MENTOR Smooth Round Moderate Profile 3501670Recalls & reported problems
Mentor Texas L.P. · Saline Breast Implant with Diaphragm Valve, 425cc |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 breast implant has 1,892 adverse event reports on record, with no deaths and 1,876 injuries. Most reports are coded as the implant material rupturing, and many describe hard scar tissue forming around the implant (capsular contracture) or the implant deflating, with some patients having the implants removed. Reports fell to 43 in the last 12 months, from 112 in the year 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
- 1,899
- Deaths reported
- 0
- Injuries reported
- 1,883
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,899 adverse event reports that list this exact device (DI 00081317001287), received between Oct 24, 2017 and Sep 28, 2026 — classified as 1,883 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (1,502 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 Rupture1,502
- Adverse Event Without Identified Device or Use Problem393
- Migration31
- Appropriate Device Problem Term/Code Not Available12
- Deflation Problem8
- Device Contamination with Chemical or Other Material5
- No Apparent Adverse Event4
- Connection Problem3
Patient problems
- Deformity/ Disfigurement777
- No Code Available770
- Capsular Contracture243
- Pain90
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available63
- Breast Discomfort/Pain36
- Autoimmune Reaction25
- Wrinkling24
Recent adverse event reports
The 25 most recent of 1,899 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50923194 ↗InjurySep 28, 2026Material Rupture
Patient problems: Deformity/ Disfigurement
MAUDE report 50923193 ↗InjurySep 28, 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. The event reportedly occurred after the patient jumped into a pool. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.The reported implantation date is prior to the device manufacture date. If additional information is received regarding the correct date of implantation or device lot number, a supplemental report will be submitted.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement
MAUDE report 50917164 ↗InjurySep 24, 2026Material Rupture
It was reported that a patient underwent primary breast augmentation with two 425cc MENTOR Smooth Round Moderate Profile saline breast prostheses. Post-operatively, the patient was diagnosed with left breast implant deflation. As a result, the patient underwent breast implant removal and replacement surgery on (b)(6)2026. The replacement devices were two Mentor saline breast prostheses.
Patient problems: Deformity/ Disfigurement
MAUDE report 50882771 ↗InjurySep 23, 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.
Patient problems: Deformity/ Disfigurement
MAUDE report 50867739 ↗InjurySep 22, 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 50856437 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent a Breast Reconstruction Revision Surgery with implantation of a 425cc MENTOR Smooth Round Moderate Profile saline breast implant prosthesis. Post-operatively, the patient was diagnosed with right breast cancer and resultantly underwent partial mastectomy and radiation. After this, she developed right breast Capsular Contracture (Baker Grade was not provided) with pain, deformity, and contour deformities. As a result, the patient underwent right-sided exchange with a Mentor saline implant on (b)(6) 2025. Additionally, during the surgery, significant inflammation of the capsule and tethering to the skin was observed. Furthermore, oozing was noted from the tissue when dissecting into the implant capsule.
Patient problems: Breast Cancer; Capsular Contracture; Local Reaction
MAUDE report 50790981 ↗InjurySep 16, 2026Material Rupture
It was reported that a patient with Saline MENTOR Smooth Round Moderate Profile breast implants experienced bilateral deflation post-operatively, which was confirmed during a physical exam. The patient experienced a fall which may have caused or contributed to the event. As a result, the patient is scheduled for removal on (b)(6) 2026.This report is for the left breast prosthesis.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement
MAUDE report 50786303 ↗InjurySep 16, 2026Material Rupture
It was reported that a patient with Saline MENTOR Smooth Round Moderate Profile breast implants experienced bilateral deflation post-operatively, which was confirmed during a physical exam. The patient experienced a fall which may have caused or contributed to the event. As a result, the patient is scheduled for removal on (b)(6) 2026.This report is for the right breast prosthesis.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement
MAUDE report 50786302 ↗InjuryAug 4, 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 50132710 ↗InjuryJul 28, 2026Material Rupture
It was reported that a patient underwent breast augmentation revision with two 425cc 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 has been scheduled for breast implant removal surgery on (b)(6)2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50059764 ↗InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 34-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 425CC 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) 2026 AND REPLACED WITH MENTOR BREAST PROSTHESES. THIS REPORT IS FOR THE LEFT SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 25494323 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
AN ADULT FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PROFILE SILICONE IMPLANTS (LEFT: 425 CC; RIGHT: 475 CC). POSTOPERATIVELY SHE DEVELOPED BILATERAL CAPSULAR CONTRACTURE OF UNSPECIFIED GRADE, A PSYCHIATRIC DISORDER, AND RIGHT-SIDED IMPLANT DEFLATION, WHICH WAS CONFIRMED BY MAMMOGRAPHY. THE PATIENT REPORTED SIGNIFICANT PHYSICAL DISCOMFORT AND EMOTIONAL DISTRESS RELATED TO THESE COMPLICATIONS. CONSEQUENTLY, SHE UNDERWENT BILATERAL EXPLANTATION (IMPLANT REMOVAL) ON (B)(6) 2026. THIS REPORT PERTAINS TO THE LEFT SIDE.
Patient problems: Capsular Contracture; Emotional Changes
MAUDE report 25304011 ↗InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III/IV). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Capsular Contracture
MAUDE report 25163996 ↗InjuryApr 16, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT IMPLANT BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. AS A RESULT, THE PATIENT UNDERWENT LEFT-SIDED EXCHANGE WITH A MENTOR SALINE IMPLANT ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 24897049 ↗InjuryMar 31, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES EXPERIENCED BILATERAL WRINKLING AND 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: Wrinkling
MAUDE report 24748442 ↗InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES EXPERIENCED BILATERAL WRINKLING AND 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: Wrinkling
MAUDE report 24748326 ↗InjuryMar 30, 2026Material Rupture
IT WAS REPORTED THAT A 40-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 425CC 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 AND REPLACED WITH A 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 24736010 ↗InjuryMar 25, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION AND HYPERTROPHIC SCARRING ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Scar Tissue
MAUDE report 24690664 ↗InjuryMar 16, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS EXPERIENCED CAPSULAR CONTRACTURE AND A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY.
Patient problems: Capsular Contracture
MAUDE report 24611199 ↗InjuryMar 11, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 425CC 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) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24569685 ↗InjuryMar 5, 2026Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 425CC 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 24524133 ↗InjuryFeb 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 UNDERWENT DEVICE REMOVAL AND REPLACEMENT.
Patient problems: Deformity/ Disfigurement
MAUDE report 24430065 ↗InjuryFeb 20, 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 AN IN-OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24401930 ↗InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI AND MAMMOGRAM, WITH LEFT BREAST SWELLING, FLUID AROUND THE DEVICES, AND CAPSULITIS. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICE WAS NON-MENTOR.
Patient problems: Capsular Contracture; Local Reaction
MAUDE report 24323970 ↗
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 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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