Motiva® SmoothSilk® Round Breast Implant RSF-315+QRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07445161002884), received between Nov 22, 2024 and Apr 1, 2026 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Break

  AUSTRALIA. ALLEGEDLY, A PATIENT WHO UNDERWENT A REVISION AUGMENTATION IN (B)(6) 2024 HAD A SCAN THAT SHOWED A DEVICE RUPTURE IN HER LEFT BREAST, CONFIRMED IN A REVISION SURGERY. SHE UNDERWENT AN EXPLANTATION SURGERY. THE INVESTIGATION IS IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758770 ↗
• InjuryNov 26, 2025Break; Break

  BRAZIL. ALLEGEDLY, A PATIENT WHO UNDERWENT AN AUGMENTATION MAMMOPLASTY IN (B)(6) 2022 STARTED EXPERIENCING DISCOMFORT, AND IN (B)(6), SHE BEGAN A SERIES OF TESTS THAT IDENTIFIED A RUPTURE IN HER LEFT PROSTHESIS. 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: Breast Discomfort/Pain; Insufficient Information

  MAUDE report 23660002 ↗
• InjuryNov 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  MEXICO. ALLEGEDLY, A PATIENT WHO UNDERWENT A BREAST AUGMENTATION IN (B)(6) 2024 PRESENTED WITH HARDNESS AND PAIN 5 MONTHS POST OP IN BOTH BREASTS, MAINLY IN HER RIGHT BREAST, AND SHE RECEIVED TREATMENT WITH ANTI-INFLAMMATORIES. AN ULTRASOUND WAS PERFORMED, AND A CAPSULAR CONTRACTURE BAKER GRADE IV IN HER RIGHT BREAST WAS FOUND. REVISION SURGERY WAS 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: Breast Discomfort/Pain; Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 23556194 ↗
• InjurySep 11, 2025Break; Break

  BRAZIL. LEGAL CASE- IT WAS REPORTED THAT THE PATIENT, WHO UNDERWENT A MASTOPEXY PROCEDURE ON (B)(6) 2023, WAS DIAGNOSED WITH AN IMPLANT RUPTURE OF THE RIGHT BREAST IMPLANT ON (B)(6) 2025 (SERIAL NUMBER 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: Insufficient Information

  MAUDE report 23031593 ↗
• InjurySep 9, 2025Break; Break

  COLOMBIA. IT WAS REPORTED THAT DURING REVISION SURGERY FOR AESTHETIC REASONS, BILATERAL IMPLANT RUPTURE WAS OBSERVED INTRAOPERATIVELY. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Insufficient Information

  MAUDE report 23009254 ↗
• InjurySep 9, 2025Break; Break

  COLOMBIA. IT WAS REPORTED THAT DURING REVISION SURGERY FOR AESTHETIC REASONS, BILATERAL IMPLANT RUPTURE WAS OBSERVED INTRAOPERATIVELY. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Insufficient Information

  MAUDE report 23009159 ↗
• InjuryMay 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ARGENTINA. IT WAS REPORTED A PATIENT OPERATED IN (B)(6) 2023. VISITED THE DOCTOR IN (B)(6) 2025 AND WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE IN RIGHT BREAST IMPLANT ((B)(6)).

  Patient problems: Capsular Contracture

  MAUDE report 22088258 ↗
• InjuryApr 25, 2025Break; Break

  (B)(6). IT WAS REPORTED THAT A PATIENT WHO HAD SURGERY IN (B)(6) 2024, VISITED THE DOCTOR IN (B)(6) 2025 FOR A REVIEW OF THE SURGERY AND WAS DIAGNOSED WITH ASYMMETRY AND LATERALIZATION. A RUPTURE IN HER RIGHT BREAST IMPLANT WAS FOUND DURING REVISION SURGERY.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 21909631 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BRAZIL. PATIENT IMPLANTED WITH MOTIVA IMPLANTS PRESENTED PSEUDOPTOSIS IN BOTH BREASTS. SHE WAS ADVISED TO UNDERGO EXPLANTATION SURGERY. NO PATIENT DEMOGRAPHICS, AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENT HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION WERE MADE, AND THE INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: Ptosis

  MAUDE report 21452889 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BRAZIL. PATIENT IMPLANTED WITH MOTIVA IMPLANTS PRESENTED PSEUDOPTOSIS IN BOTH BREASTS. SHE WAS ADVISED TO UNDERGO EXPLANTATION SURGERY. NO PATIENT DEMOGRAPHICS, AGE, WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER, AND NO ADVERSE OUTCOMES FOR THE PATIENT HAVE BEEN NOTED. EFFORTS TO GATHER ADDITIONAL INFORMATION WERE MADE, AND THE INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: Ptosis

  MAUDE report 21452870 ↗
• MalfunctionJan 30, 2025Break; Break

  THE PATIENT REPORTED PAIN AND DISCOMFORT DUE TO IMPLANT RUPTURE IN THE RIGHT BREAST. 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: Discomfort; Pain

  MAUDE report 21277187 ↗
• InjuryJan 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST IMPLANTATION SURGERY WITH MOTIVA IMPLANTS EXPERIENCED RIGHT-SIDED RUPTURE. IT IS UNKNOWN IF SHE WAS EXPLANTED YET. NO PATIENT DEMOGRAPHICS, SUCH AS 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: Insufficient Information

  MAUDE report 21256344 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COLOMBIA. PATIENT WITH MOTIVA IMPLANTS PRESENTED EARLY SEROMA, SUTURE DEHISCENCE AND EXPOSURE OF INFECTED IMPLANT. SHE WAS ADVISED O UNDERGO EXPLANTATION SURGERY. 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 WERE MADE, AND THE INVESTIGATION WAS COMPLETED.

  Patient problems: Seroma; Unspecified Infection; Wound Dehiscence

  MAUDE report 21129550 ↗
• InjuryDec 12, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  A PATIENT PRESENTED CAPSULAR CONTRACTURE IN BOTH BREASTS AND WILL UNDERGO EXPLANTATION IN (B)(6) 2025. THERE IS EVIDENCE THAT BOTH DEVICES ARE MOTIVA IMPLANTS, HOWEVER; JUST ONE SERIAL NUMBER WAS PROVIDED. NO PATIENT DEMOGRAPHICS, 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 20913470 ↗
• InjuryNov 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  A PATIENT PRESENTED CAPSULAR CONTRACTURE BAKER GRADE IV IN HER LEFT BREAST ACCORDING TO AN ULTRASOUND REPORT. NO PATIENT DEMOGRAPHICS, 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 20763023 ↗