MENTOR Smooth Round Moderate Profile 3501697Recalls & reported problems
Mentor Texas L.P. · Saline Breast Implant with Diaphragm Valve, 700cc |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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Mentor saline breast implant is a fluid-filled implant placed in the breast. Of its 127 reports, 126 are injuries and 1 is a malfunction, with no deaths; many describe the implant rupturing or deflating, and some describe deformity or hardening of the scar tissue around it. 1 recall, open and started in September 2021, concerns a possible weak spot that can cause leaking or deflation.
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
- 127
- Deaths reported
- 0
- Injuries reported
- 126
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 00081317001331), received between Jan 30, 2018 and Jun 11, 2026 — classified as 126 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (97 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall 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
Recalls naming this device
- Sep 30, 2021Class IIOpen, Classified
Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.
Z-0367-2022 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Rupture97
- Adverse Event Without Identified Device or Use Problem27
- Connection Problem2
- Migration1
- Migration or Expulsion of Device1
Patient problems
- No Code Available50
- Deformity/ Disfigurement49
- Capsular Contracture20
- Breast Discomfort/Pain5
- Wrinkling5
- Paresthesia3
- Breast Mass2
- Crushing Injury2
Recent adverse event reports
The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 700CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT 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 ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.
Patient problems: Deformity/ Disfigurement
MAUDE report 25477169 ↗InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 700CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT FELL AND SUFFERED RIGHT BREAST IMPLANT RUPTURE AND ALSO DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Capsular Contracture; Crushing Injury
MAUDE report 24624345 ↗InjuryNov 5, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ALONG WITH DEFLATION ON THE LEFT 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: Capsular Contracture
MAUDE report 23478923 ↗InjuryNov 5, 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 PROFILE BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ALONG WITH DEFLATION ON THE LEFT 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 RIGHT BREAST PROSTHESIS.
Patient problems: Capsular Contracture
MAUDE report 23478922 ↗InjuryNov 3, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 700CC 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 IMPLANT REMOVAL ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 23456464 ↗InjuryOct 29, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 38-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 700CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 23417221 ↗InjuryOct 21, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 700CC 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 IMPLANT EXCHANGE WITH A MENTOR SALINE IMPLANT ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 23350740 ↗InjuryJul 7, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 700CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND 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 22426770 ↗InjuryJun 18, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 700CC MENTOR SMOOTH ROUND MODERATE 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 22285696 ↗InjuryFeb 20, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 700CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. THE PATIENT WAS INVOLVED IN A CAR ACCIDENT AND DEFLATION OF THE RIGHT BREAST PROSTHESIS WAS OBSERVED. DEFLATION WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21424618 ↗InjuryJan 9, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 700CC MENTOR SMOOTH ROUND MODERATE 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 21121073 ↗InjuryNov 11, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 700CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT'S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL'S EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20652633 ↗InjurySep 18, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 700CC MENTOR SMOOTH ROUND MODERATE PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. IT WAS REPORTED THAT THE PATIENT WAS IN A CAR ACCIDENT. THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH MENTOR SALINE DEVICES ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20249604 ↗InjuryJul 9, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 700CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHONE CALL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19704311 ↗InjuryApr 18, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 700CC 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) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19130385 ↗InjuryApr 17, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 700CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT DURING A VIRTUAL/PHONE CONSULTATION WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT WITH AN UNDISCLOSED SALINE BREAST IMPLANT ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19126490 ↗InjuryApr 16, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 700CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024, AND REPLACED WITH A 700CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 19122403 ↗InjuryMar 6, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 700CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND 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 18852817 ↗InjuryFeb 23, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH 700CC MENTOR SMOOTH ROUND MODERATE PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 18767070 ↗InjuryFeb 20, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO UNSPECIFIED MENTOR SMOOTH SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18736561 ↗InjuryFeb 2, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 41-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH AN UNSPECIFIED SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18631252 ↗InjuryNov 29, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 36-YEAR-OLD BLACK OR AFRICAN AMERICAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 700CC MENTOR SMOOTH ROUND MODERATE PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY ON NOVEMBER 28, 2023. REPLACEMENT ORDER WAS PLACED FOR CATALOG NUMBERS 3502700, AND 3502750.
Patient problems: Deformity/ Disfigurement
MAUDE report 18228945 ↗InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 58-YEAR-OLD FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 700CC MENTOR SMOOTH ROUND MODERATE PROFILE ON BOTH SIDES AND EXPERIENCED BREAST MASS ON RIGHT SIDE, AND LEFT SIDE DEFLATION. PER INFORMATION RECEIVED, "TENNIS BALL" MASS WAS SEEN IN THE RIGHT BREAST. THE PATIENT HAS CONSULTED WITH A MEDICAL PROFESSIONAL. 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-SIDED DEVICE.
Patient problems: Breast Mass
MAUDE report 18040045 ↗InjuryOct 31, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 58-YEAR-OLD FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 700CC MENTOR SMOOTH ROUND MODERATE PROFILE ON BOTH SIDES AND EXPERIENCED BREAST MASS ON RIGHT SIDE, AND LEFT SIDE DEFLATION. PER INFORMATION RECEIVED, "TENNIS BALL" MASS WAS SEEN IN THE RIGHT BREAST. THE PATIENT HAS CONSULTED WITH A MEDICAL PROFESSIONAL. 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-SIDED DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 18040044 ↗InjuryOct 12, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 700CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023. THE REPORTED DATE OF IMPLANTATION IS PRIOR TO THE DEVICE MANUFACTURE DATE. FOLLOW-UPS ARE IN PROGRESS TO CONFIRM THE CORRECT DATE, BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: Deformity/ Disfigurement
MAUDE report 17922369 ↗
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-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 · each recall links to the FDA recall notice
- 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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