MENTOR SILTEX CONTOUR PROFILE Moderate 3542911Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00081317001850), received between Apr 30, 2018 and Jul 15, 2025 — classified as 24 injuries.

The most frequently reported specific device problem is “Material Rupture” (18 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22509888 ↗
• InjuryJan 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO UNSPECIFIED MENTOR SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT DEFLATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18427401 ↗
• InjuryAug 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 225CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THE REPLACEMENT DEVICES WERE: (LEFT) 275CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE CATALOG: 3542912 LOT: 6636664 SN: (B)(6) AND (RIGHT) 275CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE CATALOG: 3542912 LOT: 6636664 SN: (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17447163 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A CON PRO 225/250CC AND EXPERIENCED BREAST PAIN ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 16861490 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 225CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESES AND EXPERIENCED DISSATISFACTION WITH PROCEDURE OUTCOME ON BOTH SIDES POST-OPERATIVELY. THE PATIENT FELT THAT HER BREASTS WERE TOO LARGE AND WOULD LIKE SMALLER IMPLANTS. AS A RESULT, THE PATIENT IS TO UNDERGO EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16030817 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 225CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESES AND EXPERIENCED DISSATISFACTION WITH PROCEDURE OUTCOME ON BOTH SIDES POST-OPERATIVELY. THE PATIENT FELT THAT HER BREASTS WERE TOO LARGE AND WOULD LIKE SMALLER IMPLANTS. AS A RESULT, THE PATIENT IS TO UNDERGO EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16030813 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 65-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE, 225/250CC SALINE BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE UNKNOWN AND LEFT-SIDED DEFLATION POSTOPERATIVELY. THE ISSUE WAS DIAGNOSED THROUGH PATIENT SYMPTOMS. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: L/ SN#:(B)(4), CAT#: SMPB290, R/ SN#: (B)(4) CAT#: SMPB290 PLUS BILATERAL CAPSULOTOMIES ON (B)(6) 2022. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15551804 ↗
• InjuryOct 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 65-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE, 225/250CC SALINE BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE UNKNOWN AND LEFT-SIDED DEFLATION POSTOPERATIVELY. THE ISSUE WAS DIAGNOSED THROUGH PATIENT SYMPTOMS. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: L/ SN#: (B)(4), CAT#: SMPB290, R/ SN#: (B)(4) CAT#: SMPB290 PLUS BILATERAL CAPSULOTOMIES ON (B)(6) 2022. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture; Fluid Discharge

  MAUDE report 15551743 ↗
• InjuryDec 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE 225CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12910724 ↗
• InjuryDec 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A 225/250CC MENTOR SILTEX CONTOUR PROFILE MODERATE, SALINE BREAST IMPLANT EXPERIENCED LEFT-SIDED SPONTANEOUS DEFLATION POST PROCEDURE. THE WAS DIAGNOSED THROUGH VISUAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12909201 ↗
• InjuryJun 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 225/250CC MENTOR SILTEX CONTOUR PROFILE MODERATE PROSTHESIS AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH TWO 250CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES (CATALOG #: 3502501BC, LEFT SERIAL #: (B)(4), RIGHT SERIAL #: (B)(4)) ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12005871 ↗
• InjuryApr 22, 2021Migration; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE 225CC AND SUFFERED FROM A CUTANEOUS CONTOUR DEFORMITY ON THE RIGHT SIDE. THE PATIENT EXPERIENCED A CONCERN FOR POSITION AND WIDTH OF IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR SMOOTH ROUND HIGH PROFILE 210CC ON (B)(6) 2021.

