MENTOR Smooth Round SPECTRUM 3501490Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00081317002048), received between May 22, 2018 and Feb 20, 2025 — classified as 36 injuries.

The most frequently reported specific device problem is “Material Rupture” (26 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 575CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT RUPTURES. 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: Deformity/ Disfigurement

  MAUDE report 21427787 ↗
• InjuryFeb 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDEWRWENT PRIMARY BREAST AUGMENTATION WITH TWO 575CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT RUPTURES. 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: Deformity/ Disfigurement

  MAUDE report 21427778 ↗
• InjuryJun 19, 2024Break; Filling Problem; Break; Filling Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND SPECTRUM 575CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DIFFICULTY WITH EXPANSION. THERE WAS THOUGHT TO BE A KINK AND IT CREATED VISIBILITY OF THE DEVICE THROUGH THE SKIN. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6), 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19568015 ↗
• InjuryMar 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND SPECTRUM 575CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18852891 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A MENTOR SMOOTH ROUND SPECTRUM 575CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED INFECTION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON AN UNKNOWN DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 18750038 ↗
• InjuryJan 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND SPECTRUM 575CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE PATIENT HAD AN EVENT REPORTED WITH HER PREVIOUS SET OF IMPLANTS UNDER 1645337-2023-04991 AND 1645337-2023-04990.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18440296 ↗
• InjuryNov 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 67-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 575CC MENTOR SMOOTH ROUND SPECTRUM 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) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18136014 ↗
• InjuryAug 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 650CC ARTOURA BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT TISSUE EXPANDER. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023. THE DATE OF EVENT WAS NOT PROVIDED TO MENTOR. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17643182 ↗
• InjuryJun 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 68-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 575CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST IMPLANT DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. 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: Deformity/ Disfigurement

  MAUDE report 17199001 ↗
• InjuryApr 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 575CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT A BREAST LIFT OPERATION FOR AN UNDISCLOSED REASON. AFTERWARDS, SHE HAD MAMMOGRAM IMAGING PERFORMED WHICH WAS STATED TO HAVE CAUSED A DEFLATED LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL REMOVAL AND REPLACEMENT WITH 575CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANTS ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-04990 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16833921 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 575CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT A BREAST LIFT OPERATION FOR AN UNDISCLOSED REASON. AFTERWARDS, SHE HAD MAMMOGRAM IMAGING PERFORMED WHICH WAS STATED TO HAVE CAUSED A DEFLATED LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT IS SCHEDULED FOR BILATERAL REMOVAL AND REPLACEMENT WITH 575CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANTS ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-04991 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16833920 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 69-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 575CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH 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 16820846 ↗
• InjuryMar 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 70-YEAR-OLD HISPANIC FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 575CC MENTOR SMOOTH ROUND SPECTRUM SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 16533873 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 35-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH A 575CC MENTOR SMOOTH ROUND SPECTRUM BREAST IMPLANT EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A NON MENTOR BREAST IMPLANT ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 15474335 ↗
• InjuryJun 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 70-YEAR-OLD CAUCASIAN FEMALE WHO HAD A MENTOR SMOOTH ROUND SPECTRUM 575CC SALINE PROSTHESES PLACED EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED IN THE PHYSICIAN¿S OFFICE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2022. THE RIGHT SIDED DEFLATION WAS REPORTED INITIALLY UNDER 1645337-2022-05896 ON MAY 19, 2022. ON MAY 27, 2022 MENTOR BECAME AWARE THAT THE RETURNED LEFT SIDED DEVICE ALSO APPEARED TO HAVE BEEN DEFLATED. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14658723 ↗
• InjuryMay 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO HAD A MENTOR SMOOTH ROUND SPECTRUM 575CC SALINE PROSTHESIS PLACED EXPERIENCED SPONTANEOUS RIGHT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED IN THE PHYSICIAN¿S OFFICE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14459446 ↗
• InjuryMar 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH A 575CC MENTOR SMOOTH ROUND SPECTRUM EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 13915702 ↗
• InjuryFeb 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 575CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT OBSERVED HER LEFT BREAST IMPLANT PROSTHESIS TO BE DEFLATED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 275CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13537090 ↗
• InjurySep 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A SALINE MENTOR SMOOTH ROUND SPECTRUM 575CC AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A MENTOR SALINE BREAST IMPLANT (CATALOG NUMBER 3501490) ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12410197 ↗
• InjuryJul 31, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH 575CC SALINE MENTOR SMOOTH ROUND SPECTRUM BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POSTOPERATIVELY. THE DEFLATION WAS CONFIRMED WITH A PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT WITH A 575CC SALINE MENTOR SMOOTH ROUND SPECTRUM BREAST IMPLANT, CATALOG NUMBER 3501490 ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10353846 ↗
• InjuryMar 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 575CC MENTOR SMOOTH ROUND SPECTRUM PROSTHESIS AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION. THE PATIENT WENT IN FOR A CONSULTATION ON (B)(6) 2020, AND THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED SALINE IMPLANT ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9862363 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) ITALIAN-AMERICAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR SMOOTH ROUND SPECTRUM 575CC SALINE BREAST PROSTHESES WHEN THE RIGHT BREAST PROSTHESIS DEFLATED AFTER IMPLANTATION. THE PATIENT OBSERVED A CHANGED IN THE SHAPE AND FULLNESS OF HER RIGHT BREAST. DEFLATION WAS LATER CONFIRMED BY A HEALTHCARE PROFESSIONAL. IN ADDITION, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND HIGH PROFILE 630CC SALINE BREAST PROSTHESES ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9821837 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A MENTOR SMOOTH ROUND SPECTRUM 575CC AND EXPERIENCED CAPSULAR CONTRACTURE ON THE RIGHT BREAST IMPLANT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9756947 ↗
• InjuryDec 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH A 575CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A 575CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9454201 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR ASR SUBMISSION REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 575CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANTS AND SUFFERED BILATERAL CAPSULAR CONTRACTURE (GRADE UNKNOWN) POSTOPERATIVELY. THE PATIENT NOTED THAT THERE WAS SOME VISIBLE ¿FOLDING AND BUBBLING¿ OF HER CHEST. AS A RESULT, THE PATIENT HAD THE DEVICES EXPLANTED ON (B)(6) 2017. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE. ON 10/29/2019, MENTOR BECAME AWARE THAT ASR SUBMISSION REFERENCE NUMBERS (B)(4) WERE DUPLICATED. ANY ADDITIONAL EVENT INFORMATION, IF RECEIVED, WILL BE SUBMITTED UNDER THIS MANUFACTURER¿S REPORT NUMBER. THE PATIENT CONSEQUENCES HAVE BEEN UPDATED BASED ON THE BREADTH OF INFORMATION AVAILABLE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9313003 ↗

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