MENTOR SILTEX Round Moderate Profile 3542645Recalls & reported problems

Summary

The FDA's MAUDE database contains 293 adverse event reports that list this exact device (DI 00081317001782), received between Feb 13, 2018 and Jul 10, 2025 — classified as 293 injuries.

The most frequently reported specific device problem is “Material Rupture” (270 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 293 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 300CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22471572 ↗
• InjuryFeb 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 300 CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A CHEST X-RAY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21335324 ↗
• InjuryJan 9, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH AN UNKNOWN MENTOR SALINE PROSTHESIS EXPERIENCED LEFT-SIDED DEFLATION AND PTOSIS POSTOPERATIVE, WHICH WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT OF THESE COMPLICATIONS, THE PATIENT UNDERWENT BILATERAL CAPSULOTOMY, LEFT-SIDED MASTOPEXY, AND BILATERAL PROSTHESIS REPLACEMENTS ON (B)(6) 2024. THE LEFT IMPLANT WAS IDENTIFIED AS (B)(6) WITH SERIAL NUMBER (B)(6), AND THE RIGHT IMPLANT WAS IDENTIFIED AS (B)(6) WITH SERIAL NUMBER (B)(6).

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 21114674 ↗
• InjuryDec 31, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 81-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 300CC MENTOR SILTEX ROUND MODERATE PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL RIGHT SIDE REPLACEMENT SURGERY WITH CATALOG NUMBER SMPX370; SERIAL NUMBER (B)(6) ON (B)(6) 2024. DEFLATION WAS CONFIRMED UPON EXPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21047901 ↗
• 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 300CC 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 AND REPLACEMENT WITH AN UNSPECIFIED MENTOR SALINE BREAST PROSTHESIS ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21021047 ↗
• InjuryDec 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 300CC 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) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20893908 ↗
• InjuryDec 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SILTEX ROUND MODERATE PROFILE 300CC BREAST IMPLANTS AND EXPERIENCED BILATERAL DEFLATION POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2024. THIS REPORT IS FOR THE FIRST OF TWO DEVICES. 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 20865413 ↗
• InjuryDec 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SILTEX ROUND MODERATE PROFILE 300CC BREAST IMPLANTS AND EXPERIENCED BILATERAL DEFLATION POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2024. THIS REPORT IS FOR THE SECOND OF TWO DEVICES. 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 20865129 ↗
• InjuryNov 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 300CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY DEFLATED BREAST IMPLANTS 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 20707862 ↗
• InjuryNov 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 300CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY DEFLATED BREAST IMPLANTS 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 20707391 ↗
• InjuryNov 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 69-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 300CC MENTOR SILTEX ROUND MODERATE PROFILE ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III, AND RIGHT-SIDE BREAST IMPLANT DEFLATION POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 20643804 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 69-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 300CC MENTOR SILTEX ROUND MODERATE PROFILE ON BOTH SIDES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III, AND RIGHT-SIDE BREAST IMPLANT DEFLATION POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 20642688 ↗
• InjurySep 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 300CC SALINE PROSTHESIS EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: LEFT CATALOG NUMBER 3542645, LOT NUMBER 189868, RIGHT CATALOG NUMBER 3542645, SERIAL NUMBER (B)(6) ON (B)(6) 2004. THIS EVENT IS PREVIOUS EVENT TO THIS PC: MANUFACTURER REPORT NUMBER 1645337-2024-10350.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20286296 ↗
• InjurySep 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 300CC 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) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20191294 ↗
• InjurySep 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 300CC SALINE PROSTHESIS EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH PATIENTS¿ PHYSICAL EXAMINATIONS. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REPLACEMENTS WITH UNKNOWN PROSTHESIS ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20152803 ↗
• InjuryAug 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 300CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT 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 20080484 ↗
• InjuryJun 27, 2024Adverse 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 PRIMARY WITH A MENTOR SILTEX ROUND MODERATE PROFILE 300CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION AND BILATERAL PTOSIS POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH IN PERSON EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL INVERTED T MASTOPEXY, AND BILATERAL REPLACEMENTS AS FOLLOW: LEFT CATALOG NUMBER 3501645, SERIAL NUMBER (B)(6), RIGHT, CATALOG NUMBER 3501645, SERIAL NUMBER (B)(6) ON (B)(6) 2024. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19625489 ↗
• InjuryJun 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX ROUND MODERATE PROFILE 300CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION AND BILATERAL PTOSIS POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH IN PERSON EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL INVERTED T MASTOPEXY, AND BILATERAL REPLACEMENTS AS FOLLOW: LEFT CATALOG NUMBER 3501645, SERIAL NUMBER (B)(6) RIGHT, CATALOG NUMBER 3501645, SERIAL NUMBER (B)(6) ON JUNE 6, 2024. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19625401 ↗
• InjuryJun 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 300CC SALINE BREAST PROSTHESIS THAT POSSIBLY DEFLATED POST IMPLANTATION. IT WAS REPORTED THAT THE LEFT BREAST PROSTHESIS HAS A LEAK OR IS SHIFTING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE REPORTED IMPLANTATION DATE IS BEFORE THE MANUFACTURE DATE OF THE SUSPECT MEDICAL DEVICE. MENTOR WILL REPORT THE IMPLANTATION DATE AS RECEIVED. IF CLARIFICATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19472276 ↗
• InjuryMay 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 300CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (LEFT) 300CC MENTOR SMOOTH ROUND MODERATE PROFILE CATALOG: 3501645 LOT: 9981859 SN: (B)(6) AND (RIGHT) 300CC MENTOR SMOOTH ROUND MODERATE PROFILE CATALOG: 3501645 LOT: 9981859 SN: (B)(6) .

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 19262754 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 300CC SALINE BREAST IMPLANT EXPERIENCED LEFT-SIDED DEFLATION, BILATERAL CAPSULAR CONTRACTURE UNKNOWN GRADE, AND RIGHT IMPLANT INFERIOR MALPOSITION, AND NIPPLE SENSATION CHANGE POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH UNKNOWN MENTOR SILICONE IMPLANTS, BILATERAL CAPSULOTOMIES, AND INFERIOR CAPSULORRHAPHY ON (B)(6) 2024. THIS REPORT RELATES TO THE RIGHT IMPLANT.

  Patient problems: Capsular Contracture; Nipple Sensation Changes

  MAUDE report 19071085 ↗
• InjuryApr 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 300CC SALINE PROSTHESIS EXPERIENCED SPONTANEOUS LEFT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED AT THE PHYSICIAN¿S OFFICE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024. ON (B)(6) 2024 MENTOR RECEIVED TWO DAMAGED DEVICES THAT COULD NOT BE IDENTIFIED DEFINITIVELY AS THE COMPLAINT DEVICE. THE CONTRALATERAL DEVICE WAS REPORTED UNDER 1645337-2022-08740.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19042375 ↗
• InjuryMar 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 300CC SALINE BREAST IMPLANT EXPERIENCED LEFT-SIDED DEFLATION POSTOPERATIVE. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REPLACEMENTS WITH UNSPECIFIED MENTOR SILICONE PROSTHESIS ON (B)(6), 2024.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 18822538 ↗
• InjuryFeb 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 300CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18717974 ↗
• InjuryJan 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH 300CC SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS IN A CAR ACCIDENT AND EXPERIENCED BILATERAL DEFLATION OF HER PROSTHESES, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2019-25067 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18480429 ↗

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