MENTOR SILTEX Round Moderate Profile 3542615Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00081317001720), received between Jul 25, 2018 and Mar 6, 2025 — classified as 25 injuries.

The most frequently reported specific device problem is “Material Rupture” (22 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2025Adverse 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 150CC SALINE BREAST PROSTHESES WHEN THE LEFT BREAST PROSTHESIS DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PROFILE 150CC SALINE BREAST PROSTHESES ON (B)(6) 2024. IT WAS REPORTED THAT DURING EXPLANT SURGERY, BOTH OF THE PATIENT¿S BREAST IMPLANT CAPSULES WERE TIGHT. THE LEFT BREAST CAPSULE WAS NOTED TO BE TIGHTER THAN THE RIGHT. IT WAS LATER REPORTED THAT THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III-IV CAPSULAR CONTRACTURE IN THE RIGHT BREAST PRIOR TO EXPLANT SURGERY. A BAKER GRADE WAS NOT REPORTED FOR THE PATIENT¿S LEFT BREAST. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2024-15014 FOR THE REPORT FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21542886 ↗
• InjuryDec 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 150CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PROFILE 150CC SALINE BREAST PROSTHESES ON (B)(6) 2024.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 21020811 ↗
• InjuryAug 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 150CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19994563 ↗
• InjuryAug 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 150CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6), 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19945690 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH 150CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A DEFLATION OF HER RIGHT BREAST PROSTHESIS AS WELL AS PTOSIS OF THE LEFT BREAST, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. THE PATIENT ALSO REPORTED EXPERIENCING FLU AND DEHYDRATION FOLLOWING THE DEFLATION OF HER IMPLANT. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNSPECIFIED 150CC MENTOR SALINE BREAST IMPLANTS ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-15514 FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 16364798 ↗
• InjuryDec 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH A 150CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A DEFLATION OF THE RIGHT BREAST PROSTHESIS, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2023.

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

  MAUDE report 16056930 ↗
• InjuryAug 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 150CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON AN UNKNOWN DATE POST PROCEDURE. NO ADDITIONAL EVENT DETAILS ARE AVAILABLE AT THIS TIME. IF ADDITIONAL EVENT DETAILS BECOME AVAILABLE IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15238076 ↗
• InjuryMay 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 150CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14435486 ↗
• InjuryMay 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 150CC SALINE BREAST IMPLANT, EXPERIENCED RIGHT-SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAD THE DEVICE REMOVED ON AN UNSPECIFIED DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14306650 ↗
• InjuryMay 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 150CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA A VIRTUAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14287774 ↗
• InjuryAug 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR OLD CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH A 150CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS ON THE LEFT BREAST, SUFFERED SPONTANEOUS LEFT BREAST IMPLANT DEFLATION, OCCASIONAL DISCOMFORT, AND CHANGE IN SHAPE, POST-PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND BILATERAL REPLACEMENT ON (B)(6) 2021. THE REPLACEMENT DEVICES WERE: (LEFT) 275CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE CATALOG: 3502275 LOT: 9576452 SN: (B)(4) AND (RIGHT) C275CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE CATALOG: 3502275 LOT: 9576452 SN: (B)(4).

  Patient problems: Pain

  MAUDE report 12332388 ↗
• InjuryJul 20, 2021Material 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 150CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED DURING A PHYSICAL CONSULTATION. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12199813 ↗
• InjuryAug 13, 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 BREAST AUGMENTATION REVISION WITH 150CC SALINE MENTOR SILTEX ROUND MODERATE PROFILE BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE AND BILATERAL BREAST ASSYMENTRY POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE REMOVAL AND REPLACEMENT WITH 175CC MENTOR MEMORYGEL BREAST IMPLANTS, CATALOG NUMBER 3501751BC, SERIAL NUMBERS (B)(4) ON THE RIGHT SIDE AND (B)(4) ON THE LEFT SIDE ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT'S LEFT-SIDED DEVICE.

  Patient problems: No Code Available

  MAUDE report 10404050 ↗
• InjuryMay 29, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE UNDERWENT BREAST AUGMENTATION REVISION WITH A 150CC SALINE MENTOR SILTEX ROUND MODERATE PROFILE BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POSTOPERATIVELY. 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 10103715 ↗
• InjuryMay 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH 150CC TEXTURED MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT HAS EXPERIENCED POSTOPERATIVE LEFT-SIDED IMPLANT DEFLATION, CONFIRMED BY A PHYSICIAN. 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 10065687 ↗
• InjuryMar 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 150CC SALINE MENTOR SILTEX ROUND MODERATE PROFILE BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED SALINE MENTOR BREAST IMPLANT ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9789047 ↗
• InjurySep 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) OLD FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 150CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES, SUFFERED BILATERAL DEFLATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2019. UPON REMOVAL OF BOTH BREAST IMPLANTS, IT WAS NOTED THAT THE LEFT SIDE IMPLANT WAS YELLOW. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 9013572 ↗
• InjurySep 12, 2019Material Discolored; Material Rupture; Material Discolored; Material Rupture

  IT WAS REPORTED THAT A (B)(4) FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 150CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES, SUFFERED BILATERAL DEFLATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2019. UPON REMOVAL OF BOTH BREAST IMPLANTS, IT WAS NOTED THAT THE LEFT SIDE IMPLANT WAS YELLOW. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 9013555 ↗
• InjuryAug 29, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT A REVISION BREAST AUGMENTATION WITH A 150CC MENTOR SILTEX ROUND MODERATE PROFILE (RIGHT) AND A 250CC MENTOR SILTEX ROUND MODERATE PROFILE (LEFT) FOR POLAND SYNDROME EXPERIENCED POSTOPERATIVE BILATERAL DEFLATION. IT WAS DIAGNOSED BY A PHYSICIAN. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2019. THIS REPORT IS FOR THE RIGHT PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 8946805 ↗
• InjuryAug 6, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX ROUND MODERATE PROFILE 150CC SALINE BREAST IMPLANTS WHICH THE RIGHT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. AS A RESULT PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENTS WITH MENTOR GEL DEVICE ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8864375 ↗
• InjuryApr 8, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX ROUND MODERATE PROFILE 150CC SALINE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. AS A RESULT PATIENT HAD THE DEVICE REMOVED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8492410 ↗
• InjuryFeb 27, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT OF UNKNOWN AGE UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A SALINE MENTOR SILTEX ROUND MODERATE PROFILE 150CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT WILL UNDERGO REMOVAL OF THE IMPLANTS ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8375563 ↗
• InjuryOct 31, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 150CC SALINE BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR SILTEX ROUND MODERATE PROFILE 375CC SALINE BREAST PROSTHESIS (RIGHT DEVICE) WHEN THE LEFT BREAST PROSTHESIS DEFLATED AFTER IMPLANTATION. THE PATIENT WOKE UP AND NOTICED THAT THE LEFT SIDE HAD DEFLATED. DEFLATION WAS CONFIRMED BY A VISUAL EXAMINATION. IN ADDITION, THE PATIENT REPORTED FEELING PAIN IN HER LEFT SIDE AND CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER RIGHT BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Pain

  MAUDE report 8026929 ↗
• InjuryOct 5, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A SALINE MENTOR SILTEX ROUND MODERATE PROFILE 150CC AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. DEFLATION WAS CONFIRMED BY PHYSICIAN. 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 7940155 ↗
• InjuryJul 25, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR OLD FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH MENTOR SILTEX ROUND MODERATE PROFILE 150CC SALINE BREAST PROSTHESIS. DEFLATION OF THE LEFT BREAST PROSTHESIS WAS IDENTIFIED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7720805 ↗

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