MENTOR SILTEX Round Moderate Profile 3542655Recalls & reported problems

Summary

The FDA's MAUDE database contains 201 adverse event reports that list this exact device (DI 00081317001805), received between Jan 24, 2018 and Apr 16, 2026 — classified as 201 injuries.

The most frequently reported specific device problem is “Material Rupture” (181 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 201 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 350CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT IMPLANT DURING AN IN-OFFICE VISIT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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 24899185 ↗
• InjuryMar 5, 2026Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SILTEX ROUND MODERATE PROFILE, 350CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24520137 ↗
• InjuryJan 28, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 350CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24202079 ↗
• InjuryDec 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST IMPLANT DEFLATIONS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23686869 ↗
• InjuryDec 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST IMPLANT DEFLATIONS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23686858 ↗
• InjuryOct 17, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SILTEX ROUND MODERATE PROFILE, 350CC SALINE PROSTHESIS EXPERIENCES RIGHT SIDED DEFLATION POST OPERATION. THE MAMMOGRAM EXAMINATION CONFIRMED THE ISSUE. AS A RESULT, THE PATIENT SCHEDULED FOR BILATERAL REPLACEMENTS WITH UNKNOWN MENTOR PROSTHESIS ON (B)(6) 2025.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 23325861 ↗
• InjuryMay 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 350CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21981900 ↗
• InjuryMar 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH SALINE MENTOR SILTEX ROUND MODERATE PROFILE 350CC BREAST IMPLANTS AND EXPERIENCED DEFLATION (SIDE UNKNOWN) POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2013.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21708369 ↗
• InjuryMar 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 350CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST IMPLANT DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION 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 21636988 ↗
• InjuryFeb 25, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH MENTOR SILTEX ROUND MODERATE PROFILE, 350CC SALINE PROSTHESIS EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVELY. THIS ISSUE WAS IDENTIFIED AND DIAGNOSED BY A HEALTHCARE PROFESSIONAL. CONSEQUENTLY, THE PATIENT HAS SCHEDULED A REMOVAL SURGERY FOR (B)(6) 2025, TO ADDRESS THE DEFLATION OF THE PROSTHESIS.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 21460980 ↗
• InjuryJan 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 350CC 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 21241826 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 350CC SALINE PROSTHESIS EXPERIENCED LEFT-SIDED DEFLATION AND BREAST PAIN POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. [SAFETY_NOTE] IMPACTED PRODUCT NUMBER: IP-01779567/PRODUCT NAME: SAL SILTEX RND DIAP PKG 350CC/NOTES: IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH MENTOR SAL SILTEX RND DIAP PKG 350CC GEL BREAST IMPLANTS WAS DIAGNOSED WITH BREAST CANCER. PER THE ADDITIONAL INFORMATION RECEIVED ON 03-JAN-2025, THE PATIENT REPORTED BEING DIAGNOSED WITH BREAST CANCER. THE RIGHT BREAST IMPLANT WAS REPLACED, BUT THE LEFT IMPLANT WAS NOT DUE TO ONGOING CANCER TREATMENT. THE RIGHT BREAST IMPLANT WAS REMOVED ON (B)(6)2024. THE NEW REPLACEMENT ON RIGHT IS CAT:3505375BC SN (B)(6), SHE WENT FROM SALINE TO GEL. THIS REPORT RELATES TO THE RIGHT SIDE. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THIS REVIEW. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS NOTE WILL BE UPDATED AND THE CASE WILL BE REASSESSED.

  Patient problems: Breast Cancer; Deformity/ Disfigurement

  MAUDE report 21114490 ↗
• InjuryDec 30, 2024Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE SALINE PROSTHESIS (350CC) REPORTED POSTOPERATIVE DEFLATION OF THE LEFT BREAST. THIS COMPLICATION WAS CONFIRMED THROUGH IMAGING STUDIES, SPECIFICALLY A CT OR MRI EXAMINATION. CONSEQUENTLY, THE PATIENT HAS BEEN SCHEDULED FOR EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21040527 ↗
• InjuryNov 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 350CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT USING MAMMOGRAM IMAGING. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20588489 ↗
• InjurySep 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 350CC SALINE PROSTHESIS EXPERIENCED LEFT-SIDED DEFLATION POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT UNDERWENT LEFT-SIDED REPLACEMENT WITH AN UNSPECIFIED MENTOR SALINE PROSTHESIS ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20141533 ↗
• InjuryJun 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 350CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 400CC SALINE BREAST PROSTHESES ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19442939 ↗
• InjuryFeb 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH AN UNKNOWN MENTOR SALINE TEXTURED PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED THROUGH MAMMOGRAPHY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18753620 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO UNSPECIFIED MENTOR SMOOTH SALINE BREAST PROSTHESES EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE LEFT SIDE AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 18438281 ↗
• InjuryJan 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO UNSPECIFIED MENTOR SMOOTH SALINE BREAST PROSTHESES EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 ON THE LEFT SIDE AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 18438279 ↗
• InjuryDec 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 350CC MENTOR SILTEX ROUND MODERATE PROFILE ON BOTH SIDES AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2023. ON NOVEMBER 16, 2023, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICES FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY THE IMPACTED LOT NUMBER, ON NOVEMBER 30, 2023, MENTOR RECEIVED CONFIRMATION THAT LEFT RUPTURED IMPLANT SERIAL NUMBER (B)(6). RIGHT WAS INTACT BUT ASPIRATED BY THE DOCTOR TO FIND OUT SIZE OF IMPLANT SERIAL NUMBER (B)(6). THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 18348422 ↗
• InjuryNov 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 350CC MENTOR SILTEX ROUND MODERATE PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18117319 ↗
• InjuryJul 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 350CC SALINE PROSTHESIS EXPERIENCED LEFT-SIDED DEFLATION AND BREAST PAIN POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. NOTE: THIS COMPLAIN IS PART OF A LEGACY COMPLAINT THAT WAS REPORTED INITIALLY UNDER MENTOR REFERENCE NUMBER: (B)(4). THIS PC IS REPOTTING THE NEW EVENT REPORTED ON (B)(6) 2023.

  Patient problems: Breast Cancer; Breast Discomfort/Pain

  MAUDE report 17350374 ↗
• InjuryJul 12, 2023Migration; Migration

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 350CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT AND RIGHT BREAST IMPLANT INFEROMEDIAL MALPOSITION WITH PSEUDOSYMMASTIA OF THE MEDIAL INFRAMAMMARY FOLD DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A LEFT-SIDED 300CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT AND A SURGICAL INTERVENTION OF THE RIGHT BREAST WITHOUT RIGHT-SIDED REMOVAL ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-07282 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17305310 ↗
• InjuryFeb 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 350CC SALINE BREAST IMPLANT EXPERIENCED RIGHT-SIDED DEFLATION POST PROCEDURE. THE MAMMOGRAM, AND MRI EXAMINATION CONFIRMED THE ISSUE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: CATALOG NUMBER 3507350BC, SERIAL NUMBER (B)(4), RIGHT CATALOG 3507350BC, SERIAL NUMBER (B)(4) ON (B)(6) 2009. FOR OTHER PATIENTS EVENT PLEASE SEE MANUFACTURER REPORT NUMBER: 1645337-2023-01641.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16439264 ↗
• InjuryNov 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SILTEX ROUND MODERATE PROFILE 350CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15817005 ↗

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