MENTOR Smooth Round Moderate Profile 3501640Recalls & reported problems
Mentor Texas L.P. · Saline Breast Implant with Diaphragm Valve, 275cc |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 Smooth Round saline breast implant is filled with saline. Most reports describe the implant rupturing or deflating, and some describe capsular contracture, which is tightening of the scar tissue around the implant. The FDA database lists 1,289 reports, with 1,273 injuries and no deaths, and reports fell in the last 12 months, to 40 from 77. 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
- 1,294
- Deaths reported
- 0
- Injuries reported
- 1,278
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,294 adverse event reports that list this exact device (DI 00081317001232), received between Jan 23, 2018 and Sep 28, 2026 — classified as 1,278 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (972 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 Rupture972
- Adverse Event Without Identified Device or Use Problem307
- Migration20
- Deflation Problem8
- No Apparent Adverse Event7
- Appropriate Device Problem Term/Code Not Available6
- Connection Problem4
- Material Deformation2
Patient problems
- No Code Available509
- Deformity/ Disfigurement498
- Capsular Contracture205
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available50
- Pain38
- Breast Discomfort/Pain26
- Autoimmune Reaction22
- Wrinkling17
Recent adverse event reports
The 25 most recent of 1,294 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50924238 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50924237 ↗InjurySep 24, 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 50885569 ↗InjurySep 23, 2026Material Rupture
It was reported that a patient implanted with a 275cc 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)2014.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871171 ↗InjurySep 17, 2026Material Rupture
It was reported that a 57-year-old female patient underwent a primary breast augmentation with a 275cc 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 underwent explantation on (b)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50808861 ↗InjurySep 15, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50779852 ↗InjuryAug 26, 2026Material Rupture
It was reported that a patient with Saline MENTOR Smooth Round Moderate 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 50458167 ↗InjuryJun 4, 2026Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY BREAST AUGMENTATION WITH 275 CC MENTOR SMOOTH ROUND MODERATE PROFILE AND EXPERIENCED UNKNOWN SIDE BREAST IMPLANT DEFLATION. AS A RESULT, THE DEVICE WAS EXPLANTED ON AN UNKNOWN DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 25391469 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 275CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE UNSPECIFIED). AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST CAPSULECTOMY WITHOUT IMPLANT REMOVAL ON (B)(6) 2026.
Patient problems: Capsular Contracture
MAUDE report 25131237 ↗InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE BREAST IMPLANTS EXPERIENCED BILATERAL RIPPLING 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: Wrinkling
MAUDE report 25020758 ↗InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE BREAST IMPLANTS EXPERIENCED BILATERAL RIPPLING 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: Wrinkling
MAUDE report 25020675 ↗InjuryApr 24, 2026Material Rupture
IT WAS REPORTED THAT A 52-YEAR-OLD BLACK FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 275CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND 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 24988256 ↗InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 275CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANTS PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. 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: Capsular Contracture
MAUDE report 24877937 ↗InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 275CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANTS PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. 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: Capsular Contracture
MAUDE report 24877934 ↗InjuryApr 7, 2026Material Rupture
IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 275CC 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) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24801957 ↗InjuryMar 5, 2026Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 275CC 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) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 24524390 ↗InjuryMar 2, 2026Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 275CC MENTOR SMOOTH ROUND MODERATE PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3501640; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3501640; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24482991 ↗InjuryFeb 25, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 275CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE LEFT SIDE AND A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24444239 ↗InjuryFeb 19, 2026Material Rupture
IT WAS REPORTED THAT A 52-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH AN UNSPECIFIED SALINE BREAST PROSTHESIS AND 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 24396700 ↗InjuryFeb 18, 2026Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 275CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING INFERIOR DISPLACEMENT OF THE LEFT BREAST IMPLANT WITH MUSCLE PULLING/DISCOMFORT WHICH RADIATED INTO THE SHOULDER, NECK, AND UPPER BACK AREAS. IT HAS IMPACTED HER DAILY FUNCTIONS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF IMPLANTATION WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. 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: Breast Discomfort/Pain; Pain
MAUDE report 24384980 ↗InjuryFeb 13, 2026Material Rupture
IT WAS REPORTED THAT A 74-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 275CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 24337800 ↗InjuryFeb 10, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 275CC 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 LEFT-SIDED EXCHANGE WITH A MENTOR SALINE IMPLANT ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24307212 ↗InjuryFeb 10, 2026Material Rupture
IT WAS REPORTED THAT A 66-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 275CC 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) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24306092 ↗InjuryFeb 6, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE BREAST IMPLANTS EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT.
Patient problems: Deformity/ Disfigurement
MAUDE report 24280605 ↗InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Capsular Contracture
MAUDE report 24261572 ↗
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 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
- MENTOR Smooth Round High Profile 3503330Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline679 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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