MENTOR Smooth Round SPECTRUM 3501440Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 00081317001980), received between Feb 8, 2018 and Jan 27, 2026 — classified as 99 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (69 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 102 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES DEVELOPED SENSITIVITY IN BOTH BREASTS POST IMPLANTATION. THE PATIENT WAS LATER DIAGNOSED WITH CHRONIC LEUKOCYTOSIS. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction

  MAUDE report 24192542 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES DEVELOPED SENSITIVITY IN BOTH BREASTS POST IMPLANTATION. THE PATIENT WAS LATER DIAGNOSED WITH CHRONIC LEUKOCYTOSIS. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction

  MAUDE report 24192532 ↗
• MalfunctionDec 11, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN, FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 275CC MENTOR SMOOTH ROUND SPECTRUM ON BOTH SIDES AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2025. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT EXPERIENCED DEFLATION OF THE RIGHT-SIDE IMPLANT. NO PRODUCT QUALITY ISSUES WERE REPORTED FOR THE LEFT-SIDE DEVICE. ON DECEMBER 5, 2024, THE MENTOR FAILURE ANALYSIS LAB RECEIVED TWO DEVICES FOR EVALUATION AND WERE BOTH FOUND DAMAGED UPON EVALUATION. HENCE, THIS REPORT DETAILS INVESTIGATION RESULTS FOR THE SECOND DEVICE RECEIVED AS NO CLARIFICATION WAS RECEIVED AFTER MULTIPLE FOLLOW-UPS.

  Patient problems: Insufficient Information

  MAUDE report 23785743 ↗
• InjuryDec 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR SMOOTH ROUND SPECTRUM 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 AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23711317 ↗
• InjuryOct 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 275CC MENTOR SMOOTH ROUND SPECTRUM AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23389713 ↗
• InjuryAug 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND SPECTRUM 275CC 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 22716134 ↗
• InjuryAug 1, 2025Adverse 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 275CC (RIGHT) MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS AND AN UNSPECIFIED SALINE BREAST PROSTHESIS (LEFT) AND EXPERIENCED COMPLICATIONS POST-OPERATIVELY. THE PATIENT IS UNSURE IF THE REPORTED ISSUES BEING EXPERIENCED IS BREAST PROSTHESIS RELATED. NO FURTHER INFORMATION HAS BEEN PROVIDED REGARDING THIS EVENT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IF ADDITIONAL INFORMATION IS RECEIVED, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 22690103 ↗
• InjuryOct 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 275CC SALINE PROTHESES EXPERIENCED BILATERAL DEFLATION AND RIGHT SIDED CAPSULAR CONTRACTURE POST PROCEDURE. THE LEFT IMPLANT HAD BEEN PREVIOUSLY REPLACED FOR A DEFLATION IN A PREVIOUS EVENT. THE RIGHT IMPLANT HAD NOTABLY HARDENED PRIOR TO DEFLATION. AS A RESULT, IMPLANT REPLACEMENT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 20571847 ↗
• InjuryOct 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A ASIAN FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 275CC MENTOR SMOOTH ROUND SPECTRUM AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY WITH CATALOG NUMBER 3502275; SERIAL NUMBER (B)(6) ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20540123 ↗
• InjuryAug 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 275CC MENTOR SMOOTH ROUND SPECTRUM ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICE WAS A 275CC MENTOR SMOOTH ROUND SPECTRUM (CATALOG: 3501440 LOT: 9655856 SN: (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19940576 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 275CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 19567287 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 275CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 19567286 ↗
• InjuryJun 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 38-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 275CC MENTOR SMOOTH ROUND SPECTRUM AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19479196 ↗
• InjuryMay 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH 275CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUSPECTED THAT SHE EXPERIENCED BILATERAL DEFLATION OF HER PROSTHESES. AT THE TIME OF THIS REPORT, THE PATIENT HAS NOT CONSULTED WITH A MEDICAL PROFESSIONAL, AND MENTOR HAS 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. THIS REPORT IS FOR THE LEFT IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19361336 ↗
• InjuryMay 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH 275CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT SUSPECTED THAT SHE EXPERIENCED BILATERAL DEFLATION OF HER PROSTHESES. AT THE TIME OF THIS REPORT, THE PATIENT HAS NOT CONSULTED WITH A MEDICAL PROFESSIONAL, AND MENTOR HAS 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. THIS REPORT IS FOR THE RIGHT IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19361335 ↗
• InjuryMay 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND SPECTRUM 275CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19264968 ↗
• InjuryMay 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH 275CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT¿S LEFT PROSTHESIS HAD BECOME SMALLER. THE PATIENT WAS THEN DIAGNOSED WITH A DEFLATION OF HER LEFT PROSTHESIS, WHICH WAS IDENTIFIED VIA MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 300CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANTS ON (B)(6) 2024. THE DATE OF IMPLANTATION WAS PROVIDED AS AN ESTIMATE. 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 19233212 ↗
• InjuryApr 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR SMOOTH ROUND SPECTRUM 275CC 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 19165238 ↗
• MalfunctionFeb 22, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THROUGH (FDA :MED WATCH UNKNOWN NUMBER) THAT A FEMALE PATIENT WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR SMOOTH ROUND SPECTRUM, 275CC SALINE, BREAST IMPLANT EXPERIENCED UNKNOWN-SIDED DEFECTIVE VALVE INTRAOPERATIVE. THE REPORT INDICATED THAT WHEN PREPARING THE EXPANDER TO IMPLANT INTO THE PATIENT IT WAS NOTICED THAT THE OPERATOR PORT TO FILL THE EXPANDER WITH IV SALINE WAS DEFECTIVE AND WOULD NOT ALLOW SALINE TO BE INJECTED INTO EXPANDER. NO ADVERSE EVENT OR PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18760185 ↗
• InjuryFeb 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF AN UNDISCLOSED MENTOR SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2023. THE DATE OF IMPLANTATION WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. 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 18663909 ↗
• InjuryJan 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST IMPLANT DEFLATIONS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THE REPLACEMENT DEVICES WERE: (LEFT) 325CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503251BC LOT: 9948732 SN: (B)(6) AND (RIGHT) 325CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503251BC LOT: 9948732 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS. DEFLATION ON THE LEFT HAS BEEN REPORTED UNDER MRN: 1645337-2024-00228.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18546473 ↗
• InjuryJan 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 55-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 275CC MENTOR SMOOTH ROUND SPECTRUM AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR A REPLACEMENT SURGERY ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18531028 ↗
• InjuryJan 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 55-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 275CC MENTOR SMOOTH ROUND SPECTRUM AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR A REPLACEMENT SURGERY ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18528028 ↗
• InjuryJan 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THE REPLACEMENT DEVICES WERE: (LEFT) 325CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503251BC LOT: 9948732 SN: (B)(6) AND (RIGHT) 325CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3503251BC LOT: 9948732 SN: (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18452381 ↗
• InjuryDec 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 275CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18411519 ↗

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