MENTOR Smooth Round High Profile 3503230Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00081317001591), received between Feb 22, 2018 and Feb 27, 2026 — classified as 47 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (30 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 49 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 230CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24471764 ↗
• InjuryJul 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND HIGH PROFILE BREAST IMPLANTS EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22638109 ↗
• InjuryJul 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND HIGH PROFILE 230CC SALINE BREAST PROSTHESES THAT BOTH DEFLATED POST IMPLANTATION. BILATERAL DEFLATION WAS DIAGNOSED VIA MRI. ADDITIONALLY, THE PATIENT DEVELOPED BILATERAL BREAST 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: Breast Discomfort/Pain

  MAUDE report 22583636 ↗
• InjuryJul 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND HIGH PROFILE 230CC SALINE BREAST PROSTHESES THAT BOTH DEFLATED POST IMPLANTATION. BILATERAL DEFLATION WAS DIAGNOSED VIA MRI. ADDITIONALLY, THE PATIENT DEVELOPED BILATERAL BREAST 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: Breast Discomfort/Pain

  MAUDE report 22583635 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 230CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A BREAST MASS ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Mass

  MAUDE report 21961346 ↗
• InjuryApr 23, 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 230CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS EXPERIENCED CAPSULAR CONTRACTURE ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21892505 ↗
• InjuryApr 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 230CC MENTOR SMOOTH ROUND HIGH 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) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21880108 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 230CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE II (LEFT-SIDED) AND III (RIGHT-SIDED) CAPSULAR CONTRACTURE OF THE BREASTS BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 330CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANTS ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20251081 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 230CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE II (LEFT-SIDED) AND III (RIGHT-SIDED) CAPSULAR CONTRACTURE OF THE BREASTS BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 330CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANTS ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 20250007 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND HIGH PROFILE, 230CC SALINE, BREAST IMPLANT EXPERIENCED LEFT-SIDED CAPSULAR CONTRACTURE GRADE IV POSTOPERATIVE. THE ISSUE WAS DIAGNOSED DURING OFFICE VISITATION. AS A RESULT, PATIENT UNDERWENT UNILATERAL LEFT SIDED REPLACEMENT WITH SN: (B)(6) ON (B)(6) 2024. PLEASE SEE PATIENT PRIOR EVENT IN MANUFACTURER REPORT NUMBER: 1645337-2022-08872.

  Patient problems: Capsular Contracture

  MAUDE report 18759591 ↗
• MalfunctionOct 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 230CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS WAS FOUND TO BE DEFLATED PRIOR TO AN OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY ANY PATIENT AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17959547 ↗
• InjuryOct 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 230CC 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), 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17864578 ↗
• InjuryAug 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND HIGH PROFILE 230CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17597840 ↗
• MalfunctionJul 5, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT A SALINE MENTOR SMOOTH ROUND HIGH PROFILE 230CC BEING USED IN A BREAST IMPLANTATION PROCEDURE WAS FOUND HAVE A DEFECTIVE VALVE PRIOR TO THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17261318 ↗
• InjuryJun 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 50-YEAR OLD ASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 230CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH SPONTANEOUS RIGHT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023. THE DATE OF IMPLANTATION PROVIDED WAS AFTER THE EXPIRATION OF THE DEVICE. FOLLOW-UP IS IN PROGRESS AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN CLARIFYING INFORMATION IS MADE AVAILABLE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17120165 ↗
• InjuryMay 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 33-YEAR OLD ASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 230CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT DEFLATION AND LEAKING. PATIENT REPORTED THAT THE DEFLATIONS WERE MAYBE FROM EXERCISE OR HOW THEY SLEEP ON THEIR TUMMY. 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: Crushing Injury

  MAUDE report 16998588 ↗
• InjuryMay 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 33-YEAR OLD ASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 230CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT DEFLATION AND LEAKING. PATIENT REPORTED THAT THE DEFLATIONS WERE MAYBE FROM EXERCISE OR HOW THEY SLEEP ON THEIR TUMMY. 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: Crushing Injury

  MAUDE report 16998587 ↗
• InjuryApr 18, 2023Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD AN UNKNOWN MENTOR SALINE PROSTHESIS (LEFT) AND A MENTOR SMOOTH ROUND HIGH PROFILE 230CC SALINE PROSTHESIS (RIGHT) PLACED EXPERIENCED BILATERAL DEVICE MIGRATION AND SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. SHORTLY AFTER IMPLANTATION THE IMPLANTS BEGAN WRINKLING AND THE RIGHT IMPLANT WAS FLIPPING RESULTING THE VALVE FACING UP. IN 2014 THE PATIENT BEGAN HAVING CHRONIC BACK PAIN AND EXPERIENCING ANXIETY ALONG WITH SEVERAL OTHER SYMPTOMS. HAIR LOSS, NAIL DEFORMATIONS, CHANGE IN SKIN, WEIGHT LOSS, FATIGUE, DISCOMFORT IN BREASTS, LUMPS IN THE BREASTS, INCAPACITY TO SLEEP ON STOMACH, AND SMALLER BREAST SIZE WERE ALSO NOTED. 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. 1645337-2023-04579 FOR CONTRALATERAL PROSTHESIS REPORT.

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

  MAUDE report 16766102 ↗
• InjuryMar 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 230CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16645374 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 230CC MENTOR SMOOTH ROUND HIGH PROFILE ON THE RIGHT SIDE AND WITH 250CC MENTOR SMOOTH ROUND HIGH PROFILE ON THE LEFT SIDE AND EXPERIENCED RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE IV, AND HAD BILATERAL SURGICAL INTERVENTION TO ADD VOLUME. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. DIAGNOSIS WAS CONFIRMED AFTER PHYSICAL EXAM. THE DEVICES WILL BE EXPLANTED ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 16099020 ↗
• InjuryOct 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 31-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 230CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA AN OFFICE EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15600388 ↗
• InjuryAug 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 47-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 230CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA A SONOGRAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15241669 ↗
• InjuryAug 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND HIGH PROFILE 230CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6)2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15195527 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 36-YEAR-OLD HISPANIC/LATINO CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 230CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS EXPERIENCING SHARP PAINS IN HER BEASTS AS WELL AS A LOSS OF HEARING. MAMMOGRAM IMAGING, MAGNETIC RESONANCE IMAGING, AND BLOOD TESTS WERE ALL PERFORMED WITHOUT ANY REPORTED ABNORMALITIES. CONSULTATION WITH A MEDICAL PROFESSIONAL WAS CONDUCTED AND NO DIAGNOSES HAVE BEEN PROVIDED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-08644 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 15104382 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 36-YEAR-OLD HISPANIC/LATINO CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 230CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS EXPERIENCING SHARP PAINS IN HER BEASTS AS WELL AS A LOSS OF HEARING. MAMMOGRAM IMAGING, MAGNETIC RESONANCE IMAGING, AND BLOOD TESTS WERE ALL PERFORMED WITHOUT ANY REPORTED ABNORMALITIES. CONSULTATION WITH A MEDICAL PROFESSIONAL WAS CONDUCTED AND NO DIAGNOSES HAVE BEEN PROVIDED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-08643 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 15104365 ↗

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