MENTOR Smooth Round Moderate Plus Profile 3502250Recalls & reported problems

Summary

The FDA's MAUDE database contains 253 adverse event reports that list this exact device (DI 00081317001379), received between Feb 15, 2018 and Sep 29, 2026 — classified as 252 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (162 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 253 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Material Rupture

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50938091 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 29-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 250CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) 2026. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24889468 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 29-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 250CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. AS A RESULT, THE PATIENT IS TO UNDERGO BILATERAL DEVICE EXPLANTATION ON (B)(6) 2026. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24889466 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANTS AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING DIGESTIVE ISSUES, VOMITING, DIARRHEA, HEADACHES, FATIGUE, EYE ISSUES, ANXIETY, AND JOINT PAIN. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. 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 24559485 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III 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: Capsular Contracture

  MAUDE report 24475181 ↗
• InjuryFeb 11, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 250CC 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 24319086 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 250CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24274138 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 250CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24274109 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 250CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED FATIGUE, HEADACHES, AND JOINT PAIN. NO FURTHER INFORMATION WAS RECEIVED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24082516 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 250CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED FATIGUE, HEADACHES, AND JOINT PAIN. NO FURTHER INFORMATION WAS RECEIVED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24082513 ↗
• InjuryNov 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 250CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING VOLUME LOSS OF ONE IMPLANT AND THE IMPLANT HAS MOVED UNDER HER ARM. THE AFFECTED SIDE WAS NOT PROVIDED. 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. AS THE AFFECTED SIDE WAS NOT PROVIDED, THE LOT/SERIAL NUMBERS FOR BOTH PRODUCTS ARE BEING PROVIDED AS LEFT IMPLANT - LOT: 6604643 / SERIAL:(B)(6) AND RIGHT IMPLANT - LOT: 6525220 / SERIAL: (B)(6). THE CATALOG NUMBERS ARE THE SAME FOR BOTH DEVICES. FOLLOW-UPS WERE NOT PERFORMED PER THE PATIENT'S REQUEST.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23584364 ↗
• InjuryOct 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 250CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 250CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 23429882 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 250CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES EXPERIENCED LUPUS, PAIN, BREAST IMPLANT ILLNESS, AUTOIMMUNE ISSUES, AND LUMPS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Autoimmune Disorder

  MAUDE report 23415883 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 250CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES EXPERIENCED LUPUS, PAIN, BREAST IMPLANT ILLNESS, AUTOIMMUNE ISSUES, AND LUMPS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Autoimmune Disorder

  MAUDE report 23415876 ↗
• InjuryAug 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 250CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22864581 ↗
• InjuryAug 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 SURGERY WITH IMPLANTATION OF A 250CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. 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 22863269 ↗
• InjuryAug 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 SURGERY WITH IMPLANTATION OF A 250CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. 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 22862445 ↗
• InjuryJul 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 250CC SALINE PROSTHESIS EXPERIENCED SPONTANEOUS LEFT SIDED DEFLATION POST PROCEDURE. THE CONTRALATERAL SIDE WAS DEFLATED FOR SYMMETRY ON (B)(6) 2025. BILATERAL EXCHANGE IS PLANNED FOR (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22397041 ↗
• InjuryMay 5, 2025Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 250CC 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 21961827 ↗
• InjuryMar 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 250CC 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 21682814 ↗
• InjuryMar 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 250CC SALINE BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND SPECTRUM 325CC SALINE BREAST PROSTHESES ON (B)(6) 2025. DURING EXPLANT SURGERY, BILATERAL DEFLATION OF THE BREAST PROSTHESES WAS DISCOVERED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21579367 ↗
• InjuryMar 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 250CC SALINE BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND SPECTRUM 325CC SALINE BREAST PROSTHESES ON (B)(6) 2025. DURING EXPLANT SURGERY, BILATERAL DEFLATION OF THE BREAST PROSTHESES WAS DISCOVERED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21579366 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 250CC SALINE BREAST PROSTHESES DEVELOPED A RASH AND NIPPLE DISCHARGE IN HER LEFT BREAST POST IMPLANTATION. ADDITIONALLY, THE PATIENT SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING FATIGUE, HASHIMOTO¿S DISEASE, JOINT AND BACK PAIN, AND BREAST SORENESS. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6)2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Autoimmune Disorder

  MAUDE report 21370539 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 250CC SALINE BREAST PROSTHESES DEVELOPED A RASH AND NIPPLE DISCHARGE IN HER LEFT BREAST POST IMPLANTATION. ADDITIONALLY, THE PATIENT SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING FATIGUE, HASHIMOTO¿S DISEASE, JOINT AND BACK PAIN, AND BREAST SORENESS. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6)2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Autoimmune Disorder

  MAUDE report 21370532 ↗
• InjuryFeb 4, 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 250CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED THE FOLLOWING SYMPTOMS: LOSS OF PREGNANCIES, CHILDREN BORN WITH BIRTH DEFECTS, RASH, FATIGUE, TIGHTNESS IN THE CHEST, AND GENERALIZED ACHINESS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Reproductive System or Breast Problem

  MAUDE report 21309497 ↗

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