MENTOR SILTEX Round Moderate Profile 3542625Recalls & reported problems
Mentor Texas L.P. · Saline Breast Implant with Diaphragm Valve, 200cc · Class 3 · Implant
All models of MENTOR SILTEX Round Moderate Profile (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Mentor Siltex Round Moderate Profile saline breast implant is used for breast augmentation. Most of the 57 reports describe the implant losing its saline and flattening after surgery, sometimes on both sides, along with breast pain and changes in breast shape; several patients had the implants removed or replaced. No deaths were reported, and all 57 reports involved injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 57
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00081317001744), received between May 11, 2018 and Dec 3, 2025 — classified as 57 injuries.
The most frequently reported specific device problem is “Material Rupture” (53 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.
Reports received per month
Most reported problems
Device problems
- Material Rupture53
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- No Code Available29
- Deformity/ Disfigurement19
- Capsular Contracture6
- Breast Discomfort/Pain5
- Pain3
- Breast Mass1
- Crushing Injury1
- Seroma1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 200CC 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 23708818 ↗InjuryJan 29, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 200CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025.
Patient problems: Capsular Contracture; Deformity/ Disfigurement
MAUDE report 21266068 ↗InjuryOct 14, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH TWO 200CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL DEFLATIONS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 20441140 ↗InjuryOct 14, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH TWO 200CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL DEFLATIONS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 20441134 ↗InjuryJul 3, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SILTEX ROUND MODERATE PROFILE, 200CC SALINE PROSTHESIS EXPERIENCED BILATERAL BREAST PAIN AND BILATERAL DEFLATION POSTOPERATIVE. THE ISSUE WAS DISCOVERED DURING IN OFFICE VISITATION. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REMOVAL ON JULY15, 2024. THIS REPORT RELATES TO THE RIGHT SIDE.
Patient problems: Breast Discomfort/Pain
MAUDE report 19668428 ↗InjuryJul 3, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SILTEX ROUND MODERATE PROFILE, 200CC SALINE PROSTHESIS EXPERIENCED BILATERAL BREAST PAIN AND BILATERAL DEFLATION POSTOPERATIVE. THE ISSUE WAS DISCOVERED DURING IN OFFICE VISITATION. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REMOVAL ON (B)(6) 2024. THIS REPORT RELATES TO THE LEFT SIDE.
Patient problems: Breast Discomfort/Pain
MAUDE report 19667855 ↗InjuryMay 7, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 200CC SALINE PROSTHESIS EXPERIENCED LEFT-SIDED IMPLANT DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT UNILATERAL REPLACEMENT WITH L)350-1625 SN 9719698-029 ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 19262320 ↗InjuryFeb 22, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SILTEX ROUND MODERATE PROFILE 200CC 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 ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18762070 ↗InjuryMar 28, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 74-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 200CC 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 REMOVAL AND REPLACEMENT WITH A RIGHT-SIDED 200CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 16631861 ↗InjuryFeb 13, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 74-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SILTEX ROUND MODERATE PROFILE 200CC 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 16364103 ↗InjuryFeb 13, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 74-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SILTEX ROUND MODERATE PROFILE 200CC 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 16364102 ↗InjuryJan 11, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH 200CC MENTOR SILTEX MODERATE PROFILE SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL DEFLATION, WHICH WAS CONFIRMED DURING VIA ULTRASONOGRAPHY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 250CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-00349 FOR THE CONTRALATERAL EVENT.
Patient problems: Deformity/ Disfigurement
MAUDE report 16137823 ↗InjuryJan 11, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH 200CC MENTOR SILTEX MODERATE PROFILE SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL DEFLATION, WHICH WAS CONFIRMED DURING VIA ULTRASONOGRAPHY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 250CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-00348 FOR THE CONTRALATERAL EVENT.
Patient problems: Deformity/ Disfigurement
MAUDE report 16137734 ↗InjuryNov 17, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 200CC 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 BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 275CC SALINE BREAST PROSTHESES ON (B)(6) 2022.
Patient problems: Capsular Contracture; Deformity/ Disfigurement
MAUDE report 15820534 ↗InjuryAug 31, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 200CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED THROUGH A PHYSICAL. AS A RESULT, AN EXPLANT IS PLANNED FOR (B)(6) 2022.
