MENTOR SILTEX CONTOUR PROFILE Moderate 3542912Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00081317001867), received between Jan 25, 2018 and Feb 18, 2025 — classified as 43 injuries.

The most frequently reported specific device problem is “Material Rupture” (36 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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 275/300CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 275CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANTS ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21405292 ↗
• InjuryNov 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED THOUGH A PHYSICAL EXAMINATION. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20761179 ↗
• InjuryJan 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 275/300CC MENTOR SILTEX CONTOUR PROFILE MODERATE700CC AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3502325; SERIAL NUMBER:(B)(6) ON THE RIGHT SIDE, AND WITH CATALOG NUMBER 3502325; SERIAL NUMBER: (B)(6) ON THE LEFT SIDE ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18451452 ↗
• InjuryOct 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 275/300CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A DEFLATION OF HER RIGHT PROSTHESIS, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 275CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT ON (B)(6) 2023. THE LOT AND SERIAL NUMBERS WERE PROVIDED FOR BOTH IMPLANTED DEVICES, BUT THE CORRESPONDING SIDES WERE NOT DISCLOSED TO MENTOR. DEVICE A WAS IDENTIFIED AS SERIAL NUMBER (B)(6) AND DEVICE B WAS IDENTIFIED AS SERIAL NUMBER (B)(6). BOTH DEVICES HAVE THE SAME CATALOG NUMBER. AS SUCH, THE SERIAL NUMBER AND LOT NUMBERS FOR EACH DEVICE HAS BEEN POPULATED IN THE LOT AND SERIAL NUMBER FIELDS. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17876638 ↗
• InjuryOct 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 275/300CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED HER HEALTHCARE PROFESSIONAL REQUESTED A MAMMOGRAM TO BE PERFORMED DUE TO BILATERAL BREAST CYSTS. AFTER THE MAMMOGRAM WAS PERFORMED, HER BREASTS FELT DIFFERENT AND BECAME PAINFUL. ADDITIONALLY, SHE REPORTS BILATERALLY DEFLATED BREAST IMPLANTS. MAGNETIC RESONANCE IMAGING AND A CONSULTATION WITH A MEDICAL PROFESSIONAL HAVE BEEN CONDUCTED; HOWEVER, AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-11794 FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Discomfort/Pain; Cyst(s)

  MAUDE report 17873784 ↗
• InjuryOct 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 275/300CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED HER HEALTHCARE PROFESSIONAL REQUESTED A MAMMOGRAM TO BE PERFORMED DUE TO BILATERAL BREAST CYSTS. AFTER THE MAMMOGRAM WAS PERFORMED, HER BREASTS FELT DIFFERENT AND BECAME PAINFUL. ADDITIONALLY, SHE REPORTS BILATERALLY DEFLATED BREAST IMPLANTS. MAGNETIC RESONANCE IMAGING AND A CONSULTATION WITH A MEDICAL PROFESSIONAL HAVE BEEN CONDUCTED; HOWEVER, AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-11795 FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Discomfort/Pain; Cyst(s)

  MAUDE report 17873783 ↗
• InjurySep 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE, 275/300CC SALINE BREAST IMPLANT EXPERIENCED LEFT-SIDED DEFLATION POSTOPERATIVELY. THE ISSUE WAS DIAGNOSED THROUGH PATIENT SYMPTOMS, PALPITATION OF BREAST, VISUAL, AND FEEL. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENT WITH SN: (B)(6), SN:(B)(6) ON (B)(6), 2023. THE SITE OF REPLACEMENTS IS NOT SPECIFIED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17783091 ↗
• InjuryAug 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 67-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 275/300CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 250CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANTS ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17436178 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH 275/300CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-08136 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 17299593 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH 275/300CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL BAKER GRADE III CAPSULAR CONTRACTURE, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-08135 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 17299592 ↗
• InjuryJul 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 27-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESIS AND EXPERIENCED BREAST PAIN AND A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 17260631 ↗
• InjuryMar 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 72-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST RECONSTRUCTION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE PROSTHESIS 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: Deformity/ Disfigurement

