MENTOR Smooth Round SPECTRUMRecalls & reported problems across all models
Mentor Texas L.P. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 846
- Deaths reported
- 0
- Injuries reported
- 835
- Recalls
- 0
We found 10 models of MENTOR Smooth Round SPECTRUM by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 846 adverse event reports in the FDA's MAUDE database, received between Feb 8, 2018 and Sep 16, 2026 — classified as 835 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (637 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 Smooth Round SPECTRUM problems
Device problems
- Material Rupture637
- Adverse Event Without Identified Device or Use Problem192
- Migration10
- Connection Problem9
- No Apparent Adverse Event4
- Infusion or Flow Problem3
- Material Deformation3
- Deflation Problem2
Patient problems
- No Code Available388
- Deformity/ Disfigurement278
- Capsular Contracture121
- Pain38
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available25
- Breast Discomfort/Pain17
- Wrinkling15
- Autoimmune Reaction9
MENTOR Smooth Round SPECTRUM models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR Smooth Round SPECTRUM 3501470Prosthesis, breast, inflatable, internal, saline215 reports
- MENTOR Smooth Round SPECTRUM 3501460Prosthesis, breast, inflatable, internal, saline164 reports
- MENTOR Smooth Round SPECTRUM 3501450Prosthesis, breast, inflatable, internal, saline156 reports
- MENTOR Smooth Round SPECTRUM 3501440Prosthesis, breast, inflatable, internal, saline102 reports
- MENTOR Smooth Round SPECTRUM 3501480Prosthesis, breast, inflatable, internal, saline85 reports
- MENTOR Smooth Round SPECTRUM 3501430Prosthesis, breast, inflatable, internal, saline36 reports
- MENTOR Smooth Round SPECTRUM 3501490Prosthesis, breast, inflatable, internal, saline36 reports
- MENTOR Smooth Round SPECTRUM 3501485Prosthesis, breast, inflatable, internal, saline35 reports
- MENTOR Smooth Round SPECTRUM 3501420Prosthesis, breast, inflatable, internal, saline15 reports
- MENTOR Smooth Round SPECTRUM 3501410Prosthesis, breast, inflatable, internal, saline2 reports
Recent MENTOR Smooth Round SPECTRUM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Material Rupture
Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement
MAUDE report 50782443 ↗InjurySep 16, 2026Material Rupture
Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement
MAUDE report 50782442 ↗InjuryJun 16, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND SPECTRUM BREAST IMPLANTS EXPERIENCED BREAST PAIN AND 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: Breast Discomfort/Pain
MAUDE report 25521015 ↗InjuryApr 16, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT DEFLATIONS. 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
MAUDE report 24897763 ↗InjuryApr 16, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT DEFLATIONS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 24897759 ↗InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 325CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT IMPLANT REMOVAL ON (B)(6) 2026.
Patient problems: Capsular Contracture
MAUDE report 24897125 ↗InjuryMar 25, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT IMPLANT 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 24683482 ↗InjuryMar 23, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND SPECTRUM 425CC SALINE PROSTHESES EXPERIENCED BILATERAL PTOSIS AND BILATERAL DEFLATION POST PROCEDURE. THE LEFT SIDED DEFLATION WAS DIAGNOSED THROUGH DAMAGES SEEN WITH ULTRASOUND. AS A RESULT, REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2026. THE RIGHT SIDED DEVICE WAS REMOVED INTACT BUT WAS HALFWAY DEFLATED. THE LEFT SIDED DEVICE WAS REPORTED INITIALLY UNDER 1645337-2024-08078. ON FEBRUARY 26, 2026 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 24664227 ↗InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS EXPERIENCED CAPSULAR CONTRACTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Capsular Contracture
MAUDE report 24420163 ↗InjuryJan 30, 2026Material Rupture
IT WAS REPORTED THAT A 42-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 325CC MENTOR SMOOTH ROUND 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) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24226531 ↗InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES DEVELOPED SENSITIVITY IN BOTH BREASTS POST IMPLANTATION. THE PATIENT WAS LATER DIAGNOSED WITH CHRONIC LEUKOCYTOSIS. 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 BREAST PROSTHESIS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction
MAUDE report 24192542 ↗InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES DEVELOPED SENSITIVITY IN BOTH BREASTS POST IMPLANTATION. THE PATIENT WAS LATER DIAGNOSED WITH CHRONIC LEUKOCYTOSIS. 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 BREAST PROSTHESIS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction
MAUDE report 24192532 ↗InjuryJan 15, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 425CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT IMPLANT AND A LEFT BREAST THAT WAS HANGING LOW AND BUMPING OUTWARDLY DURING A PHYSICAL EXAM AFTER HAVING EXPERIENCED A FALL AND A BACK INJURY. MAGNETIC RESONANCE IMAGING WAS ALSO CONDUCTED. A DIAGNOSIS OF POSSIBLE CAPSULAR CONTRACTURE WAS MENTIONED, BUT NO FURTHER INFORMATION WAS PROVIDED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) , 2025. 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: Capsular Contracture
MAUDE report 24087723 ↗MalfunctionDec 11, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN, FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 275CC MENTOR SMOOTH ROUND SPECTRUM ON BOTH SIDES AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2025. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT EXPERIENCED DEFLATION OF THE RIGHT-SIDE IMPLANT. NO PRODUCT QUALITY ISSUES WERE REPORTED FOR THE LEFT-SIDE DEVICE. ON DECEMBER 5, 2024, THE MENTOR FAILURE ANALYSIS LAB RECEIVED TWO DEVICES FOR EVALUATION AND WERE BOTH FOUND DAMAGED UPON EVALUATION. HENCE, THIS REPORT DETAILS INVESTIGATION RESULTS FOR THE SECOND DEVICE RECEIVED AS NO CLARIFICATION WAS RECEIVED AFTER MULTIPLE FOLLOW-UPS.
Patient problems: Insufficient Information
MAUDE report 23785743 ↗InjuryDec 3, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS.
Patient problems: Deformity/ Disfigurement
MAUDE report 23711317 ↗
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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