MENTOR SILTEX CONTOUR PROFILE High 3542714Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00081317001935), received between Mar 20, 2018 and Jul 3, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Material Rupture” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 74-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 550CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. IT WAS REPORTED THAT THE PATIENT WAS IN A CAR ACCIDENT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19667580 ↗
• InjuryMay 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 550CC MENTOR SILTEX CONTOUR PROFILE HIGH 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 NATRELLE BREAST IMPLANT ON (B)(6) 2023. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19249060 ↗
• InjuryFeb 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 550CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A SUSPECTED DEFLATION OF HER RIGHT PROSTHESIS, WHICH WAS DIAGNOSED OVER THE PHONE BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18699109 ↗
• InjuryAug 1, 2022Material Discolored; Material Rupture; Material Discolored; Material Rupture

  IT WAS REPORTED (VIA FDA MEDWATCH 0700280000-2022-8014) THAT A 74-YEAR-OLD WHITE FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH A 550CC MENTOR SILTEX CONTOUR PROFILE HIGH AND EXPERIENCED LEFT SIDE BREAST IMPLANT DEFLATION. THE DEVICE WAS EXPALNTED ON (B)(6) 2022, AND WAS FOUND TO BE DEFLATED DURING BILATERAL IMPLANT EXCHANGE SURGERY. IT WAS REPORTED THAT DATE OF IMPLANT IS UNKNOWN AS IT WAS NOT DOCUMENTED. LEFT BREAST EXPLANTED DEVICE WAS SENT TO PATHOLOGY. THE REPORT CONFIRMED DEFLATION WITH A TAN, YELLOW TEXTURED WALL. THE WALL DISPLAYS A 1.1 CM SLIT LIKE DEFECT ON THE POSTERIOR SURFACE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15143224 ↗
• InjuryOct 6, 2021Adverse 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 WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR SILTEX CONTOUR PROFILE HIGH 550CC SALINE BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 12584104 ↗
• InjuryOct 6, 2021Adverse 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 WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR SILTEX CONTOUR PROFILE HIGH 550CC SALINE BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH OF HER BREASTS POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 12584101 ↗
• InjurySep 8, 2021Adverse 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 REVISION BREAST AUGMENTATION WITH A 550CC MENTOR SILTEX CONTOUR PROFILE HIGH ON THE LEFT SIDE, AND WITH A 650CC MENTOR SILTEX CONTOUR PROFILE HIGH ON THE RIGHT SIDE, AND EXPERIENCED RIGHT SIDE BREAST MASS, BILATERAL INFLAMMATION OF LYMPH NODES, AND GENERALIZED ILLNESS SYMPTOMS INCLUDING BOILS UNDER ARM, ABNORMAL SWEATING, WEIGHT GAIN, TIRED ALL THE TIME, WORSENING SYMPTOMS, FEELS TERRIBLE ALL THE TIME/. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Swollen Lymph Nodes/Glands

  MAUDE report 12438668 ↗
• InjurySep 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 550CC SALINE PROSTHESIS EXPERIENCED SPONTANEOUS RIGHT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED BY A PHYSICAL EXAMINATION. 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 10550403 ↗
• InjuryMar 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 550CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESIS ON THE RIGHT BREAST, SUFFERED DEFLATION, POST-OPERATIVELY. THE DEFLATION OCCURRED NINETEEN YEARS AGO, WITHIN ONE YEAR OF IMPLANTATION. 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 9829325 ↗
• InjuryAug 20, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 550CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE PROSTHESIS EXPERIENCED SPONTANEOUS LEFT SIDED DEFLATION POST PROCEDURE. THE PATIENT RECEIVED AN OFFICIAL MEDICAL DIAGNOSIS OF THE DEFLATION. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH MENTOR GEL ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8912931 ↗
• InjuryAug 19, 2019Migration; Migration

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH MENTOR SILTEX CONTOUR PROFILE HIGH 550CC SALINE BREAST PROSTHESES IS CONCERNED ABOUT THE SHAPE OF HER BREASTS. THE PATIENT REPORTED THAT IT FEELS LIKE SHE IS DEVELOPING MORE SCAR TISSUE, AND THE SHAPE AND LOOK OF HER BREASTS HAVE CHANGED, PARTICULARLY THE RIGHT BREAST. THE PATIENT REPORTED THAT BOTH IMPLANTS HAVE MOVED. THE RIGHT BREAST IS SHIFTING MORE TO THE RIGHT AND DESCENDS ONE INCH LOWER THAN THE LEFT BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 8908660 ↗
• InjuryAug 19, 2019Migration; Migration

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH MENTOR SILTEX CONTOUR PROFILE HIGH 550CC SALINE BREAST PROSTHESES IS CONCERNED ABOUT THE SHAPE OF HER BREASTS. THE PATIENT REPORTED THAT IT FEELS LIKE SHE IS DEVELOPING MORE SCAR TISSUE, AND THE SHAPE AND LOOK OF HER BREASTS HAVE CHANGED, PARTICULARLY THE RIGHT BREAST. THE PATIENT REPORTED THAT BOTH IMPLANTS HAVE MOVED. THE RIGHT BREAST IS SHIFTING MORE TO THE RIGHT AND DESCENDS ONE INCH LOWER THAN THE LEFT BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 8908659 ↗
• InjuryFeb 13, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH MENTOR SILTEX CONTOUR PROFILE HIGH 550CC SALINE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE DOCTOR UPON EXAMINATION. AS A RESULT PATIENT HAD THE DEVICE REMOVED AND REPLACED WITH CATALOG NUMBER 3542714, SERIAL NUMBER (B)(4) ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8336069 ↗
• InjuryMar 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 550CC SALINE PROSTHESIS. DEFLATION ON THE RIGHT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE VIA SELF-EXAMINATION. AS A RESULT THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 570CC GEL PROSTHESIS ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7355660 ↗

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