Motiva SmoothSilk Round Breast ImplantRecalls & reported problems across all models
Establishment Labs S.A. · 53 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 261
- Deaths reported
- 0
- Injuries reported
- 257
- Recalls
- 0
We found 53 models of Motiva SmoothSilk Round Breast Implant by Establishment Labs S.A. in the FDA's device registry (GUDID). Together they are named in 261 adverse event reports in the FDA's MAUDE database, received between Oct 4, 2024 and Sep 28, 2026 — classified as 257 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (136 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 Breast Implant problems
Device problems
- Device Appears to Trigger Rejection136
- Break91
- Adverse Event Without Identified Device or Use Problem44
- Device Slipped3
- Fracture3
- Patient-Device Incompatibility2
- Positioning Problem2
- Insufficient Device Problem Information1
Patient problems
- Capsular Contracture135
- Insufficient Information59
- Breast Discomfort/Pain44
- Seroma24
- Physical Asymmetry19
- Unspecified Infection19
- Ptosis13
- Impaired Healing10
Motiva SmoothSilk Round Breast Implant models
53 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Motiva® SmoothSilk® Round Breast Implant RSF-275+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled16 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-400+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled16 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-315+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled15 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-375+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled13 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-500+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled11 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-335+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled11 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-355+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled11 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-400+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled10 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-450+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled10 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-425+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled9 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-315+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled8 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-355+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled8 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-550+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled8 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-550+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled8 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-425+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled7 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-375+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled6 reports
- Motiva® SmoothSilk® Round Breast Implant RSD-360+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled6 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-255+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled6 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-295+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled6 reports
- Motiva® SmoothSilk® Round Breast Implant RSD-425+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled5 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-275+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled5 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-335+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled5 reports
- Motiva® SmoothSilk® Round Breast Implant RSD-300+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled4 reports
- Motiva® SmoothSilk® Round Breast Implant RSD-320+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled4 reports
- Motiva® SmoothSilk® Round Breast Implant RSD-300+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled4 reports
- Motiva® SmoothSilk® Round Breast Implant RSD-320+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled4 reports
- Motiva® SmoothSilk® Round Breast Implant RSD-205+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled3 reports
- Motiva® SmoothSilk® Round Breast Implant RSD-285+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled3 reports
- Motiva® SmoothSilk® Round Breast Implant RSD-380+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled3 reports
- Motiva® SmoothSilk® Round Breast Implant RSD-475+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled3 reports
- Motiva® SmoothSilk® Round Breast Implant RSD-265+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled3 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-450+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled3 reports
- Motiva® SmoothSilk® Round Breast Implant RSD-245+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2 reports
- Motiva® SmoothSilk® Round Breast Implant RSD-340+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-295+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2 reports
- Motiva® SmoothSilk® Round Breast Implant RSD-245+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2 reports
- Motiva® SmoothSilk® Round Breast Implant RSD-340+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2 reports
- Motiva® SmoothSilk® Round Breast Implant RSF-500+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled2 reports
- Motiva® SmoothSilk® Round Breast Implant RSM-275+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Breast Implant RSM-290+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Breast Implant RSM-310+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Breast Implant RSD-230+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Breast Implant RSD-360+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Breast Implant RSD-525+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Breast Implant RSF-625+Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Breast Implant RSM-290+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Breast Implant RSD-215+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Breast Implant RSD-230+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Breast Implant RSD-285+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Breast Implant RSD-380+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Breast Implant RSD-425+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Breast Implant RSD-475+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
- Motiva® SmoothSilk® Round Breast Implant RSF-625+QProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 report
Recent Motiva SmoothSilk Round 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 28, 2026Break
Patient problems: Implant Pain
MAUDE report 50925319 ↗InjurySep 22, 2026Device Appears to Trigger Rejection
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Immune System Problem
MAUDE report 50862351 ↗InjurySep 22, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture; Swollen Lymph Nodes/Glands
MAUDE report 50860980 ↗InjurySep 11, 2026Device Appears to Trigger Rejection
USA. Allegedly, a patient who underwent a breast augmentation surgery on (b)(6) 2026, developed an infection and then a capsular contracture on her left breast. Revision surgery was required. The investigation is ongoing.
