MENTOR SILTEX CONTOUR PROFILE SPECTRUMRecalls & reported problems across all models
Mentor Texas L.P. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 81
- Deaths reported
- 0
- Injuries reported
- 81
- Recalls
- 0
We found 5 models of MENTOR SILTEX CONTOUR PROFILE SPECTRUM by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 81 adverse event reports in the FDA's MAUDE database, received between Mar 22, 2018 and May 14, 2026 — classified as 81 injuries.
The most frequently reported specific device problem is “Material Rupture” (64 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MENTOR SILTEX CONTOUR PROFILE SPECTRUM problems
Device problems
- Material Rupture64
- Adverse Event Without Identified Device or Use Problem19
- Deflation Problem2
- Off-Label Use2
- Use of Device Problem1
Patient problems
- No Code Available40
- Deformity/ Disfigurement21
- Capsular Contracture10
- Pain10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Autoimmune Reaction2
- Breast Discomfort/Pain2
- Breast Mass2
MENTOR SILTEX CONTOUR PROFILE SPECTRUM models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR SILTEX CONTOUR PROFILE SPECTRUM 3542515Prosthesis, breast, inflatable, internal, saline23 reports
- MENTOR SILTEX CONTOUR PROFILE SPECTRUM 3542512Prosthesis, breast, inflatable, internal, saline20 reports
- MENTOR SILTEX CONTOUR PROFILE SPECTRUM 3542511Prosthesis, breast, inflatable, internal, saline15 reports
- MENTOR SILTEX CONTOUR PROFILE SPECTRUM 3542513Prosthesis, breast, inflatable, internal, saline12 reports
- MENTOR SILTEX CONTOUR PROFILE SPECTRUM 3542514Prosthesis, breast, inflatable, internal, saline11 reports
Recent MENTOR SILTEX CONTOUR PROFILE SPECTRUM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 14, 2026Material Rupture
IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 650CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) AND DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026, AND REPLACED WITH A 550CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 25167455 ↗InjuryDec 12, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF AN UNDISCLOSED MENTOR TEXTURED SALINE IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. A DEFLATED RIGHT IMPLANT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Deformity/ Disfigurement
MAUDE report 23791397 ↗InjurySep 11, 2025Material 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 WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND SKIN REACTION 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.
Patient problems: Capsular Contracture; Local Reaction
MAUDE report 23031194 ↗InjuryOct 7, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 450CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20391119 ↗InjuryApr 11, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM, 450CC SALINE PROSTHESIS EXPERIENCED LEFT-SIDED DEFLATION POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19091235 ↗InjuryOct 17, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH UNSPECIFIED MENTOR SALINE 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) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 17950913 ↗InjuryOct 13, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. A DISCREPANCY WAS OBSERVED WHEN THE INFORMATION REPORTED INCLUDED A DATE OF IMPLANTATION THAT OCCURRED PRIOR TO THE MANUFACTURING DATE OF THE BREAST IMPLANT. AS THIS IS NOT POSSIBLE, MENTOR ASSOCIATES WILL REACH OUT FOR FURTHER INFORMATION. IF NEW INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT.
Patient problems: Deformity/ Disfigurement
MAUDE report 17932671 ↗InjuryOct 6, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 24-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 350CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM 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 UNDERWENT EXPLANTATION ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 17887368 ↗InjurySep 18, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT DEFLATION. THE BREAST LOOKED DIFFERENT. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 17762788 ↗InjurySep 1, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 75-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 350CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. IT WAS REPORTED THAT THERE IS LESS FLUID IN THE LEFT BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 17674610 ↗InjuryApr 14, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 350CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT DEFLATION. 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 LEFT-SIDED DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 16744714 ↗InjuryApr 14, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 350CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT DEFLATION. 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-SIDED DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 16744522 ↗InjuryApr 10, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 41-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 650CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM 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 THE RIGHT BREAST WAS SMALLER. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 800CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 16708854 ↗InjuryFeb 10, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 450CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED STABBING PAINS IN HER BREASTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH ALLERGAN BREAST IMPLANTS ON (B)(6) 2022. DURING THE SURGERY, THE PATIENT WAS DISCOVERED TO HAVE BILATERALLY DEFLATED BREAST IMPLANTS. NO PROCEDURAL DELAYS OR PATIENT CONSEQUENCES WERE REPORTED DUE TO THE DISCOVERY. REFER TO MANUFACTURING REPORT NUMBER (B)(4) FOR THE CONTRALATERAL EVENT.
Patient problems: Breast Discomfort/Pain
MAUDE report 16357359 ↗InjuryFeb 10, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 450CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED STABBING PAINS IN HER BREASTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH ALLERGAN BREAST IMPLANTS ON (B)(6) 2022. DURING THE SURGERY, THE PATIENT WAS DISCOVERED TO HAVE BILATERALLY DEFLATED BREAST IMPLANTS. NO PROCEDURAL DELAYS OR PATIENT CONSEQUENCES WERE REPORTED DUE TO THE DISCOVERY. REFER TO MANUFACTURING REPORT NUMBER (B)(4) FOR THE CONTRALATERAL EVENT.
Patient problems: Breast Discomfort/Pain
MAUDE report 16357313 ↗
Other Mentor Texas L.P. products
- MENTOR MemoryGel Breast Implants368 models · 56,155 reports
- MENTOR MemoryGel Breast Implant211 models · 49,379 reports
- MENTOR Smooth Round Moderate Profile20 models · 14,918 reports · 1 recall
- MENTOR Smooth Round Moderate Plus Profile22 models · 6,091 reports · 1 recall
- MENTOR MemoryGel Xtra Breast Implant88 models · 5,679 reports
- MENTOR Smooth Round High Profile17 models · 4,098 reports · 1 recall
- MENTOR SILTEX Round Moderate Profile13 models · 2,160 reports
- MENTOR MemoryShape Breast Implant65 models · 1,595 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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