MENTOR SILTEX Round SPECTRUM 3542450MRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00081317002093), received between Mar 8, 2018 and Aug 7, 2024 — classified as 23 injuries.

The most frequently reported specific device problem is “Material Rupture” (17 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 325CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A VIDEO CALL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19932969 ↗
• InjuryMar 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18951293 ↗
• InjuryJan 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SILTEX ROUND SPECTRUM 325CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18596762 ↗
• InjuryNov 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO UNSPECIFIED MENTOR SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18049549 ↗
• InjuryMar 7, 2023Adverse 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 TWO 325CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL RIPPLING POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Wrinkling

  MAUDE report 16499169 ↗
• InjuryMar 7, 2023Adverse 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 TWO 325CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL RIPPLING POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Wrinkling

  MAUDE report 16499040 ↗
• InjuryJul 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 51-YEAR-OLD FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH A 325CC MENTOR SILTEX ROUND SPECTRUM ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3501655 (B)(4) ON ONE SIDE, AND WITH CATALOG NUMBER 3501655 (B)(4) ON THE OTHER ON (B)(6) 2021. MENTOR IS AWARE THAT THE DATE OF ADVERSE EVENT ((B)(6) 2022) IS AFTER THE EXPLANT DATE ((B)(6) 2021) OF DEVICE. FOLLOW-UPS ARE IN PROGRESS, AND NO RESPONSE HAS BEEN RECEIVED REGARDING THE DISCREPANCY. IF ANY CLARIFICATION OR INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14959722 ↗
• InjuryJul 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 51-YEAR-OLD FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH A 325CC MENTOR SILTEX ROUND SPECTRUM ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT RUPTURES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3501655 (B)(4) ON ONE SIDE, AND WITH CATALOG NUMBER 3501655 (B)(4) ON THE OTHER ON (B)(6) 2021. MENTOR IS AWARE THAT THE DATE OF ADVERSE EVENT ((B)(6) 2022) IS AFTER THE EXPLANT DATE ((B)(6) 2021) OF DEVICE. FOLLOW-UPS ARE IN PROGRESS, AND NO RESPONSE HAS BEEN RECEIVED REGARDING THE DISCREPANCY. IF ANY CLARIFICATION OR INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14959664 ↗
• InjuryJan 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH A 325CC MENTOR SILTEX ROUND SPECTRUM AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH SPECTRUM; 390CC CATALOG NUMBER 3501450 ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13137669 ↗
• InjuryDec 30, 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 (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 325CC MENTOR SILTEX ROUND SPECTRUM IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT OBSERVED A LUMP ABOVE HER LEFT BREAST WHICH THEY BELIEVE TO BE A CYST. A CONSULTATION WITH A HEALTHCARE PROFESSIONAL HAS OCCURRED AND A BIOPSY WILL BE PERFORMED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Cyst(s)

  MAUDE report 13119944 ↗
• InjuryJul 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESES, SUFFERED SPONTANEOUS LEFT BREAST IMPLANT DEFLATION POST-PROCEDURE. THE DEFLATION WAS CONFIRMED VIA PHYSICAL EXAMINATION BY A DOCTOR. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH THE FOLLOWING DEVICES ON (B)(6) 2020: (LEFT) 555CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3507555MC LOT: 7673644 SN: (B)(4) AND (RIGHT) 555CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3507555MC LOT: 7673644 SN: (B)(4).

  Patient problems: No Code Available

  MAUDE report 10272263 ↗
• InjuryMar 19, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESES, SUFFERED LEFT BREAST IMPLANT DEFLATION POST-OPERATIVELY. THE PATIENT NOTICED THE ASYMMETRY A YEAR AGO AND DEFLATION WAS CONFIRMED BY THEIR DOCTOR ON (B)(6) 2019. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9853855 ↗
• InjuryFeb 25, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR SILTEX ROUND SPECTRUM, 325CC SALINE BREAST IMPLANTS WHICH THE RIGHT SIDE DEFLATED AND LEFT SIDE HAS ISSUE WITH CAPSULAR CONTRACTURE BAKER GRADE II AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. AS A RESULT PATIENT HAD THE IMPLANTS REMOVED ON (B)(6) 2020. THIS REPORT IS FOR THE RIGHT SIDE.

  Patient problems: No Code Available

  MAUDE report 9752001 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR SILTEX ROUND SPECTRUM, 325CC SALINE BREAST IMPLANTS WHICH THE RIGHT SIDE DEFLATED AND LEFT SIDE HAS ISSUE WITH CAPSULAR CONTRACTURE BAKER GRADE II AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. AS A RESULT PATIENT HAD THE IMPLANTS REMOVED ON (B)(6) 2020. THIS REPORT IS FOR THE LEFT SIDE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9751918 ↗
• InjuryFeb 7, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 325CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST IMPLANTS. THE PATIENT REPORTED THAT SHE SUSPECTED THAT HER RIGHT-SIDED DEVICE WAS DEFLATED. SHE REPORTED THAT SHE IS SCHEDULED FOR A MAMMOGRAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 9682706 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SILTEX ROUND SPECTRUM 325CC BREAST IMPLANTS AND EXPERIENCED BILATERAL HARDNESS AND DIFFICULTY BREATHING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8360262 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SILTEX ROUND SPECTRUM 325CC BREAST IMPLANTS AND EXPERIENCED BILATERAL HARDNESS AND DIFFICULTY BREATHING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8360260 ↗
• InjuryFeb 5, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SILTEX ROUND SPECTRUM 325CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE RIGHT BREAST PROSTHESIS WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 8305985 ↗
• InjuryNov 1, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) WHITE HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND SPECTRUM 325CC SALINE BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL BREAST PROSTHESIS (RIGHT DEVICE). THE VALVE IN THE LEFT BREAST PROSTHESIS WAS PROTRUDING OUT AND PUSHING THROUGH THE SKIN. THE DOCTOR¿S OFFICE DIAGNOSED IT AS A DEFECTIVE PROJECTOR VALVE. IN ADDITION, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE III) IN BOTH BREASTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2018. THIS MEDWATCH REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8031309 ↗
• InjuryOct 1, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SILTEX ROUND SPECTRUM 325CC AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. DEFLATION WAS CONFIRMED BY PHYSICIAN DURING EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 7924309 ↗
• InjurySep 5, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A SALINE MENTOR SILTEX ROUND SPECTRUM 325CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 7847184 ↗
• InjuryMay 23, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH SALINE MENTOR SILTEX ROUND SPECTRUM 325CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH GEL MENTOR MEMORYGEL BREAST IMPLANT 450CC ON THE RIGHT BREAST IMPLANT AND WITH MENTOR MEMORYGEL BREAST IMPLANT 415CC O THE LEFT BREAST IMPLANT ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7537248 ↗
• InjuryMar 8, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND SPECTRUM POST-OPERATIVELY ADJUSTABLE 325CC SALINE PROSTHESIS AND EXPERIENCED DEFLATION POST PROCEDURE. AS A RESULT, UNILATERAL PROSTHESIS REPLACEMENT WAS PERFORMED ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7325504 ↗

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