MENTOR Smooth Round Moderate Plus Profile 3502425Recalls & reported problems
Mentor Texas L.P. · Saline Breast Implant with Diaphragm Valve, 425cc |Smooth|Round|Saline| · Class 3 · Implant
All models of MENTOR Smooth Round Moderate Plus Profile (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Mentor saline breast implant has 393 reports in the FDA database, 385 of them describing injuries and no deaths. Many reports describe the implant rupturing or deflating, along with patients who have deformity, capsular contracture (hardening of the scar tissue around the implant), and pain. In the last 12 months there were 8 reports, compared with 35 in the 12 months before. 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
- 396
- Deaths reported
- 0
- Injuries reported
- 388
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 396 adverse event reports that list this exact device (DI 00081317001447), received between Feb 9, 2018 and Sep 29, 2026 — classified as 388 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (238 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 Rupture238
- Adverse Event Without Identified Device or Use Problem142
- Migration18
- Connection Problem5
- Device Contamination with Chemical or Other Material2
- Off-Label Use2
- Air/Gas in Device1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Deformity/ Disfigurement140
- No Code Available134
- Capsular Contracture68
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available24
- Pain20
- Breast Discomfort/Pain18
- Neurological Deficit/Dysfunction8
- Autoimmune Reaction7
Recent adverse event reports
The 25 most recent of 396 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Material Rupture
It was reported that a patient underwent a primary breast augmentation procedure with a MENTOR Smooth Round Moderate Plus Profile saline breast prosthesis that deflated post implantation. Deflation of the patient¿s right breast prosthesis was diagnosed via a physical exam. As a result, the patient underwent explantation.
Patient problems: Deformity/ Disfigurement
MAUDE report 50936607 ↗InjurySep 22, 2026Material Rupture
It was reported that a patient underwent a breast augmentation revision procedure with a MENTOR Smooth Round Moderate Plus Profile saline breast prosthesis that deflated post implantation. Deflation of the patient¿s right breast prosthesis was reported. The patient noticed ripples on her right breast. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.
Patient problems: Deformity/ Disfigurement
MAUDE report 50857343 ↗InjurySep 16, 2026Material Rupture
It was reported that a patient with Saline MENTOR Smooth Round Moderate Plus Profile 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 50787582 ↗InjuryJun 8, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 425CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE LEFT 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 25435120 ↗InjuryMay 9, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 425CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT 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 25133169 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 425CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE II). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICE WAS A MENTOR SALINE IMPLANT.
Patient problems: Capsular Contracture
MAUDE report 24779890 ↗InjuryMar 4, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANTS EXPERIENCED ITCHING, RASHES, 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: Skin Inflammation/ Irritation
MAUDE report 24507084 ↗InjuryJan 8, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH A 425CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED 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 SALINE IMPLANTS.
Patient problems: Deformity/ Disfigurement
MAUDE report 24000583 ↗InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANTS EXPERIENCED RASHES AND BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN 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. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture; Skin Inflammation/ Irritation
MAUDE report 23649455 ↗InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANTS EXPERIENCED RASHES AND BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN 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. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Capsular Contracture; Skin Inflammation/ Irritation
MAUDE report 23649453 ↗InjuryNov 5, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES EXPERIENCED BILATERAL DEFLATIONS 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 23479610 ↗InjurySep 15, 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 REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 425CC SALINE BREAST PROSTHESIS (LEFT DEVICE) AND AN UNSPECIFIED MENTOR SALINE BREAST PROSTHESIS (RIGHT DEVICE) WHEN THE LEFT BREAST PROSTHESIS DEFLATED POST IMPLANTATION. ADDITIONALLY, THE PATIENT SUFFERED FROM BILATERAL BREAST HYPERPLASIA. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION AND REPLACEMENT OF THE LEFT BREAST PROSTHESIS WAS AN UNSPECIFIED MENTOR SMOOTH SALINE BREAST PROSTHESIS ON (B)(6) 2025. THE RIGHT BREAST PROSTHESIS WAS NOT OPERATED ON AND REMAINS IMPLANTED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 23057509 ↗InjurySep 15, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 425CC SALINE BREAST PROSTHESIS (LEFT DEVICE) AND AN UNSPECIFIED MENTOR SALINE BREAST PROSTHESIS (RIGHT DEVICE) WHEN THE LEFT BREAST PROSTHESIS DEFLATED POST IMPLANTATION. ADDITIONALLY, THE PATIENT SUFFERED FROM BILATERAL BREAST HYPERPLASIA. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION AND REPLACEMENT OF THE LEFT BREAST PROSTHESIS WAS AN UNSPECIFIED MENTOR SMOOTH SALINE BREAST PROSTHESIS ON (B)(6) 2025. THE RIGHT BREAST PROSTHESIS WAS NOT OPERATED ON AND REMAINS IMPLANTED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 23057507 ↗InjuryAug 21, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 425CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT IMPLANT USING MAGNETIC RESONANCE IMAGING. ADDITIONALLY, DURING AN IN-OFFICE VISIT SHE WAS OBSERVED TO HAVE DOUBLE BUBBLE DEFORMITY WITHOUT RIPPLING ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR SALINE IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 22868260 ↗InjuryAug 21, 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 REVISION SURGERY WITH IMPLANTATION OF A 425CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT IMPLANT USING MAGNETIC RESONANCE IMAGING. ADDITIONALLY, DURING AN IN-OFFICE VISIT SHE WAS OBSERVED TO HAVE DOUBLE BUBBLE DEFORMITY WITHOUT RIPPLING ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR SALINE IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Wrinkling
MAUDE report 22865931 ↗InjuryAug 20, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 425CC MENTOR SMOOTH ROUND MODERATE PLUS 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 UNDERWENT LEFT-SIDED EXCHANGE WITH A MENTOR SALINE IMPLANT ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 22853874 ↗InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 425CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Capsular Contracture
MAUDE report 22666563 ↗InjuryJul 21, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION WITH TWO 425CC MENTOR SMOOTH ROUND MODERATE PLUS 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) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 22559964 ↗InjuryJul 11, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 425CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Capsular Contracture; Deformity/ Disfigurement
MAUDE report 22481681 ↗InjuryJun 10, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANTS AND 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 22179282 ↗InjuryJun 4, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 425CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST 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 22141460 ↗InjuryMay 30, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 425 CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION SURGERY.
Patient problems: Deformity/ Disfigurement
MAUDE report 22116986 ↗MalfunctionMay 21, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT A 425CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS BEING USED IN A PRIMARY BREAST AUGMENTATION HAD A DEFECTED VALVE DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22062902 ↗InjuryMay 21, 2025Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANTS AND EXPERIENCED BILATERAL DEVICE MIGRATION ALONG WITH BILATERAL NIPPLE SENSATION CHANGES (¿NIPPLE FEELS WEIRD¿) POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Nipple Sensation Changes
MAUDE report 22060079 ↗InjuryMay 21, 2025Migration; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANTS AND EXPERIENCED BILATERAL DEVICE MIGRATION ALONG WITH BILATERAL NIPPLE SENSATION CHANGES (¿NIPPLE FEELS WEIRD¿) POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Nipple Sensation Changes
MAUDE report 22060078 ↗
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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