Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-425Recalls & reported problems
Establishment Labs S.A. · Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi 425 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
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07445161010612), received between Mar 24, 2025 and Mar 10, 2026 — classified as 13 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (10 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 Rejection10
- Adverse Event Without Identified Device or Use Problem2
- Break1
- No Apparent Adverse Event1
Patient problems
- Capsular Contracture10
- Ptosis2
- Unspecified Infection2
- Wound Dehiscence2
- Failure of Implant1
- Pain1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
USA. ALLEGEDLY, A PATIENT PRESENTED WITH BILATERAL FLUID LEAKING THROUGH THE POINTS AND WOUNDS (SIGNS OF INFECTION), ADDITIONALLY, BOTTOMING OUT, AND VISIBILITY OF THE LEFT BREAST IMPLANT THROUGH THE T-POINT WOUND. DURING SURGERY, PURULENCE WAS OBSERVED IN BOTH BREAST POCKETS; A CULTURE WAS PERFORMED, BUT THE RESULTS ARE NOT READY YET (R: (B)(6) L: (B)(6).
Patient problems: Ptosis; Unspecified Infection; Wound Dehiscence
MAUDE report 24562731 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
USA. ALLEGEDLY, A PATIENT PRESENTED WITH BILATERAL FLUID LEAKING THROUGH THE POINTS AND WOUNDS (SIGNS OF INFECTION), ADDITIONALLY, BOTTOMING OUT, AND VISIBILITY OF THE LEFT BREAST IMPLANT THROUGH THE T-POINT WOUND. DURING SURGERY, PURULENCE WAS OBSERVED IN BOTH BREAST POCKETS; A CULTURE WAS PERFORMED, BUT THE RESULTS ARE NOT READY YET (R: (B)(6), L: (B)(6)).
Patient problems: Ptosis; Unspecified Infection; Wound Dehiscence
MAUDE report 24562716 ↗InjuryFeb 5, 2026Device Appears to Trigger Rejection
USA. ALLEGEDLY, THE PATIENT PRESENTS WITH BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE IV, ASSOCIATED WITH IMPLANT LATERALIZATION. IMPLANT REPLACEMENT SURGERY IS SCHEDULED FOR ON (B)(6) 2026. THE INVESTIGATION IS COMPLETE.
Patient problems: Capsular Contracture
MAUDE report 24267386 ↗InjuryFeb 4, 2026Device Appears to Trigger Rejection
USA. ALLEGEDLY, THE PATIENT PRESENTS WITH BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE IV, ASSOCIATED WITH IMPLANT LATERALIZATION. IMPLANT REPLACEMENT SURGERY IS SCHEDULED FOR (B)(6) 2026. THE INVESTIGATION IS COMPLETE.
Patient problems: Capsular Contracture
MAUDE report 24262135 ↗InjuryDec 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
USA. ALLEGEDLY, A PATIENT DEVELOPED A BAKER GRADE III CAPSULAR CONTRACTURE; THE SIDE AFFECTED IS UNKNOWN (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.
Patient problems: Capsular Contracture
MAUDE report 23822125 ↗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 LEFT BREAST, AND A REVISION SURGERY IS REQUIRED. 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 23771240 ↗InjuryDec 10, 2025Device Appears to Trigger Rejection; No Apparent Adverse Event; Device Appears to Trigger Rejection; No Apparent Adverse Event
USA. ALLEGEDLY, A PATIENT DEVELOPED A CAPSULAR CONTRACTURE IN HER RIGHT BREAST; A REVISION SURGERY WAS PERFORMED IN (B)(6) 2025. AT THIS POINT, BAKER'S GRADE IS UNKNOWN. 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 23771023 ↗InjurySep 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
GERMANY. IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANT EXCHANGE WITH REMOVAL OF THE CAPSULE ON THE RIGHT SIDE (POLYTECH IMPLANT). HOWEVER, WITHIN WEEKS AFTER THE REVISION SURGERY, CAPSULAR CONTRACTURE RECURRED ON THE SAME SIDE. SN: (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.
Patient problems: Capsular Contracture
MAUDE report 23103072 ↗InjurySep 3, 2025Break; Break
KOREA. IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AUGMENTATION SURGERY WITH IMPLANTS ON (B)(6) 2022 REQUIRED A REVISION SURGERY DUE TO A RUPTURE IN THE LEFT BREAST. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Failure of Implant; Pain
MAUDE report 22956874 ↗InjuryApr 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
USA- IT WAS REPORTED THAT A PATIENT STATES HER BREASTS LOOK ODD AND THAT HER IMPLANTS HAVE NOT DROPPED. ON EXAM, SHE HAS FIRMBILATERAL BREAST IMPLANT. SHE HAS BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III. LEFT SIDE ((B)(6)).
Patient problems: Capsular Contracture
MAUDE report 21936500 ↗InjuryApr 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
USA- IT WAS REPORTED THAT A PATIENT STATES HER BREASTS LOOK ODD AND THAT HER IMPLANTS HAVE NOT DROPPED. ON EXAM, SHE HAS FIRM BILATERAL BREAST IMPLANT. SHE HAS BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III. RIGHT SIDE ((B)()).
Patient problems: Capsular Contracture
MAUDE report 21936449 ↗InjuryMar 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED A CAPSULAR CONTRACTURE BACKER GRADE III/IV.
Patient problems: Capsular Contracture
MAUDE report 21683491 ↗InjuryMar 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED A CAPSULAR CONTRACTURE BACKER GRADE III/IV.
Patient problems: Capsular Contracture
MAUDE report 21682428 ↗
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