MENTOR SILTEX CONTOUR PROFILE ModerateRecalls & 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
- 146
- Deaths reported
- 0
- Injuries reported
- 146
- Recalls
- 0
We found 5 models of MENTOR SILTEX CONTOUR PROFILE Moderate by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 146 adverse event reports in the FDA's MAUDE database, received between Jan 25, 2018 and Feb 11, 2026 — classified as 146 injuries.
The most frequently reported specific device problem is “Material Rupture” (115 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 Moderate problems
Device problems
- Material Rupture115
- Adverse Event Without Identified Device or Use Problem28
- Migration2
- Deflation Problem1
Patient problems
- No Code Available78
- Deformity/ Disfigurement37
- Capsular Contracture26
- Pain7
- Wrinkling5
- Breast Discomfort/Pain4
- Cancer3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
MENTOR SILTEX CONTOUR PROFILE Moderate models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR SILTEX CONTOUR PROFILE Moderate 3542912Prosthesis, breast, inflatable, internal, saline43 reports
- MENTOR SILTEX CONTOUR PROFILE Moderate 3542913Prosthesis, breast, inflatable, internal, saline34 reports
- MENTOR SILTEX CONTOUR PROFILE Moderate 3542914Prosthesis, breast, inflatable, internal, saline27 reports
- MENTOR SILTEX CONTOUR PROFILE Moderate 3542911Prosthesis, breast, inflatable, internal, saline24 reports
- MENTOR SILTEX CONTOUR PROFILE Moderate 3542915Prosthesis, breast, inflatable, internal, saline18 reports
Recent MENTOR SILTEX CONTOUR PROFILE Moderate adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 11, 2026Material Rupture
IT WAS REPORTED THAT A 58-YEAR-OLD BLACK FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 425CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Crushing Injury; Deformity/ Disfigurement
MAUDE report 24319230 ↗InjuryJul 15, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 22509888 ↗InjuryJul 7, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 55-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 425 CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH 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 22427788 ↗InjuryFeb 18, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 275/300CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 275CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANTS ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21405292 ↗InjuryJan 29, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21266483 ↗InjuryNov 25, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE, 525/575 CC, SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20773135 ↗InjuryNov 22, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED THOUGH A PHYSICAL EXAMINATION. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20761179 ↗InjuryOct 10, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SILTEX CONTOUR PROFILE MODERATE, 400CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENT WITH UNSPECIFIED MENTOR SILICONE PROSTHESIS ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20424575 ↗InjuryMay 14, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 350CC MENTOR SILTEX CONTOUR PROFILE MODERATE 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 19312343 ↗InjuryFeb 21, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE, 425/475CC SALINE, BREAST IMPLANT EXPERIENCED LEFT-SIDED DEFLATION POSTOPERATIVE. THE PHYSICAL EXAMINATION DIAGNOSED THE ISSUE. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REPLACEMENT WITH CAT: SMHX630 ON AN UNSPECIFIED DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 18749414 ↗InjuryJan 24, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH 350/400CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18574088 ↗InjuryJan 18, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 525CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON AN UNKNOWN SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE PATIENT REPORTED TWO DEVICE SERIAL NUMBERS, HOWEVER, IT IS UNKNOWN WHICH SERIAL NUMBER BELONGS TO THE IMPACTED SIDE. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.
Patient problems: Deformity/ Disfigurement
MAUDE report 18540646 ↗InjuryJan 5, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 275/300CC MENTOR SILTEX CONTOUR PROFILE MODERATE700CC AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3502325; SERIAL NUMBER:(B)(6) ON THE RIGHT SIDE, AND WITH CATALOG NUMBER 3502325; SERIAL NUMBER: (B)(6) ON THE LEFT SIDE ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 18451452 ↗InjuryJan 2, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO UNSPECIFIED MENTOR SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED 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 18427401 ↗InjuryOct 5, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 275/300CC MENTOR SILTEX CONTOUR PROFILE MODERATE 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 275CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT ON (B)(6) 2023. THE LOT AND SERIAL NUMBERS WERE PROVIDED FOR BOTH IMPLANTED DEVICES, BUT THE CORRESPONDING SIDES WERE NOT DISCLOSED TO MENTOR. DEVICE A WAS IDENTIFIED AS SERIAL NUMBER (B)(6) AND DEVICE B WAS IDENTIFIED AS SERIAL NUMBER (B)(6). BOTH DEVICES HAVE THE SAME CATALOG NUMBER. AS SUCH, THE SERIAL NUMBER AND LOT NUMBERS FOR EACH DEVICE HAS BEEN POPULATED IN THE LOT AND SERIAL NUMBER FIELDS. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: Deformity/ Disfigurement
MAUDE report 17876638 ↗
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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