MENTOR SILTEX Round SPECTRUM 3542440MRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00081317002086), received between Mar 14, 2018 and Apr 12, 2024 — classified as 17 injuries.

The most frequently reported specific device problem is “Material Rupture” (16 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 275CC MENTOR SILTEX ROUND SPECTRUM AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE REPLACEMENT SURGERY WAS SCHEDULED FOR (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19096170 ↗
• InjuryApr 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH MENTOR SILTEX ROUND SPECTRUM 275CC SALINE PROSTHESES EXPERIENCED RIGHT SIDED DEFLATION AND LEFT SIDED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST PROCEDURE. THE DEFLATION WAS DETECTED THROUGH MAMMOGRAPHY. MENTOR IS AWARE THAT THE MANUFACTURED DATE PROVIDED OCCURS AFTER THE IMPLANT DATE PROVIDED. THIS IS THE ONLY INFORMATION AVAILABLE TO MENTOR AT THIS TIME. IF ADDITIONAL CLARIFICATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SEE 1645337-2023-04335 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16728939 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH MENTOR SILTEX ROUND SPECTRUM 275CC SALINE PROSTHESES EXPERIENCED RIGHT SIDED DEFLATION AND LEFT SIDED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST PROCEDURE. THE DEFLATION WAS DETECTED THROUGH MAMMOGRAPHY. MENTOR IS AWARE THAT THE MANUFACTURED DATE PROVIDED OCCURS AFTER THE IMPLANT DATE PROVIDED. THIS IS THE ONLY INFORMATION AVAILABLE TO MENTOR AT THIS TIME. IF ADDITIONAL CLARIFICATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SEE 1645337-2023-04336 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 16728938 ↗
• InjuryApr 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 72-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR SILTEX ROUND SPECTRUM 275CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16678111 ↗
• InjuryAug 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 67-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX ROUND SPECTRUM, 275CC SILICONE IMPLANT HAS EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVELY. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15250390 ↗
• InjurySep 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 275CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA A MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12448193 ↗
• InjuryApr 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH AN UNSPECIFIED MENTOR SMOOTH SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS CONFIRMED BY A PHYSICIAN¿S PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9941836 ↗
• InjuryFeb 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 275CC SALINE MENTOR SILTEX ROUND SPECTRUM BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT WITH SALINE MENTOR MEMORYGEL BREAST IMPLANTS, CATALOG NUMBERS 3507400BC ON THE RIGHT SIDE AND 3507350BC ON THE LEFT SIDE, SERIAL NUMBERS (B)(4) ON THE RIGHT SIDE AND (B)(4) ON THE LEFT SIDE ON (B)(6) 2006.

  Patient problems: No Code Available

  MAUDE report 9732855 ↗
• InjuryJan 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 275CC MENTOR SILTEX ROUND SPECTRUM PROSTHESIS AND EXPERIENCED POSTOPERATIVE LEFT-SIDED DEFLATION. THE PATIENT EXPERIENCED THE DEFLATION IN 6TH WEEK EXPANSION PROCESS OF HER LEFT TISSUE EXPANDER. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNSPECIFIED IMPLANTS ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9597503 ↗
• InjuryApr 29, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESES, EXPERIENCED RIGHT SIDE DEFLATION CAUSED BY AN UNSPECIFIED ACCIDENT POST-OPERATIVELY. AS A RESULT, THE PATIENT WAS SCHEDULED FOR REMOVAL ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8562687 ↗
• InjuryMar 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR SILTEX ROUND SPECTRUM 275CC PROSTHESIS AND EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED BY A PHYSICIAN. AS A RESULT, AN EXPLANT IS PLANNED FOR (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8430726 ↗
• InjuryMar 16, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 275CC MENTOR SILTEX ROUND SPECTRUM SALINE PROSTHESIS AND EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. 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 8426703 ↗
• InjuryAug 14, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SILTEX ROUND SPECTRUM 275CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH GEL MENTOR MEMORYGEL BREAST IMPLANT 450CC ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7783192 ↗
• InjuryApr 23, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A SALINE MENTOR SILTEX ROUND SPECTRUM 275CC BREAST IMPLANT 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 7451591 ↗
• InjuryApr 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY PROCEDURE WITH SALINE MENTOR SILTEX ROUND SPECTRUM 275CC BREAST IMPLANTS AND EXPERIENCED BILATERAL DEFLATION. THE DEFLATION WAS DIAGNOSED BY THE HEALTHCARE PROFESSIONAL BY THE MAMMOGRAM ON (B)(6) 2017. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT ON (B)(6) 2018. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 7412662 ↗
• InjuryApr 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY PROCEDURE WITH SALINE MENTOR SILTEX ROUND SPECTRUM 275CC BREAST IMPLANTS AND EXPERIENCED BILATERAL DEFLATION. THE DEFLATION WAS DIAGNOSED BY THE HEALTHCARE PROFESSIONAL BY THE MAMMOGRAM ON (B)(6) 2017. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT ON (B)(6) 2018. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 7412661 ↗
• InjuryMar 14, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD (B)(6) FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 275CC MENTOR SILTEX ROUND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE BREAST IMPLANT. DEFLATION WAS DIAGNOSED ON (B)(6) 2018 THROUGH A PHYSICIAN¿S EXAMINATION ON (B)(6) 2018. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WAS PERFORMED ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7340180 ↗

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