MENTOR Smooth Round Moderate Plus Profile 3502700Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 00081317001515), received between Feb 27, 2018 and Sep 16, 2025 — classified as 100 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (77 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 105 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT IMPLANT DURING A PHYSICAL EXAM AS THERE WAS A DECREASED VOLUME. AS A RESULT, THE PATIENT UNDERWENT IMPLANT REMOVAL ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23065234 ↗
• InjuryAug 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED 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: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 22797232 ↗
• InjuryMay 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A POSSIBLE 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 22015326 ↗
• InjuryMar 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. 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 21638245 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 700CC SALINE BREAST PROSTHESES WHEN THE LEFT BREAST PROSTHESIS DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED DURING AN OFFICE VISIT. ADDITIONALLY, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN BOTH BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2024-14120 FOR THE REPORT FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21318659 ↗
• InjuryJan 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH AN UNKNOWN MENTOR SMOOTH SALINE IMPLANT ON THE LEFT BREAST AND A 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT DEFLATIONS. 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 21259975 ↗
• InjuryDec 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 700CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 20835455 ↗
• InjuryOct 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH AN UNSPECIFIED MENTOR 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 MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESES ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20391557 ↗
• MalfunctionSep 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS WAS FOUND TO BE DEFLATED DURING AN OPERATION. A PROCEDURAL DELAY OF FIVE MINUTES WAS REPORTED. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT AND THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20323539 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 64-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED BY A PHOTO. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 20295497 ↗
• InjuryJun 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 67-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19482044 ↗
• InjuryMay 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 700CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. LEFT BREAST PROSTHESIS DEFLATION WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S EXAM. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT FELL WHILE CHASING HER DAUGHTER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19334055 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT 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 19186531 ↗
• InjuryApr 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 700CC BREAST IMPLANTS AND 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 19122080 ↗
• InjuryMar 28, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED SEEPAGE UNDERNEATH HER LEFT BREAST INCISION SITE. THE SEEPAGE INCREASED AND THE PATIENT REPORTED THAT SHE WAS SOAKING THROUGH DRAINAGE PADS RAPIDLY. THE PATIENT WAS SEEN BY A SURGEON AND SUTURES WERE PLACED UNDER HER LEFT BREAST TO STOP THE LEAKING. THE DAY AFTER SUTURES WERE PLACED, THE PATIENT WOKE UP WITH A FEVER AND SWELLING OF THE LEFT BREAST AS WELL AS PAIN IN HER LEFT ARM AND SHOOTING PAIN IN HER SHOULDER AREA. THE PATIENT WAS ADMITTED TO A HOSPITAL WHERE A SEPSIS PROTOCOL WAS IMPLEMENTED DUE TO THE PATIENT¿S PRIOR HISTORY OF SEPSIS. SAMPLES WERE TAKEN FROM BOTH BREASTS AND SENT TO PATHOLOGY, THOUGH THE PATHOLOGY REPORTS WERE NOT DISCLOSED TO MENTOR. IT WAS ALSO REPORTED THAT THE PATIENT¿S BLOOD PRESSURE DROPPED, AND HER INFECTION WAS TREATED WITH ANTIBIOTICS. THE PATIENT WAS DIAGNOSED WITH CELLULITIS BILATERALLY. UNSPECIFIED SCANS INDICATED THAT DEFECTS WERE ALSO OBSERVED ON BOTH PATIENT¿S IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL SURGERY WITHOUT IMPLANT RE

  Patient problems: Post Operative Wound Infection

  MAUDE report 18997142 ↗
• InjuryMar 28, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED SEEPAGE UNDERNEATH HER LEFT BREAST INCISION SITE. THE SEEPAGE INCREASED AND THE PATIENT REPORTED THAT SHE WAS SOAKING THROUGH DRAINAGE PADS RAPIDLY. THE PATIENT WAS SEEN BY A SURGEON AND SUTURES WERE PLACED UNDER HER LEFT BREAST TO STOP THE LEAKING. THE DAY AFTER SUTURES WERE PLACED, THE PATIENT WOKE UP WITH A FEVER AND SWELLING OF THE LEFT BREAST AS WELL AS PAIN IN HER LEFT ARM AND SHOOTING PAIN IN HER SHOULDER AREA. THE PATIENT WAS ADMITTED TO A HOSPITAL WHERE A SEPSIS PROTOCOL WAS IMPLEMENTED DUE TO THE PATIENT¿S PRIOR HISTORY OF SEPSIS. SAMPLES WERE TAKEN FROM BOTH BREASTS AND SENT TO PATHOLOGY, THOUGH THE PATHOLOGY REPORTS WERE NOT DISCLOSED TO MENTOR. IT WAS ALSO REPORTED THAT THE PATIENT¿S BLOOD PRESSURE DROPPED, AND HER INFECTION WAS TREATED WITH ANTIBIOTICS. THE PATIENT WAS DIAGNOSED WITH CELLULITIS BILATERALLY. UNSPECIFIED SCANS INDICATED THAT DEFECTS WERE ALSO OBSERVED ON BOTH PATIENT¿S IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL SURGERY WITHOUT IMPLANT RE

  Patient problems: Post Operative Wound Infection

  MAUDE report 18994623 ↗
• InjuryDec 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 700CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT IS SCHEDULED FOR (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18247958 ↗
• InjuryNov 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 35-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED BREAST PAIN AND A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT MENTIONED THAT THE BREAST WAS GETTING SMALLER AND HAVING DISCOMFORT, ACHING, AND SORENESS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 18156703 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, IN-OFFICE, WITH LEFT BREAST IMPLANT DEFLATION AND PARTIAL WOUND DEHISCENCE ON THE RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THE REPLACEMENT DEVICES WERE: (LEFT) 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE CATALOG: 3502700, LOT: 9893601, SN: (B)(6) AND (RIGHT) 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE CATALOG: 3502700, LOT: 9927819, SN: (B)(6). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Impaired Healing

  MAUDE report 18125555 ↗
• InjuryNov 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, IN-OFFICE, WITH LEFT BREAST IMPLANT DEFLATION AND PARTIAL WOUND DEHISCENCE ON THE RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023. THE REPLACEMENT DEVICES WERE: (LEFT) 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE CATALOG: 3502700 LOT: 9893601 SN: (B)(6) AND (RIGHT) 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE CATALOG: 3502700 LOT: 9927819 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18125554 ↗
• InjuryOct 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17882923 ↗
• InjuryOct 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 700CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 700CC SALINE BREAST PROSTHESIS ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17870791 ↗
• InjuryMay 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 40-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT OBSERVED HER RIGHT BREAST WAS SMALLER THAN THE LEFT. DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL, SHE WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A RIGHT-SIDED 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17025420 ↗
• InjuryMay 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 34-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS TO UNDERGO EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16865813 ↗
• InjuryMay 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 43-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 700CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16854202 ↗

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