Motiva SmoothSilk Round Ergonomix Breast ImplantRecalls & reported problems across all models
Establishment Labs S.A. · 69 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 309
- Deaths reported
- 0
- Injuries reported
- 304
- Recalls
- 0
We found 69 models of Motiva SmoothSilk Round Ergonomix Breast Implant by Establishment Labs S.A. in the FDA's device registry (GUDID). Together they are named in 309 adverse event reports in the FDA's MAUDE database, received between Oct 3, 2024 and Sep 16, 2026 — classified as 304 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (190 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Motiva SmoothSilk Round Ergonomix Breast Implant problems
Device problems
- Device Appears to Trigger Rejection190
- Break96
- Adverse Event Without Identified Device or Use Problem36
- Patient-Device Incompatibility5
- Device Handling Problem1
- Fracture1
- Improper or Incorrect Procedure or Method1
- Increased Sensitivity1
Patient problems
- Capsular Contracture183
- Insufficient Information57
- Breast Discomfort/Pain41
- No Clinical Signs, Symptoms or Conditions20
- Ptosis18
- Unspecified Infection16
- Seroma11
- Discomfort8
Motiva SmoothSilk Round Ergonomix Breast Implant models
69 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-320Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled14 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-265Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled13 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-425Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled13 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-295QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled13 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-300Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled12 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-360QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled12 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-375Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled11 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-300QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled11 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-320QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled10 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-340QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled9 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-285Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled8 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-355Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled8 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-245Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled7 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-400Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled7 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-230Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled6 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-360Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled6 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-425Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled6 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-450Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled6 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-285QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled6 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-315QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled6 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-335QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled6 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-340Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled5 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-380Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled5 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-335Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled5 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-245QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled5 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-425QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled5 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-170Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled4 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-275Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled4 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-310Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled4 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-500Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled4 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-550Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled4 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-310QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled4 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-275QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled4 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-375QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled4 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-400QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled4 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-425QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled4 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-185Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled3 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-475Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled3 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-290QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled3 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-265QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled3 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-355QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled3 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-205Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-360Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-215Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-295Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-625Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-360QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-430QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-380QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-525QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-450QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-550QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2 reports
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-150Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-160Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-220Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-260Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-290Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-400Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-475Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-255Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-275Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-185QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-220QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-400QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-180QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-215QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSD-230QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-255QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-500QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
Recent Motiva SmoothSilk Round Ergonomix Breast Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50796558 ↗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. It was alleged that a patient who underwent breast revision surgery in (b)(6) 2025 developed Baker Grade III capsular contracture, implant flipping, bottoming out, and rippling of the left breast. Revision surgery was performed, during which a gel fracture was observed. The investigation is ongoing.
Patient problems: Capsular Contracture
MAUDE report 50726422 ↗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 ↗InjurySep 11, 2026Break
Singapore. Allegedly, during revision augmentation surgery, the left breast implant was found ruptured upon entry into the breast capsule and was subsequently explanted. The investigation is ongoing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50726076 ↗InjurySep 2, 2026Device Appears to Trigger Rejection
USA. Allegedly, a patient who underwent a breast revision augmentation surgery on (b)(6) 2025, developed a bilateral Capsular Contracture Baker Grade III, she presented asymmetry and pain due the capsular contracture. During the explant surgery, a late seroma was found. The investigation is ongoing.
Patient problems: Capsular Contracture; Seroma
MAUDE report 50570059 ↗InjuryAug 4, 2026Device Appears to Trigger Rejection
Brazil. It was alleged that approximately three months after surgery, the patient developed a deformity of the left breast in the upper outer quadrant. It was further alleged that asymmetry of the inframammary fold was observed, prompting a bilateral breast MRI. Left breast implant was found to be ruptured. The investigation is ongoing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50130857 ↗InjuryJul 31, 2026Device Appears to Trigger Rejection
USA. Allegedly, a patient presents an exposed implant, that required an explant surgery. The investigation is ongoing.
Patient problems: Impaired Healing
MAUDE report 50100958 ↗InjuryJul 27, 2026Break
Mexico. Allegedly, a patient attended a gynecological follow-up appointment during which an ultrasound and mammogram were ordered; imaging findings suggested a possible implant rupture, and the report was attached to the medical record. The investigation is ongoing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50021690 ↗InjuryJun 11, 2026Break
INDONESIA: ALLEGEDLY, A PATIENT IS EXPERIENCING FINDINGS SUGGESTIVE OF AN INTRACAPSULAR RUPTURE OF THE RIGHT SILICONE IMPLANT, AS REPORTED FOLLOWING AN ULTRASOUND EXAMINATION PERFORMED IN (B)(6) 2026. THE INVESTIGATION IS ONGOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25478589 ↗InjuryMay 25, 2026Device Appears to Trigger Rejection
MEXICO. ALLEGEDLY, A PHYSICAL EXAMINATION OF BOTH BREASTS WAS PERFORMED, REVEALING INCREASED PROJECTION AND FIRMNESS IN THE RIGHT BREAST, CAPSULAR CONTRACTURE BAKER GRADE III WAS CONFIRMED. SHE UNDERWENT AN EXPLANTATION SURGERY. THE INVESTIGATION WAS COMPLETED.
Patient problems: Capsular Contracture
MAUDE report 25272681 ↗InjuryMay 19, 2026Device Appears to Trigger Rejection
LOCATION: (B)(6). ALLEGEDLY, A PATIENT REQUIRED A REVISION SURGERY DUE TO A BAKER GRADE III/IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST. THE INVESTIGATION WAS COMPLETED.
Patient problems: Capsular Contracture
MAUDE report 25219455 ↗InjuryMay 11, 2026Device Appears to Trigger Rejection
TAIWAN. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2023 REQUIRED A REVISION SURGERY DUE TO A BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE. 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 25139232 ↗InjuryMay 11, 2026Device Appears to Trigger Rejection
TAIWAN. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2023 REQUIRED A REVISION SURGERY DUE TO A BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE. 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 25139224 ↗InjuryMay 11, 2026Device Appears to Trigger Rejection
USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST AUGMENTATION SURGERY IN (B)(6) 2025 DEVELOPED A BAKER GRADE III CAPSULAR CONTRACTURE ON HER RIGHT BREAST (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 25137507 ↗
Other Establishment Labs S.A. products
All Establishment Labs S.A. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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