MENTOR Smooth Round High Profile 3503210Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00081317001584), received between Jun 4, 2018 and Sep 17, 2026 — classified as 42 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (28 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 43 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50809786 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50809784 ↗
• InjuryFeb 23, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 210CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MAMMOGRAM, WITH RIGHT BREAST IMPLANT DEFLATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24417562 ↗
• InjuryAug 26, 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 IS SCHEDULED FOR REMOVAL ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22897441 ↗
• InjuryApr 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 210CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS 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 21893386 ↗
• InjuryMar 21, 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 WITH SALINE MENTOR SMOOTH ROUND HIGH PROFILE 210CC BREAST IMPLANTS AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III/IV ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21667832 ↗
• InjuryMar 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION WITH SALINE MENTOR SMOOTH ROUND HIGH PROFILE BREAST IMPLANTS 210CC 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. 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 21664409 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 210CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS EXPERIENCED 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 20251302 ↗
• InjuryAug 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 41-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 210CC 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), 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17655156 ↗
• InjuryAug 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 44-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 210CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. MAMMOGRAM IMAGING WAS ALSO CONDUCTED. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17572015 ↗
• InjuryMay 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 27-YEAR-OLD HISPANIC FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH AN UNKNOWN MENTOR SILICONE PROSTHESIS EXPERIENCED SPONTANEOUS LEFT-SIDED SILENT RUPTURE POST PROCEDURE. AN ULTRASOUND EXAMINATION CONFIRMED THE RUPTURE.. AS A RESULT, PATIENT UNDERWENT REPLACEMENT WITH UNKNOWN PROSTHESIS ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16910657 ↗
• InjuryMar 20, 2023Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A 64-YEAR-OLD HISPANIC/LATINO CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH 210CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL DEFLATION OF HER PROSTHESES AS WELL AS A CYST IN HER LEFT BREAST, WHICH WERE CONFIRMED VIA SONOGRAM AND MAMMOGRAM. THE PATIENT ALSO REPORTED THAT BOTH OF HER IMPLANTS ARE OUT OF PLACE, AND SHE HAS BEGUN TO FEEL SICK AND EXHAUSTED. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2023. 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. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-03193 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 16576594 ↗
• InjuryMar 20, 2023Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A 64-YEAR-OLD HISPANIC/LATINO CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH 210CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL DEFLATION OF HER PROSTHESES AS WELL AS A CYST IN HER LEFT BREAST, WHICH WERE CONFIRMED VIA SONOGRAM AND MAMMOGRAM. THE PATIENT ALSO REPORTED THAT BOTH OF HER IMPLANTS ARE OUT OF PLACE, AND SHE HAS BEGUN TO FEEL SICK AND EXHAUSTED. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2023. 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. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-03192 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 16576582 ↗
• InjuryDec 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH TWO 210CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES AND WAS DIAGNOSED, VIA VISUAL AND PHYSICAL EXAMINATION, WITH LEFT BREAST IMPLANT DEFLATION, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15955725 ↗
• InjuryJul 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 210CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT RIGHT BREAST IMPLANT HAS INCREASED IN VOLUME AND IS FULLER THAN THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2022. UPON REMOVAL OF THE IMPLANTS, IT WAS NOTED THAT THE RIGHT BREAST IMPLANT HAS YELLOWISH LIQUID INSIDE. SUBSEQUENTLY, BOTH IMPLANTS WERE REPLACED WITH TWO UNSPECIFIED MENTOR SALINE BREAST PROSTHESES. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15023627 ↗
• InjuryJul 14, 2022Material Discolored; Material Discolored

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 210CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT RIGHT BREAST IMPLANT HAS INCREASED IN VOLUME AND IS FULLER THAN THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2022. UPON REMOVAL OF THE IMPLANTS, IT WAS NOTED THAT THE RIGHT BREAST IMPLANT HAS YELLOWISH LIQUID INSIDE. SUBSEQUENTLY, BOTH IMPLANTS WERE REPLACED WITH TWO UNSPECIFIED MENTOR SALINE BREAST PROSTHESES. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Local Reaction

  MAUDE report 15023198 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 21-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A (LEFT) 230CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE (JULY 12, 2007) AND BREAST AUGMENTATION REVISION WITH A (RIGHT) UNSPECIFIED MENTOR SALINE IMPLANT ((B)(6) 2012). POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST PAIN, AND RIPPLING ON THE RIGHT BREAST. 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

