MENTOR SILTEX Round Moderate ProfileRecalls & reported problems across all models
Mentor Texas L.P. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,160
- Deaths reported
- 0
- Injuries reported
- 2,157
- Recalls
- 0
We found 13 models of MENTOR SILTEX Round Moderate Profile by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 2,160 adverse event reports in the FDA's MAUDE database, received between Jan 23, 2018 and Sep 28, 2026 — classified as 2,157 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (1,944 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 Moderate Profile problems
Device problems
- Material Rupture1,944
- Adverse Event Without Identified Device or Use Problem215
- Deflation Problem11
- Migration9
- Connection Problem4
- Appropriate Device Problem Term/Code Not Available3
- Off-Label Use3
- Defective Device2
Patient problems
- No Code Available1,216
- Deformity/ Disfigurement754
- Capsular Contracture208
- Pain68
- Breast Discomfort/Pain25
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available23
- Autoimmune Reaction19
- Seroma14
MENTOR SILTEX Round Moderate Profile models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR SILTEX Round Moderate Profile 3542650Prosthesis, breast, inflatable, internal, saline373 reports
- MENTOR SILTEX Round Moderate Profile 3542660Prosthesis, breast, inflatable, internal, saline294 reports
- MENTOR SILTEX Round Moderate Profile 3542645Prosthesis, breast, inflatable, internal, saline293 reports
- MENTOR SILTEX Round Moderate Profile 3542640Prosthesis, breast, inflatable, internal, saline278 reports
- MENTOR SILTEX Round Moderate Profile 3542670Prosthesis, breast, inflatable, internal, saline207 reports
- MENTOR SILTEX Round Moderate Profile 3542655Prosthesis, breast, inflatable, internal, saline201 reports
- MENTOR SILTEX Round Moderate Profile 3542635Prosthesis, breast, inflatable, internal, saline163 reports
- MENTOR SILTEX Round Moderate Profile 3542630Prosthesis, breast, inflatable, internal, saline119 reports
- MENTOR SILTEX Round Moderate Profile 3542680Prosthesis, breast, inflatable, internal, saline110 reports
- MENTOR SILTEX Round Moderate Profile 3542625Prosthesis, breast, inflatable, internal, saline57 reports
- MENTOR SILTEX Round Moderate Profile 3542620Prosthesis, breast, inflatable, internal, saline30 reports
- MENTOR SILTEX Round Moderate Profile 3542615Prosthesis, breast, inflatable, internal, saline25 reports
- MENTOR SILTEX Round Moderate Profile 3542610Prosthesis, breast, inflatable, internal, saline10 reports
Recent MENTOR SILTEX Round Moderate Profile adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50926654 ↗InjurySep 28, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50926653 ↗InjurySep 16, 2026Material Rupture
It was reported that a female patient underwent a breast surgery with a 325cc 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)2016, and replaced with a 325cc MENTOR SILTEX Round Moderate Profile saline breast prosthesis.
Patient problems: Deformity/ Disfigurement
MAUDE report 50791545 ↗InjurySep 14, 2026Material Rupture
It was reported that a patient implanted with a 325cc MENTOR SILTEX Round Moderate Profile saline breast prosthesis experienced a deflation on the right side post-operatively. As a result, the patient underwent explantation on (b)(6)2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50756301 ↗InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 40-YEAR OLD AFRICAN AMERICAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX ROUND MODERATE PROFILE 425CC SALINE BREAST PROSTHESIS. THE PATIENT FELT THE LEFT BREAST WAS GOING FLAT AND THAT THERE WAS POSSIBLE DEFLATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement; Emotional Changes; Pain
MAUDE report 25487921 ↗InjuryJun 2, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 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 BREAST PROSTHESES.
Patient problems: Deformity/ Disfigurement
MAUDE report 25363542 ↗InjuryMay 12, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 325CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED IMPLANTS DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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 25154349 ↗InjuryMay 12, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 325CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED IMPLANTS DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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 25154346 ↗InjuryApr 16, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 350CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT IMPLANT DURING AN IN-OFFICE VISIT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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 24899185 ↗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 ↗InjuryMar 11, 2026Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 375CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON AN UNSPECIFIED 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 24570983 ↗InjuryMar 5, 2026Material Rupture
A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SILTEX ROUND MODERATE PROFILE, 350CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24520137 ↗InjuryFeb 11, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 375CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS 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: Breast Discomfort/Pain
MAUDE report 24315344 ↗InjuryFeb 5, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 425CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT 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 24274388 ↗
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 MemoryShape Breast Implant65 models · 1,595 reports
- MENTOR MemoryGel BOOST Breast Implant53 models · 1,078 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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