MENTOR Smooth Round Moderate Profile 3501610Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00081317001171), received between Mar 14, 2018 and Sep 2, 2025 — classified as 56 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (39 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 59 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE, 125CC SALINE PROSTHESIS EXPERIENCED RIGHT-SIDED DEFLATION, AND BILATERAL WRINKLING POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH VISUAL EXAMINATIONS. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENTS OF IMPLANTS AND REVISION INFRAMAMMARY FOLD BILATERALLY ON (B)(6) 2025. THE REPLACEMENT SERIAL NUMBERS: LEFT: SN: (B)(6), RIGHT: SN: (B)(6). THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Wrinkling

  MAUDE report 22938952 ↗
• InjuryFeb 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 125CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21423966 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR SMOOTH ROUND MODERATE PROFILE, 125CC ON THE A SIDE, AND 175CC ON THE B SIDE, SILICONE BREAST IMPLANTS EXPERIENCED DISSATISFACTION WITH IMPLANTS POSTOPERATIVE. THE HEALTH CARE PROFESSIONAL REPORTED THAT ON THE DAY OF SURGERY WITH THE PATIENT ASLEEP ON THE TABLE, THEY REALIZE THAT J&J CUSTOMER CARE MADE AN ERROR AND ONLY ORDERED 1 IMPLANT OF EACH SIZE - NOT 2 IMPLANTS. SINCE THEY WERE SALINE IMPLANTS AND THE PATIENT ON THE TABLE DECIDED TO PROCEED WITH THE SURGERY AND ADJUST THE SALINE LEVELS TO MAKE THEM LOOK AS EVEN AS POSSIBLE. AFTER THE SURGERY, THE PATIENT NOTIFIED THE MD RIGHT AWAY ABOUT THE ISSUE, TOLD THE PATIENT WHAT HAD HAPPENED, SHE SAID RIGHT AWAY SHOULD FEEL ONE BREAST WAS FIRMER THAN THE OTHER AND WANTED TO WAIT UNTIL 3-MONTH POST OP TO SEE THE RESULTS. IT HAS NOW BEEN 3 MONTHS, AND THE PATIENT IS EXTREMELY UPSET AND UNHAPPY., AND WANTS TO EXPLANT THE IMPLANTS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE A SIDE.

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

  MAUDE report 20836077 ↗
• InjurySep 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE, 125CC SALINE PROSTHESIS EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH VISUAL EXAMINATIONS. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20302762 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 125CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 3 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: Capsular Contracture

  MAUDE report 19615818 ↗
• InjuryJun 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

  ONE SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 125CC BREAST IMPLANT WAS RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB ON MAY 31, 2024, WITH NO ACCOMPANYING INFORMATION. ON JUN 3, 2024, THE DEVICE WAS DETERMINED TO NOT BE ASSOCIATED WITH ANY EXISTING COMPLAINT. IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHY THIS DEVICE WAS RETURNED TO MENTOR. HOWEVER, THE RETURN OF A PROSTHESIS IS CHARACTERISTIC OF A REMOVAL AND REPLACEMENT SURGERY. AS A RESULT, THIS WILL BE CONSERVATIVELY REPORTED TO FDA.

  Patient problems: Insufficient Information

  MAUDE report 19568051 ↗
• InjuryMay 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 39-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 125CC MENTOR SMOOTH ROUND MODERATE PROFILE AND LEFT SIDE BREAST IMPLANT DEFLATION WAS FOUND DURING BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3501610; SERIAL NUMBER: (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3501625; SERIAL NUMBER: (B)(6) ON THE RIGHT SIDE ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19264403 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 125CC (LEFT), 175CC (RIGHT), MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS EXPERIENCED UNSPECIFIED ILLNESS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

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

  MAUDE report 19197077 ↗
• InjuryMar 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 125CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA IMAGING. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18915388 ↗
• InjuryFeb 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 125CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A DEFLATED RIGHT BREAST IMPLANT. A MAMMOGRAM WAS CONDUCTED IN ADDITION TO A CONSULTATION WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL 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 18763956 ↗
• InjuryAug 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH A 125CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS ON AN UNSPECIFIED BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17447377 ↗
• InjuryJul 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE, 125CC SALINE PROSTHESIS EXPERIENCED LEFT-SIDED DEFLATION POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH ULTERASOUND EXAMINATION. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17261981 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 48-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH UNSPECIFIED MENTOR SALINE BREAST IMPLANTS AND EXPERIENCED BILATERAL BREAST PAIN ALONG WITH DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. REPORTEDLY, THE PATIENT EXPERIENCED THE PAIN DURING A MAMMOGRAM, AND NOTICED THE DEFLATION THE NEXT MORNING. THE MAMMOGRAM MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2023-06712 FOR CONTRALATERAL SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Discomfort/Pain

