MENTOR SILTEX CONTOUR PROFILE Moderate 3542913Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00081317001874), received between Jan 31, 2018 and Jan 29, 2025 — classified as 34 injuries.

The most frequently reported specific device problem is “Material Rupture” (28 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 34 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21266483 ↗
• InjuryOct 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SILTEX CONTOUR PROFILE MODERATE, 400CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENT WITH UNSPECIFIED MENTOR SILICONE PROSTHESIS ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20424575 ↗
• InjuryMay 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH 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 19312343 ↗
• InjuryJan 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH 350/400CC 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) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18574088 ↗
• InjuryMay 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) WHITE FEMALE PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 350CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESIS ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED BREAST ASYMMETRY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY IN (B)(6) 2022. UPON REMOVAL, IT WAS DISCOVERED THAT THE LEFT IMPLANT HAD A SLIT-LIKE DEFECT ON ITS WALL.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14466621 ↗
• InjuryJan 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 350CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESES AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING BAD RASHES, ANXIETY, DEPRESSION, BRAIN FOG, FEELING TIRED ALL THE TIME, AND FEELING AS IF SHE IS DYING FROM THE INSIDE OUT POST-OPERATIVELY. THE PATIENT ALSO REPORTED BILATERAL RUPTURE. 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 DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13296396 ↗
• InjuryJan 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 350CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESES AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING BAD RASHES, ANXIETY, DEPRESSION, BRAIN FOG, FEELING TIRED ALL THE TIME, AND FEELING AS IF SHE IS DYING FROM THE INSIDE OUT POST-OPERATIVELY. THE PATIENT ALSO REPORTED BILATERAL RUPTURE. 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 DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13296365 ↗
• InjuryAug 20, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD AFRICAN AMERICAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH A 400CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST IMPLANT EXPERIENCED LEFT SIDED DEVICE EXTRUSION AND DEFLATION POST PROCEDURE. PATIENT STATED THAT THE VALVE STEM FROM THE IMPLANT IS STICKING THROUGH HER SKIN FROM WHERE THE ORIGINAL INCISION WAS MADE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON AN UNSPECIFIED DATE.

  Patient problems: Pocket Erosion

  MAUDE report 12349979 ↗
• InjuryJun 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE, 350/400CC, SALINE PROSTHESIS EXPERIENCED UNKNOWN-SIDED DEFLATION POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 11962255 ↗
• InjuryMar 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE 350CC AND SUFFERED FROM A DEFLATION ON THE LEFT SIDE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11583307 ↗
• InjuryDec 27, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION SURGERY WITH A 350/400CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2020.

  Patient problems: Capsular Contracture

  MAUDE report 11074110 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE 350CC AND SUFFERED FROM BILATERAL CAPSULAR CONTRACTURE, PAIN, HARDENING OF BREAST AND OTHER COMPLICATIONS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 10962034 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE 350CC AND SUFFERED FROM BILATERAL CAPSULAR CONTRACTURE, PAIN, HARDENING OF BREAST AND OTHER COMPLICATIONS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 10962026 ↗
• InjuryOct 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 350/400CC MENTOR SILTEX CONTOUR PROFILE MODERATE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE DEVICE WILL BE EXPLANTED ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10680902 ↗
• InjuryAug 17, 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 350CC 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 10417153 ↗
• InjuryJul 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESES, SUFFERED SPONTANEOUS LEFT BREAST IMPLANT DEFLATION, POST-PROCEDURE. THE PATIENT SELF-DIAGNOSED THE DEFLATION ON (B)(6) 2020 AND WENT TO THE DOCTOR'S OFFICE ON (B)(6) 2020 FOR MEDICAL DIAGNOSIS. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION AND REPLACEMENT WITH A NON-MENTOR IMPLANT ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10305882 ↗
• InjuryJul 1, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH 350CC SALINE MENTOR SILTEX CONTOUR PROFILE MODERATE BREAST IMPLANTS AND EXPERIENCED BILATERAL DEFLATION POSTOPERATIVELY. THE PATIENT ALSO EXPERIENCED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING BLURRED VISION, NO SLEEP, LEG PAIN, HUGE RASH ALL OVER CHEST, BREAST PAIN, HORRIBLE SMELL WHEN SHE SWEATS, DOES NOT FEEL LIKE HERSELF, BRAIN FOG, MIGRAINES, NECK ISSUES, ALWAYS TIRED, TAKES EFFORT TO GET OUT OF BED AND METAL TASTE IN MOUTH. THE PATIENT REPORTED SHE EXPERIENCED STAGE 4 MELANOMA IN 2010. THE PATIENT UNDERWENT SURGERY IN FEBRUARY 2010 TO REMOVE ALL CANVER. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT'S LEFT-SIDED DEVICE.

