MENTOR Smooth Round Moderate Profile 3501650Recalls & 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 Profile (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Mentor saline breast implant has 2,186 reports, with 2,172 listed as injuries and no deaths. Most describe the implant rupturing and deflating, and some describe deformity or capsular contracture. Some reports describe removal of the implant. No recalls name this device. Reports fell to 57 in the last 12 months from 125 in the previous 12.
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
- 2,187
- Deaths reported
- 0
- Injuries reported
- 2,173
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,187 adverse event reports that list this exact device (DI 00081317001256), received between Jan 23, 2018 and Sep 29, 2026 — classified as 2,173 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (1,630 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 Rupture1,630
- Adverse Event Without Identified Device or Use Problem558
- Migration25
- Deflation Problem9
- No Apparent Adverse Event8
- Use of Device Problem8
- Connection Problem7
- Microbial Contamination of Device6
Patient problems
- Deformity/ Disfigurement896
- No Code Available819
- Capsular Contracture329
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available115
- Pain85
- Breast Discomfort/Pain38
- Wrinkling32
- Autoimmune Disorder30
Recent adverse event reports
The 25 most recent of 2,187 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Material Rupture
It was reported that a patient underwent a primary breast augmentation 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 50936721 ↗InjurySep 28, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50926111 ↗InjurySep 23, 2026Material Rupture
It was reported that a female patient underwent Breast Augmentation Revision with MENTOR Smooth Round Moderate Profile 325cc saline prosthesis. subsequently the patient experienced right sided Deflation postoperatively. The issue was diagnosed through physical examinations. At the time of this report, Mentor received no information regarding explantation or an expected explantation date.
Patient problems: Deformity/ Disfigurement
MAUDE report 50871578 ↗InjurySep 23, 2026Material Rupture
It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 325cc 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 bilateral exchange with Mentor saline implants on (b)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50869356 ↗InjurySep 17, 2026Material Rupture
It was reported that a 68-year-old Caucasian female patient underwent a breast augmentation revision with a 325cc 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 50806407 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50791836 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Capsular Contracture
MAUDE report 50763358 ↗InjuryAug 24, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50416521 ↗InjuryAug 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 is scheduled for removal on (b)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50161587 ↗InjuryAug 4, 2026Material Rupture
It was reported that a patient underwent a primary breast augmentation procedure with MENTOR Smooth Round Moderate Profile saline breast prostheses that both deflated post implantation. As a result, the patient underwent bilateral explantation and replacement with MENTOR Smooth Round Moderate Plus Profile saline breast prostheses.This MedWatch report is for the patient¿s right breast prosthesis.
Patient problems: Deformity/ Disfigurement
MAUDE report 50131250 ↗InjuryAug 4, 2026Material Rupture
It was reported that a patient underwent a primary breast augmentation procedure with MENTOR Smooth Round Moderate Profile saline breast prostheses that both deflated post implantation. As a result, the patient underwent bilateral explantation and replacement with MENTOR Smooth Round Moderate Plus Profile saline breast prostheses.This MedWatch report is for the patient¿s left breast prosthesis.
Patient problems: Deformity/ Disfigurement
MAUDE report 50131247 ↗InjuryJul 22, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF AN UNDISCLOSED MENTOR SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT BILATERAL IMPLANT EXCHANGE WITH MENTOR SALINE IMPLANTS ON (B)(6), 2026, FOR AN UNDISCLOSED REASON. HOWEVER, DURING THE SURGERY, THE LEFT IMPLANT WAS OBSERVED TO BE DEFLATED. THE DATE OF IMPLANTATION WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.
Patient problems: Capsular Contracture; Deformity/ Disfigurement
MAUDE report 25906649 ↗InjuryJul 8, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC 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: Capsular Contracture; Deformity/ Disfigurement
MAUDE report 25749682 ↗InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 325CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED CAPSULAR CONTRACTURE OF AN UNDISCLOSED SIDE AND BAKER GRADE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2017. AS THE AFFECTED SIDE WAS NOT PROVIDED, THE LOT/SERIAL NUMBERS FOR BOTH PRODUCTS ARE BEING PROVIDED AS LEFT IMPLANT - LOT: 5634461 / SERIAL: (B)(6) AND RIGHT IMPLANT - LOT: 5632785 / SERIAL: (B)(6). THE CATALOG NUMBERS ARE THE SAME FOR BOTH DEVICES. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.
Patient problems: Capsular Contracture
MAUDE report 25524124 ↗InjuryJun 3, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC 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 25376644 ↗InjuryMay 21, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 325CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED A DEFLATED RIGHT IMPLANT. AS A RESULT, THE PATIENT UNDERWENT RIGHT-SIDED EXCHANGE WITH A MENTOR SALINE IMPLANT ON (B)(6), 2016. 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 25248244 ↗InjuryMay 19, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 325 CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT IMPLANT DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT WAS SCHEDULED FOR IMPLANT REMOVAL ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 25220095 ↗InjuryMay 14, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES.
Patient problems: Deformity/ Disfigurement
MAUDE report 25167078 ↗InjuryApr 16, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 325CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT IMPLANT DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR SALINE IMPLANTS ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24904734 ↗InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 52-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 325CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED CUTANEOUS CONTOUR DEFORMITY (RIPPLING AND FOLDING) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH A 350CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS.
Patient problems: Wrinkling
MAUDE report 24818665 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 27-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2014 AND REPLACED WITH TWO 425CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 24760720 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 27-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2014, AND REPLACED WITH TWO 425CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 24760718 ↗InjuryMar 30, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 325CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR SALINE IMPLANTS ON (B)(6) 2026. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.
Patient problems: Deformity/ Disfigurement
MAUDE report 24721815 ↗InjuryMar 20, 2026Material Rupture
IT WAS REPORTED THAT A 41-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 325CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24651115 ↗InjuryMar 13, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 325CC 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 24589667 ↗
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 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
- 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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