MENTOR Smooth Round High Profile 3503250Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00081317001607), received between Apr 12, 2018 and Oct 21, 2025 — classified as 91 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (52 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 92 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR SMOOTH ROUND HIGH PROFILE 250CC SALINE BREAST PROSTHESIS DEVELOPED SHARP PAIN IN HER LEFT BREAST POST IMPLANTATION. ADDITIONALLY, THE IMPLANT ¿DOESN¿T FEEL CORRECT¿ AND FEELS ¿MUSHY¿. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 23354208 ↗
• InjurySep 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND HIGH PROFILE 250CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR SMOOTH ROUND HIGH PROFILE 250CC SALINE BREAST PROSTHESIS ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23074387 ↗
• InjuryJul 3, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SMOOTH ROUND HIGH PROFILE, 250CC SALINE PROSTHESIS EXPERIENCE LEFT DEFLATION POST PROCEDURE. AS A RESULT, THE PATIENT SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22398557 ↗
• InjuryJun 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 250CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT LEAKAGE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22334091 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 47-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 250CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) 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 21953920 ↗
• InjurySep 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR SMOOTH ROUND HIGH PROFILE, 250CC SALINE PROSTHESIS EXPERIENCED LEFT-SIDED DEFLATION POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENT AS FOLLOW: L) SN: (B)(6) / CAT: 3502475, R) SN: (B)(6) / CAT: 3502475 ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20325889 ↗
• InjuryMar 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND HIGH PROFILE 250CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18944485 ↗
• InjuryFeb 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 250CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT DEFLATION AND RIGHT BREAST SWOLLEN GLANDS. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Local Reaction

  MAUDE report 18753739 ↗
• InjuryDec 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH AN UNSPECIFIED MENTOR SMOOTH SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 375CC GEL BREAST PROSTHESES ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18347761 ↗
• InjuryDec 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 250CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18275582 ↗
• InjuryOct 25, 2023Adverse 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 250CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV), JOIN PAIN, CHEST PAIN, AND SJOGREN'S SYNDROME. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Autoimmune Disorder; Capsular Contracture

  MAUDE report 18008233 ↗
• InjuryOct 25, 2023Adverse 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 250CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV), JOIN PAIN, CHEST PAIN, AND SJOGREN'S SYNDROME. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Autoimmune Disorder; Capsular Contracture

  MAUDE report 18008216 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SMOOTH ROUND HIGH PROFILE, 250CC SALINE PROSTHESIS EXPERIENCED LEFT-SIDED BREAST MASS POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Mass

  MAUDE report 17950713 ↗
• InjurySep 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH AN UNKNOWN MENTOR SALINE BREAST IMPLANT EXPERIENCED LEFT-SIDED DEFLATION POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH IN OFFICE EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: LEFT CATALOG NUMBER 3504001BC, SERIAL NUMBER (B)(6), RIGHT CATALOG NUMBER 3504001BC, SERIAL NUMBER (B)(6) ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17834023 ↗
• InjuryJul 5, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 20-YEAR-OLD HISPANIC/LATINO FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 250CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE OF THE RIGHT BREAST DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Capsular Contracture

  MAUDE report 17262112 ↗
• InjuryJun 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 63-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 250CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17243859 ↗
• InjuryJun 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH SALINE MENTOR SMOOTH ROUND HIGH PROFILE 250CC BREAST IMPLANTS AND EXPERIENCED DEFLATION 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.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17199882 ↗
• InjuryJun 5, 2023Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR SMOOTH ROUND HIGH PROFILE 250CC SALINE PROSTHESES EXPERIENCED LEFT SIDED BREAST PAIN AND RIGHT SIDED DEVICE MIGRATION POST PROCEDURE. THE PAIN OCCURS WHEN THE PATIENT LIFTS OR STRETCHES HER ARM. THE RIGHT IMPLANT IS SITTING HIGH AND MOVING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2023-06594 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17062275 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR SMOOTH ROUND HIGH PROFILE 250CC SALINE PROSTHESES EXPERIENCED LEFT SIDED BREAST PAIN AND RIGHT SIDED DEVICE MIGRATION POST PROCEDURE. THE PAIN OCCURS WHEN THE PATIENT LIFTS OR STRETCHES HER ARM. THE RIGHT IMPLANT IS SITTING HIGH AND MOVING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2023-06587 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 17061776 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 35-YEAR-OLD BLACK FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 250CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED RASHES, BODY ACHES, JOINT PAIN, NAUSEA, AND BRAIN FOG. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED AND THE HEALTHCARE PROFESSIONAL CONFIRMED NO FURTHER DIAGNOSIS WAS PROVIDED. 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. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-04502 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 16762540 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 35-YEAR-OLD BLACK FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 250CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED RASHES, BODY ACHES, JOINT PAIN, NAUSEA, AND BRAIN FOG. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED AND THE HEALTHCARE PROFESSIONAL CONFIRMED NO FURTHER DIAGNOSIS WAS PROVIDED. 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. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-04503 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 16762536 ↗
• MalfunctionMar 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A SALINE MENTOR SMOOTH ROUND HIGH PROFILE 250CC BREAST IMPLANT BEING USED IN A BREAST RECONSTRUCTION PRIMARY WAS FOUND TO BE DEFLATION DURING 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 16515410 ↗
• 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 LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16099015 ↗
• InjuryOct 12, 2022Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT A 49-YEAR-OLD HISPANIC FEMALE PATIENT WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR SMOOTH ROUND HIGH PROFILE, 250CC SALINE BREAST PROSTHESIS DEVELOPED UNEXPLAINED SYSTEMIC SYMPTOMS POSTOPERATIVELY, INCLUDING SWELLING, ALLERGIES, AND MOLD. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2022. UPON REMOVAL, IT WAS NOTED THAT THE IMPLANTS HAD MOLD. THIS REPORT RELATES TO THE LEFT PROSTHESIS. AT THE TIME OF THIS REPORT, MENTOR IS UNABLE TO INDEPENDENTLY VERIFY THE PRESENCE OF MICROBIAL CONTAMINATION, AS THE DEVICES HAVE NOT BEEN RETURNED FOR ANALYSIS.

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

  MAUDE report 15589033 ↗
• InjuryOct 12, 2022Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT A 49-YEAR-OLD HISPANIC FEMALE PATIENT WHO UNDERWENT A UNKNOWN BREAST SURGERY WITH A MENTOR SMOOTH ROUND HIGH PROFILE, 250CC SALINE BREAST PROSTHESIS DEVELOPED UNEXPLAINED SYSTEMIC SYMPTOMS POSTOPERATIVELY, INCLUDING SWELLING, ALLERGIES, AND MOLD. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2022. UPON REMOVAL, IT WAS NOTED THAT THE IMPLANTS HAD MOLD. THIS REPORT RELATES TO THE RIGHT PROSTHESIS. AT THE TIME OF THIS REPORT, MENTOR IS UNABLE TO INDEPENDENTLY VERIFY THE PRESENCE OF MICROBIAL CONTAMINATION, AS THE DEVICES HAVE NOT BEEN RETURNED FOR ANALYSIS.

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

  MAUDE report 15588977 ↗

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