MENTOR Smooth Round Moderate Plus Profile 3502475Recalls & reported problems

Summary

The FDA's MAUDE database contains 258 adverse event reports that list this exact device (DI 00081317001461), received between Jan 26, 2018 and Sep 16, 2026 — classified as 252 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (189 reports).

2 other recalls cover devices cleared under the same FDA submission (P990075); they may or may not involve this specific model.

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 25 most recent of 258 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Material Rupture

  It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 475cc MENTOR Smooth Round Moderate Plus Profile saline breast implant prosthesis. Post-operatively, the patient was diagnosed with a deflated left implant during a physical exam. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.Follow-ups have been conducted, and no additional information has been received. If more information becomes available, Mentor will submit a supplemental report accordingly.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50792452 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50765917 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient who underwent a primary breast augmentation procedure with MENTOR Smooth Round Moderate Plus Profile saline breast prostheses developed hardening in both breasts post implantation. The breasts are swollen and causing pain. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.This MedWatch report is for the patient¿s right breast prosthesis.

  Patient problems: Capsular Contracture; Local Reaction

  MAUDE report 50089143 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient who underwent a primary breast augmentation procedure with MENTOR Smooth Round Moderate Plus Profile saline breast prostheses developed hardening in both breasts post implantation. The breasts are swollen and causing pain. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.This MedWatch report is for the patient¿s left breast prosthesis.

  Patient problems: Capsular Contracture; Local Reaction

  MAUDE report 50089127 ↗
• InjuryMar 6, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 475CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT IMPLANT. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXCHANGE WITH A MENTOR SALINE IMPLANT ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24533263 ↗
• InjuryFeb 13, 2026Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 475CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON AN UNKNOWN SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE PATIENT REPORTED DEVICE INFORMATION FOR TWO DEVICES, HOWEVER, IT IS UNKNOWN WHICH DEVICE BELONGS TO THE IMPACTED SIDE. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24333848 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 475CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 23830385 ↗
• InjuryOct 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 31-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 475CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION AND PARESTHESIA ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. THE PATIENT HAD PRESSURE BUT NO PAIN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Paresthesia

  MAUDE report 23373331 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH 475CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS EXPERIENCED BILATERAL REACTIONS POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Local Reaction

  MAUDE report 23016952 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH 475CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS EXPERIENCED BILATERAL REACTIONS POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Local Reaction

  MAUDE report 23016950 ↗
• InjuryJun 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 475CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22293948 ↗
• InjuryApr 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 70-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH 475CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21874011 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 475CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture

  MAUDE report 21462590 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 38-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 475CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21426802 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 475CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21380191 ↗
• InjuryJan 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH 475CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21245059 ↗
• InjuryJan 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 475CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21145885 ↗
• InjuryJan 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 475CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21098226 ↗
• InjuryNov 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 44-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 475CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20797834 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 475CC SALINE BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING FATIGUE, WEIGHT GAIN, JOINT PAIN, AND BRAIN FOG. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHTBREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20789123 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 475CC SALINE BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING FATIGUE, WEIGHT GAIN, JOINT PAIN, AND BRAIN FOG. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20788649 ↗
• InjuryOct 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 475CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20429989 ↗
• InjurySep 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 475CC SALINE PROSTHESIS EXPERIENCED SPONTANEOUS LEFT SIDED DEFLATION POST PROCEDURE. THE PATIENT NOTED THE BREAST HAD FLATTENED AFTER GETTING OUT OF THE SHOWER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20274603 ↗
• InjurySep 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 475CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST IMPLANT DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20261872 ↗
• InjurySep 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 475CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024 .

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20254449 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990075. One submission often covers many models, so check the product and lot details in each record.

• Z-0367-2022 · Sep 30, 2021 · Open, Classified
  MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shel
• Z-2070-2017 · Mar 27, 2017 · Terminated
  Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048