MENTOR Smooth Round Moderate Plus Profile 3502200Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00081317001355), received between Jan 30, 2018 and Sep 23, 2026 — classified as 68 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (41 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 69 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 female patient underwent Breast Augmentation Primary with MENTOR Smooth Round Moderate Plus Profile, 200cc Saline prosthesis. subsequently the patient experienced right sided Capsular contracture grade III postoperatively. The issue was diagnosed through physical examinations. At the time of this report, Mentor received no information regarding explantation or an expected explantation date.

  Patient problems: Capsular Contracture

  MAUDE report 50872114 ↗
• MalfunctionMar 20, 2026Appropriate Device Problem Term/Code Not Available

  A 200CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654602 ↗
• InjurySep 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 200CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. THE PATIENT NOTICED THAT HER RIGHT BREAST IS DECREASING IN SIZE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23020372 ↗
• InjuryJun 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22196732 ↗
• InjuryMay 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANTS 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.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22012622 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 56-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 200CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT REPORTED HAVING PAIN. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21955344 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 200CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE ON THE 4) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20653860 ↗
• InjurySep 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 200CC BREAST IMPLANTS 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 JUL 29, 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20138898 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 200CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN 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 19611303 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARYWITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE, 200CC SALINE, BREAST IMPLANT EXPERIENCED LEFT-SIDED DEFLATION, AND RIGHT SIDED SCAR WIDENING POSTOPERATIVE. THE MRI EXAMINATION CONFIRMED THE DEFLATION. AS A RESULT, PATIENT UNDERWENT RIGHT-SIDED SCAR REVISION AND LEFT BREAST AUGMENTATION REVISION WITH REPLACEMENT OF AN UNKNOWN MENTOR MODERATE PROFILE SALINE PROSTHESIS ON (B)(6) 2024. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Scar Tissue

  MAUDE report 19574972 ↗
• InjuryMay 10, 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 200CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS EXPERIENCED BREAST MASS 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 Mass

  MAUDE report 19288237 ↗
• InjuryApr 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE, 200CC SALINE, BREAST IMPLANT EXPERIENCED LEFT-SIDED DEFLATION POSTOPERATIVE. THE MRI EXAMINATION CONFIRMED THE ISSUE. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19174241 ↗
• InjuryMar 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 200CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A DEFLATED RIGHT BREAST IMPLANT. ULTRASOUND IMAGING AND A CONSULTATION WITH A MEDICAL PROFESSIONAL WERE CONDUCTED. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18968752 ↗
• InjuryFeb 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 200CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST IMPLANT DURING A VIDEO CONSULTATION WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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: Deformity/ Disfigurement

  MAUDE report 18768833 ↗
• InjuryFeb 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 200CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18708290 ↗
• InjuryFeb 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANTS 200CC AND EXPERIENCED INFECTION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2023.

  Patient problems: Post Operative Wound Infection

  MAUDE report 18681951 ↗
• InjuryDec 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 200CC AND EXPERIENCED DEFLATION ON THE LEFT 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), 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18302482 ↗
• InjuryDec 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 200CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT UNDERWENT A REVISION SURGERY. DURING SURGERY, IT WAS DISCOVERED THAT THE PATIENT EXPERIENCED BILATERAL DEFLATION OF HER PROSTHESES. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANTS ON (B)(6) 2023. THERE WERE NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED DUE TO THE DEFLATIONS DISCOVERED DURING THE REVISION SURGERY. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-14252 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18267719 ↗
• InjuryDec 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 200CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT UNDERWENT A REVISION SURGERY. DURING SURGERY, IT WAS DISCOVERED THAT THE PATIENT EXPERIENCED BILATERAL DEFLATION OF HER PROSTHESES. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANTS ON (B)(6) 2023. THERE WERE NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED DUE TO THE DEFLATIONS DISCOVERED DURING THE REVISION SURGERY. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-14253 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18267711 ↗
• InjuryOct 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 35-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 200CC 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. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17959553 ↗
• InjurySep 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 200CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED 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 17793172 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 76-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 200CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL CAPSULAR CONTRACTURES (BAKER GRADE IV ON THE RIGHT AND BAKER GRADE II ON THE LEFT). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 17694623 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 76-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 200CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL CAPSULAR CONTRACTURES (BAKER GRADE IV ON THE RIGHT AND BAKER GRADE II ON THE LEFT). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 17694622 ↗
• InjuryJun 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 77-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH A A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE, 200CC, SALINE BREAST IMPLANT EXPERIENCED LEFT-SIDED DEFLATION POSTOPERATIVELY. THE ISSUE WAS DIAGNOSED BY IN OFFICE EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH UNKNOWN PROSTHESIS ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17232306 ↗
• InjuryMar 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 200CC 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) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16499430 ↗

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