MENTOR Smooth Round High Profile 3503460Recalls & reported problems

Summary

The FDA's MAUDE database contains 413 adverse event reports that list this exact device (DI 00081317001676), received between Jan 29, 2018 and Sep 29, 2026 — classified as 410 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (249 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 413 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Material Rupture

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50935446 ↗
• InjuryJun 1, 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 RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S 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 25355544 ↗
• InjuryMay 18, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND HIGH PROFILE BREAST IMPLANTS EXPERIENCED BREAST PAIN AND DEFLATION ON THE RIGHT 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: Breast Discomfort/Pain

  MAUDE report 25206243 ↗
• InjuryMar 18, 2026Material 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 24627435 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 460CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS EXPERIENCED CAPSULAR CONTRACTURE 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: Capsular Contracture

  MAUDE report 24260195 ↗
• InjuryNov 26, 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 460CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III-IV) AND LEFT BREAST 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 23659497 ↗
• InjuryNov 26, 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 460CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III-IV) AND LEFT BREAST 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 RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23659496 ↗
• InjuryOct 24, 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 AND REPLACEMENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23383752 ↗
• InjurySep 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 66-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 460CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION 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 23101120 ↗
• InjurySep 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 460CC 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) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23017062 ↗
• InjurySep 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 460CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22980076 ↗
• InjurySep 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 460CC 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) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22954527 ↗
• InjuryJul 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND HIGH PROFILE 460CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22569540 ↗
• InjuryJul 9, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 460CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFECTIVE IMPLANT AND BREAST PAIN ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22460706 ↗
• InjuryJul 2, 2025Material Rupture; Migration; Material Rupture; Migration

  A FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND HIGH PROFILE, 460C SALINE PROSTHESIS EXPERIENCE RIGHT SIDED DEFLATION POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH IN OFFICE VISITATIONS. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 22384282 ↗
• InjuryJul 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND HIGH PROFILE BREAST IMPLANTS AND EXPERIENCED BILATERAL DEFLATION POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22374769 ↗
• InjuryJul 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND HIGH PROFILE BREAST IMPLANTS AND EXPERIENCED BILATERAL DEFLATION POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. THE REPORTED IMPLANTATION DATE IS PRIOR TO THE DEVICE MANUFACTURE DATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE CORRECT DATE OF IMPLANTATION OR DEVICE LOT NUMBER, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22374744 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 460 CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED CUTANEOUS CONTOUR DEFORMITY (RIPPLING), ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2025, AND REPLACED WITH A 500CC MENTOR MEMORYGEL BOOST BREAST IMPLANT (CATALOG NUMBER SMHB500) WITH SERIAL NUMBER (B)(6).

  Patient problems: Wrinkling

  MAUDE report 22056712 ↗
• InjuryMay 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND HIGH PROFILE 460CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 400CC SALINE BREAST PROSTHESES ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21987996 ↗
• InjuryMay 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH SALINE MENTOR SMOOTH ROUND HIGH PROFILE 460CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21969863 ↗
• InjuryApr 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 460 CC 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) 2025 AND REPLACED WITH A 500CC MENTOR MEMORYGEL BOOST BREAST IMPLANT (CATALOG NUMBER SMHB500) WITH SERIAL NUMBER (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21893178 ↗
• InjuryApr 4, 2025Adverse 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 300CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21775345 ↗
• InjuryMar 17, 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 460CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A BREAST MASS 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: Breast Mass

  MAUDE report 21622550 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 460CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A BACTERIAL INFECTION OF AN UNDISCLOSED BREAST WHICH REQUIRED TWO ADDITIONAL SURGERIES WITHOUT ANY REPORTED IMPLANT REMOVAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. AS THE AFFECTED SIDE WAS NOT PROVIDED, THE SERIAL NUMBERS FOR BOTH PRODUCTS ARE BEING PROVIDED AS LEFT IMPLANT, SERIAL NUMBER: (B)(6) AND RIGHT IMPLANT, SERIAL NUMBER: (B)(6). THE CATALOG AND LOT NUMBERS ARE THE SAME FOR BOTH DEVICES. 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: Post Operative Wound Infection

  MAUDE report 21527245 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 37-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 460CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED AUTOIMMUNE DISORDER SYMPTOMS INCLUDING BREAST IMPLANT ILLNESS, FATIGUE, MEMORY LOSS, DEPRESSION, ANXIETY, MIGRAINES, YEAST INFECTIONS, ANTI-PHOSPHOLIPID SYNDROME, LUPUS, TENDINITIS, ARTHRITIS, HYPOTHYROIDISM, PAIN, SLEEP PARALYSIS, MEMORY ISSUES, BRAIN FOG, CONCENTRATION ISSUES, SLEEPING ISSUES, ISSUES WITH SPEECH, UNEXPLAINED BRUISING, HEARING ISSUES, NOSEBLEEDS, INSOMNIA, CONSTANT FATIGUE, HIVES, RASHES, MENTAL HEALTH ISSUES, DEPRESSION, ANXIETY, ATTENTION DEFICIT DISORDER, EATING DISORDER, HEADACHES, MIGRAINES, OCULAR MIGRAINE, CARPOOL TUNNEL ISSUES, HEART BURN, STOMACH ISSUES, CONSTIPATION, DIARRHEA, FOOD SENSITIVITY, HOT FLASHES, CLAMMINESS, NIGHT SWEATS, LOW SEX DRIVE, ISSUES SWALLOWING, CHOCKING, NAUSEA, PANIC ATTACKS, FEELING LIKE THINGS AREN¿T REAL, ISSUES LOOKING AT SCREENS, SLEEPING TOO MUCH, TAPPING TEETH, GRINDING TEETH, ANTI-SOCIAL, POST NASAL DRIP, HARD TO SWALLOW, HARD TO CLEAR THROAT, EXTREME WEIGHT GAIN, FOOD ADDICTION, SWELLING, HIGH HEART RATE, BREATHING ISSUES, BLOOD CLOTS, H

  Patient problems: Autoimmune Disorder

  MAUDE report 21428873 ↗

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