MENTOR SILTEX Round Moderate Profile 3542635Recalls & reported problems

Summary

The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI 00081317001768), received between Feb 15, 2018 and Jul 17, 2025 — classified as 163 injuries.

The most frequently reported specific device problem is “Material Rupture” (141 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 163 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 250CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. THE PATIENT FELT A COOLNESS SENSATION IN HER RIGHT BREAST AND DAYS LATER NOTICED A CHANGE IN THE BREAST SIZE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 225CC SALINE BREAST PROSTHESIS AND A MENTOR SMOOTH ROUND MODERATE PROFILE 200CC SALINE BREAST PROSTHESIS ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement; Paresthesia

  MAUDE report 22538751 ↗
• InjuryMar 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 250CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED THROUGH A PHYSICAL 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 21654715 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 250CC MENTOR SILTEX ROUND MODERATE PROFILE ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST PAIN. 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: Breast Discomfort/Pain

  MAUDE report 21627895 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 250CC MENTOR SILTEX ROUND MODERATE PROFILE ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST PAIN. 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: Breast Discomfort/Pain

  MAUDE report 21627894 ↗
• InjuryFeb 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SILTEX ROUND MODERATE PROFILE 250CC 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 MENTOR GEL BREAST IMPLANTS ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21469689 ↗
• InjuryNov 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 250CC MENTOR SILTEX ROUND MODERATE PROFILE AND EXPERIENCED UNKNOWN SIDE BREAST IMPLANT DEFLATION. THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3502751BC; SERIAL NUMBER (B)(6) ON ONE SIDE AND WITH CATALOG NUMBER 3502751BC; SERIAL NUMBER (B)(6) ON THE OTHER SIDE ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20695254 ↗
• InjurySep 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 250CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST IMPLANT DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL RIGHT-SIDED REMOVAL AND REPLACEMENT WITH AN UNDISCLOSED BREAST IMPLANT ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20203729 ↗
• InjurySep 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 250CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2016 AND REPLACED WITH A 250CC MENTOR SILTEX ROUND MODERATE PROFILE (CATALOG NUMBER 3542635) WITH SERIAL NUMBER (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20182812 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SILTEX ROUND MODERATE PROFILE 250CC SALINE BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING SKIN RASH, DISCOLORATION, ITCHINESS, SCALY APPEARANCE ON BREASTS, STINGING AND TIGHTNESS ON CHEST, ONE NIPPLE APPEARS GRAY AND THE OTHER NIPPLES APPEARS BROWN AND PURPLE, FATIGUE, AND CHRONIC INFLAMMATION. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. THE PATIENT REPORTED THAT SHE HAS BREAST IMPLANT ILLNESS. ADDITIONALLY, IT WAS REPORTED HER LEFT BREAST IS BIGGER THAN HER RIGHT. 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 BREAST PROSTHESIS.

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

  MAUDE report 20044872 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SILTEX ROUND MODERATE PROFILE 250CC SALINE BREAST PROSTHESES AND SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING SKIN RASH, DISCOLORATION, ITCHINESS, SCALY APPEARANCE ON BREASTS, STINGING AND TIGHTNESS ON CHEST, ONE NIPPLE APPEARS GRAY AND THE OTHER NIPPLES APPEARS BROWN AND PURPLE, FATIGUE, AND CHRONIC INFLAMMATION. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. THE PATIENT REPORTED THAT SHE HAS BREAST IMPLANT ILLNESS. ADDITIONALLY, IT WAS REPORTED HER LEFT BREAST IS BIGGER THAN HER RIGHT. 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 BREAST PROSTHESIS.

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

  MAUDE report 20043678 ↗
• InjuryJun 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 250CC 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. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19443209 ↗
• InjuryMar 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 250CC SILICONE, BREAST IMPLANT EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVE. THE DEFLATION WAS DIAGNOSED DURING THE OFFICE VISITATION. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18838714 ↗
• InjuryJan 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 250CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18515122 ↗
• InjuryDec 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 250CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT LEAKING AND RIGHT BREAST IMPLANT COLLAPSE. 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 18312952 ↗
• InjuryDec 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 250CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT LEAKING AND RIGHT BREAST IMPLANT COLLAPSE. 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 18312890 ↗
• InjuryDec 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 250CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH 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 18276474 ↗
• InjuryOct 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 250CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED DURING AN OFFICE VISIT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. TWO LOT NUMBERS WERE REPORTED: LOT #79581 AND LOT #79195. IT WAS NOT SPECIFIED WHICH OF THESE TWO LOT NUMBERS BELONGS TO THE PATIENT¿S RIGHT BREAST PROSTHESIS. IF CLARIFICATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17907246 ↗
• InjuryOct 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 300CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE LEFT 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 17900179 ↗
• InjuryAug 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 55-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 250CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. IT WAS INDICATED THE PATIENT NOTICED THE DEFLATION FOLLOWING A MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17436746 ↗
• InjuryJul 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 32-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 250CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17409810 ↗
• InjuryJun 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 250CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17163457 ↗
• InjuryMay 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 250CC 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 16987994 ↗
• InjuryApr 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 250CC MENTOR SILTEX ROUND MODERATE PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16769390 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO DEVICES (A MENTOR SILTEX ROUND MODERATE PROFILE 250CC SALINE BREAST PROSTHESIS AND A MENTOR SILTEX ROUND MODERATE PROFILE 300CC SALINE BREAST PROSTHESIS) WERE RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB WITH NO ACCOMPANYING INFORMATION. THE DEVICES COULD NOT BE ASSOCIATED WITH AN EXISTING COMPLAINT. IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHY THIS DEVICE WAS RETURNED TO MENTOR. HOWEVER, THE RETURN OF TWO SALINE BREAST PROSTHESES IS CHARACTERISTIC OF BILATERAL REMOVAL AND REPLACEMENT. AS A RESULT, THIS WILL BE CONSERVATIVELY REPORTED TO FDA. THIS MEDWATCH REPORT IS FOR THE MENTOR SILTEX ROUND MODERATE PROFILE 250CC SALINE BREAST PROSTHESIS.

  Patient problems: Insufficient Information

  MAUDE report 16629961 ↗
• InjuryMar 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 250CC SALINE BREAST IMPLANT EXPERIENCED LEFT-SIDED DEFLATION POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16482167 ↗

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