MENTOR Smooth Round High Profile 3503290Recalls & reported problems

Summary

The FDA's MAUDE database contains 254 adverse event reports that list this exact device (DI 00081317001621), received between Jan 30, 2018 and Jun 4, 2026 — classified as 251 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (135 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 254 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 290CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL SEVERE BREAST PAIN AND BURNING SENSATION THAT COMES AND GOES. IN ADDITION, SHE ALSO HAD RED BUMPS ALL OVER THE BREASTS AND AROUND THE NIPPLES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Paresthesia; Skin Inflammation/ Irritation

  MAUDE report 25402643 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 290CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL SEVERE BREAST PAIN AND BURNING SENSATION THAT COMES AND GOES. IN ADDITION, SHE ALSO HAD RED BUMPS ALL OVER THE BREASTS AND AROUND THE NIPPLES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Paresthesia; Skin Inflammation/ Irritation

  MAUDE report 25402641 ↗
• InjuryMar 31, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 290CC MENTOR SMOOTH ROUND HIGH PROFILE ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST UPPER POLE FLATNESS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24738548 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 290CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREASTS RIPPLING, WITH THE LEFT BREAST SMALLER THAN THE RIGHT BREAST. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 24724723 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 290CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREASTS RIPPLING, WITH THE LEFT BREAST SMALLER THAN THE RIGHT BREAST. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 24723895 ↗
• InjuryJan 16, 2026Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH A SALINE MENTOR SMOOTH ROUND HIGH PROFILE BREAST IMPLANT (REPORTED TO BE DEFLATED) AND AN UNSPECIFIED MENTOR SALINE BREAST IMPLANT AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING SHORTNESS OF BREATH, REPEATED BLADDER INFLAMMATION, AND DRY EYES/MOUTH. 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 REPORT IS FOR THE FIRST OF TWO DEVICES.

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

  MAUDE report 24095822 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 290CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING NAUSEA, VOMITING, ANXIETY, PANIC ATTACK, FATIGUE, BREASTS ACHE, KIDNEY ACHE, SUDDEN INCREASE IN WEIGHT, HAIR LOSS, REFLUX HIATAL HERNIA, STOMACH PROBLEM, SHORTNESS OF BREATH, NIGHT SWEAT, DEPRESSION, COLDS, AND PERSISTENT COUGH POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

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

  MAUDE report 24069974 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 290CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING NAUSEA, VOMITING, ANXIETY, PANIC ATTACK, FATIGUE, BREASTS ACHE, KIDNEY ACHE, SUDDEN INCREASE IN WEIGHT, HAIR LOSS, REFLUX HIATAL HERNIA, STOMACH PROBLEM, SHORTNESS OF BREATH, NIGHT SWEAT, DEPRESSION, COLDS, AND PERSISTENT COUGH POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

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

  MAUDE report 24069972 ↗
• InjuryJan 12, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. IT WAS REPORTED THAT THERE IS A LEAK IN THE RIGHT BREAST PROSTHESIS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24049194 ↗
• InjuryNov 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 290CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A DEFLATED RIGHT IMPLANT. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED. 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 23583215 ↗
• InjuryOct 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND HIGH PROFILE BREAST IMPLANTS EXPERIENCED BILATERAL DEFLATION AND CAPSULAR CONTRACTURE BAKER GRADE IV ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23373025 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 290CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS EXPERIENCED RIPPLING ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Wrinkling

  MAUDE report 22873752 ↗
• InjuryJul 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 290CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST IMPLANT DURING AN IN-OFFICE EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR SALINE IMPLANTS ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22496716 ↗
• InjuryMay 20, 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 TWO 290CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE UNSPECIFIED). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22049792 ↗
• InjuryMay 20, 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 TWO 290CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE UNSPECIFIED). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22049791 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 290CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 2 ON THE LEFT AND BAKER GRADE UNKNOWN ON THE RIGHT) AND BILATERAL PARESTHESIA POST-OPERATIVELY. THE PATIENT REPORTED FEELING ODD AND THAT THE BREAST WERE UNCOMFORTABLE WITH HARDENING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture; Paresthesia

  MAUDE report 21910950 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 290CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 2 ON THE LEFT AND BAKER GRADE UNKNOWN ON THE RIGHT) AND BILATERAL PARESTHESIA POST-OPERATIVELY. THE PATIENT REPORTED FEELING ODD AND THAT THE BREAST WERE UNCOMFORTABLE WITH HARDENING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture; Paresthesia

  MAUDE report 21910932 ↗
• InjuryFeb 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND HIGH PROFILE 290CC SALINE PROSTHESIS EXPERIENCED SPONTANEOUS LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21364245 ↗
• InjuryJan 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 290CC MENTOR SMOOTH ROUND HIGH PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21160108 ↗
• InjuryDec 4, 2024Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR SMOOTH ROUND HIGH PROFILE, 290CC SALINE BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN AND DEVICE MIGRATION POSTOPERATIVE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 20845679 ↗
• InjuryDec 4, 2024Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR SMOOTH ROUND HIGH PROFILE, 290CC SALINE BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN AND DEVICE MIGRATION POSTOPERATIVE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 20845649 ↗
• InjuryNov 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 33-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 290CC MENTOR SMOOTH ROUND HIGH 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 20653127 ↗
• InjuryOct 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 290 CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20507959 ↗
• InjuryOct 10, 2024Adverse 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 TWO 290CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED TENDERNESS, SWELLING, BRAIN FOG, TIRED, NO ENERGY, AND MENTAL HEALTH ISSUES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2021. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

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

  MAUDE report 20420157 ↗
• InjuryOct 10, 2024Adverse 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 TWO 290CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED TENDERNESS, SWELLING, BRAIN FOG, TIRED, NO ENERGY, AND MENTAL HEALTH ISSUES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2021. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

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

  MAUDE report 20420107 ↗

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 she
• Z-2070-2017 · Mar 27, 2017 · Terminated
  Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048