MENTOR Smooth Round Moderate Plus Profile 3502375Recalls & reported problems

Summary

The FDA's MAUDE database contains 573 adverse event reports that list this exact device (DI 00081317001423), received between Jan 23, 2018 and Sep 30, 2026 — classified as 566 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (360 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 573 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Material Rupture

  It was reported that a 63-year-old Caucasian female patient underwent a breast augmentation revision with a 375cc MENTOR Smooth Round Moderate Plus Profile saline breast prosthesis and experienced a deflation on the left side post-operatively. As a result, the patient underwent explantation on (b)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50942148 ↗
• InjurySep 16, 2026Material Rupture

  It was reported that a patient implanted with a 375cc 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) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50791428 ↗
• InjuryMar 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 375CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT DEVELOPED INVASIVE LOBULAR CARCINOMA GRADE 2 IN THE LEFT BREAST, AND AS A RESULT, THE PATIENT UNDERWENT LEFT BREAST SEED-GUIDED LUMPECTOMY ON (B)(6) 2023. IT WAS FOLLOWED BY CHEMOTHERAPY AND RADIOTHERAPY (THE FINAL PATHOLOGY: LEFT BREAST CARCINOMA PT1B PN1A PM0). IT WAS ALSO REPORTED THAT IN THE POSTOPERATIVE PERIOD, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV IN THE LEFT BREAST AND BAKER GRADE III IN THE RIGHT BREAST). AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24542050 ↗
• InjuryMar 6, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 375CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT IMPLANT DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT WAS SCHEDULED FOR EXCHANGE WITH A MENTOR SALINE IMPLANT ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24537371 ↗
• InjuryFeb 24, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 375CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT IMPLANT BY A MEDICAL PROFESSIONAL. 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 24437723 ↗
• InjuryFeb 20, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT 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 24408210 ↗
• InjuryFeb 20, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24403388 ↗
• InjuryFeb 6, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 375CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24280311 ↗
• InjuryJan 27, 2026Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A SCAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement; Insufficient Information

  MAUDE report 24190242 ↗
• InjuryJan 27, 2026Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A SCAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement; Insufficient Information

  MAUDE report 24190229 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 375CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV ON THE RIGHT AND BAKER GRADE II ON THE LEFT). AS A RESULT, THE PATIENT UNDERWENT RIGHT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. FOR THE LEFT 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: Capsular Contracture

  MAUDE report 24062809 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 375CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV ON THE RIGHT AND BAKER GRADE II ON THE LEFT). AS A RESULT, THE PATIENT UNDERWENT RIGHT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICE WAS A MENTOR SALINE IMPLANT. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24062805 ↗
• InjuryJan 5, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 375CC 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 AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR SALINE BREAST PROSTHESES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23961454 ↗
• InjuryDec 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 40-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 475CC MENTOR MEMORYGEL BREAST IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23697642 ↗
• InjuryNov 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 375CC 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. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23660408 ↗
• 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 PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 375CC SALINE BREAST PROSTHESES WHEN THE RIGHT BREAST PROSTHESIS DEFLATED POST IMPLANTATION. THE PATIENT TRIPPED AND FELL ON HER RIGHT BREAST. DEFLATION WAS DIAGNOSED VIA A PHYSICAL EXAM. ADDITIONALLY, THE PATIENT DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 375CC SALINE BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23647732 ↗
• InjuryNov 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 375CC SALINE BREAST PROSTHESES WHEN THE RIGHT BREAST PROSTHESIS DEFLATED POST IMPLANTATION. THE PATIENT TRIPPED AND FELL ON HER RIGHT BREAST. DEFLATION WAS DIAGNOSED VIA A PHYSICAL EXAM. ADDITIONALLY, THE PATIENT DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 375CC SALINE BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23647728 ↗
• InjuryNov 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 23466716 ↗
• InjuryNov 3, 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 DISSATISFACTION WITH THE PROCEDURE OUTCOME BILATERALLY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

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

  MAUDE report 23452935 ↗
• InjuryNov 3, 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 DISSATISFACTION WITH THE PROCEDURE OUTCOME BILATERALLY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

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

  MAUDE report 23452453 ↗
• InjurySep 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 375CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION 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: Deformity/ Disfigurement

  MAUDE report 23016798 ↗
• InjurySep 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR SMOOTH ROUND MODERATE PLUS 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 22984201 ↗
• InjurySep 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST IMPLANT DEFLATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 22983592 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 375CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICE WAS A MENTOR GEL IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 22920418 ↗
• InjuryAug 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 375CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 375CC SALINE BREAST PROSTHESES ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22896887 ↗

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