Motiva® SmoothSilk® Round Breast Implant RSD-360+QRecalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 360 cc · Class 3 · Implant
All models of Motiva SmoothSilk Round Breast Implant (53)
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 07445161002730), received between Feb 5, 2025 and Dec 10, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (6 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 Rejection6
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Capsular Contracture6
- Seroma1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ARGENTINA. ALLEGEDLY, THE PATIENT UNDERWENT SURGERY IN OCTOBER 2024 AND WAS SUBSEQUENTLY DIAGNOSED WITH BAKER GRADE III/IV CAPSULAR CONTRACTURE (SN: (B)(6)). SIDE AFFECTED NOT SPECIFIED. 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 23770951 ↗InjuryDec 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ARGENTINA. ALLEGEDLY, THE PATIENT UNDERWENT SURGERY IN (B)(6) 2024 AND WAS SUBSEQUENTLY DIAGNOSED WITH BAKER GRADE III/IV CAPSULAR CONTRACTURE (SN: (B)(6)). SIDE AFFECTED NOT SPECIFIED. 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 23770950 ↗InjuryMar 31, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD A PAIN IN HER RIGHT BREAST ONE MONTH POST OP, SHE VISITED HER DOCTOR, DID AN ULTRASOUND, AN EARLY SEROMA WAS DETECTED AND REMOVED. CURRENTLY THE PATIENT CONTINUE WITH PAIN IN HER RIGHT BREAST OCCURRED BY A CAPSULAR CONTRACTURE BACKER GRADE III.
Patient problems: Capsular Contracture; Seroma
MAUDE report 21732187 ↗InjuryMar 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED A CAPSULAR CONTRACTURE BAKER GRADE III. NO PATIENT DEMOGRAPHICS, SUCH AS AGE, 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 21567037 ↗InjuryFeb 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED A CAPSULAR CONTRACTURE BAKER GRADE III. NO PATIENTS DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENTS HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Capsular Contracture
MAUDE report 21316133 ↗InjuryFeb 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED A CAPSULAR CONTRACTURE BAKER GRADE III. NO PATIENTS DEMOGRAPHICS, SUCH AS AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENTS HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Capsular Contracture
MAUDE report 21315799 ↗
Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices
- MENTOR MemoryGel Breast Implant 3503501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,167 reports
- MENTOR MemoryGel Breast Implant 3504001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,130 reports
- MENTOR MemoryGel Breast Implant 3504004BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,012 reports
- MENTOR MemoryGel Breast Implant 3504504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,754 reports
- MENTOR MemoryGel Breast Implant 3503001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,752 reports
- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
- MENTOR MemoryGel Breast Implant 3504501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,690 reports
- MENTOR MemoryGel Breast Implant 3503251BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,684 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page