MENTOR Smooth Round Moderate Plus Profile 3502400Recalls & reported problems

Summary

The FDA's MAUDE database contains 471 adverse event reports that list this exact device (DI 00081317001430), received between Jan 26, 2018 and Sep 23, 2026 — classified as 458 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (298 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 471 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a 55-year-old Caucasian female patient underwent a breast augmentation revision with a 400cc MENTOR Smooth Round Moderate Plus Profile saline breast prosthesis and 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 50871427 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent primary breast augmentation with two 400cc MENTOR Smooth Round Moderate Plus Profile saline breast prostheses. Post-operatively, the patient was diagnosed, via physical examination, with bilateral breast capsular contractures (baker grades IV). 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 50488720 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent primary breast augmentation with two 400cc MENTOR Smooth Round Moderate Plus Profile saline breast prostheses. Post-operatively, the patient was diagnosed, via physical examination, with bilateral breast capsular contractures (baker grades IV). 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 50488715 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 25285229 ↗
• InjuryFeb 12, 2026Material Rupture

  IT WAS REPORTED THAT A 40-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. THE PATIENT REPORTED LOSS OF VOLUME. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24325552 ↗
• InjuryFeb 12, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24324734 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) 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 24215690 ↗
• InjuryJan 13, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT IMPLANT DURING A VISUAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24058236 ↗
• InjuryDec 3, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE, 400CC SALINE PROSTHESIS EXPERIENCE RIGHT SIDED DEFLATION POST OPERATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOWS: LEFT CATALOG NUMBER 3506001BC, SERIAL NUMBER (B)(6), RIGHT CATALOG 3505751BC, SERIAL NUMBER (B)(6) ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23709036 ↗
• InjuryNov 25, 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 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED A FIRM AND ENCAPSULATED RIGHT BREAST. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED. 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 23648696 ↗
• InjuryNov 21, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION PRIMARY WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE, 400CC SALINE PROSTHESIS EXPERIENCES RIGHT SIDED DEFLATION POST OPERATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23619512 ↗
• InjuryNov 5, 2025Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES EXPERIENCED BILATERAL DEFLATIONS POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479608 ↗
• InjuryOct 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 400CC MENTOR SMOOTH ROUND MODERATE PLUS 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 23302760 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 54-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) AND A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH MENTOR BREAST PROSTHESES. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23032920 ↗
• InjurySep 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) AND A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH MENTOR BREAST PROSTHESES. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23032917 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23030976 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23030975 ↗
• InjurySep 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 400CC MENTOR SMOOTH ROUND MODERATE PLUS 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) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22959797 ↗
• InjuryAug 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 490CC MENTOR MEMORYGEL XTRA BREAST IMPLANT (CATALOG NUMBER SHPX490).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22907539 ↗
• MalfunctionAug 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS BEING USED IN A BREAST AUGMENTATION DEFLATED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON MENTIONED THAT THE BREAST PROSTHESIS WAS LEAKING "AROUND THE CONNECTION". 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 22904781 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 36-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED PSYCHIATRIC DISORDER BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) AND POST-OPERATIVELY. THE PATIENT EXPERIENCED SHARP BREAST PAIN BILATERALLY AS WELL AS FIRM/HARDNESS. THERE WAS INCREASED TIGHTNESS AND A GENERAL FEELING OF DISCOMFORT IN THE CHEST AREA. THE PATIENT ALSO MENTIONED PAIN IN THE LOWER BACK. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture; Emotional Changes

  MAUDE report 22854144 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 36-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED PSYCHIATRIC DISORDER BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) AND POST-OPERATIVELY. THE PATIENT EXPERIENCED SHARP BREAST PAIN BILATERALLY AS WELL AS FIRM/HARDNESS. THERE WAS INCREASED TIGHTNESS AND A GENERAL FEELING OF DISCOMFORT IN THE CHEST AREA. THE PATIENT ALSO MENTIONED PAIN IN THE LOWER BACK. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture; Emotional Changes

  MAUDE report 22854143 ↗
• InjuryJul 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR SALINE IMPLANTS ON (B)(6) , 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22570216 ↗
• InjuryJul 14, 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 SURGERY WITH IMPLANTATION OF A 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A MUSCLE CRAMP THAT RESULTED IN BRUISING OF THE BOTTOM RIGHT SIDE OF THE RIGHT BREAST. NO FURTHER INFORMATION WAS PROVIDED. 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: Hematoma; Pain

  MAUDE report 22502962 ↗
• InjuryJul 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST IMPLANT AND ASYMMETRY BY A MEDICAL PROFESSIONAL DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXCHANGE WITH A MENTOR SALINE IMPLANT ON (B)(6) 2025. 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 22441682 ↗

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