MENTOR Smooth Round Moderate Profile 3501645Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,655 adverse event reports that list this exact device (DI 00081317001249), received between Jan 19, 2018 and Sep 30, 2026 — classified as 1,639 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (1,273 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,655 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Material Rupture

  It was reported that a female patient underwent Breast Augmentation Revisionwith MENTOR Smooth Round Moderate Profile, 300cc Saline prosthesis. Subsequently the patient experienced right side deflation post operation. The issue was diagnosed through physical examination. As a result, the patient underwent bilateral replacements with CAT: 3501650 on (b)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50949030 ↗
• InjurySep 23, 2026Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Breast Augmentation Revision Surgery with implantation of a 300cc MENTOR Smooth Round Moderate Profile saline breast implant prosthesis. Immediate post-operative issues occurred where the patient reported experiencing significant swelling and bruising of the right breast with loss of sensation on the right side. The right implant apparently folded and Capsular Contracture developed with persistent and significant pain on the right side. A drain was subsequently placed, after which the condition temporally improved. The implant later eroded through the skin, requiring emergency surgical removal, and that there was concern for a serious infection. No confirmed diagnosis of infection was provided. Later, the patient indicated that the same implant was reimplanted under the breast and is continuing to causing ongoing symptoms including breast deformity, persistent hardness, and daily discomfort. The patient expressed concern regarding a potentially defective implant. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.Mentor Smooth Round Moderate Profile breast implants are not

  Patient problems: Capsular Contracture; Local Reaction; Pocket Erosion

  MAUDE report 50872582 ↗
• InjurySep 16, 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. The patient developed pain in her right breast and noticed a difference in size of the breast. Right breast prosthesis deflation was later diagnosed by mammogram. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 50792427 ↗
• InjurySep 15, 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. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50774819 ↗
• InjurySep 14, 2026Material Rupture

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50765414 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Breast Surgery with implantation of a 300cc MENTOR Smooth Round Moderate Profile saline breast implant prosthesis. Post-operatively, the patient reported developing cancer in the left breast and she can feel the plastic bag of the right implant. To date, the pathology/cytology report has not been provided. 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.This report is for the left breast prosthesis.

  Patient problems: Breast Cancer

  MAUDE report 50376482 ↗
• InjuryAug 7, 2026Material Rupture

  It was reported that a female patient underwent revision breast augmentation with 300cc MENTOR Smooth Round Moderate Profile and experienced breast implant deflation on her left side postoperatively. The patient underwent replacement surgery with catalog number 3501645 on (b)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50174929 ↗
• InjuryApr 23, 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 PARESTHESIA 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: Paresthesia

  MAUDE report 24971441 ↗
• InjuryApr 23, 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 PARESTHESIA 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: Paresthesia

  MAUDE report 24971354 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS DEVELOPED A HEMATOMA IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESIS.

  Patient problems: Hematoma

  MAUDE report 24917909 ↗
• InjuryApr 8, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 300CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICE WAS A MENTOR SALINE IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24818916 ↗
• InjuryMar 30, 2026Migration

  IT WAS REPORTED THAT A 40-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 300CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL CUTANEOUS CONTOUR DEFORMITY AND BILATERAL DEVICE MIGRATION POST-OPERATIVELY. THE BREAST WERE RIPPLING AND THE PATIENT FELT THEY WERE MOVING AROUND. 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: Wrinkling

  MAUDE report 24719081 ↗
• InjuryMar 30, 2026Migration

  IT WAS REPORTED THAT A 40-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 300 CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL CUTANEOUS CONTOUR DEFORMITY AND BILATERAL DEVICE MIGRATION POST-OPERATIVELY. THE BREAST WERE RIPPLING AND THE PATIENT FELT THEY WERE MOVING AROUND. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Wrinkling

  MAUDE report 24719017 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SMOOTH ROUND MODERATE PROFILE, 300CC SALINE PROSTHESIS EXPERIENCED UNEXPLAINED SYSTEMATIC SYMPTOMS POST OPERATION INCLUDING PAIN, PRESSURE, DULLNESS, AND BURNING SENSATION. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24701069 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR SMOOTH ROUND MODERATE PROFILE, 300CC SALINE PROSTHESIS EXPERIENCED UNEXPLAINED SYSTEMATIC SYMPTOMS POST OPERATION INCLUDING PAIN, PRESSURE, DULLNESS, AND BURNING SENSATION. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24701029 ↗
• InjuryMar 5, 2026Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 300CC 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 24522236 ↗
• InjuryFeb 25, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 300CC 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 24443894 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT 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 24329197 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 300CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH REPORTED EXPERIENCING JOINT AND SHOULDER PAIN. A CONSULTATION WITH A MEDICAL PROFESSIONAL WAS CONDUCTED BUT NO FURTHER INFORMATION WAS PROVIDED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF IMPLANTATION AND EVENT WERE PROVIDED TO MENTOR AS A BEST ESTIMATE. MENTOR BECAME AWARE THAT A DISCREPANCY WAS OBSERVED WHEN THE INFORMATION REPORTED INCLUDED A DATE OF IMPLANTATION THAT OCCURRED PRIOR TO THE MANUFACTURING DATE OF THE BREAST IMPLANT. 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: Pain

  MAUDE report 24274524 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 300CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH REPORTED EXPERIENCING JOINT AND SHOULDER PAIN. A CONSULTATION WITH A MEDICAL PROFESSIONAL WAS CONDUCTED BUT NO FURTHER INFORMATION WAS PROVIDED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF IMPLANTATION AND EVENT WERE PROVIDED TO MENTOR AS A BEST ESTIMATE. MENTOR BECAME AWARE THAT A DISCREPANCY WAS OBSERVED WHEN THE INFORMATION REPORTED INCLUDED A DATE OF IMPLANTATION THAT OCCURRED PRIOR TO THE MANUFACTURING DATE OF THE BREAST IMPLANT. 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: Pain

  MAUDE report 24274523 ↗
• InjuryJan 29, 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. SLOW LEAK OF THE RIGHT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES. THE REPORTED IMPLANTATION DATE IS AFTER THE EXPIRATION DATE OF THE SUSPECT MEDICAL DEVICE. MENTOR WILL REPORT THE IMPLANTATION DATE AS RECEIVED. IF CLARIFICATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24215161 ↗
• InjuryJan 28, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 300CC 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 24201143 ↗
• InjuryDec 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 47-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 300CC 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 23936932 ↗
• InjuryDec 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 300CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A BREAST CYST AND A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Cyst(s)

  MAUDE report 23926194 ↗
• InjuryDec 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 36-YEAR-OLD BLACK FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 300CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH 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: Deformity/ Disfigurement

  MAUDE report 23898382 ↗

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, Classified
  MENTOR 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 · Terminated
  Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048