Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-230Recalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi 230 cc · Class 3 · Implant
All models of Motiva SmoothSilk Round Ergonomix Breast Implant (69)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07445161010520), received between Dec 13, 2024 and Sep 11, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Appears to Trigger Rejection5
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Capsular Contracture5
- Deformity/ Disfigurement1
- Impaired Healing1
- Infiltration into Tissue1
- Insufficient Information1
- Ptosis1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture; Deformity/ Disfigurement; Ptosis
MAUDE report 50741393 ↗InjurySep 11, 2026Device Appears to Trigger Rejection
USA. In (b)(6) 2026, underwent a breast revision surgery with Motiva Implants, subsecuently experienced Grade III capsular contracture on both breast. The patient hasn't undergone any additional surgery. The investigation is complete.
Patient problems: Capsular Contracture
MAUDE report 50726265 ↗InjuryAug 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ARGENTINA. IT WAS REPORTED THAT, LESS THAN ONE MONTH AFTER SURGERY, A PATIENT DEVELOPED A BAKER GRADE IV CAPSULAR CONTRACTURE IN HER LEFT BREAST THAT CAUSED DEFORMATION. ATTEMPTS TO GATHER ADDITIONAL INFORMATION WERE MADE AND THE INVESTIGATION WAS COMPLETED.
Patient problems: Capsular Contracture
MAUDE report 22917383 ↗InjuryJan 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
A PATIENT REPORTED EXPERIENCING FIRMNESS ON BOTH BREASTS AND WAS DIAGNOSED WITH CAPSULAR CONTRACTURE BAKER GRADE III. THE PATIENT WAS ADVISED TO UNDERGO BREAST IMPLANT REMOVAL SURGERY. NO PATIENT DEMOGRAPHICS, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENT HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Capsular Contracture
MAUDE report 21060518 ↗InjuryJan 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
A PATIENT REPORTED EXPERIENCING FIRMNESS ON BOTH BREASTS AND WAS DIAGNOSED WITH CAPSULAR CONTRACTURE BAKER GRADE III. THE PATIENT WAS ADVISED TO UNDERGO BREAST IMPLANT REMOVAL SURGERY. NO PATIENT DEMOGRAPHICS, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENT HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Capsular Contracture
MAUDE report 21060458 ↗InjuryDec 13, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
LEFT BREAST: RUPTURE, DISCOVERED DURING SURGERY, EXTRACAPSULAR DIFFUSION OF SILICONE. FLEXIBILITY AND SHAPE OF THE BREAST ARE NORMAL. THERE WAS PAIN AND EXPOSURE OF THE PROSTHESIS. IMPLANT WAS REMOVED.
Patient problems: Impaired Healing; Infiltration into Tissue; Insufficient Information
MAUDE report 20929270 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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