MENTOR SILTEX CONTOUR PROFILE SPECTRUM 3542513Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00081317002154), received between Aug 2, 2019 and Oct 7, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Material Rupture” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 450CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20391119 ↗
• InjuryApr 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM, 450CC SALINE PROSTHESIS EXPERIENCED LEFT-SIDED DEFLATION POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19091235 ↗
• InjuryFeb 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 450CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED STABBING PAINS IN HER BREASTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH ALLERGAN BREAST IMPLANTS ON (B)(6) 2022. DURING THE SURGERY, THE PATIENT WAS DISCOVERED TO HAVE BILATERALLY DEFLATED BREAST IMPLANTS. NO PROCEDURAL DELAYS OR PATIENT CONSEQUENCES WERE REPORTED DUE TO THE DISCOVERY. REFER TO MANUFACTURING REPORT NUMBER (B)(4) FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 16357359 ↗
• InjuryFeb 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 450CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED STABBING PAINS IN HER BREASTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH ALLERGAN BREAST IMPLANTS ON (B)(6) 2022. DURING THE SURGERY, THE PATIENT WAS DISCOVERED TO HAVE BILATERALLY DEFLATED BREAST IMPLANTS. NO PROCEDURAL DELAYS OR PATIENT CONSEQUENCES WERE REPORTED DUE TO THE DISCOVERY. REFER TO MANUFACTURING REPORT NUMBER (B)(4) FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 16357313 ↗
• InjuryJan 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH A 450CC MMENTOR SILTEX CONTOUR PROFILE SPECTRUM AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE DEVICE WILL BE EXPLANTED ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13137748 ↗
• InjuryAug 20, 2021Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM 450CC BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN 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 BREAST PROSTHESIS. THE REPORTED DATE OF IMPLANTATION IS AFTER THE DEVICE EXPIRATION DATE. THIS IS AN OFF LABEL USE OF THE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 12349025 ↗
• InjuryAug 20, 2021Off-Label Use; Material Rupture; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM 450CC BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN 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 BREAST PROSTHESIS. THE REPORTED DATE OF IMPLANTATION IS AFTER THE DEVICE EXPIRATION DATE. THIS IS AN OFF LABEL USE OF THE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 12348988 ↗
• InjuryNov 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A SALINE MENTOR SILTEX CONTOUR PROFILE SPECTRUM BREAST IMPLANT 450CC AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH NON-MENTOR IMPLANTS ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10861681 ↗
• InjuryDec 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A SALINE MENTOR SILTEX CONTOUR PROFILE SPECTRUM 450CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 440CC, CATALOG NUMBER 3341252, SERIAL NUMBER (B)(4) ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9521927 ↗
• InjuryNov 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH AN 450CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE BILATERAL DEFLATION. THE DIAGNOSIS WAS CONFIRMED BY A PHYSICIAN UPON EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2019 AND REPLACED WITH UNSPECIFIED BREAST IMPLANTS. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

  Patient problems: No Code Available

  MAUDE report 9377819 ↗
• InjuryAug 20, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 450CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST PROSTHESIS ON THE LEFT SIDE, SUFFERED A FLATTENING OF THE TOP OF THE IMPLANTS, POST-OPERATIVELY. 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 8913677 ↗
• InjuryAug 2, 2019Adverse 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 475CC (LEFT) AND MENTOR SILTEX CONTOUR PROFILE SPECTRUM 450CC (RIGHT) AND EXPERIENCED A BILATERAL CHEST INJURY, A DEFLATION AND DEVICE MIGRATION ON THE LEFT SIDE, AND CAPSULAR CONTRACTURE BAKER GRADE 4 ON THE RIGHT SIDE POST-OPERATIVELY. ALL WERE CONFIRMED BY A PHYSICIAN VIA 3D MAMMOGRAM AND AN ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 425CC, CATALOG # 3504254BC, SERIAL # (B)(4) (LEFT) AND (B)(4) (RIGHT) ON (B)(6) 2019. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture; Injury; No Code Available

  MAUDE report 8857734 ↗

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