MENTOR Smooth Round Moderate Profile 3501620Recalls & reported problems
Mentor Texas L.P. · Saline Breast Implant with Diaphragm Valve, 175cc |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 saline breast implant has 166 reports, with no deaths and 163 injuries. Many reports describe the implant deflating after surgery, sometimes from a possible leak or fold, which led to removal and replacement, and some describe changes in breast shape and tightened scar tissue. No recalls name this device, and reports fell from 13 in the prior 12 months to 2 in the latest 12 months.
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
- 166
- Deaths reported
- 0
- Injuries reported
- 163
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 166 adverse event reports that list this exact device (DI 00081317001195), received between Jan 23, 2018 and Aug 3, 2026 — classified as 163 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (132 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 Rupture132
- Adverse Event Without Identified Device or Use Problem30
- Material Deformation2
- Appropriate Device Problem Term/Code Not Available1
- Deflation Problem1
- Off-Label Use1
Patient problems
- Deformity/ Disfigurement73
- No Code Available59
- Capsular Contracture21
- Pain8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Autoimmune Reaction4
- Cyst(s)3
- Wrinkling3
Recent adverse event reports
The 25 most recent of 166 reports, in the reporter's own words as published by the FDA.
InjuryAug 3, 2026Material Rupture
It was reported that a patient implanted with a 175cc 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 50117483 ↗InjuryFeb 13, 2026Material 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 IS SCHEDULED FOR REMOVAL ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24337649 ↗InjuryAug 5, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PROFILE 175CC SALINE BREAST PROSTHESES THAT BOTH POSSIBLY DEFLATED POST IMPLANTATION. IT WAS REPORTED THAT THERE IS ¿POSSIBLE LEAK OR FLAP FOLD¿ IN BOTH DEVICES. 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 BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 22722892 ↗InjuryAug 5, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PROFILE 175CC SALINE BREAST PROSTHESES THAT BOTH POSSIBLY DEFLATED POST IMPLANTATION. IT WAS REPORTED THAT THERE IS ¿POSSIBLE LEAK OR FLAP FOLD¿ IN BOTH DEVICES. 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 BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 22722888 ↗InjuryMay 23, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 175CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT DEFLATIONS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 22081176 ↗InjuryMay 23, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 175CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT DEFLATIONS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 22081173 ↗InjuryApr 23, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 175CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT LEFT-SIDED REMOVAL AND REPLACEMENT WITH A 175CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 21891850 ↗InjuryApr 21, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 175CC 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 AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21873672 ↗MalfunctionMar 31, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON MARCH 11, 2025, MENTOR DETERMINED THAT TWO DEVICES WITH THE SAME LOT NUMBER RETURNED FOR A LEFT SIDED DEFLATION DEMONSTRATED REPORTABLE DAMAGE. THE DEVICE BELONGING TO THE LEFT SIDED DEFLATION COULD NOT BE DETERMINED. THEREFORE, A SECOND IMPACTED PRODUCT IS BEING REPORTED DUE TO DEVICE DAMAGE WITHOUT A KNOWN CAUSE.
Patient problems: Insufficient Information
MAUDE report 21730718 ↗InjuryMar 17, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH AN UNSPECIFIED SMOOTH SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 21625464 ↗InjuryMar 11, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 22-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 175CC 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 IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21579980 ↗InjuryFeb 5, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 175 CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, REPLACEMENT WITH MENTOR SALINE WAS PERFORMED ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 21312379 ↗InjuryJan 2, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 175CC 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) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 21056828 ↗InjuryNov 27, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 175CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20803329 ↗InjuryNov 4, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 175CC 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) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20600673 ↗InjuryOct 30, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 175CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST IMPLANT RUPTURE AND RIGHT BREAST CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. UPON RECEIPT AND EVALUATION OF THE SUSPECT MEDICAL DEVICE AND THE CONTRALATERAL DEVICE, BOTH WERE IDENTIFIED TO BE RUPTURED. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 20570715 ↗InjuryOct 24, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 175CC 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) 2024.
Patient problems: Capsular Contracture; Deformity/ Disfigurement
MAUDE report 20526520 ↗InjurySep 3, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 175CC 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 20127623 ↗InjuryAug 1, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO UNKNOWN MENTOR GEL IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST IMPLANT RUPTURE AND RIGHT BREAST CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.
Patient problems: Capsular Contracture
MAUDE report 19885922 ↗InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 175CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 2 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 19819824 ↗InjuryJul 22, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PROFILE 175CC SALINE PROSTHESES EXPERIENCED RIGHT SIDED DEFLATION AND LEFT SIDED CUTANEOUS CONTOUR DEFORMITY POST PROCEDURE. AS A RESULT, REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19801652 ↗InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PROFILE 175CC SALINE PROSTHESES EXPERIENCED RIGHT SIDED DEFLATION AND LEFT SIDED CUTANEOUS CONTOUR DEFORMITY POST PROCEDURE. AS A RESULT, REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2024.
Patient problems: Wrinkling
MAUDE report 19801000 ↗InjuryJul 3, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 175CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY DEFLATED BREAST IMPLANTS DURING A VISUAL EXAM WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 350CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19669188 ↗InjuryJul 3, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 175CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY DEFLATED BREAST IMPLANTS DURING A VISUAL EXAM WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 350CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19668904 ↗InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH TWO 175CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED GENERALIZED ILLNESS INCLUDING ANXIETY, PANIC ATTACKS, ALLERGIES, CHRONIC SINUSITIS, URTICARIA, BRAIN FOG, FATIGUE, GI PROBLEMS, AND DEPRESSION 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 SIDE DEVICE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19651592 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page