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

Catalog Number	RSF-500+
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Unspecified Infection (1930); Swollen Lymph Nodes/Glands (4432); Unspecified Immune System Problem (4435); Skin Inflammation/ Irritation (4545); Nodule (4551); Physical Asymmetry (4573)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: bii: " over the past several years, the fda has received new information about systemic symptoms commonly referred to as breast implant illness (bii), which some patients attribute to their implants.Some people with bii also get diagnosed with a specific autoimmune or connective tissue disease, but many do not.Researchers are investigating the symptoms to understand their origins better.These symptoms and what causes them are poorly understood.In some cases, removing breast implants without replacement is reported to reverse bii symptoms.Symptoms can include central nervous system (cns) disorders (e.G., brain fog, memory loss, tinnitus, vertigo, headaches, blurred vision and migraines); musculoskeletal disorders (e.G., fibromyalgia, muscle pain, hand discoloration, numbness, headaches and migraines); psychological disorders (e.G., anxiety, panic attacks, and feeling of imminent death); immune/inflammatory disorders (e.G., raynaud syndrome, scleroderma, hashimoto¿s thyroiditis, sjogren¿s syndrome, autoimmune disease, recurrent infections, rheumatoid arthritis, night sweats, toxic shock, chronic fatigue, dry eye, sudden food intolerance, systemic lupus erythematosus, and multiple sclerosis); as well as anemia and symptoms related to the cardiorespiratory and genitourinary systems".Infection: "signs of acute infection reported in association with breast tissue expanders 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." lymphadenopathy: "silicone-induced lymphadenopathy is a well-known rare complication of implant insertion.It is a disease of the lymph nodes (small, round structures that operate as part of the body¿s immune system).They become abnormal in size or consistency (most commonly producing swollen or enlarged lymph nodes).After implant insertion, axillary lymphadenopathy causes are multifactorial, with possible factors including granulomatous reaction, inflammation, and/or malignancy.Literature reports associate lymphadenopathy with intact and ruptured silicone breast implants since microscopic silicone droplets can migrate to body tissues even when the implant surface remains intact.Breast implant rupture and/ or leakage through an intact surface can cause fibrosis and granulomatous reactions, which in turn can result in a contracture or regional lymphadenopathy that sometimes mimics malignancy.Various patterns of lymphadenopathy and even extranodal pathology may be observed.Tissue examination is essential to identify the cause of lymphadenopathy.When in doubt, spectrometry analysis can confirm a diagnosis of silicone-induced lymphadenopathy".Lump: "sometimes there are symptoms associated with gel implant rupture, such as lumps surrounding the implant or in the armpit"."the patient should be advised that the presence of lumps, persistent pain, swelling, hardening, or change in the implant shape could suggest symptomatic rupture of the implant".Asymmetry: "preoperative asymmetries include areolas in different positions medially or regarding height, different breast shapes (e.G., one round and the other tuberous), or different breast sizes.These asymmetry types should be differentiated from a postoperative aesthetic difference in the two breasts produced by factors described previously, such as a fall of the fold, a high implant, or a rotation of the implant.Asymmetries caused by the implant¿s unequal fitting or by creating different sub-mammary grooves.They can be prevented using adequate preoperative planning, correct dissection of the pockets, and comparing the two breasts after fitting the implants.It is possible that after a breast augmentation, small deformities in the wall of the thorax or a morphologic mammary disorder may become much more evident.For this reason, the predicted correction of these anomalies should be discussed with the patient before her operation".Inflammation: "breast implants are no different from any foreign material implanted into the human body, and can trigger a host's protective immune reaction.It is a foreign body response demonstrated by redness, swelling, warmth, pain, and or loss of function"."this foreign body response is universal and ideally removes or otherwise surrounds the ¿irritant material¿ with fibrous tissue to prevent unwanted immune consequences".
Event or Problem Description
Usa.Allegedly, a patient is experiencing bilateral breast pain and a bi-rads 4 suspicious breast mass adjacent to the left breast implant.The patient also reports systemic symptoms including fatigue, joint pain, lymphadenopathy, night sweats, brain fog, rash, raynaud¿s-type vascular discoloration, unintentional and extreme weight loss, anemia, and positive ana testing.Also, she presents infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts, initial encounter, progressive inferior pole discoloration, contour change, and asymmetry temporally associated with reported adverse device findings.The patient indicates ongoing medical evaluation and reports implant removal with full capsulectomy has been recommended.

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: SMOOTHSILK PLUS
• 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
• Manufacturer Contact: susana hidalgo ; building b-25, coyol free zone; alajuela,alajuela 20113 ; 8003554164
• MDR Report Key: 24618166
• Report Number: 3012883202-2026-02085
• Device Sequence Number: 18676353
• Product Code: FTR
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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-500+
• Device Lot Number: 24101083
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2024
• 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: Other
• Patient Sex: Unknown
• Patient Race: White