MENTOR Smooth Round SPECTRUM 3501480Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 00081317002024), received between Mar 1, 2018 and Apr 16, 2026 — classified as 82 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (68 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 85 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT DEFLATIONS. 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 24897759 ↗
• InjuryFeb 4, 2025Material Rupture; Material Rupture

  FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION USING A MENTOR SMOOTH ROUND SPECTRUM IMPLANT (475CC ON THE LEFT) AND AN UNKNOWN ALLERGAN SCLP SALINE IMPLANT ON THE RIGHT EXPERIENCED A LEFT-SIDED DEFLATION, AND RIGHT SIDED ASYMMETRY ISSUE POST-IMPLANTATION. IN RESPONSE TO THIS COMPLICATION, THE PATIENT UNDERWENT A BILATERAL PERIPROSTHETIC CAPSULECTOMY AND BILATERAL REPLACEMENTS. THE LEFT BREAST IMPLANT WAS REPLACED WITH CATALOG NUMBER SMPB450, SERIAL NUMBER (B)(6), WHILE THE RIGHT BREAST IMPLANT WAS REPLACED WITH CATALOG NUMBER SMPB480, SERIAL NUMBER (B)(6). ADDITIONALLY, THE PROCEDURE INCLUDED BILATERAL FAT GRAFTING TO THE RECONSTRUCTED BREASTS AND BILATERAL MASTOPEXY, WHICH WAS PERFORMED ON (B)(6) 2024. THIS REPORT SPECIFICALLY PERTAINS TO THE LEFT SIDE OF THE PATIENT'S RECONSTRUCTION.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21307257 ↗
• InjuryJan 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND SPECTRUM 475CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21203869 ↗
• InjuryOct 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND SPECTRUM 475CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. THIS WAS THOUGHT TO HAVE BEEN POSSIBLY CAUSED BY A FALL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20515638 ↗
• InjuryAug 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 475CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19885108 ↗
• InjuryMay 15, 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 AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 475CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE II AND III CAPSULAR CONTRACTURE OF THE LEFT AND RIGHT BREASTS, RESPECTIVELY, DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR BREAST IMPLANT REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 19319830 ↗
• InjuryMay 15, 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 AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 475CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE II AND III CAPSULAR CONTRACTURE OF THE LEFT AND RIGHT BREASTS, RESPECTIVELY, DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR BREAST IMPLANT REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 19319829 ↗
• InjuryMay 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH IMPLANTATION OF A 475CC 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. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 475CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANTS ON (B)(6) 2024.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 19287147 ↗
• InjuryOct 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 475CC 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 SURGERY ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 18007137 ↗
• InjurySep 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND SPECTRUM, 475CC SALINE BREAST IMPLANT EXPERIENCED LEFT-SIDED DEFLATION POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH IN OFFICE EXAMINATION. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17833774 ↗
• InjurySep 27, 2023Adverse 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 PRIMARY WITH SALINE MENTOR SMOOTH ROUND SPECTRUM 475CC BREAST IMPLANTS AND EXPERIENCED ANISOMASTIA 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 17829270 ↗
• InjuryJan 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 48-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 475CC 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) 2023.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 16243730 ↗
• InjuryNov 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 475CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A DEFLATION ON THE LEFT SIDE, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 460CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15709260 ↗
• InjuryAug 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 67-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A RIGHT-SIDED 475CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT NOTED SWELLING OF HER RIGHT BREAST AFTER A BREAST LIFT SURGERY. THE SWELLING EVENTUALLY SUBSIDED. UPON A YEARLY CHECK IN WITH HER SURGEON, SHE WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT WAS SCHEDULED FOR REMOVAL ON (B)(6), 2023.