  Patient problems: Wrinkling

  MAUDE report 11709111 ↗
• InjurySep 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 250CC MENTOR SILTEX CONTOUR PROFILE MODERATE PROSTHESIS AND EXPERIENCED POSTOPERATIVE DEFLATION (SIDE UNKNOWN). A HEALTHCARE PROFESSIONAL STATES THAT THE PATIENT IS POSSIBLY EXPERIENCING UNILATERAL DEFLATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 10555438 ↗
• InjuryAug 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATIONS SURGERY WITH A 225CC MENTOR SILTEX CONTOUR PROFILE MODERATE BREAST IMPLANT EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10440376 ↗
• InjuryMar 3, 2020Migration; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 225CC TEXTURED MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST IMPLANT HAS EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION OF IMPLANT AND LEFT-SIDED MISSHAPEN BREAST. THE PATIENT¿S RIGHT BREAST HAS BECOME SMALLER. HER LEFT BREAST HAS FULLNESS IN THE MEDIAL UPPER POLE, AND FLATTENING IN THE LOWER LATERAL POLE, AND THE PATIENT REPORTED SHE CAN FEEL THE EDGE OF THE LEFT IMPLANT; HEALTHCARE PROFESSIONAL STATED THAT THIS IS CONSISTENT WITH THIS CONTOUR IMPLANT ROTATING TO WHAT APPEARS TO BE UPSIDE DOWN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH 325CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANTS, CATALOG # 3502325, LEFT SERIAL # (B)(4) AND RIGHT SERIAL # (B)(4) ON (B)(6) 2020. UPON EXPLANTATION, THE RIGHT IMPLANT WAS CONFIRMED TO BE DEFLATED AND HAD ROTATED SIDEWAYS, AND THE LEFT IMPLANT WAS CONFIRMED TO BE ROTATED. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: No Code Available

  MAUDE report 9781499 ↗
• InjuryFeb 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE 225CC AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9721724 ↗
• InjuryJan 29, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A 225CC TEXTURED MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST IMPLANT HAS EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION, CONFIRMED BY A PHYSICIAN. HCP REPORTED THAT THE RIGHT SIDE HAS BECOME SMALLER. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9645211 ↗
• InjuryDec 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE 225CC AND EXPERIENCED LEFT IMPLANT DEFLATION. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH SALINE MENTOR BREAST IMPLANT OF UNKNOWN TYPE ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9401416 ↗
• InjuryMay 30, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH MENTOR SILTEX CONTOUR PROFILE MODERATE 225/250CC SALINE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. AS A RESULT PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT LEFT WITH CATALOG NUMBER 3341107, SERIAL NUMBER (B)(4), AND RIGHT REPLACED WITH ON CATALOG NUMBER 3341107, SERIAL NUMBER (B)(4) ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8654926 ↗
• InjuryMay 29, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SILTEX CONTOUR PROFILE MODERATE 225CC BREAST IMPLANTS AND EXPERIENCED BILATERAL DEFLATION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019. THIS REPORT IS FOR THE RIGHT SIDE.

  Patient problems: No Code Available

  MAUDE report 8652318 ↗
• InjuryMay 29, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SILTEX CONTOUR PROFILE MODERATE 225CC BREAST IMPLANTS AND EXPERIENCED BILATERAL DEFLATION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019. THIS REPORT IS FOR THE LEFT SIDE.

  Patient problems: No Code Available

  MAUDE report 8652316 ↗
• InjuryMay 2, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A SALINE MENTOR SILTEX CONTOUR PROFILE MODERATE 225CC AND EXPERIENCED DEFLATION ON THE RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8575356 ↗
• InjuryNov 15, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX CONTOUR PROFILE MODERATE 225/250CC SALINE BREAST IMPLANTS WHICH THE RIGHT SIDE DEFLATED AFTER IMPLANTATION. PATIENT WOKE UP AND VISIBLY OBSERVED THE RIGHT BREAST DEFLATED. AS A RESULT, PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8075043 ↗
• InjuryApr 30, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE 225/250CC SALINE PROSTHESIS. DEFLATION ON THE LEFT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE VIA SELF-EXAMINATION, THEN CONFIRMED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT IS SCHEDULED FOR BREAST PROSTHESIS EXPLANT ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7474763 ↗

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