MENTOR SILTEX Round SPECTRUMRecalls & reported problems across all models
Mentor Texas L.P. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 95
- Deaths reported
- 0
- Injuries reported
- 95
- Recalls
- 0
We found 8 models of MENTOR SILTEX Round SPECTRUM by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 95 adverse event reports in the FDA's MAUDE database, received between Feb 24, 2018 and May 13, 2025 — classified as 95 injuries.
The most frequently reported specific device problem is “Material Rupture” (83 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 Round SPECTRUM problems
Device problems
- Material Rupture83
- Adverse Event Without Identified Device or Use Problem12
- Defective Device1
- Migration1
Patient problems
- No Code Available51
- Deformity/ Disfigurement34
- Capsular Contracture9
- Wrinkling3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Breast Discomfort/Pain2
- Calcium Deposits/Calcification2
- Cyst(s)1
MENTOR SILTEX Round SPECTRUM models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR SILTEX Round SPECTRUM 3542450MProsthesis, breast, inflatable, internal, saline23 reports
- MENTOR SILTEX Round SPECTRUM 3542440MProsthesis, breast, inflatable, internal, saline17 reports
- MENTOR SILTEX Round SPECTRUM 3542460MProsthesis, breast, inflatable, internal, saline15 reports
- MENTOR SILTEX Round SPECTRUM 3542470MProsthesis, breast, inflatable, internal, saline14 reports
- MENTOR SILTEX Round SPECTRUM 3542420MProsthesis, breast, inflatable, internal, saline8 reports
- MENTOR SILTEX Round SPECTRUM 3542430MProsthesis, breast, inflatable, internal, saline8 reports
- MENTOR SILTEX Round SPECTRUM 3542480MProsthesis, breast, inflatable, internal, saline8 reports
- MENTOR SILTEX Round SPECTRUM 3542410MProsthesis, breast, inflatable, internal, saline2 reports
Recent MENTOR SILTEX Round SPECTRUM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 13, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH SALINE MENTOR SILTEX ROUND SPECTRUM BREAST IMPLANTS AND 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 22012561 ↗InjuryFeb 5, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 56-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 375CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED IN PERSON. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21318118 ↗InjurySep 26, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX ROUND SPECTRUM 225CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REPORTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 20313034 ↗InjuryAug 7, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 325CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A VIDEO CALL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19932969 ↗InjuryMay 13, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX ROUND SPECTRUM 125CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 19299999 ↗InjuryMay 13, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 33-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 225CC MENTOR SILTEX ROUND SPECTRUM 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 DEVICE WAS EXPLANTED ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19297610 ↗InjuryApr 12, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 275CC MENTOR SILTEX ROUND SPECTRUM AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE REPLACEMENT SURGERY WAS SCHEDULED FOR (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19096170 ↗InjuryMar 27, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR SILTEX ROUND SPECTRUM, 175CC SALINE BREAST IMPLANT EXPERIENCED RIGHT-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 18988921 ↗InjuryMar 21, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC MENTOR SILTEX ROUND SPECTRUM 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 18951293 ↗InjuryFeb 22, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 375CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED IN PERSON. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024, AND REPLACED WITH A SALINE BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 18763703 ↗InjuryJan 29, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SILTEX ROUND SPECTRUM 325CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18596762 ↗InjuryNov 1, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO UNSPECIFIED MENTOR SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 18049549 ↗InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH 375CC MENTOR SILTEX ROUND SPECTRUM ON BOTH SIDES AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE. ON (B)(6) 2023, MENTOR BECAME AWARE THAT THE PATIENT ALSO EXPERIENCED BILATERAL IMPLANT SITE CALCIFICATION IN ADDITION TO RIGHT SIDE DEFLATION, AND REPLACEMENT DEVICES USED ON (B)(6) 2023 WERE CATALOG NUMBER 3503330; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE, AND CATALOG NUMBER 3503330; SERIAL NUMBER (B)(6) ON THE LEFT SIDE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.
Patient problems: Calcium Deposits/Calcification
MAUDE report 17647626 ↗InjuryApr 12, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH MENTOR SILTEX ROUND SPECTRUM 275CC SALINE PROSTHESES EXPERIENCED RIGHT SIDED DEFLATION AND LEFT SIDED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST PROCEDURE. THE DEFLATION WAS DETECTED THROUGH MAMMOGRAPHY. MENTOR IS AWARE THAT THE MANUFACTURED DATE PROVIDED OCCURS AFTER THE IMPLANT DATE PROVIDED. THIS IS THE ONLY INFORMATION AVAILABLE TO MENTOR AT THIS TIME. IF ADDITIONAL CLARIFICATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SEE 1645337-2023-04335 FOR CONTRALATERAL PROSTHESIS REPORT.
Patient problems: Deformity/ Disfigurement
MAUDE report 16728939 ↗InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH MENTOR SILTEX ROUND SPECTRUM 275CC SALINE PROSTHESES EXPERIENCED RIGHT SIDED DEFLATION AND LEFT SIDED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST PROCEDURE. THE DEFLATION WAS DETECTED THROUGH MAMMOGRAPHY. MENTOR IS AWARE THAT THE MANUFACTURED DATE PROVIDED OCCURS AFTER THE IMPLANT DATE PROVIDED. THIS IS THE ONLY INFORMATION AVAILABLE TO MENTOR AT THIS TIME. IF ADDITIONAL CLARIFICATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SEE 1645337-2023-04336 FOR CONTRALATERAL PROSTHESIS REPORT.
Patient problems: Capsular Contracture
MAUDE report 16728938 ↗
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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