MENTOR SILTEX Round Moderate Profile 3542670Recalls & reported problems
Mentor Texas L.P. · Saline Breast Implant with Diaphragm Valve, 425cc · 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 saline breast implant has 207 adverse event reports: no deaths and 207 injuries. Most reports describe the implant rupturing or deflating after surgery, often noticed as one breast going flat. Some also mention capsular contracture and breast deformity. 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
- 207
- Deaths reported
- 0
- Injuries reported
- 207
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 207 adverse event reports that list this exact device (DI 00081317001829), received between Jan 31, 2018 and Jun 12, 2026 — classified as 207 injuries.
The most frequently reported specific device problem is “Material Rupture” (190 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 Rupture190
- Adverse Event Without Identified Device or Use Problem20
- Migration2
- Defective Device1
- Deflation Problem1
- Off-Label Use1
Patient problems
- No Code Available119
- Deformity/ Disfigurement74
- Capsular Contracture21
- Pain11
- Cyst(s)2
- Insufficient Information2
- Swollen Lymph Nodes/Glands2
- Emotional Changes1
Recent adverse event reports
The 25 most recent of 207 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 40-YEAR OLD AFRICAN AMERICAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX ROUND MODERATE PROFILE 425CC SALINE BREAST PROSTHESIS. THE PATIENT FELT THE LEFT BREAST WAS GOING FLAT AND THAT THERE WAS POSSIBLE DEFLATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement; Emotional Changes; Pain
MAUDE report 25487921 ↗InjuryFeb 5, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 425CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT 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 24274388 ↗InjuryAug 28, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 425CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT INDICATED THEY NOTICED THE DEFLATION FOLLOWING A MAMMOGRAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 22916277 ↗InjuryFeb 20, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 425CC 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 IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21428883 ↗InjuryJan 3, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION WITH SALINE MENTOR SILTEX ROUND MODERATE PROFILE BREAST IMPLANTS AND EXPERIENCED BILATERAL DEFLATION POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 21070163 ↗InjuryOct 15, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 425CC MENTOR SILTEX ROUND MODERATE PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20450916 ↗InjuryAug 12, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH AN UNKNOWN MENTOR SILTEX ROUND MODERATE PROFILE, 425CC SALINE PROSTHESIS EXPERIENCED UNKNOWN SIDED IMPLANT DEFLATION POSTOPERATIVE. VISUAL INSPECTION CONFIRMED THE RUPTURE AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2015.
Patient problems: Deformity/ Disfigurement
MAUDE report 19960979 ↗InjuryJul 10, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 425CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. 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 19716311 ↗InjuryMay 3, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SILTEX ROUND MODERATE PROFILE 425CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE RIGHT 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.
Patient problems: Deformity/ Disfigurement
MAUDE report 19241970 ↗InjuryApr 5, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR SILTEX ROUND MODERATE PROFILE 425CC SALINE BREAST PROSTHESIS BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. THE PATIENT NOTICED THAT HER LEFT BREAST LOOKED ¿OFF¿ AND ¿VERY SQUISHY¿. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 19051802 ↗InjuryMar 20, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 425CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 18943687 ↗InjuryMar 19, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 425CC SALINE BREAST IMPLANT EXPERIENCED LEFT-SIDED DEFLATION POSTOPERATIVE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 18933875 ↗InjuryMar 14, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 54-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 425CC MENTOR SILTEX ROUND MODERATE PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18905471 ↗InjuryFeb 12, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 62-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 425CC MENTOR SILTEX ROUND MODERATE PROFILE AND EXPERIENCED LEFT SIDE BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY WITH CATALOG NUMBER 3501650; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3501650; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18684714 ↗InjuryJan 2, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 425CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18431464 ↗InjuryDec 18, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH A 425CC MENTOR SILTEX ROUND MODERATE PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY. THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH MENTOR SALINE DEVICES ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 18352502 ↗InjuryOct 23, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 425CC, SALINE BREAST IMPLANT EXPERIENCED BILATERAL DEFLATION POSTOPERATIVELY. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATIONS. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH CAT: 3501650 ON (B)(6) 2023. THIS REPORT RELATES TO THE LEFT SIDE. NOTE: MENTOR RECEIVED TWO DEFLATED DEVICES, THEREFORE BOTH IMPLANTS ARE REPORTED.
Patient problems: Deformity/ Disfigurement
MAUDE report 17986241 ↗InjurySep 26, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH A 425CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A DEFLATION OF HER LEFT PROSTHESIS, WHICH WAS CONFIRMED BY 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 17818756 ↗InjurySep 21, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 425CC, SALINE BREAST IMPLANT EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVELY. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATIONS. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REPLACEMENTS WITH CAT: 3501650 ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 17795307 ↗InjuryAug 2, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 425CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 17444559 ↗InjuryJul 28, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 33-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 425CC SALINE BREAST IMPLANT EXPERIENCED LEFT-SIDED CAPSULAR CONTRACTURE GRADE IV, AND RIGHT-SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH NON-MENTOR PROSTHESIS ON (B)(6) 2023. THIS REPORT RELATES TO THE RIGHT SIDE
Patient problems: Deformity/ Disfigurement
MAUDE report 17417159 ↗InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 33-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 425CC SALINE BREAST IMPLANT EXPERIENCED LEFT-SIDED CAPSULAR CONTRACTURE GRADE IV, AND RIGHT-SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH NON-MENTOR PROSTHESIS ON (B)(6) 2023. THIS REPORT RELATES TO THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 17416977 ↗InjuryMay 23, 2023Migration; Migration
IT WAS REPORTED THAT A 34-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SILTEX ROUND MODERATE PROFILE 425CC SALINE BREAST PROSTHESES WHEN THE LEFT BREAST PROSTHESIS DEFLATED POST IMPLANTATION. DEFLATION OF THE LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA MAMMOGRAM/ULTRASOUND. IMAGING ALSO INDICATED THAT THE PATIENT DEVELOPED CYSTS IN HER RIGHT BREAST. ADDITIONALLY, THE PATIENT DEVELOPED BILATERAL LATERAL IMPLANT MALPOSITION POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 425CC GEL BREAST PROSTHESES ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2019-10555 FOR THE REPORT FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Cyst(s); Deformity/ Disfigurement
MAUDE report 16987400 ↗InjuryMay 19, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 59-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 425CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 16964314 ↗InjuryMay 16, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR SILTEX ROUND MODERATE PROFILE 425CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2009.
Patient problems: Deformity/ Disfigurement
MAUDE report 16943417 ↗
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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