  Patient problems: Local Reaction

  MAUDE report 15255655 ↗
• InjuryAug 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 62-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH UNKNOWN SIZE UNKNOWN SALINE IMPLANTS AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY. THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3501480; SERIAL NUMBER (B)(4) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3501480; SERIAL NUMBER (B)(4) ON THE RIGHT SIDE ON (B)(6) 2016.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15188759 ↗
• InjuryNov 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR SMOOTH ROUND SPECTRUM 475CC SALINE BREAST PROSTHESES THAT BOTH DEFLATED AFTER IMPLANTATION. BILATERAL DEFLATION WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 560CC GEL BREAST PROSTHESES ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12755831 ↗
• InjuryAug 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND SPECTRUM 475CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. THE DEFLATION 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) 2021. TWO LOT NUMBERS WERE REPORTED FOR THIS EVENT: LOT #230769 FOR LEFT BREAST PROSTHESIS AND LOT #225401 FOR RIGHT BREAST PROSTHESIS. IT WAS NOT SPECIFIED WHICH SIDE DEFLATED. IF CLARIFICATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12356997 ↗
• InjuryJul 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND SPECTRUM 475CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS CONFIRMED VISUALLY DURING A PHYSICIAN¿S EXAM. AS A RESULT, AN EXPLANT IS PLANNED FOR (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12242505 ↗
• MalfunctionJul 1, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO MENTOR THAT THE MENTOR SMOOTH ROUND SPECTRUM 475CC WAS NOT WORKING PROPERLY. THE SURGEON WAS PLACING PATIENTS TISSUE EXPANDER WHEN HE OBSERVED THAT THE PORT WAS NOT WORKING. HE USED A DIFFERENT PORT AND WAS ABLE TO USE THE TISSUE EXPANDER. THERE WAS NO PROCEDURE DELAY AND NO PATIENT CONSEQUENCE AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12100569 ↗
• InjuryJun 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD HISPANIC FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH TWO 475CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES, SUFFERED SPONTANEOUS BILATERAL BREAST IMPLANT DEFLATIONS AND DISCOMFORT, POST-PROCEDURE. CT SCAN CONFIRMED THE DEFLATIONS. 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: Calcium Deposits/Calcification; Pain

  MAUDE report 11968443 ↗
• InjuryJun 9, 2021Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD HISPANIC FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH TWO 475CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES, SUFFERED SPONTANEOUS BILATERAL BREAST IMPLANT DEFLATIONS AND DISCOMFORT, POST-PROCEDURE. CT SCAN CONFIRMED THE DEFLATIONS. 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: Calcium Deposits/Calcification; Necrosis; Pain

  MAUDE report 11968436 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH TWO 475CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT EXPERIENCED LEFT SIDED DEFLATION AND RIGHT SIDED MASTOPEXY SCARRING POST PROCEDURE. AS A RESULT, UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH TWO NON MENTOR BREAST IMPLANTS ON (B)(6) 2021. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Scar Tissue

  MAUDE report 11898682 ↗
• InjuryApr 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH 475CC SALINE MENTOR SMOOTH ROUND SPECTRUM BREAST IMPLANTS AND EXPERIENCED BILATERAL DEFLATION POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE REMOVAL AND REPLACEMENT WITH 550CC MENTOR MEMORYGEL BREAST IMPLANTS, CATALOG NUMBER 3505504BC, SERIAL NUMBERS (B)(4) ON THE LEFT SIDE AND (B)(4) ON THE RIGHT SIDE ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11690947 ↗
• InjuryApr 14, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH A 475CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS ON THE RIGHT SIDE, SUFFERED RIGHT BREAST PAIN AND RIGHT BREAST IMPLANT DEFLATION, POST-PROCEDURE. THE PATIENT EXPERIENCED TRAUMA PRIOR TO THE DEFLATION. THE PATIENT WAS IN A CAR ACCIDENT, WHERE THE AIRBAG DEPLOYED AND THE SEATBELT YANKED HER BACK. CT SCAN CONFIRMED THE DEFLATION. AS A RESULT, THE PATIENT WAS SCHEDULED FOR IMPLANT EXPLANTATION SURGERY ON (B)(6) 2021.

  Patient problems: Crushing Injury; Pain

  MAUDE report 11668858 ↗
• InjuryApr 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 475CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON AN UNKNOWN SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11624450 ↗

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