records, there is no evidence indicating a causal link between this specific case and any product-related factors, including raw materials or manufacturing processes.The etiology of the alleged event is recognized as multifactorial, given the absence of manufacturing deviations or anomalies, and in line with current clinical literature, the event is considered not attributable to the manufacturing process and/or the product itself.Dfu and labeling evaluation the event is a known, well-documented complication associated with silicone breast implants.It is clearly addressed in the product¿s directions for use (dfu), which states: capsular contracture ¿ a capsular contracture pertains to hypertrophic scar tissue investing in a foreign body or surgically implanted device, compromising the aesthetic outcome, resulting in pain, breast deformity, and often necessitating further operations.Detection of breast cancer by mammography may also be challenging.Capsular contracture may be more common following infection, hematoma and seroma, and the chance of it happening may increase over time.Capsular contracture occurs more commonly in patients undergoing revision surgery than in patients undergoing primary implantation surgery.Capsular contracture is the most common complication following implant- based breast surgery and is one of the most common reasons for reoperation.Capsular contracture is graded into four levels depending on its severity: baker grade i: the breast is normally soft and looks natural.Baker grade ii: the breast is a little fi rm but looks normal.Baker grade iii: the breast is fi rm and looks abnormal.Baker grade iv: the breast is hard and painful and looks abnormal.Symmastia ¿ this is a relatively rare implant-displacement problem that occurs when the skin and muscle between the breasts over the sternum (breastbone) detaches and the two pockets of tissue that hold the breast implants come together to form one pocket.This allows the implants to come together in the middle, creating the appearance of a ¿uniboob¿ and sometimes causing discomfort or pain.It¿s often difficult to correct symmastia and it may require more than one surgery.In most cases, surgery will involve removing the implants and replacing them with new (usually smaller) implants.Rippling/wrinkling ¿ 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.The dfu also emphasizes the responsibility of the surgeon to fully inform the patient of potential risks and complications during the pre-operative consultation.Patients are provided with the document ¿motiva implants®: information for the patient,¿ accessible at ifu.Motiva.Health.Literature reference: capsular contracture: 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 has been identified several significant risk factors for capsular contracture, including device features (surface, size), surgical factors (periareolar incision, subglandular placement, antibiotic irrigation), the development of hematoma/seroma, and the use of a surgical bra.(calobrace, 2018).Periprosthetic capsules become pathologically active and undergo a ¿constrictive fibrosis¿ due to retraction of the fibrous tissue, which deforms their contents and impairs the aesthetic outcome, manifested by hardening of variable degree and, in advanced cases, by deformity of the breast.(baker et al., 1990).Peri-implant fibrosis is the most common local side effect of silicone implants, with a reported incidence of 0.5% - 50% (wick, et al.,2013, wolfram, et al., 2012, and handel, et al., 2006).Capsular contracture produces asymmetry between both breasts either in bilateral (when the degree of affectation is different) or unilateral cases.The patient may present discomfort in the contracting breasts, such as coldness and pain.(f.J.Escudero et al., 2005).Capsular contracture occurs approximately five times more frequently with smooth surface implants compared with textured surface implants.(barnsley, et al.2006).Device history record (dhr) review a comprehensive review of the device history record (dhr) for the affected lot was completed.No deviations, non-conformances, or anomalies were identified during manufacturing.All raw materials and process parameters conformed to specified quality requirements.Trend and signal monitoring the event has been evaluated as part of ongoing trend analysis activities within the pms program.Per the current complaint data report: no adverse or unexpected trends related to device rupture have been identified.No further corrective or preventive actions are required at this time.Establishment labs will continue to monitor for similar events as part of routine pms surveillance.

• 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
• 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: 23828955
• Report Number: 3012883202-2025-01636
• Device Sequence Number: 8954432
• Product Code: FTR
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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-475
• Device Lot Number: 25020487
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2025
• 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