MENTOR Smooth Round Moderate Profile 3501655Recalls & reported problems
Mentor Texas L.P. · Saline Breast Implant with Diaphragm Valve, 350cc |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 used in breast augmentation and revision surgery. Most of the 1,529 reports describe the implant shell rupturing or the implant deflating after surgery, and many mention deformity or capsular contracture. The reports list no deaths and 1,514 injuries. The reports in the last 12 months number 40, compared with 93 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
- 1,534
- Deaths reported
- 0
- Injuries reported
- 1,518
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,534 adverse event reports that list this exact device (DI 00081317001263), received between Oct 27, 2017 and Sep 30, 2026 — classified as 1,518 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (1,181 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 Rupture1,181
- Adverse Event Without Identified Device or Use Problem339
- Migration15
- Deflation Problem9
- Appropriate Device Problem Term/Code Not Available7
- No Apparent Adverse Event6
- Microbial Contamination of Device4
- Use of Device Problem4
Patient problems
- No Code Available638
- Deformity/ Disfigurement571
- Capsular Contracture209
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available78
- Pain66
- Breast Discomfort/Pain29
- Autoimmune Reaction26
- Wrinkling21
Recent adverse event reports
The 25 most recent of 1,534 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Material Rupture
It was reported that a patient underwent a breast augmentation revision procedure with a MENTOR Smooth Round Moderate 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 is scheduled to undergo explantation.
Patient problems: Deformity/ Disfigurement
MAUDE report 50949104 ↗InjurySep 28, 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 50915690 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent primary breast reconstruction with two 350cc MENTOR Smooth Round Moderate Profile saline breast prostheses. Post-operatively, the patient developed left breast calcification, breast pain, and dislocation. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.
Patient problems: Capsular Contracture
MAUDE report 50791577 ↗InjurySep 16, 2026Material Rupture
It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 350cc MENTOR Smooth Round Moderate Profile saline breast implant prosthesis. Post-operatively, the patient was diagnosed with right breast Baker Grade IV Capsular Contracture and a deflated right implant by a medical professional using the patient's symptoms. As a result, the patient underwent bilateral exchange with Natrelle (non-Mentor) implants on (b)(6), 2026.
Patient problems: Capsular Contracture
MAUDE report 50791352 ↗InjurySep 16, 2026Material Rupture
It was reported that a patient implanted with a 350cc 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) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50790667 ↗InjurySep 16, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50782474 ↗InjuryAug 17, 2026Material Rupture
It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of an undisclosed Mentor 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 bilateral exchange with mentor gel implants on (b)(6) 2026.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: Deformity/ Disfigurement
MAUDE report 50284494 ↗MalfunctionAug 12, 2026Material Rupture
It was reported that an undisclosed Mentor breast implant prosthesis was observed ruptured during a Breast Augmentation Revision Surgery. No adverse events, patient harms, or patient consequences were reported. No further information was provided.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: No Clinical Signs, Symptoms or Conditions
MAUDE report 50223818 ↗InjuryJul 28, 2026Material Rupture
It was reported that a patient underwent breast augmentation with two MENTOR Smooth Round Moderate Profile saline breast prostheses. Post-operatively, the patient developed extreme bilateral breast pain and suffered bilateral breast implant deflation. 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: Breast Discomfort/Pain; Deformity/ Disfigurement
MAUDE report 50060967 ↗InjuryJun 18, 2026Material Rupture
IT WAS REPORTED THAT A 44-YEAR-OLD INDIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 350CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A MAMMOGRAM AND ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 25554556 ↗InjuryMay 27, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 350CC 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 25304506 ↗InjuryMay 16, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 350CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT LEAKAGES. 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 25196046 ↗InjuryMay 16, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 350CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT LEAKAGES. 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 25196045 ↗InjuryMay 12, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 350CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS REPORTED TO HAVE EXPERIENCED A LEAKING LEFT IMPLANT AFTER RECEIVING A MASSAGE. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED. 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 25153723 ↗InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 350CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST IMPLANT DEFLATION AND DEVELOPED LEFT BREAST PAIN AND BILATERAL BREAST SNOOPING. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 25141981 ↗InjuryMay 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 350CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE UNSPECIFIED), ON AND OFF PAIN TO THE LEFT OF THEIR SPINE, RIB AND CHEST DISCOMFORT. 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: Capsular Contracture; Pain
MAUDE report 25064338 ↗InjuryMay 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 350CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT DEVELOPED LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE UNSPECIFIED), ON AND OFF PAIN TO THE LEFT OF THEIR SPINE, RIB AND CHEST DISCOMFORT. 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: Pain
MAUDE report 25064337 ↗InjuryMar 30, 2026Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH 350CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON UNSPECIFIED 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 24709215 ↗InjuryMar 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. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT.
Patient problems: Deformity/ Disfigurement
MAUDE report 24701597 ↗InjuryMar 24, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 350CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT BELIEVED SHE HAD EXPERIENCED A DEFLATED RIGHT IMPLANT. SUBSEQUENTLY, SHE WAS INVOLVED IN A CAR ACCIDENT. DURING A PHYSICAL EXAM, SHE WAS DIAGNOSED WITH A DEFLATED LEFT IMPLANT AND A POSSIBLY DEFLATED RIGHT IMPLANT. 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 24682726 ↗InjuryMar 24, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 350CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT BELIEVED SHE HAD EXPERIENCED A DEFLATED RIGHT IMPLANT. SUBSEQUENTLY, SHE WAS INVOLVED IN A CAR ACCIDENT. DURING A PHYSICAL EXAM, SHE WAS DIAGNOSED WITH A DEFLATED LEFT IMPLANT AND A POSSIBLY DEFLATED RIGHT IMPLANT. 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 24677115 ↗InjuryMar 6, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 350CC 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) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24533837 ↗InjuryMar 4, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT GEL BREAST PROSTHESES.
Patient problems: Deformity/ Disfigurement
MAUDE report 24508153 ↗MalfunctionMar 3, 2026Appropriate Device Problem Term/Code Not Available
A 350CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS WAS RECEIVED BY THE MENTOR ANALYSIS LAB WITHOUT A COMPLAINT IN REGARD TO THE PRODUCT QUALITY OR PATIENT ISSUES. AS A RESULT, THE DEVICE WAS TESTED AND DETERMINED TO HAVE A REPORTABLE FAILURE MODE.
Patient problems: Insufficient Information
MAUDE report 24503787 ↗InjuryFeb 12, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 350CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT 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 24328277 ↗
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 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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page