MENTOR Smooth Round Moderate Plus Profile 3502325Recalls & reported problems
Mentor Texas L.P. · Saline Breast Implant with Diaphragm Valve, 325cc |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 Smooth Round Moderate Plus saline breast implant is used for breast augmentation. Most of the 580 reports describe the implant rupturing or deflating, and others mention deformity and hardening of scar tissue around the implant. The reports include 573 injuries and no deaths. 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
- 578
- Deaths reported
- 0
- Injuries reported
- 571
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 578 adverse event reports that list this exact device (DI 00081317001409), received between Feb 7, 2018 and Aug 4, 2026 — classified as 571 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (365 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 Rupture365
- Adverse Event Without Identified Device or Use Problem195
- Migration29
- Connection Problem6
- Appropriate Device Problem Term/Code Not Available3
- Microbial Contamination of Device3
- Off-Label Use3
- Air/Gas in Device2
Patient problems
- No Code Available234
- Deformity/ Disfigurement172
- Capsular Contracture94
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available30
- Pain27
- Breast Discomfort/Pain22
- Wrinkling21
- Autoimmune Reaction12
Recent adverse event reports
The 25 most recent of 578 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent primary breast augmentation with a 325cc MENTOR Smooth Round Moderate Plus Profile saline breast prosthesis on the left breast. Post-operatively, the patient developed left breast capsular contracture (baker grade III). At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.
Patient problems: Capsular Contracture
MAUDE report 50133181 ↗InjuryJun 17, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 25536746 ↗InjuryMay 27, 2026Material Rupture
A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 175CC ON THE LEFT, AND 325CC ON THE RIGHT PROSTHESIS DEVELOPED BILATERAL DEFLATIONS POSTOPERATIVE. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT SIDE.
Patient problems: Deformity/ Disfigurement
MAUDE report 25306770 ↗InjuryApr 15, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24886588 ↗InjuryApr 7, 2026Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST IMPLANTS DISPLACEMENT. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR SALINE IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 24810934 ↗InjuryApr 7, 2026Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST IMPLANTS DISPLACEMENT. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR SALINE IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 24810933 ↗InjuryApr 6, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24792303 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 24784045 ↗MalfunctionApr 2, 2026Contamination of Device Ingredient or Reagent
IT WAS REPORTED THAT A 325CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS BEING USED IN A BREAST SURGERY WAS FOUND TO BE HAIR BEFORE THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24772078 ↗InjuryApr 1, 2026Migration
IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANTS EXPERIENCED BILATERAL MIGRATION ALONG WITH DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 24757196 ↗InjuryMar 31, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS 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 24746789 ↗InjuryMar 17, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC MENTOR SMOOTH ROUND MODERATE PLUS 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: Deformity/ Disfigurement
MAUDE report 24618014 ↗InjuryMar 5, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 325CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT 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 24521800 ↗InjuryFeb 24, 2026Material Rupture; Migration
IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANTS EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24431391 ↗InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 59-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 325CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED INFLAMMATION ON THE INCISION SITE, BUMPS, SWELLING ON THE NIPPLE AREA, BREAST PAIN (AFTER MAMMOGRAM), AND CALCIUM DEPOSITS 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: Calcium Deposits/Calcification; Local Reaction
MAUDE report 24335886 ↗InjuryJan 13, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. 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 24050820 ↗InjuryDec 17, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 325CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND 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 23832953 ↗InjuryDec 17, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 325CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND 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 23832639 ↗InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 325CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.
Patient problems: Capsular Contracture
MAUDE report 23816163 ↗InjuryDec 10, 2025Material Rupture; Migration; Material Rupture; Migration
IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO UNSPECIFIED SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL DEVICE MIGRATION WITH BILATERAL BREAST PAIN POST-OPERATIVELY. THE PATIENT REPORTED THAT THEY FELT THEY WERE "FALLING OUT OF THE POCKET". 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: Breast Discomfort/Pain
MAUDE report 23771351 ↗InjuryDec 10, 2025Migration; Migration
IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO UNSPECIFIED SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL DEVICE MIGRATION WITH BILATERAL BREAST PAIN POST-OPERATIVELY. THE PATIENT REPORTED THAT THEY FELT THEY WERE "FALLING OUT OF THE POCKET". 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: Breast Discomfort/Pain
MAUDE report 23771350 ↗InjuryNov 20, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 325CC (LEFT) MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND A 350 (RIGHT) MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE AND BILATERAL BREAST PTOSIS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH MENTOR BREAST PROSTHESES. THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 23609240 ↗InjuryNov 13, 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 325CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Capsular Contracture
MAUDE report 23544363 ↗MalfunctionNov 11, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT A SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE BREAST IMPLANT BEING USED IN A BREAST IMPLANTATION PROCEDURE WAS FOUND TO HAVE A DEFECTIVE 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 23524215 ↗InjuryOct 29, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC 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 23415303 ↗
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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