MENTOR Smooth Round High Profile 3503500Recalls & reported problems
Mentor Texas L.P. · Saline Breast Implant with Diaphragm Valve, 500cc |Smooth|Round|Saline| · Class 3 · Implant
All models of MENTOR Smooth Round High Profile (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Mentor saline breast implant has 323 reports, including 314 injuries and no deaths. Most describe the implant shell rupturing or the implant deflating, with many mentioning hardened scar tissue and breast deformity. No recalls name this device.
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
- 330
- Deaths reported
- 0
- Injuries reported
- 321
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 330 adverse event reports that list this exact device (DI 00081317001683), received between Mar 1, 2018 and Sep 28, 2026 — classified as 321 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (209 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 Rupture209
- Adverse Event Without Identified Device or Use Problem123
- Migration8
- Air/Gas in Device2
- Appropriate Device Problem Term/Code Not Available2
- Connection Problem2
- Deflation Problem1
- Device Contamination with Chemical or Other Material1
Patient problems
- Deformity/ Disfigurement111
- No Code Available98
- Capsular Contracture84
- Pain18
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available15
- Breast Discomfort/Pain15
- No Clinical Signs, Symptoms or Conditions10
- Wrinkling6
Recent adverse event reports
The 25 most recent of 330 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Migration
Patient problems: Deformity/ Disfigurement
MAUDE report 50923590 ↗InjurySep 28, 2026Migration
Patient problems: Deformity/ Disfigurement
MAUDE report 50923589 ↗InjurySep 28, 2026Material Rupture
It was reported that a 29-year-old Hispanic female patient underwent revision breast augmentation with 500cc MENTOR Smooth Round High Profile and experienced breast implant deflation on her left side postoperatively; diagnosed after physical exam. The patient has consulted with the healthcare professional. As a result, the patient underwent replacement surgery on (b)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50916619 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Deformity/ Disfigurement; Wrinkling
MAUDE report 50573697 ↗InjurySep 2, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50573694 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Breast Discomfort/Pain
MAUDE report 50555460 ↗InjurySep 2, 2026Material Rupture; Adverse Event Without Identified Device or Use Problem
Patient problems: Breast Discomfort/Pain
MAUDE report 50555458 ↗InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 500CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS EXPERIENCED CAPSULAR CONTRACTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Capsular Contracture
MAUDE report 25072335 ↗InjuryMay 1, 2026Material Rupture
A FEMALE PATIENT WHO PREVIOUSLY UNDERWENT BREAST AUGMENTATION PRIMARY WITH MENTOR SMOOTH ROUND HIGH PROFILE, 500CC SALINE IMPLANTS DEVELOPED RIGHT SIDED DEFLATION POST OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 25059358 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS DEVELOPED PAIN AND RIPPLING IN HER LEFT BREAST POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Breast Discomfort/Pain; Wrinkling
MAUDE report 24719745 ↗InjuryFeb 19, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 500CC MENTOR SMOOTH ROUND HIGH 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 AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS.
Patient problems: Deformity/ Disfigurement
MAUDE report 24397329 ↗InjuryJan 22, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE AND SKIN LAXITY IN BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, THE RIGHT BREAST PROSTHESIS DEFLATED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 24150105 ↗InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE AND SKIN LAXITY IN BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, THE RIGHT BREAST PROSTHESIS DEFLATED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 24150009 ↗MalfunctionJan 13, 2026No Apparent Adverse Event
A MENTOR SMOOTH ROUND HIGH PROFILE 500CC SALINE BREAST PROSTHESIS WAS RECEIVED BY THE MENTOR ANALYSIS LAB WITHOUT A COMPLAINT IN REGARD TO THE PRODUCT QUALITY OR PATIENT ISSUES. AS A RESULT, THE DEVICE WAS TESTED AND DETERMINED TO HAVE A REPORTABLE FAILURE MODE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24062914 ↗InjuryJan 7, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 500CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 23998927 ↗InjuryDec 12, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 500CC MENTOR SMOOTH ROUND HIGH 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 23790570 ↗InjuryDec 11, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND HIGH PROFILE 500CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND HIGH PROFILE 500CC SALINE BREAST PROSTHESES ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 23780790 ↗InjuryDec 10, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND HIGH PROFILE BREAST IMPLANTS 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 23770796 ↗InjuryNov 26, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 500CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS ON THE RIGHT. 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 23662963 ↗InjurySep 16, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND HIGH PROFILE 500CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 23064529 ↗InjuryAug 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SMOOTH ROUND HIGH PROFILE, 500CC SALINE PROSTHESIS EXPERIENCE LEFT SIDED BREAST PAIN AND FOREIGN MATTER INSIDE IMPLANT POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2025.
Patient problems: Breast Discomfort/Pain
MAUDE report 22873160 ↗InjuryJul 23, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 500CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST IMPLANT DURING AN IN-OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT RIGHT-SIDED EXCHANGE WITH A MENTOR SALINE IMPLANT ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 22579411 ↗InjuryJul 16, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND HIGH PROFILE BREAST IMPLANTS EXPERIENCED DEFLATION ON THE RIGHT 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 22519341 ↗InjuryMay 30, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH 500CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT INDICATED THAT HER LEFT SIDE HAD ¿DROPPED¿ SHORTLY AFTER IMPLANTATION. ADDITIONALLY, A RIGHT SIDED DEFLATION WAS NOTED. AS A RESULT, RIGHT SIDED REPLACEMENT WAS PERFORMED ON (B)(6) 2025. THE LEFT SIDE WAS NOT EXPLANTED. THE LEFT SIDED DEVICE WAS REPORTED INITIALLY UNDER 1645337-2024-08459. ON JULY 17, 2024 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 22113743 ↗InjuryMay 15, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 39-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 500CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT MENTIONED THAT HER BREAST "GOT MASSIVE" AND STARTED TO LEAK. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Local Reaction
MAUDE report 22032381 ↗
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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