  MAUDE report 16496654 ↗
• InjuryMay 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) ASIAN FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR SILTEX CONTOUR PROFILE MODERATE 275CC A SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14340995 ↗
• InjuryJul 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 300CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12137352 ↗
• InjuryApr 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION SURGERY WITH A 275/300CC MENTOR SILTEX CONTOUR PROFILE MODERATE BREAST IMPLANT EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11611742 ↗
• InjuryDec 5, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR SILTEX CONTOUR PROFILE MODERATE 275CC AND SUFFERED FROM A BILATERAL SALINE BREAST IMPLANT DEFLATION. THE LEFT BREAST IMPLANT WAS COMPLETELY DEFLATED. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 300CC ON (B)(6) 2020. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 10954105 ↗
• InjuryDec 5, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR SILTEX CONTOUR PROFILE MODERATE 275CC AND SUFFERED FROM A BILATERAL SALINE BREAST IMPLANT DEFLATION. THE LEFT BREAST IMPLANT WAS COMPLETELY DEFLATED. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 300CC ON (B)(6) 2020. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 10954043 ↗
• InjuryOct 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH 275CC SALINE MENTOR SILTEX CONTOUR PROFILE MODERATE BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POSTOPERATIVELY. THE DEFLATION WAS CONFIRMED WITH A PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE REMOVAL AND REPLACEMENT WITH 325CC MENTOR MEMORYGEL BREAST IMPLANTS, CATALOG NUMBER 3503254BC, SERIAL NUMBERS (B)(4) ON THE LEFT SIDE AND (B)(4) ON THE LEFT SIDE ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10686718 ↗
• InjurySep 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX CONTOUR PROFILE MODERATE 275CC AND EXPERIENCED A DEFLATION ON THE RIGHT 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 10532335 ↗
• InjuryFeb 3, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX CONTOUR PROFILE MODERATE, 275/300CC, SALINE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE HAS NOT BEEN CONFIRMED BY THE PHYSICIAN. AS A RESULT PATIENT HAD THE DEVICE REMOVED AND REPLACED WITH MENTOR SILICONE IMPLANT ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9659619 ↗
• InjuryNov 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A SALINE MENTOR SILTEX CONTOUR PROFILE MODERATE 275CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH CATALOG NUMBER 3502275, SERIAL NUMBER (B)(4) ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9305735 ↗
• InjuryOct 1, 2019Material Rupture; Material Rupture

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR ASR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH A 275/300CC MENTOR SILTEX CONTOUR PROFILE MODERATE AND WAS PRESENTED WITH RIGHT SIDE DEFLATION POSTOPERATIVELY. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2017. ON (B)(6) 2019, MENTOR BECAME AWARE THAT ASR SUBMISSION REFERENCE NUMBERS (B)(4) WERE DUPLICATED. ANY ADDITIONAL EVENT INFORMATION RECEIVED WILL BE REPORTED UNDER THIS MANUFACTURER'S REPORT NUMBER.

  Patient problems: No Code Available

  MAUDE report 9142344 ↗
• InjuryAug 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 275CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED CAPSULAR CONTRACTURE BAKER GRADE III AND RIGHT-SIDED DEFLATION. THE PATIENT STATED THAT HER GRANDDAUGHTER HIT HER RIGHT BREAST AND CAUSED THE DEFLATION. THE DIAGNOSIS WAS CONFIRMED BY PHYSICIAN UPON EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT A BILATERAL EXPLANTATION OF THEIR IMPACTED DEVICES ON (B)(6) 2019 AND DID NOT REPLACE WITH NEW DEVICES. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8933055 ↗
• InjuryJul 29, 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 UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A SALINE MENTOR SILTEX CONTOUR PROFILE MODERATE 275CC BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTION ON THE RIGHT SIDE POST-OPERATIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 8839632 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX CONTOUR PROFILE MODERATE 275/300CC SALINE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED AND THE RIGHT SIDE HAS ISSUE WITH CAPSULAR CONTRACTURE BAKER GRADE 2 1/2 AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. 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; No Code Available

  MAUDE report 8822267 ↗

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