  MAUDE report 14758659 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC/LATINO FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 210CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT OBSERVED THAT HER LEFT AND RIGHT BREASTS HAVE CHANGED IN SIZE. A CONSULTATION WITH A MEDICAL PROFESSIONAL WAS CONDUCTED, BUT NO DIAGNOSIS WAS MADE. AS A RESULT, THE PATIENT WILL UNDERGO REMOVAL ON (B)(6) 2022. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-04934 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14272301 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC/LATINO FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 210CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT OBSERVED THAT HER LEFT AND RIGHT BREASTS HAVE CHANGED IN SIZE. A CONSULTATION WITH A MEDICAL PROFESSIONAL WAS CONDUCTED, BUT NO DIAGNOSIS WAS MADE. AS A RESULT, THE PATIENT WILL UNDERGO REMOVAL ON (B)(6), 2022. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-04933 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14272296 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD HISPANIC FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH TWO 210CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANTS HAS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE II AND UNEXPLAINED SYSTEMIC SYMPTOMS POSTOPERATIVELY, INCLUDING FATIGUE, JOINT PAIN, MEMORY LOSS,AND SHOOTING PAIN IN BREASTS. THE ISSUE OF CAPSULAR CONTRACTURE WAS CONFIRMED BY THE DOCTOR. THE PATIENT WILL HAVE REMOVAL WITHOUT REPLACEMENTS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13543869 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH TWO 210CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANTS HAS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE II AND UNEXPLAINED SYSTEMIC SYMPTOMS POSTOPERATIVELY, INCLUDING FATIGUE, JOINT PAIN, MEMORY LOSS,AND SHOOTING PAIN IN BREASTS. THE ISSUE OF CAPSULAR CONTRACTURE WAS CONFIRMED BY THE DOCTOR. THE PATIENT WILL HAVE REMOVAL WITHOUT REPLACEMENTS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13543848 ↗
• InjuryFeb 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SMOOTH ROUND HIGH PROFILE 210CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR GEL BREAST IMPLANTS ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13415734 ↗
• InjuryDec 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 210CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT THAT DEFLATED POSTOPERATIVELY, SECONDARY TO A MOTOR VEHICLE ACCIDENT. THE DEFLATION WAS CONFIRMED DURING A PHYSICAL EXAM. THE PATIENT HAS INDICATED A DESIRE TO HAVE THE DEVICE EXPLANTED AND REPLACED WITH ANOTHER SMOOTH SALINE DEVICE, HOWEVER THE INTERVENTION HAS NOT YET BEEN PLANNED.

  Patient problems: Crushing Injury

  MAUDE report 13097365 ↗
• InjuryFeb 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 210CC MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS (LEFT) AND A 190CC MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS (RIGHT) EXPERIENCED BILATERAL LOCAL REACTION POSTOPERATIVELY. THE PATIENT EXPERIENCED SHARP BREAST PAIN AND PRESSURE IN HER BREASTS. THE PATIENT STATED THAT HER RIGHT BREAST APPEARED LARGER THAN THE LEFT SIDE. DUE TO THE SYMPTOMS, THE PATIENT HAD A CONSULTATION WITH A HEALTHCARE PROFESSIONAL. HOWEVER, NO DIAGNOSIS WAS CONFIRMED. THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2020. THE SURGEON¿S OFFICE STATED THE PATIENT UNDERWENT THE REVISION SURGERY BY HER OWN CHOICE WITHOUT CONFIRMED DIAGNOSIS. THE PATIENT RETAINED THE DEVICES AFTER THE REVISION SURGERY. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

  Patient problems: Local Reaction

  MAUDE report 11269828 ↗
• InjuryNov 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 210 CC MENTOR SMOOTH ROUND HIGH PROFILE ON BOTH SIDES AND EXPERIENCED BREAST IMPLANT DEFLATION ON THE RIGHT SIDE AS THE IMPLANT LOOKS SMALLER. ALSO, LEFT SIDE IS LARGER THAN THE RIGHT, AND MAY REQUIRE CAPSULOTOMY. AS A RESULT, THE DEVICES WILL BE EXPLANTED ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 10919408 ↗

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