Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-185Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07445161010322), received between Jan 8, 2026 and Sep 2, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMar 4, 2026Device Appears to Trigger Rejection

  AS REPORTED BY OUR EDWARDS LIFESCIENCES AFFILIATE IN BRAZIL, APPROXIMATELY FOUR (4) MONTHS AFTER THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 23 MM SAPIEN 3 ULTRA VALVE, THE PATIENT DEVELOPED PROGRESSIVE DYSPNEA, WHICH LED TO A HOSPITAL ADMISSION FOR FURTHER EVALUATION. DURING THE HOSPITALIZATION, VENOUS THROMBOEMBOLISM WAS DIAGNOSED, INCLUDING DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM. ADDITIONAL DIAGNOSTIC ASSESSMENT IDENTIFIED HYPOATTENUATED LEAFLET THICKENING (HALT) WITH EVIDENCE OF LEAFLET THROMBOSIS. AS PART OF THE ETIOLOGICAL EVALUATION, A COLONIC NEOPLASM WAS DIAGNOSED. APPROXIMATELY 1 YEAR AND 9 MONTHS AFTER THE INITIAL TAVR PROCEDURE, THE PATIENT UNDERWENT A VALVE-IN-VALVE PROCEDURE. A NEW TRANSCATHETER HEART VALVE (THV) WAS SUCCESSFULLY IMPLANTED, AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT WAS REPORTED THAT THE ROOT CAUSE OF THE EVENT WAS SUSPECTED TO BE AN UNDERLYING HYPERCOAGULABLE STATE, POSSIBLY RELATED TO A PARANEOPLASTIC SYNDROME ASSOCIATED WITH A DIAGNOSED COLONIC NEOPLASM. IF THE SUSPECTED COLONIC NEOPLASM IS CONFIRMED, A POTENTIAL SURGICAL APPROACH IS BEING CONSIDERED. MEDICAL RECORDS WERE RECEIVED FOR EVALUATION. ACCORDIN

  Patient problems: Breast Discomfort/Pain; Capsular Contracture

  MAUDE report 24512624 ↗
• InjuryJan 8, 2026Device Appears to Trigger Rejection

  USA. ALLEGEDLY, A PATIENT DEVELOPED A BAKER GRADE IV CAPSULAR CONTRACTURE IN HER LEFT BREAST. A REVISION SURGERY IS SCHEDULED. 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 24005162 ↗