MENTOR Smooth Round High Profile 3503330Recalls & reported problems

Summary

The FDA's MAUDE database contains 679 adverse event reports that list this exact device (DI 00081317001645), received between Jan 29, 2018 and Sep 22, 2026 — classified as 673 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (404 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 679 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Material Rupture

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

  MAUDE report 50862921 ↗
• InjurySep 22, 2026Material Rupture

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

  MAUDE report 50862920 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient who underwent a breast augmentation revision procedure with MENTOR Smooth Round High Profile saline breast prostheses developed pain with itching and burning in both breasts post implantation. 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; Skin Inflammation/ Irritation

  MAUDE report 50766131 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient who underwent a breast augmentation revision procedure with MENTOR Smooth Round High Profile saline breast prostheses developed pain with itching and burning in both breasts post implantation. 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; Skin Inflammation/ Irritation

  MAUDE report 50766119 ↗
• InjuryAug 24, 2026Material Rupture; Migration

  It was reported that a patient implanted with PRODUCT saline breast prosthesis experienced bilateral deflations, device migration, and breast pain 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: Deformity/ Disfigurement

  MAUDE report 50413013 ↗
• InjuryAug 24, 2026Material Rupture; Migration

  It was reported that a patient implanted with PRODUCT saline breast prosthesis experienced bilateral deflations, device migration, and breast pain 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 Discomfort/Pain

  MAUDE report 50413011 ↗
• InjuryMay 19, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 330CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25225304 ↗
• InjuryMay 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES II), WITH PAIN. 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 25133189 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH TWO MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL DOUBLE CAPSULES. 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: Capsular Contracture

  MAUDE report 25053273 ↗
• InjuryApr 16, 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 HIGH PROFILE SALINE BREAST PROSTHESES DEVELOPED PAIN AND HARDENING IN BOTH BREAST POST IMPLANTATION. 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

  MAUDE report 24906094 ↗
• InjuryApr 16, 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 HIGH PROFILE SALINE BREAST PROSTHESES DEVELOPED PAIN AND HARDENING IN BOTH BREAST POST IMPLANTATION. 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

  MAUDE report 24903022 ↗
• InjuryMar 24, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 330CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BREAST BAKER GRADE III CAPSULAR CONTRACTURE AND A DEFLATED RIGHT IMPLANT DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL IMPLANT REMOVAL ON (B)(6) 2026. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24682142 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 330CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BREAST BAKER GRADE III CAPSULAR CONTRACTURE AND A DEFLATED RIGHT IMPLANT DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL IMPLANT REMOVAL ON (B)(6) 2026. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24676516 ↗
• InjuryFeb 14, 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 HIGH PROFILE SALINE BREAST PROSTHESES DEVELOPED PAIN IN BOTH BREASTS POST IMPLANTATION. THE PATIENT ¿DOESN¿T FEEL GOOD¿ AND WANTS TO REMOVE HER BREAST PROSTHESES. 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 24341229 ↗
• InjuryFeb 14, 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 HIGH PROFILE SALINE BREAST PROSTHESES DEVELOPED PAIN IN BOTH BREASTS POST IMPLANTATION. THE PATIENT ¿DOESN¿T FEEL GOOD¿ AND WANTS TO REMOVE HER BREAST PROSTHESES. 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 24341228 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 24261744 ↗
• InjuryFeb 4, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 330CC 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) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24261261 ↗
• InjuryJan 5, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND HIGH PROFILE BREAST IMPLANTS EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. THE PATIENT EXPERIENCED TRAUMA (GUNSHOT WOUND) WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.

  Patient problems: Crushing Injury; Deformity/ Disfigurement

  MAUDE report 23960709 ↗
• MalfunctionNov 27, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A 330CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS PROSTHESIS WAS RECEIVED BY THE MENTOR ANALYSIS LAB WITHOUT A COMPLAINT IN REGARD TO THE PRODUCT QUALITY OR PATIENT ISSUES. AS A RESULT, THE DEVICE WAS TESTED AND DETERMINED TO HAVE A REPORTABLE FAILURE MODE.

  Patient problems: Insufficient Information

  MAUDE report 23666258 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 330CC MENTOR SMOOTH ROUND HIGH PROFILE ON BOTH SIDES AND EXPERIENCED BILATERAL IMPLANT SITE FLUID COLLECTION. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633631 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 330CC MENTOR SMOOTH ROUND HIGH PROFILE ON BOTH SIDES AND EXPERIENCED BILATERAL IMPLANT SITE FLUID COLLECTION. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633628 ↗
• InjuryOct 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 330CC MENTOR SMOOTH ROUND HIGH 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 23408017 ↗
• InjuryOct 27, 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 330CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT IMPLANT USING MAMMOGRAM IMAGING. MULTIPLE STABLE BILATERAL OIL CYSTS WERE IDENTIFIED ON THE IMAGING REPORT AS WELL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Cyst(s)

  MAUDE report 23393770 ↗
• InjuryOct 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 330CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT IMPLANT USING MAMMOGRAM IMAGING. MULTIPLE STABLE BILATERAL OIL CYSTS WERE IDENTIFIED ON THE IMAGING REPORT AS WELL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Cyst(s); Deformity/ Disfigurement

  MAUDE report 23393768 ↗
• InjuryOct 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 56-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 330CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23386538 ↗

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