MENTOR SILTEX CONTOUR PROFILE High 3542715Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00081317001942), received between Feb 13, 2018 and Oct 29, 2025 — classified as 30 injuries.

The most frequently reported specific device problem is “Material Rupture” (24 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR SILTEX CONTOUR PROFILE HIGH BREAST IMPLANTS EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23417042 ↗
• InjurySep 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 650CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20131626 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 44-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 650CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESIS AND EXPERIENCED BREAST PAIN ON THE LEFT SIDE POST-OPERATIVELY. THE PATIENT MENTIONED FEELING A SHARP SHOOTING PAIN. 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 18058671 ↗
• InjuryOct 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH UNSPECIFIED MENTOR SMOOTH SALINE BREAST PROSTHESES THAT BILATERALLY DEFLATED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED SMOOTH GEL BREAST PROSTHESES ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17917351 ↗
• InjuryOct 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH UNSPECIFIED MENTOR SMOOTH SALINE BREAST PROSTHESES THAT BILATERALLY DEFLATED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED SMOOTH GEL BREAST PROSTHESES ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17917349 ↗
• InjuryJul 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 69-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH, 650CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17405462 ↗
• InjuryMar 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 650CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED SPONTANEOUS RIGHT 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 13878508 ↗
• InjuryJan 5, 2022Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 650CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION AND DEVICE MIGRATION POST PROCEDURE. THE DEVICE WAS LOOKED DIFFERENT AND HAD BECOME SOFTER. THE DEVICE SLIDES TOWARDS THE ARMPIT AREA. FUTURE EXPLANT IS INDICATED, HOWEVER, AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13172000 ↗
• 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 RIGHT-SIDED DEVICE.

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

  MAUDE report 12438664 ↗
• InjuryMay 10, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 650CC AND SUFFERED FROM A 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: Deformity/ Disfigurement

  MAUDE report 11803119 ↗
• InjuryApr 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH 650CC TEXTURED MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST IMPLANT EXPERIENCED RIGHT-SIDED IMPLANT DEFLATION POSTOPERATIVELY. THE PATIENT REPORTED THAT THE IMPLANT IS OCCASIONALLY PALPABLE WITH THE VALVE STICKING OUT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH NON-MENTOR (ALLERGAN) BREAST IMPLANTS ON (B)(6) 2021. UPON EXPLANTATION, THE RIGHT BREAST IMPLANT WAS CONFIRMED TO BE DEFLATED, AND THE LEFT BREAST IMPLANT WAS INTACT. THE MENTOR FAILURE ANALYSIS LAB RECEIVED TWO DEVICES FOR EVALUATION, AND IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHICH DEVICE IS THE SUSPECT MEDICAL DEVICE FOR THE REPORTED ADVERSE EVENT. AS A RESULT, THE SECOND DEVICE RECEIVED WILL BE CONSERVATIVELY REPORTED TO FDA. THIS MEDWATCH REPORT IS FOR THE SECOND OF TWO IMPLANTS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2021-02073 FOR THE FIRST OF TWO IMPLANTS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11675812 ↗
• InjuryFeb 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH 650CC TEXTURED MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST IMPLANT EXPERIENCED RIGHT-SIDED IMPLANT DEFLATION POSTOPERATIVELY. THE PATIENT REPORTED THAT THE IMPLANT IS OCCASIONALLY PALPABLE WITH THE VALVE STICKING OUT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH UNKNOWN NON-MENTOR BREAST IMPLANTS ON (B)(6) 2021. THE PATIENT PROVIDED BOTH SERIAL NUMBERS (B)(4), BUT IT IS UNKNOWN WHICH SERIAL NUMBER BELONGS TO THE SUSPECT MEDICAL DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS APPLICABLE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11382885 ↗
• InjuryFeb 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX CONTOUR HIGH PROFILE 650CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11269704 ↗
• InjuryDec 29, 2020Material 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 HIGH 650CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11088945 ↗
• InjurySep 4, 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 CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH 650CC SALINE MENTOR SILTEX ONTOUR PROFILE HIGH BREAST IMPLANTS AND EXPERIENCED RUPTURE ON THE LEFT SIDE AND CAPSULAR CONTRACTURE ON THE RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE REMOVAL ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10497832 ↗
• InjurySep 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH 650CC SALINE MENTOR SILTEX ONTOUR PROFILE HIGH BREAST IMPLANTS AND EXPERIENCED RUPTURE ON THE LEFT SIDE AND CAPSULAR CONTRACTURE ON THE RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE REMOVAL ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT'S LEFT-SIDED DEVICE.

  Patient problems: No Code Available

  MAUDE report 10497825 ↗
• InjuryJan 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH 650CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST IMPLANT 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: No Code Available

  MAUDE report 9555641 ↗
• InjuryJun 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 650CC AND EXPERIENCED DEFLATION ON THE RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT WILL UNDERGO EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8732901 ↗
• InjuryJun 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH MENTOR SILTEX CONTOUR PROFILE HIGH 650CC SALINE BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE 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 8689533 ↗
• InjuryApr 9, 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 650CC SALINE BREAST IMPLANTS WHICH RIGHT SIDE DEFLATED AFTER IMPLANTATION. AS A RESULT PATIENT HAD THE DEVICE REMOVED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8496173 ↗
• InjuryFeb 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 650CC SALINE PROSTHESIS AND EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8367722 ↗
• InjuryOct 22, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH MENTOR SILTEX CONTOUR PROFILE HIGH 650CC SALINE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE DOCTOR DURING THE PHYSICAL EXAMINATION. AS A RESULT PATIENT HAD THE DEVICE REMOVED ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7992619 ↗
• InjuryOct 17, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A SALINE MENTOR SILTEX CONTOUR PROFILE HIGH 650CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE EXPLANTATION ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7975579 ↗
• InjuryOct 4, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX CONTOUR PROFILE HIGH 650CC SALINE BREAST PROSTHESES. DEFLATION OF THE RIGHT BREAST PROSTHESIS WAS DETERMINED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7936768 ↗
• InjuryAug 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH MENTOR SILTEX CONTOUR PROFILE HIGH 650CC SALINE BREAST PROSTHESIS. DEFLATION AND LOSS OF VOLUME ON THE RIGHT BREAST PROSTHESIS WAS IDENTIFIED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7798711 ↗

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