MENTOR Smooth Round Moderate Profile 3501690Recalls & reported problems
Mentor Texas L.P. · Saline Breast Implant with Diaphragm Valve, 575cc |Smooth|Round|Saline| · Class 3 · Implant
All models of MENTOR Smooth Round Moderate Profile (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Mentor Smooth Round saline breast implant is used in breast augmentation. All 354 reports are injuries with no deaths, and most describe the implant rupturing, while many mention deformity or disfigurement of the breast. Some mention capsular contracture, where scar tissue tightens around the implant. No recalls name this device, and reports fell to 9 in the last 12 months from 19 before that.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 354
- Deaths reported
- 0
- Injuries reported
- 354
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 354 adverse event reports that list this exact device (DI 00081317001317), received between Feb 14, 2018 and Sep 28, 2026 — classified as 354 injuries.
The most frequently reported specific device problem is “Material Rupture” (299 reports).
2 other recalls cover devices cleared under the same FDA submission (P990075); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture299
- Adverse Event Without Identified Device or Use Problem52
- Migration10
- Use of Device Problem3
- Deflation Problem2
- Appropriate Device Problem Term/Code Not Available1
- Device Contamination with Chemical or Other Material1
Patient problems
- Deformity/ Disfigurement170
- No Code Available143
- Capsular Contracture45
- Pain13
- Breast Discomfort/Pain7
- Ptosis6
- Breast Mass5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
Recent adverse event reports
The 25 most recent of 354 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50924818 ↗InjuryJun 8, 2026Migration
IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 575CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL PARESTHESIA AND BILATERAL DEVICE MIGRATION POST-OPERATIVELY. THE PATIENT ALSO EXPERIENCED A DEFLATION ON THE RIGHT SIDE AND ANISOMASTIA ON THE LEFT SIDE. THE PATIENT HAD MENTIONED THAT THE IMPLANTS FEEL ¿WEIRD AND NOT RIGHT¿. THAT THERE WAS A CRACKLING FEELING. WHEN THE PATIENT WOULD LAY DOWN, THE IMPLANTS FALL INTO THE ARM PITS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Deformity/ Disfigurement; Paresthesia
MAUDE report 25433071 ↗InjuryJun 8, 2026Material Rupture; Migration
IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 575CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL PARESTHESIA AND BILATERAL DEVICE MIGRATION POST-OPERATIVELY. THE PATIENT ALSO EXPERIENCED A DEFLATION ON THE RIGHT SIDE AND ANISOMASTIA ON THE LEFT SIDE. THE PATIENT HAD MENTIONED THAT THE IMPLANTS FEEL ¿WEIRD AND NOT RIGHT¿. THAT THERE WAS A CRACKLING FEELING. WHEN THE PATIENT WOULD LAY DOWN, THE IMPLANTS FALL INTO THE ARM PITS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.
Patient problems: Paresthesia
MAUDE report 25433014 ↗InjuryMar 19, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 575CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24641406 ↗InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 575CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED A RUPTURE ON THE LEFT SIDE AND ASYMMETRY (LOWER) ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 24045922 ↗InjuryJan 12, 2026Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 575CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED A RUPTURE ON THE LEFT SIDE AND ASYMMETRY (LOWER) ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 24045920 ↗InjuryDec 18, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 575CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT WAS SCHEDULED FOR IMPLANT REMOVAL ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 23846273 ↗InjuryDec 17, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 575CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 23829068 ↗InjuryNov 19, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 575CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 23598082 ↗InjurySep 19, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 575CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT IMPLANT DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR SALINE IMPLANTS ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 23099696 ↗InjurySep 9, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE BREAST IMPLANTS EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.
Patient problems: Deformity/ Disfigurement
MAUDE report 23009546 ↗InjuryAug 4, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 575CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 22699628 ↗InjuryJul 28, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 575CC MENTOR SMOOTH ROUND MODERATE PROFILE 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 SURGERY ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 22634409 ↗InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 575CC BREAST IMPLANTS AND EXPERIENCED BILATERAL PTOSIS ALONG WITH DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 22293285 ↗InjuryJun 6, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 575CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 575CC SALINE BREAST PROSTHESIS ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 22160863 ↗InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 575CC SALINE PROSTHESES EXPERIENCED LEFT SIDED DEFLATION AND RIGHT SIDED CAPSULAR CONTRACTURE POST PROCEDURE. AS A RESULT, REPLACEMENT WAS PERFORMED ON (B)(6) 2025. THE LEFT SIDED DEFLATION WAS REPORTED INITIALLY UNDER 1645337-2025-01687. ON MAY 13, 2025, MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 22095641 ↗InjuryMay 26, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 575CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 22084963 ↗InjuryMay 21, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 575CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 22060189 ↗InjuryApr 21, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 575CC MENTOR SMOOTH 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) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21873884 ↗InjuryApr 2, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 575CC MENTOR SMOOTH ROUND MODERATE PROFILE 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) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21753313 ↗InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR SMOOTH ROUND MODERATE PROFILE, 575CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED BREAST PAIN AND BREAST MASS POST OPERATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Breast Discomfort/Pain; Breast Mass
MAUDE report 21710490 ↗InjuryMar 17, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 575CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Calcium Deposits/Calcification; Deformity/ Disfigurement
MAUDE report 21627593 ↗InjuryMar 4, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 575CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21515478 ↗InjuryFeb 19, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 575CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21413976 ↗InjuryDec 10, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 575CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED DURING A PHONE CONSULTATION. ADDITIONALLY, THE PATIENT DEVELOPED PAIN IN HER LEFT BREAST AND SHOULDER. 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 20898702 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P990075. One submission often covers many models, so check the product and lot details in each record.
- Z-0367-2022 · Sep 30, 2021 · Open, ClassifiedMENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shel
- Z-2070-2017 · Mar 27, 2017 · TerminatedMentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Other Prosthesis, breast, inflatable, internal, saline devices
- MENTOR Smooth Round Moderate Profile 3501650Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline2,187 reports
- MENTOR Smooth Round Moderate Profile 3501660Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,972 reports
- MENTOR Smooth Round Moderate Profile 3501670Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,899 reports
- MENTOR Smooth Round Moderate Profile 3501645Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,655 reports
- MENTOR Smooth Round Moderate Profile 3501655Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,534 reports
- MENTOR Smooth Round Moderate Profile 3501640Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,294 reports
- MENTOR Smooth Round Moderate Profile 3501680Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,095 reports
- MENTOR Smooth Round Moderate Profile 3501635Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline864 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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