MENTOR SILTEX Round SPECTRUM 3542460MRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00081317002109), received between Nov 23, 2018 and Feb 5, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Material Rupture” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 56-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 375CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED IN PERSON. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21318118 ↗
• InjuryFeb 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 375CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED IN PERSON. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024, AND REPLACED WITH A SALINE BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18763703 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH 375CC MENTOR SILTEX ROUND SPECTRUM ON BOTH SIDES AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE. ON (B)(6) 2023, MENTOR BECAME AWARE THAT THE PATIENT ALSO EXPERIENCED BILATERAL IMPLANT SITE CALCIFICATION IN ADDITION TO RIGHT SIDE DEFLATION, AND REPLACEMENT DEVICES USED ON (B)(6) 2023 WERE CATALOG NUMBER 3503330; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE, AND CATALOG NUMBER 3503330; SERIAL NUMBER (B)(6) ON THE LEFT SIDE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 17647626 ↗
• InjuryJan 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 375CC 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), 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16134129 ↗
• InjuryJun 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH 375CC MENTOR SILTEX ROUND SPECTRUM AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Calcium Deposits/Calcification; Deformity/ Disfigurement

  MAUDE report 14829834 ↗
• InjuryMar 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE WHO UNDERWENT BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND SPECTRUM 375CC SALINE PROSTHESIS EXPERIENCED SPONTANEOUS LEFT SIDED DEFLATION POST PROCEDURE. THE DEVICE APPEARED COMPLETELY FLATTENED. THE DEFLATION WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13863287 ↗
• InjuryDec 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 375CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST IMPLANT AND EXPERIENCED A PAINFUL DEFLATION POSTOPERATIVELY. THE DEFLATION WAS SPONTANEOUS AND WAS CONFIRMED DURING AN IN-OFFICE VISIT. AS A RESULT, THE PATIENT HAD THE DEVICE EXPLANTED ON (B)(6) 2021.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 13065704 ↗
• InjuryMar 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT AN (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR SILTEX ROUND SPECTRUM 375CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER 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 WITH NO REPLACEMENT BREAST PROSTHESIS ON (B)(6) 2021. THE REPORTED IMPLANTATION DATE IS BEFORE THE MANUFACTURE DATE OF THE SUSPECT MEDICAL DEVICE. MENTOR WILL REPORT THE DATES AS RECEIVED. IF CLARIFICATION ON THE DATE IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11558662 ↗
• InjuryDec 1, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AGUMENTATION WITH 375CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST IMPLANTS AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION. THE DIAGNOSIS WAS CONFIRMED BY A PHYSICIAN UPON EXAMINATION. AS A RESULT, THE PATIENT'S IMPACTED DEVICE WILL BE EXPLANTED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9392849 ↗
• InjurySep 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND SPECTRUM 375CC SALINE PROSTHESIS EXPERIENCED SPONTANEOUS LEFT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS CONFIRMED BY A PHYSICIAN. 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 9120029 ↗
• InjurySep 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH SALINE MENTOR SILTEX ROUND SPECTRUM 375CC BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND BILATERAL DEFLATION. 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

  MAUDE report 8983088 ↗
• InjurySep 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH SALINE MENTOR SILTEX ROUND SPECTRUM 375CC BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND BILATERAL DEFLATION. 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

  MAUDE report 8983086 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A (LEFT) 250CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE AND A (RIGHT) 375CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESES, SUFFERED LEFT SIDE DEFLATION AND RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE III, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH THE FOLLOWING DEVICES ON (B)(6) 2019: (LEFT) 300CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE CATALOG: 3502300 LOT: 7328209 SN: (B)(4) AND (RIGHT) 475CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE CATALOG: 3502475 LOT: 7716786 SN: (B)(4). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8967779 ↗
• InjuryAug 6, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND SPECTRUM 375CC 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 8866547 ↗
• InjuryNov 23, 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 375 CC AND EXPERIENCED DEFLATION ON THE RIGHT BREAST IMPLANT. THE DEFLATION WAS CONFIRMED BY THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT HAD UNDERGONE EXPLANTATION ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8100024 ↗

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