MENTOR SILTEX CONTOUR PROFILE HighRecalls & 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
- 201
- Deaths reported
- 0
- Injuries reported
- 201
- Recalls
- 0
We found 5 models of MENTOR SILTEX CONTOUR PROFILE High by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 201 adverse event reports in the FDA's MAUDE database, received between Jan 23, 2018 and Dec 26, 2025 — classified as 201 injuries.
The most frequently reported specific device problem is “Material Rupture” (152 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 High problems
Device problems
- Material Rupture152
- Adverse Event Without Identified Device or Use Problem45
- Migration4
- Migration or Expulsion of Device4
- Filling Problem1
- Material Discolored1
- No Apparent Adverse Event1
Patient problems
- No Code Available111
- Deformity/ Disfigurement56
- Capsular Contracture47
- Pain6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Breast Mass3
- Crushing Injury3
- Wrinkling3
MENTOR SILTEX CONTOUR PROFILE High models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR SILTEX CONTOUR PROFILE High 3542712Prosthesis, breast, inflatable, internal, saline74 reports
- MENTOR SILTEX CONTOUR PROFILE High 3542711Prosthesis, breast, inflatable, internal, saline57 reports
- MENTOR SILTEX CONTOUR PROFILE High 3542715Prosthesis, breast, inflatable, internal, saline30 reports
- MENTOR SILTEX CONTOUR PROFILE High 3542713Prosthesis, breast, inflatable, internal, saline26 reports
- MENTOR SILTEX CONTOUR PROFILE High 3542714Prosthesis, breast, inflatable, internal, saline14 reports
Recent MENTOR SILTEX CONTOUR PROFILE High adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 26, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WITH MENTOR SILTEX CONTOUR PROFILE HIGH BREAST IMPLANTS EXPERIENCED DEFLATION 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: Deformity/ Disfigurement
MAUDE report 23899065 ↗InjuryDec 12, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 275CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) , 2025, AND REPLACED WITH A 350CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 23796622 ↗InjuryOct 29, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WITH MENTOR SILTEX CONTOUR PROFILE HIGH BREAST IMPLANTS EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT.
Patient problems: Deformity/ Disfigurement
MAUDE report 23417042 ↗InjuryFeb 6, 2025Material Rupture; Material Rupture
A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH, 275CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST IMPLANTATION. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21323999 ↗InjuryJan 6, 2025Material Rupture; Material Rupture
A REPORT HAS NOTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH, 350 CC SALINE PROSTHESIS EXPERIENCED POSTOPERATIVE LEFT-SIDED DEFLATION, WHICH WAS DIAGNOSED THROUGH A PHONE CALL WITH THE PATIENT. AS OF THE TIME OF THIS REPORT, MENTOR HAS NOT RECEIVED ANY INFORMATION CONCERNING EXPLANTATION OR AN ANTICIPATED DATE FOR THE EXPLANTATION PROCEDURE.
Patient problems: Deformity/ Disfigurement
MAUDE report 21083137 ↗InjuryOct 15, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SILTEX CONTOUR PROFILE HIGH BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR GEL BREAST IMPLANTS ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20455684 ↗InjurySep 20, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 350CC SALINE PROSTHESIS EXPERIENCED SPONTANEOUS RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT AND REPLACEMENT WITH MENTOR SALINE IS PLANNED FOR (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20274860 ↗InjurySep 3, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 650CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20131626 ↗InjuryJul 3, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 74-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 550CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. IT WAS REPORTED THAT THE PATIENT WAS IN A CAR ACCIDENT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19667580 ↗InjuryJun 27, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR SILTEX ROUND MODERATE PROFILE 325CC SALINE BREAST PROSTHESES THAT BOTH DEFLATED POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED BAKER GRADE II CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESES ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 19625784 ↗InjuryJun 27, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR SILTEX ROUND MODERATE PROFILE 325CC SALINE BREAST PROSTHESES THAT BOTH DEFLATED POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED BAKER GRADE II CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESES ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 19625752 ↗InjuryMay 6, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 550CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A DEFLATION OF HER RIGHT PROSTHESIS, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A NATRELLE BREAST IMPLANT ON (B)(6) 2023. 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 19249060 ↗InjuryApr 10, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA IN-OFFICE EXAMINATION, WITH LEFT 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 19081167 ↗InjuryFeb 13, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 550CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED A SUSPECTED DEFLATION OF HER RIGHT PROSTHESIS, WHICH WAS DIAGNOSED OVER THE PHONE BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18699109 ↗InjuryJan 3, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH AN UNKNOWN TEXTURED MENTOR SALINE PROSTHESIS EXPERIENCED LEFT-SIDED DEFLATION POST PROCEDURE. THE IMAGING EXAMINATION CONFIRMED THE ISSUE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 18438290 ↗
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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