  Patient problems: Cancer; Impaired Healing; No Code Available; Pain

  MAUDE report 10222293 ↗
• InjuryJul 1, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH 350CC SALINE MENTOR SILTEX CONTOUR PROFILE MODERATE BREAST IMPLANTS AND EXPERIENCED BILATERAL DEFLATION POSTOPERATIVELY. THE PATIENT ALSO EXPERIENCED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING BLURRED VISION, NO SLEEP, LEG PAIN, HUGE RASH ALL OVER CHEST, BREAST PAIN, HORRIBLE SMELL WHEN SHE SWEATS, DOES NOT FEEL LIKE HERSELF, BRAIN FOG, MIGRAINES, NECK ISSUES, ALWAYS TIRED, TAKES EFFORT TO GET OUT OF BED AND METAL TASTE IN MOUTH. THE PATIENT REPORTED SHE EXPERIENCED STAGE 4 MELANOMA IN 2010. THE PATIENT UNDERWENT SURGERY IN FEBRUARY 2010 TO REMOVE ALL CANVER. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

  Patient problems: Cancer; Impaired Healing; No Code Available; Pain

  MAUDE report 10222290 ↗
• InjuryJan 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 350CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESES, SUFFERED LEFT BREAST DEFLATION, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9640144 ↗
• InjurySep 24, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 350CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESIS ON HER LEFT SIDE, SUFFERED DEFLATION AND BREAST CANCER POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION ON (B)(6) 2018.

  Patient problems: Cancer; No Code Available

  MAUDE report 9110107 ↗
• InjuryAug 27, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH MENTOR SILTEX CONTOUR PROFILE MODERATE 350CC SALINE BREAST PROSTHESES WHEN THE RIGHT BREAST PROSTHESES DEFLATED AFTER IMPLANTATION. IN ADDITION, THE PATIENT DEVELOPED RIPPLING IN BOTH BREASTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2018. THIS MEDWATCH REPORT IS FOR THE RIGHT BREAST PROSTHESIS. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR ASR REFERENCE NUMBER 1-Z286RB.

  Patient problems: No Code Available; Wrinkling

  MAUDE report 8936001 ↗
• InjuryMar 26, 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 FEMALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH MENTOR SILTEX CONTOUR PROFILE MODERATE 350CC SALINE BREAST PROSTHESES WHEN THE RIGHT BREAST PROSTHESES DEFLATED AFTER IMPLANTATION. IN ADDITION, THE PATIENT DEVELOPED RIPPLING IN BOTH BREASTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2018. THIS MEDWATCH REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: No Code Available; Wrinkling

  MAUDE report 8454564 ↗
• InjuryFeb 21, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A SALINE MENTOR SILTEX CONTOUR PROFILE MODERATE 350CC AND EXPERIENCED DEFLATION ON THE RIGHT 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 8358061 ↗
• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST AUGMENTATION WITH MENTOR SILTEX CONTOUR MODERATE PROFILE 350/400CC SALINE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED, AND THE RIGHT SIDE HAS ISSUE WITH CAPSULAR CONTRACTURE BAKER GRADE IV AFTER IMPLANTATION.. 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 8351062 ↗
• InjuryFeb 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST AUGMENTATION WITH MENTOR SILTEX CONTOUR MODERATE PROFILE 350/400CC SALINE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED, AND THE RIGHT SIDE HAS ISSUE WITH CAPSULAR CONTRACTURE BAKER GRADE IV AFTER IMPLANTATION. 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: No Code Available

  MAUDE report 8350996 ↗

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