MENTOR Smooth Round High Profile 3503170Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00081317001560), received between Sep 28, 2020 and Jun 20, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MENTOR SMOOTH ROUND HIGH PROFILE 170CC SALINE PROSTHESES EXPERIENCED BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE AND SKIN REACTION POST PROCEDURE. THE PATIENT WAS GETTING RASHES ON HER BODY. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2023. SEE 1645337-2023-07294 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture; Skin Inflammation/ Irritation

  MAUDE report 17164425 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MENTOR SMOOTH ROUND HIGH PROFILE 170CC SALINE PROSTHESES EXPERIENCED BILATERAL BAKER GRADE IV CAPSULAR CONTRACTURE AND SKIN REACTION POST PROCEDURE. THE PATIENT WAS GETTING RASHES ON HER BODY. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2023. 1645337-2023-07293 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture; Skin Inflammation/ Irritation

  MAUDE report 17164420 ↗
• InjuryNov 22, 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 UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 170CC MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS AND EXPERIENCED LEFT-SIDED GRADE IV CAPSULAR CONTRACTURE POSTOPERATIVELY. THE DIAGNOSIS WAS CONFIRMED BASED ON PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED BREAST IMPLANT ON (B)(6) 2021.

  Patient problems: Capsular Contracture

  MAUDE report 12857918 ↗
• InjurySep 28, 2020Migration; Migration

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR SMOOTH ROUND HIGH PROFILE 170CC AND SUFFERED FROM BILATERAL DEVICE MIGRATION AND BLEEDING FROM NIPPLES AND PAIN. THE IMPLANTS NEVER SETTLED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: Local Reaction

  MAUDE report 10593818 ↗
• InjurySep 28, 2020Migration; Migration

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR SMOOTH ROUND HIGH PROFILE 170CC AND SUFFERED FROM BILATERAL DEVICE MIGRATION AND BLEEDING FROM NIPPLES AND PAIN. THE IMPLANTS NEVER SETTLED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: Local Reaction

  MAUDE report 10593804 ↗

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