  MAUDE report 17079731 ↗
• InjuryJun 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 48-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH UNSPECIFIED MENTOR SALINE BREAST IMPLANTS AND EXPERIENCED BILATERAL BREAST PAIN ALONG WITH DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. REPORTEDLY, THE PATIENT EXPERIENCED THE PAIN DURING A MAMMOGRAM, AND NOTICED THE DEFLATION THE NEXT MORNING. THE MAMMOGRAM MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2023-06714 FOR CONTRALATERAL SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Discomfort/Pain

  MAUDE report 17079725 ↗
• InjuryMay 25, 2023Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  ON (B)(6) 2021, MENTOR RECEIVED A 125CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS WITHOUT ANY COMPLAINT INFORMATION ATTACHED AND IT COULD NOT BE ASSOCIATED WITH AN EXISTING COMPLAINT. ON (B)(6) 2021, A LEAK TEST WAS PERFORMED IN ACCORDANCE WITH MENTOR'S PROCEDURES. FINDINGS REVEALED A TEAR NEAR THE VALVE. MENTOR WILL REPORT THIS CONSERVATIVELY AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN FURTHER CLARIFYING INFORMATION IS MADE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17007678 ↗
• InjuryMay 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 76-YEAR-OLD FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SMOOTH ROUND MODERATE PROFILE, 125CC SALINE PROSTHESIS EXPERIENCED BILATERAL DEFLATION POSTOPERATIVELY. PATIENT HAD AN ACCIDENT WITH MOTOR VEHICLE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION AND CONFIRMED WITH MAMMOGRAM EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6)2023. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16864798 ↗
• InjuryMay 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 76-YEAR-OLD FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SMOOTH ROUND MODERATE PROFILE, 125CC SALINE PROSTHESIS EXPERIENCED BILATERAL DEFLATION POSTOPERATIVELY. PATIENT HAD AN ACCIDENT WITH MOTOR VEHICLE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION AND CONFIRMED WITH MAMMOGRAM EXAMINATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2023. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16864776 ↗
• InjuryApr 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 125CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED RIGHT BREAST SORENESS, AND THE FOLLOWING DAY OBSERVED THE RIGHT BREAST HAD DEFLATED. DURING A CONSULTATION WITH A MEDICAL PROFESSIONAL, SHE WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 300CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANTS ON (B)(6) 2023.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 16685965 ↗
• InjuryNov 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 66-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH AN UNKNOWN MENTOR SALINE PROSTHESIS EXPERIENCED SPONTANEOUS RIGHT SIDED DEFLATION POST PROCEDURE. A PHYSICAL, AND SCAN EXAMINATION CONFIRMED THE DEFLATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH CAT#: 3501610 ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15846519 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 125CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN POST-OPERATIVELY. 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: Capsular Contracture

  MAUDE report 15710288 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 125CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN POST-OPERATIVELY. 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: Capsular Contracture

  MAUDE report 15710285 ↗
• MalfunctionOct 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BRAND NEW 125CC MENTOR SMOOTH ROUND MODERATE PROFILE WAS OPENED AND IT TORE AT THE VALVE AREA. THERE WERE NO PATIENT CONSEQUENCES OR ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614810 ↗
• InjurySep 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 125CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA MAMMOGRAM. ADDITIONALLY, THE MAMMOGRAM INDICATED THAT PATIENT HAS DEVELOPED MASSES ON HER RIGHT BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Mass

  MAUDE report 15371856 ↗
• InjuryJun 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 73-YEAR-OLD FEMALE PATIENT WHO UNDERWENT BREAST PATIENT SURGERY WITH A 125CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14705042 ↗
• InjuryApr 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH TWO 125CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANTS EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON AN UNSPECIFIED DATE. THIS MEDWATCH FORM IS FOR THE BREAST PROSTHESIS B.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14055979 ↗

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