MENTOR SILTEX Round Moderate Profile 3542610Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00081317001713), received between May 1, 2018 and Dec 26, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Material Rupture” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 125CC MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025, FOR AN UNDISCLOSED REASON. HOWEVER, DURING THE SURGERY A DEFLATED LEFT IMPLANT WAS DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT HARMS/CONSEQUENCES DUE TO THE FINDINGS. THE DATE OF IMPLANTATION WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. 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 23900226 ↗
• InjuryJun 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH SALINE MENTOR SILTEX ROUND MODERATE PROFILE 125CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE LEFT SIDE 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. THE REPORTED IMPLANTATION DATE IS PRIOR TO THE DEVICE MANUFACTURE DATE. 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 19595156 ↗
• InjuryMay 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH A 125CC 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 UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THE REPLACEMENT DEVICE WAS A 125CC MENTOR SMOOTH ROUND MODERATE PROFILE (CATALOG: 3501610 LOT: 9778116 SN: (B)(6)).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16950693 ↗
• InjuryJun 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 125CC MENTOR SILTEX ROUND MODERATE PROFILE AND EXPERIENCED UNKNOWN SIDE BREAST IMPLANT DEFLATION POSTOPERATIVELY DIAGNOSED UPON PHYSICAL EXAM. AS A RESULT, THE DEVICE WILL BE EXPLANTED ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11966770 ↗
• InjuryFeb 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 125CC SALINE BREAST PROSTHESIS (RIGHT DEVICE) AND AN UNSPECIFIED MENTOR SALINE BREAST PROSTHESIS (LEFT DEVICE) WHEN THE RIGHT BREAST PROSTHESIS DEFLATED AFTER IMPLANTATION. THE PATIENT REPORTED THAT HER RIGHT BREAST HAS COLLAPSED, THE EDGES ARE FOLDING OVER, IT HURTS WHEN TOUCHED OR WHEN LYING ON IT OR WHEN NOT DOING ANYTHING. IN ADDITION, THE PATIENT REPORTED THAT THE IMPLANT STICKS UP AND IS HARD, INDICATIVE OF CAPSULAR CONTRACTURE. BAKER GRADE OF THE CAPSULAR CONTRACTURE IS CURRENTLY UNKNOWN. THE PATIENT ALSO REPORTED THAT SHE SUFFERED FROM SOME SYSTEMIC SYMPTOMS LIKE JOINT PAIN AND FATIGUE. THE ROOT CAUSE OF PATIENT¿S SYSTEMIC SYMPTOMS IS UNCLEAR. 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: Capsular Contracture; No Code Available

  MAUDE report 9707839 ↗
• InjuryAug 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR SILTEX ROUND MODERATE PROFILE 125CC SALINE BREAST IMPLANTS WHICH THE RIGHT SIDE DEFLATED AFTER IMPLANTATION. PATIENT STATED THAT SHE HADN'T HAVE A LOT OF PAIN WITH IT, HOWEVER, THE COLLAPSED IMPLANT DOES PROTRUDE AND IS UNCOMFORTABLE. 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 8883814 ↗
• InjuryDec 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 125CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION WAS ON THE PATIENT¿S RIGHT SIDE. IN ADDITION, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE I) IN HER RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 175CC GEL BREAST PROSTHESIS ON (B)(6) 2018.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8147747 ↗
• InjuryAug 1, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR SILTEX ROUND MODERATE PROFILE 125 CC BREAST PROSTHESES. BILATERAL DEFLATION WAS DIAGNOSED BY ULTRASONOGRAPHY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 150 CC GEL AND A MENTOR CPG 311 GEL BREAST PROSTHESES ON (B)(6) 2018. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 7739734 ↗
• InjuryMay 4, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR SILTEX ROUND MODERATE PROFILE 125CC BREAST PROSTHESES. DEFLATION ON THE RIGHT BREAST PROSTHESIS WAS DIAGNOSED BY ULTRASONOGRAPHY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 150CC GEL BREAST PROSTHESIS ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7489007 ↗
• InjuryMay 1, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 125CC SALINE PROSTHESIS. RUPTURE ON THE LEFT BREAST PROSTHESIS WAS DIAGNOSED INTRA-OPERATIVELY THROUGH A VISUAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A MEMORYSHAPE BREAST IMPLANT 225CC GEL PROSTHESIS ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7478477 ↗

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