MENTOR Smooth Round High Profile 3503190Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00081317001577), received between Jun 6, 2018 and Apr 15, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Material Rupture” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

1. Sep 30, 2021Class IIOpen, Classified

   Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.

   Z-0367-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND HIGH PROFILE 190CC SALINE PROTHESIS EXPERIENCED SPONTANEOUS LEFT SIDED DEFLATION POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19111342 ↗
• InjuryFeb 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND HIGH PROFILE 190CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. THE PATIENT DEVELOPED PAIN IN HER LEFT BREAST AND NOTICED THAT THE BREAST LACKED FIRMNESS. DEFLATION WAS LATER DIAGNOSED BY A HEALTHCARE PROFESSIONAL. 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 16387309 ↗
• InjuryAug 31, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 190CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR UNILATERAL REMOVAL AND REPLACEMENT WITH A LEFT-SIDED 190CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15329401 ↗
• InjuryFeb 2, 2021Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 210CC MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS (LEFT) AND A 190CC MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS (RIGHT) EXPERIENCED BILATERAL LOCAL REACTION POSTOPERATIVELY. THE PATIENT EXPERIENCED SHARP BREAST PAIN AND PRESSURE IN HER BREASTS. THE PATIENT STATED THAT HER RIGHT BREAST APPEARED LARGER THAN THE LEFT SIDE. DUE TO THE SYMPTOMS, THE PATIENT HAD A CONSULTATION WITH A HEALTHCARE PROFESSIONAL. HOWEVER, NO DIAGNOSIS WAS CONFIRMED. THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2020. THE SURGEON¿S OFFICE STATED THE PATIENT UNDERWENT THE REVISION SURGERY BY HER OWN CHOICE WITHOUT CONFIRMED DIAGNOSIS. THE PATIENT RETAINED THE DEVICES AFTER THE REVISION SURGERY. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: Local Reaction

  MAUDE report 11269968 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH TWO 190CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES, SUFFERED BILATERAL BREAST RIPPLING, WITH THE LEFT SIDE SIGNIFICANTLY SMALLER AND HAS DECREASED IN SIZE, POST-PROCEDURE. 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: Wrinkling

  MAUDE report 11261811 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR OLD CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH TWO 190CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES, SUFFERED BILATERAL BREAST RIPPLING, WITH THE LEFT SIDE SIGNIFICANTLY SMALLER AND HAS DECREASED IN SIZE, POST-PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Wrinkling

  MAUDE report 11261803 ↗
• InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6 YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SMOOTH ROUND HIGH PROFILE 190CC BREAST IMPLANT AND EXPERIENCED IMPLANT PALPABILITY ON THE LEFT SIDE POST-OPERATIVELY. MAMMOGRAM AND ULTRASOUND WERE PERFORMED, AND NO BREAST MASS WAS DISCOVERED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Wrinkling

  MAUDE report 10879307 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND HIGH PROFILE 190CC SALINE PROSTHESIS. LEFT SIDED DEFLATION AND RIGHT SIDED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) WERE NOTED POST PROCEDURE. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH 500CC MENTOR MEMORYGEL BREAST IMPLANTS WAS PERFORMED ON (B)(6) 2020. THE LEFT SIDED DEFLATION WAS REPORTED UNDER 1645337-2018-03525 ON (B)(6) 2018. ON (B)(6) 2020 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF THE RIGHT SIDED CAPSULAR CONTRACTURE. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10781500 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 190CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE PATIENT HAS CONSULTED A HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 10305002 ↗
• InjuryJun 6, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND HIGH PROFILE 190CC SALINE PROSTHESIS. ON (B)(6) 2018 LEFT SIDED DEFLATION WAS OBSERVED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 7575955 ↗

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-2070-2017 · Mar 27, 2017 · Terminated
  Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048