MENTOR SILTEX Round SPECTRUM 3542470MRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00081317002116), received between Apr 24, 2018 and May 13, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Material Rupture” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH SALINE MENTOR SILTEX ROUND SPECTRUM 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 22012561 ↗
• InjuryMar 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 63-YEAR-OLD NON HISPANIC/LATINO FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 425CC MENTOR SILTEX ROUND SPECTRUM ON BOTH SIDES AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. ON (B)(6) 2023, MENTOR BECAME AWARE THAT THE REPLACEMENT DEVICES USED ON (B)(6) 2023 WERE SERIAL NUMBERS (B)(4) ON THE LEFT SIDE, AND (B)(4) ON THE RIGHT SIDE. ON (B)(6) 2023, THE MENTOR FAILURE ANALYSIS LAB RECEIVED TWO DEVICE FOR EVALUATION. PAPERWORK RECEIVED WITH THE DEVICE INDICATED THAT THE REPLACEMENT SURGERY WAS ON (B)(6)2023. ON (B)(6) 2023, THE MENTOR FAILURE ANALYSIS LAB COMPLETED PRELIMINARY ANALYSIS OF THE DEVICES RECEIVED WHICH WERE FOUND DAMAGED SINCE BOTH PRODUCTS RECEIVED HAD THE SAME VOLUME ENGRAVED, IT COULD NOT BE DETERMINED WHICH DEVICE IS THE SUSPECT MEDICAL DEVICE FOR THE REPORTED RUPTURE. HENCE, THIS REPORT IS BEING SUBMITTED FOR THE PATIENT¿S SECOND RUPTURED (LEFT-SIDED) DEVICE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16659765 ↗
• InjuryOct 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 425CC MENTOR SILTEX 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) 1998.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15668751 ↗
• InjuryOct 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 63-YEAR-OLD NON HISPANIC/LATINO FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 425CC MENTOR SILTEX ROUND SPECTRUM AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT IS SCHEDULED FOR REPLACEMENT SURGERY ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15621154 ↗
• InjuryOct 26, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD AMERICAN INDIAN FEMALE PATIENT, WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 425CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESES, SUFFERED BILATERAL BREAST IMPLANT DEFLATIONS POST-PROCEDURE. THE PATIENT INITIALLY NOTICED ONE OF THE IMPLANTS GOING FLAT AND TWO MONTHS AFTER, THE OTHER DID THE SAME. IN ADDITION, THE PATIENT INQUIRED IF THE IMPLANT WERE GOING TO CAUSE THEM ANY BAD PROBLEMS FOR STAYING FLAT AND FOR SITTING AT THE BOTTOM OF THEIR BREASTS. 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: No Code Available

  MAUDE report 10738471 ↗
• InjuryOct 26, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD AMERICAN (B)(6) FEMALE PATIENT, WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 425CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESES, SUFFERED BILATERAL BREAST IMPLANT DEFLATIONS POST-PROCEDURE. THE PATIENT INITIALLY NOTICED ONE OF THE IMPLANTS GOING FLAT AND TWO MONTHS AFTER, THE OTHER DID THE SAME. IN ADDITION, THE PATIENT INQUIRED IF THE IMPLANT WERE GOING TO CAUSE THEM ANY BAD PROBLEMS FOR STAYING FLAT AND FOR SITTING AT THE BOTTOM OF THEIR BREASTS. 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: No Code Available

  MAUDE report 10738470 ↗
• InjuryApr 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 425CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESES, SUFFERED RIGHT BREAST IMPLANT RUPTURE, POST-OPERATIVELY. THE PATIENT NOTICED THAT THE BREAST IMPLANT WAS GETTING SMALLER AND NOW IT HAS COMPLETELY DRAINED. 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 9992922 ↗
• InjuryJun 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND SPECTRUM 425 CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS CONFIRMED BY A PHYSICIAN THROUGH A PHYSICAL EXAMINATION. 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 8735647 ↗
• InjuryMay 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SILTEX ROUND SPECTRUM 425CC, AND EXPERIENCED DEFLATION ON THE RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT WILL UNDERGO REMOVAL ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8599642 ↗
• InjuryNov 7, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A SALINE MENTOR SILTEX ROUND SPECTRUM 425CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE RIGHT SIDE. AS A RESULT, THE PATIENT WILL UNDERGO BILATERAL REMOVAL AND REPLACEMENT WITH UNSPECIFIED BREAST IMPLANTS ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8048906 ↗
• InjuryOct 3, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND SPECTRUM 425CC SALINE PROSTHESIS. SPONTANEOUS LEFT SIDED DEFLATION WAS OBSERVED BY A VISUAL EXAMINATION ON (B)(6) 2018. AS A RESULT, THE LEFT PROSTHESIS WAS REPLACED WITH A 515CC MENTOR GEL IMPLANT, AND THE RIGHT PROSTHESIS WAS REPLACED 555CC MENTOR GEL IMPLANT.

  Patient problems: No Code Available

  MAUDE report 7932224 ↗
• InjuryMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, SALINE MENTOR SILTEX ROUND SPECTRUM 425CC BREAST IMPLANTS WERE RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB WITH NO ACCOMPANYING INFORMATION. THE DEVICES COULD NOT BE ASSOCIATED WITH AN EXISTING COMPLAINT. IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHY THIS DEVICE WAS RETURNED TO MENTOR. HOWEVER, IT WILL BE CONSERVATIVELY REPORTED TO (B)(4) AS AN EVENT REQUIRING MEDICAL DEVICE REMOVAL FROM A PATIENT. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 7520885 ↗
• InjuryMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, SALINE MENTOR SILTEX ROUND SPECTRUM 425CC BREAST IMPLANTS WERE RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB WITH NO ACCOMPANYING INFORMATION. THE DEVICES COULD NOT BE ASSOCIATED WITH AN EXISTING COMPLAINT. IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHY THIS DEVICE WAS RETURNED TO MENTOR. HOWEVER, IT WILL BE CONSERVATIVELY REPORTED TO FDA AS AN EVENT REQUIRING MEDICAL DEVICE REMOVAL FROM A PATIENT. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 7520880 ↗
• InjuryApr 24, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND SPECTRUM 500CC SALINE PROSTHESIS. DEFLATION ON THE LEFT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE THROUGH A PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANT DATE.

  Patient problems: Deformity/ Disfigurement; No Code Available

  MAUDE report 7454286 ↗

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