MENTOR SILTEX Round Moderate Profile 3542630Recalls & reported problems

Summary

The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 00081317001751), received between Jan 25, 2018 and Oct 22, 2025 — classified as 119 injuries.

The most frequently reported specific device problem is “Material Rupture” (103 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 119 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 225CC MENTOR SILTEX ROUND MODERATE PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23362341 ↗
• InjuryJan 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 65-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 225CC MENTOR SILTEX ROUND MODERATE PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21194383 ↗
• InjuryOct 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 225CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20559897 ↗
• InjuryAug 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX ROUND MODERATE PROFILE 225CC SALINE PROSTHESES EXPERIENCED BILATERAL DEFLATION WITH LEFT SIDED BREAST DISCOMFORT POST PROCEDURE. THE DEFLATIONS WERE DIAGNOSED THROUGH A CLINICAL EXAMINATION. 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 19892340 ↗
• InjuryAug 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX ROUND MODERATE PROFILE 225CC SALINE PROSTHESES EXPERIENCED BILATERAL DEFLATION WITH LEFT SIDED BREAST DISCOMFORT POST PROCEDURE. THE DEFLATIONS WERE DIAGNOSED THROUGH A CLINICAL 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 19892328 ↗
• InjuryMay 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR SILTEX ROUND MODERATE PROFILE 225CC SALINE BREAST PROSTHESES THAT BOTH DEFLATED POST IMPLANTATION. BILATERAL DEFLATION WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PROFILE 250CC SALINE BREAST PROSTHESES ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2024-05315 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19396708 ↗
• InjuryMay 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 225CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT 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 19250247 ↗
• InjuryFeb 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH UNSPECIFIED MENTOR SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL DEFLATION OF HER PROSTHESES, WHICH WAS CHARACTERIZED BY VOLUME LOSS ON BOTH SIDES AND DIAGNOSED BY A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF IMPLANTATION WAS PROVIDED AS AN ESTIMATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR IMPLANT B. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-01978 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18735642 ↗
• InjuryFeb 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH UNSPECIFIED MENTOR SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL DEFLATION OF HER PROSTHESES, WHICH WAS CHARACTERIZED BY VOLUME LOSS ON BOTH SIDES AND DIAGNOSED BY A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF IMPLANTATION WAS PROVIDED AS AN ESTIMATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR IMPLANT A. REFER TO MANUFACTURING REPORT NUMBER 1645337-2024-01979 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18735640 ↗
• InjuryDec 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH A 225CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED LEAKING ON AN UNDISCLOSED SIDE, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON AN UNDISCLOSED DATE. 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 18383500 ↗
• InjuryDec 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 225CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A 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: Deformity/ Disfigurement

  MAUDE report 18283613 ↗
• InjuryNov 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 225CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2023. THE PATIENT HAD PREVIOUS REPORTED UNDER 1645337-2023-13529 AND 1645337-2023-13461.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18163109 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 73-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH UNKNOWN SIZE UNKNOWN SALINE IMPLANTS SMOOTH ON BOTH SIDES AND EXPERIENCED LEFT SIDE DEFLATION, AND BILATERAL CAPSULAR CONTRACTURE; LEFT SIDE BAKER GRADE IV, AND RIGHT SIDE BAKER GRADE II POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3501640; SERIAL NUMBER (B)(6), ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3501640; SERIAL NUMBER (B)(6), ON THE RIGHT SIDE ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 17904401 ↗
• InjurySep 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SILTEX ROUND MODERATE PROFILE 225CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17725604 ↗
• InjuryApr 17, 2023Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 225CC MENTOR SILTEX ROUND MODERATE PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT LEFT SIDE EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3501630; SERIAL NUMBER (B)(4) ON (B)(6) 2023. MENTOR IS AWARE THAT EXPIRATION DATE OF LOT 211764 IS "(B)(6) 2004" IS BEFORE DATE OF IMPLANT ((B)(6) 2008) OF LOT 211764.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16753237 ↗
• InjuryDec 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 41-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 225CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND SUFFERED RIGHT BREAST IMPLANT DEFLATION, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT ON NOVEMBER 29, 2022. THE REPLACEMENT DEVICES WERE: (RIGHT) 450CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504501BC LOT: 9773698 SN: (B)(4) AND (LEFT) 450CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504501BC LOT: 9526987 SN: (B)(4).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16016460 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 63-YEAR-OLD ASIAN FEMALE PATIENT WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 225CC SALINE BREAST PROSTHESIS, EXPERIENCED LEFT-SIDED SILENT DEFLATION, AND RIGHT-SIDED CAPSULAR CONTRACTURE GRADE IV POSTOPERATIVELY. THE ISSUE WAS DIAGNOSED VIA OFFICE VISITATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH UNSPECIFIED MENTOR SALINE IMPLANTS ON (B)(6) 2022. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 15639180 ↗
• InjuryOct 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 63-YEAR-OLD ASIAN FEMALE PATIENT WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 225CC SALINE BREAST PROSTHESIS, EXPERIENCED LEFT-SIDED SILENT DEFLATION, AND RIGHT-SIDED CAPSULAR CONTRACTURE GRADE IV POSTOPERATIVELY. THE ISSUE WAS DIAGNOSED VIA OFFICE VISITATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH UNSPECIFIED MENTOR SALINE IMPLANTS ON (B)(6) 2022. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15639144 ↗
• InjuryOct 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 225CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT AND BILATERAL REPLACEMENT WITH UNSPECIFIED SALINE IMPLANTS WAS PERFORMED ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15601980 ↗
• InjuryAug 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD A MENTOR SILTEX ROUND MODERATE PROFILE 225CC SALINE PROSTHESIS PLACED EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15280330 ↗
• InjuryJun 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 425CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022. THE DEVICE MANUFACTURE DATE IS AFTER THE REPORTED DATE OF IMPLANTATION. FOLLOW UPS WERE PERFORMED BUT NO NEW INFORMATION HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE CORRECT DATE OF IMPLANTATION OR DEVICE LOT NUMBER, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14853880 ↗
• InjuryJun 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 57-YEAR-OLD FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR SILTEX ROUND MODERATE PROFILE 225CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH ALLERGAN BREAST PROSTHESES ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14848396 ↗
• InjuryJun 1, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 225CC SALINE BREAST IMPLANT EXPERIENCED BILATERAL 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. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14569701 ↗
• InjuryJun 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 225CC SALINE BREAST IMPLANT EXPERIENCED BILATERAL 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. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14569660 ↗
• InjuryMay 31, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 225CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A 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: Deformity/ Disfigurement

  MAUDE report 14550477 ↗

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