MENTOR Smooth Round SPECTRUM 3501460Recalls & reported problems

Summary

The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 00081317002000), received between Feb 27, 2018 and Mar 25, 2026 — classified as 163 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (129 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 164 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT IMPLANT DURING A PHYSICAL EXAM. 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 24683482 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS EXPERIENCED CAPSULAR CONTRACTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24420163 ↗
• InjuryNov 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23633527 ↗
• InjuryNov 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2016.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23596829 ↗
• InjuryNov 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 375CC MENTOR SMOOTH ROUND MODERATE 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 23479014 ↗
• InjuryOct 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) AND POSSIBLE RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 450CC MENTOR MEMORYGEL BREAST IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 23375680 ↗
• InjuryOct 15, 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 MENTOR SMOOTH ROUND SPECTRUM 375CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE LEFT SIDE AND PTOSIS ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23285501 ↗
• InjuryAug 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 37-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING SURGERY. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG NUMBER 3503251BC) WITH LOT NUMBER 9939858. A DISCREPANCY WAS OBSERVED WHEN THE INFORMATION REPORTED INCLUDED A DATE OF IMPLANTATION (2004) THAT OCCURRED PRIOR TO THE MANUFACTURING DATE OF THE BREAST IMPLANT. IF NEW INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22896291 ↗
• InjuryAug 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT IMPLANT DURING AN IN-OFFICE VISIT. AS A RESULT, THE PATIENT WAS SCHEDULED FOR IMPLANT REMOVAL ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22797621 ↗
• InjuryJul 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON AN UNKNOWN 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; Deformity/ Disfigurement

  MAUDE report 22584104 ↗
• InjuryJun 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS EXPERIENCED BREAST PAIN AND 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: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 22285675 ↗
• InjuryMay 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR SMOOTH ROUND SPECTRUM AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A MENTOR BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22057391 ↗
• InjuryApr 29, 2025Material Rupture; Use of Device Problem; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH AN UNKNOWN MENTOR SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6), 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21930879 ↗
• InjuryMar 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 375CC MENTOR SMOOTH ROUND SPECTRUM 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 21732518 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS EXPERIENCED CAPSULAR CONTRACTURE 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 21692251 ↗
• InjuryMar 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A DEFLATED RIGHT BREAST IMPLANT. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS YET TO BE CONDUCTED. 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 21678184 ↗
• InjuryMar 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR SMOOTH ROUND SPECTRUM 375 CC BREAST IMPLANT 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 21633951 ↗
• InjuryMar 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND SPECTRUM 375CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA AN IN-OFFICE 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 21596510 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND SPECTRUM 375CC SALINE BREAST PROSTHESES AND SUFFERED FROM UNSPECIFIED AUTOIMMUNE ISSUES, FIBROMYALGIA, AND CHRONIC FATIGUE. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES FOR ENCAPSULATION IN HER RIGHT BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Autoimmune Disorder; Capsular Contracture

  MAUDE report 21358208 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND SPECTRUM 375CC SALINE BREAST PROSTHESES AND SUFFERED FROM UNSPECIFIED AUTOIMMUNE ISSUES, FIBROMYALGIA, AND CHRONIC FATIGUE. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES FOR ENCAPSULATION IN HER RIGHT BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Autoimmune Disorder

  MAUDE report 21358207 ↗
• InjuryNov 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR SMOOTH ROUND SPECTRUM 375CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 375CC GEL BREAST PROSTHESIS AND A MENTOR MEMORYGEL BOOST BREAST IMPLANT 480CC GEL BREAST PROSTHESIS ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20810929 ↗
• InjuryOct 24, 2024Material Rupture; Connection Problem; Material Rupture; Connection Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST RIPPLING AND IMPLANT DEFLATIONS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (LEFT) 500CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMHB500 LOT: 9987904 SN: (B)(6) AND (RIGHT) 500CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMHB500 LOT: 9991355 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 20526957 ↗
• InjuryOct 24, 2024Material Rupture; Connection Problem; Material Rupture; Connection Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST RIPPLING AND IMPLANT DEFLATIONS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (LEFT) 500CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMHB500 LOT: 9987904 SN: (B)(6) AND (RIGHT) 500CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMHB500 LOT: 9991355 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 20526703 ↗
• InjurySep 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN ULTRASOUND. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20303938 ↗
• InjurySep 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT DURING A VISUAL EXAM WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20303665 ↗

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 she
• Z-2070-2017 · Mar 27, 2017 · Terminated
  Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048