MENTOR SILTEX Round Moderate Profile 3542620Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00081317001737), received between Jan 31, 2018 and Jun 11, 2025 — classified as 30 injuries.

The most frequently reported specific device problem is “Material Rupture” (26 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.

• InjuryJun 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH SALINE MENTOR SILTEX ROUND MODERATE PROFILE BREAST IMPLANTS AND EXPERIENCED BILATERAL DEFLATION 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. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22188472 ↗
• InjuryJun 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH SALINE MENTOR SILTEX ROUND MODERATE PROFILE BREAST IMPLANTS AND EXPERIENCED BILATERAL DEFLATION 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. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22188468 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 175CC SALINE BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 225CC GEL BREAST PROSTHESIS ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 21509599 ↗
• InjuryNov 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH MENTOR SILTEX ROUND MODERATE PROFILE, 175CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20716261 ↗
• InjuryJun 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 175CC MENTOR SILTEX ROUND MODERATE PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19529360 ↗
• InjuryJul 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED (VIA ANSM REPORT #R2309839) THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR SILTEX ROUND MODERATE PROFILE 175CC SALINE BREAST PROSTHESES WHEN THE LEFT BREAST PROSTHESIS DEFLATED POST IMPLANTATION. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT DEVELOPED BAKER GRADE I CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6)2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 17386262 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED (VIA ANSM REPORT #(B)(4)) THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR SILTEX ROUND MODERATE PROFILE 175CC SALINE BREAST PROSTHESES WHEN THE LEFT BREAST PROSTHESIS DEFLATED POST IMPLANTATION. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT DEVELOPED BAKER GRADE I CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 17386174 ↗
• InjuryAug 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 68-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH AN UNSPECIFIED MENTOR SALINE IMPLANT (LEFT) AND A 175CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS (RIGHT) AND EXPERIENCED BILATERAL DEFLATIONS CAPSULAR CONTRACTURE (BAKER GRADE 3/4) POST-OPERATIVELY, WHICH WAS CONFIRMED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 15193609 ↗
• InjuryMay 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 175CC MENTOR SILTEX ROUND MODERATE PROFILE ON THE LEFT SIDE, AND WITH 200CC MENTOR SILTEX ROUND MODERATE PROFILE ON THE RIGHT SIDE AND EXPERIENCED BILATERAL BREAST IMPLANT DEFLATION POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH CATALOG 3501620; SERIAL NUMBER (B)(4) ON THE LEFT SIDE, AND WITH CATALOG 3501625; SERIAL NUMBER (B)(4) ON THE RIGHT SIDE ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14274876 ↗
• InjuryJun 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH 175CC MENTOR SILTEX ROUND MODERATE PROFILE ON BOTH SIDES ON (B)(6) 1995, AND EXPERIENCED BILATERAL BREAST IMPLANT DEFLATION POSTOPERATIVELY. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11938831 ↗
• InjuryJun 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH 175CC MENTOR SILTEX ROUND MODERATE PROFILE ON BOTH SIDES ON (B)(6) 1995, AND EXPERIENCED BILATERAL BREAST IMPLANT DEFLATION POSTOPERATIVELY. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11938823 ↗
• InjuryMay 31, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 175CC TEXTURED MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT EXPERIENCED LEFT-SIDED IMPLANT DEFLATION POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH 175CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT, CATALOG # 3501620, ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11909745 ↗
• InjuryDec 8, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 175CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. THE PATIENT EXPERIENCED MAJOR ASYMMETRY ISSUE DUE TO THE LEFT DEFLATION. AS A RESULT, REPLACEMENT WITH CAT#: 3501645, SN#: (B)(4) WAS PERFORMED ON (B)(6) 2020.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 10971261 ↗
• InjuryOct 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 175CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED BY A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED BREAST PROSTHESES ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10681364 ↗
• InjuryFeb 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH MENTOR SILTEX ROUND MODERATE PROFILE 175CC AND EXPERIENCED A DEFLATION ON THE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9723116 ↗
• InjuryDec 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT OF UNKNOWN AGE AND RACE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 175CC MENTOR SILTEX ROUND MODERATE PROFILE AND WAS PRESENTED WITH RIGHT SIDE BREAST IMPLANT DEFLATION POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3501620; SERIAL NUMBER (B)(4) ON (B)(6) 2008.

  Patient problems: No Code Available

  MAUDE report 9414265 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT OF UNKNOWN AGE WHO UNDERWENT BREAST AUGMENTATION WITH A (LEFT) 175CC MENTOR SILTEX ROUND MODERATE PROFILE AND A (RIGHT) 175CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES, SUFFERED RIGHT BREAST IMPLANT DEFLATION WAS DIAGNOSED WITH MONOCLONAL GAMMAPATHY AND AN AUTOIMMUNE DISEASE, POST-OPERATIVELY. 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: Autoimmune Reaction

  MAUDE report 9413902 ↗
• InjuryOct 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 175CC MENTOR SILTEX ROUND MODERATE PROFILE BREAST IMPLANT EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH A 275CC MENTOR SMOOTH ROUND MODERATE PROFILE BREAST IMPLANT ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9204443 ↗
• InjuryAug 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT REVISION RECONSTRUCTION BREAST SURGERY WITH A 175 CC MENTOR SILTEX ROUND MODERATE PROFILE AND WAS PRESENTED WITH LEFT SIDE BREAST IMPLANT DEFLATION OBSERVED DURING A CONSULTATION WITH THE SURGEON ON (B)(6) 2019. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH ALLERGAN BRAND DEVICE LOT NUMBER 3192741, AND SERIAL NUMBER (B)(4) ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8925344 ↗
• InjuryMay 14, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 175CC MENTOR SILTEX ROUND MODERATE PROFILE, AND WAS PRESENTED WITH LEFT SIDE BREAST IMPLANT RUPTURE POSTOPERATIVELY. AS A RESULT, THE DEVICE WAS EXPLANTED, AND REPLACED WITH CATALOG#: 3501620 AND SERIAL # (B)(4) ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8608714 ↗
• InjuryMar 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SILTEX ROUND MODERATE PROFILE 175CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT, CATALOG NUMBER 3502501BC, LOT NUMBER 7540872 ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8429230 ↗
• InjuryDec 26, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A SALINE MENTOR SILTEX ROUND MODERATE PROFILE 175CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. THE DEFLATION WAS CONFIRMED VIA MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL OF THE IMPLANT ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8197311 ↗
• InjuryOct 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR SILTEX ROUND MODERATE PROFILE 175CC SALINE BREAST IMPLANTS WHICH THE RIGHT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE DIAGNOSED BY PALPATION. AS A RESULT, PATIENT HAD THE DEVICE REMOVED AND REPLACED WITH CATALOG NUMBER 3501620, LOT NUMBER 7469652 ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7953507 ↗
• InjuryAug 16, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 175 CC SALINE PROSTHESIS. DEFLATION ON THE LEFT BREAST PROSTHESIS AND CAPSULAR CONTRACTURE BAKER GRADE III WERE DIAGNOSED POST PROCEDURE VIA SELF-EXAMINATION AND THEN CONFIRMED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 150 CC GEL PROSTHESIS ON (B)(6) 2018; CATALOG # 3501501BC, S/NS (B)(4).

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 7790245 ↗
• InjuryJul 6, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 175CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 225CC GEL BREAST PROSTHESIS ON (B)(6) 2017.

  Patient problems: No Code Available

  MAUDE report 7666976 ↗

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