Patient problems: Capsular Contracture; Post Operative Wound Infection
MAUDE report 50735210 ↗InjurySep 7, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50657001 ↗InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Physical Asymmetry; Ptosis
MAUDE report 50213851 ↗InjuryJul 28, 2026Break
Brazil. Allegedly, a patient who underwent a breast augmentation surgery, had an ultrasound that reveals signs of extrcapsular rupture on her left implan and a small amount of silicone present in the breast tissue and in the axilary lymph nodes. THere is no information on wheter th patient underwent an explantation surgery. The investigation is ongoing.
Patient problems: Swollen Lymph Nodes/Glands
MAUDE report 50055809 ↗InjuryMay 25, 2026Device Appears to Trigger Rejection
ITALY. ALLEGEDLY, A PATIENT WHO UNDERWENT MOTIVA IMPLANTS, HAD AN MIR MENTIONS A CAPSULAR CONTRACTRE BAKER GRADE IS UNKNOWN, REVISION SURGERY WAS PERFORMED (R: (B)(6)).
Patient problems: Capsular Contracture
MAUDE report 25272739 ↗InjuryMay 14, 2026Break
COLOMBIA. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY HAD AN MRI SCAN THAT SHOWED SIGNS OF SEROMA AND RUPTURE ON THE RIGHT SIDE. DURING THE REVISION SURGERY, THOSE FINDINGS WERE CONFIRMED. THE INVESTIGATION IS ONGOING.
Patient problems: Seroma
MAUDE report 25178537 ↗InjuryMay 13, 2026Device Appears to Trigger Rejection
FRANCE. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREASTS SURGERY AUGMENTATION ON (B)(6) 2024, DEVELOP A UNILATERAL LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV ((B)(6)).
Patient problems: Capsular Contracture
MAUDE report 25161974 ↗InjuryMay 5, 2026Break
COLOMBIA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION ON (B)(6) 2023, HAD AND ULTRASOUND AND MRI THAT REVEALS SILICONOMAS AND DEVICE RUPTURE ON HER LEFT BREAST. REVISION SURGERY WAS PERFORMED. THE INVESTIGATION IS IN PROCESS.
Patient problems: Granuloma; Swollen Lymph Nodes/Glands
MAUDE report 25087648 ↗InjuryMay 5, 2026Device Appears to Trigger Rejection
USA. ALLEGEDLY A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION ON (B)(6) 2025, DEVELOPED A CAPSULAR CONTRACTURE BAKER GRADE III ON HER LEFT BREAST, AN EXPLANTATION SURGERY HAS BEEN SCHEDULED. THE INVESTIGATION WAS COMPLETED.
Patient problems: Capsular Contracture
MAUDE report 25083424 ↗InjuryMay 4, 2026Device Appears to Trigger Rejection
USA: ALLEGEDLY A PATIENT WHO UNDERWENT A BREAST SURGERY AUGMENTATION ON (B)(6) 2025, DEVELOPED A RIGHT BREAST CAPSULAR CONTRACTURE BAKER GRADE III. THE INVESTIGATION WAS COMPLETED.
Patient problems: Capsular Contracture
MAUDE report 25070333 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
USA. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST AUGMENTATION SURGERY IN (B)(6) 2026 PRESENTED WITH A SEROMA AND EXTRUSION ON THE RIGHT BREAST (SN (B)(6)). A REVISION SURGERY WAS PERFORMED. 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: Seroma; Wound Dehiscence
MAUDE report 25050904 ↗InjuryApr 30, 2026Break
ARGENTINA. ALLEGEDLY, IN MARCH, A PATIENT UNDERWENT IMPLANTATION SURGERY. A FEW DAYS AFTER THE PROCEDURE, ONE OF THE IMPLANTS BECAME EXPOSED. DUE TO THIS COMPLICATION, THE TREATING PHYSICIAN DECIDED TO REINTERVENE SURGICALLY TO EVALUATE THE SITUATION. DURING THE SURGICAL PROCEDURE, BOTH IMPLANTS WERE REMOVED FOR ASSESSMENT. UPON INSPECTION, IT WAS CONFIRMED THAT THE IMPLANT IN THE RIGHT BREAST WAS RUPTURED, WITH SERIAL NUMBER 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: Wound Dehiscence
MAUDE report 25046489 ↗
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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