Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-170Recalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini 170 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07445161010315), received between Jan 3, 2025 and Dec 10, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 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 Rejection4
Patient problems
- Capsular Contracture4
- Breast Discomfort/Pain2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
USA. ALLEGEDLY, A PATIENT DEVELOPED A BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST. SHE REPORTED NUMBNESS, UNABLE TO FEEL TOUCH OR TEMPERATURE, PAIN, TIGHTNESS AND SWELLING. A CAPSULEPTOMY WAS PERFORMED, AND THE SAME IMPLANTS WERE LEFT IN PLACE IN (B)(6) 2025.
Patient problems: Capsular Contracture
MAUDE report 23771500 ↗InjuryDec 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
USA. ALLEGEDLY, A PATIENT DEVELOPED A BAKER GRADE IV CAPSULAR CONTRACTURE; THE CAPSULE WAS NOTED ON A FOLLOW-UP VISIT. 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.
Patient problems: Capsular Contracture
MAUDE report 23771123 ↗InjuryJan 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE PATIENT UNDERWENT A VERTICAL MASTOPEXY WITH MOTIVA IMPLANTS ON (B)(6) 2023. ON (B)(6) 2024, THE PATIENT PRESENTED WITH COMPLAINTS OF BREAST HARDNESS AND PAIN, LEADING TO A DIAGNOSIS OF CAPSULAR CONTRACTURE, GRADE III. SUBSEQUENTLY, REVISIONAL SURGERY WAS PERFORMED, WHICH INCLUDED A TOTAL CAPSULECTOMY AND REPLACEMENT OF THE IMPLANTS. LEFT SIDE.
Patient problems: Breast Discomfort/Pain; Capsular Contracture
MAUDE report 21068517 ↗InjuryJan 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE PATIENT UNDERWENT A VERTICAL MASTOPEXY WITH MOTIVA IMPLANTS ON (B)(6) 2023. ON (B)(6) 2024, THE PATIENT PRESENTED WITH COMPLAINTS OF BREAST HARDNESS AND PAIN, LEADING TO A DIAGNOSIS OF CAPSULAR CONTRACTURE, GRADE III. SUBSEQUENTLY, REVISIONAL SURGERY WAS PERFORMED, WHICH INCLUDED A TOTAL CAPSULECTOMY AND REPLACEMENT OF THE IMPLANTS. RIGHT SIDE
Patient problems: Breast Discomfort/Pain; Capsular Contracture
MAUDE report 21068044 ↗
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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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