MENTOR SILTEX Round Moderate Profile 3542640Recalls & reported problems
Mentor Texas L.P. · Saline Breast Implant with Diaphragm Valve, 275cc · 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 breast implant is a saline-filled breast implant. Of its 278 reports, 275 are injury reports, most describing implants that deflated after surgery, often followed by removal or replacement surgery. There were no deaths, and 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
- 278
- Deaths reported
- 0
- Injuries reported
- 275
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 278 adverse event reports that list this exact device (DI 00081317001775), received between Jan 31, 2018 and Mar 31, 2026 — classified as 275 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (255 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 Rupture255
- Adverse Event Without Identified Device or Use Problem22
- Connection Problem2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Code Available152
- Deformity/ Disfigurement103
- Capsular Contracture29
- Pain7
- Local Reaction3
- Wrinkling3
- Autoimmune Reaction2
- Crushing Injury2
Recent adverse event reports
The 25 most recent of 278 reports, in the reporter's own words as published by the FDA.
InjuryMar 31, 2026Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 275CC 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) 2007.
Patient problems: Deformity/ Disfigurement
MAUDE report 24746359 ↗InjuryMar 13, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 275CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH NATRELLE (NON-MENTOR) IMPLANTS ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24590259 ↗MalfunctionDec 16, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 275CC 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 IS SCHEDULED FOR SURGERY ON (B)(6) 2025. ON (B)(6) 2025, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE TWO DEVICES WITH SAME LOT NUMBER ENGRAVED AND WERE BOTH FOUND DAMAGED UPON EVALUATION. HENCE, THIS REPORT DETAILS INVESTIGATION RESULTS FOR THE SECOND (RIGHT SIDE) AS MALFUNCTION SINCE NO ISSUE WAS REPORTED FOR THE RIGHT SIDE.
Patient problems: Insufficient Information
MAUDE report 23818886 ↗InjuryJun 9, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SILTEX ROUND MODERATE PROFILE BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 22166582 ↗InjuryMay 14, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 275 CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST IMPLANT DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF IMPLANTATION WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. 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 22022303 ↗InjuryMar 25, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 275CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21692338 ↗InjuryFeb 12, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH UNSPECIFIED MENTOR SALINE BREAST PROSTHESES THAT BOTH DEFLATED POST IMPLANTATION. ADDITIONALLY, BILATERAL MAMMARY PTOSIS WAS REPORTED. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 21368653 ↗InjuryFeb 12, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH UNSPECIFIED MENTOR SALINE BREAST PROSTHESES THAT BOTH DEFLATED POST IMPLANTATION. ADDITIONALLY, BILATERAL MAMMARY PTOSIS WAS REPORTED. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 21368652 ↗InjuryNov 20, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 55-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 275CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20741180 ↗InjuryNov 19, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SILTEX ROUND MODERATE PROFILE, 275CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20725255 ↗InjuryOct 28, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR SILTEX ROUND MODERATE PROFILE 275CC SALINE PROSTHESIS EXPERIENCED SPONTANEOUS BILATERAL 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 20550395 ↗InjuryOct 28, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR SILTEX ROUND MODERATE PROFILE 275CC SALINE PROSTHESIS EXPERIENCED SPONTANEOUS BILATERAL 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 20550219 ↗InjuryOct 11, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENATION SURGERY WITH IMPLANTATION OF A 275CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE II-III CAPSULAR CONTRACTURE OF THE BREASTS AND SUSPECTED IMPLANT DEFLATIONS, BILATERALLY, BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 375CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 20429045 ↗InjuryOct 11, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 275CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE II-III CAPSULAR CONTRACTURE OF THE BREASTS AND SUSPECTED IMPLANT DEFLATIONS, BILATERALLY, BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 375CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture; Deformity/ Disfigurement
MAUDE report 20429002 ↗InjurySep 16, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 275CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20230154 ↗InjuryAug 31, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 57-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 275CC 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 RIGHT SIDE REPLACEMENT SURGERY WITH CATALOG NUMBER 3502250; SERIAL NUMBER (B)(6) ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20114179 ↗InjuryAug 23, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO HAD A MENTOR SILTEX ROUND MODERATE PROFILE 275CC SALINE PROSTHESIS PLACED EXPERIENCED RIGHT 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 20045838 ↗InjuryAug 8, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 275CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS ON THE LEFT BREAST. 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 MEMORYGEL BREAST IMPLANT CATALOG: 3507300MC LOT: 9990031 SN: (B)(6) AND (RIGHT) 300CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3507300MC LOT: 9990031 SN: (B)(6).
Patient problems: Deformity/ Disfigurement
MAUDE report 19939779 ↗InjuryJul 10, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 275CC 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 19715689 ↗InjuryJun 20, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 275CC MENTOR SILTEX ROUND MODERATE PROFILE EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19576938 ↗InjuryMay 15, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 275CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024. ON APRIL 25, 2024 AN INITIAL ASSESSMENT OF THE RETURNED DEVICES REVEALED THE POTENTIAL FOR BILATERAL DEFLATION. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 19324327 ↗InjuryApr 23, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 54-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL DEFLATION POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH 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 SIDE DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 19169615 ↗InjuryApr 23, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 54-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL DEFLATION POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH 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 SIDE DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 19169614 ↗InjuryFeb 12, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 275CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 300CC GEL BREAST PROSTHESES ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18692521 ↗InjuryFeb 9, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX ROUND MODERATE PROFILE, 275CC SILICONE, BREAST IMPLANT EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH VISUAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 18676822 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page