Patient problems: Deformity/ Disfigurement
MAUDE report 15331964 ↗InjuryJun 28, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 200CC SALINE BREAST IMPLANT, EXPERIENCED LEFT-SIDED SILENT DEFLATION POST PROCEDURE. THE ISSUE WAS DISCOVERED DURING OFFICE VISITATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH CAT#: SMPX-270 ON (B)(6) 2022.
Patient problems: Deformity/ Disfigurement
MAUDE report 14842883 ↗InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 57-YEAR-OLD FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX ROUND MODERATE PROFILE 200CC SALINE PROSTHESES EXPERIENCED LEFT SIDED DEFLATION ACCOMPANIED BY PAIN AND A RIGHT SIDED BREAST MASS POST PROCEDURE. THE DEFLATION WAS CONFIRMED THROUGH MAMMOGRAPHY. THERE IS A LUMP ON THE RIGHT SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2022-06133 FOR CONTRALATERAL PROSTHESIS REPORT.
Patient problems: Breast Mass
MAUDE report 14502899 ↗InjuryMay 25, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX ROUND MODERATE PROFILE 200CC SALINE PROSTHESES EXPERIENCED LEFT SIDED DEFLATION ACCOMPANIED BY PAIN AND A RIGHT SIDED BREAST MASS POST PROCEDURE. THE DEFLATION WAS CONFIRMED THROUGH MAMMOGRAPHY. THERE IS A LUMP ON THE RIGHT SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2022-06134 FOR CONTRALATERAL PROSTHESIS REPORT.
Patient problems: Breast Discomfort/Pain
MAUDE report 14502851 ↗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 RIGHT-SIDED DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 14274868 ↗InjuryMay 4, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION PROCEDURE WITH TWO 200CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST PAIN AND HAD A SUSPICION OF POSSIBLE BREAST IMPLANT LEAKAGE. AS A RESULT, THE PATIENT VISITED A GYNECOLOGIST AND ULTRASOUND CONFIRMED BILATERAL BREAST IMPLANT RUPTURES. SUBSEQUENTLY, THE PATIENT WAS SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2022. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Breast Discomfort/Pain
MAUDE report 14274203 ↗InjuryMay 4, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION PROCEDURE WITH TWO 200CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST PAIN AND HAD A SUSPICION OF POSSIBLE BREAST IMPLANT LEAKAGE. AS A RESULT, THE PATIENT VISITED A GYNECOLOGIST AND ULTRASOUND CONFIRMED BILATERAL BREAST IMPLANT RUPTURES. SUBSEQUENTLY, THE PATIENT WAS SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2022. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Breast Discomfort/Pain
MAUDE report 14274189 ↗InjuryFeb 17, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 200CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS PHYSICALLY DIAGNOSED WITH RIGHT BREAST IMPLANT DEFLATION. IT WAS INDICATED THAT THE DEFLATION WAS RIGHT AFTER A MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT IMPLANT REMOVAL ON (B)(6) 2022.
Patient problems: Crushing Injury
MAUDE report 13552307 ↗InjuryNov 16, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 200CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA ULTRASONOGRAPHY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 175CC SALINE BREAST PROSTHESIS ON (B)(6) 2021.
Patient problems: Deformity/ Disfigurement
MAUDE report 12824945 ↗InjuryMay 15, 2021Adverse 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 PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH TWO 200CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT EXPERIENCED LEFT SIDED DEFLATION AND RIGHT SIDED ANISOMASTIA POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH TWO 330CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST ON (B)(6) 2021. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 11829718 ↗InjuryJan 28, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 200CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 11248349 ↗
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, ClassifiedMENTOR 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 · TerminatedMentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Other Prosthesis, breast, inflatable, internal, saline devices
- MENTOR Smooth Round Moderate Profile 3501650Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline2,187 reports
- MENTOR Smooth Round Moderate Profile 3501660Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,972 reports
- MENTOR Smooth Round Moderate Profile 3501670Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,899 reports
- MENTOR Smooth Round Moderate Profile 3501645Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,655 reports
- MENTOR Smooth Round Moderate Profile 3501655Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,534 reports
- MENTOR Smooth Round Moderate Profile 3501640Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,294 reports
- MENTOR Smooth Round Moderate Profile 3501680Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,095 reports
- MENTOR Smooth Round Moderate Profile 3501635Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline864 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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