MENTOR Smooth Round SPECTRUM 3501485Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00081317002031), received between Feb 27, 2018 and Apr 16, 2026 — classified as 35 injuries.

The most frequently reported specific device problem is “Material Rupture” (29 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES. 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 24897763 ↗
• InjuryNov 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 67-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 525CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. IT WAS REPORTED THAT THE PATIENT ALSO EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKE GRADE UNKNOWN). AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH MENTOR BREAST PROSTHESES. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23663054 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 67-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 525CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. IT WAS REPORTED THAT THE PATIENT ALSO EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKE GRADE UNKNOWN). AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH MENTOR BREAST PROSTHESES. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23663053 ↗
• InjuryJan 21, 2025Material Rupture; Use of Device Problem; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH SALINE MENTOR SMOOTH ROUND SPECTRUM 525CC 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. THE REPORTED DATE OF IMPLANTATION IS AFTER THE DEVICE MANUFACTURE DATE. THIS IS AN OFF LABEL USE OF THE DEVICE PER THE IFU.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21199980 ↗
• InjuryAug 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 525CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICE IS ANOTHER MENTOR SALINE IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20071742 ↗
• InjuryJan 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH UNKNOWN SIZE UNKNOWN SALINE IMPLANTS AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18563912 ↗
• InjuryJan 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SMOOTH ROUND SPECTRUM, 525CC, SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18447389 ↗
• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 49-YEAR-OLD FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 525CC MENTOR SMOOTH ROUND SPECTRUM ON BOTH SIDES AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE; DIAGNOSED VIRTUALLY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2023. ON (B)(6) 2023, MENTOR BECAME AWARE THAT THE PATIENT ALSO EXPERIENCED BILATERAL BREAST PTOSIS WITH WATERFALL DEFORMITY IN ADDITION TO RIGHT SIDE DEFLATION, AND UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3505535BC; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE, AND WITH CATALOG NUMBER 3505535BC; SERIAL NUMBER (B)(6) ON THE LEFT SIDE ON (B)(6) 2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17992795 ↗
• InjuryOct 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 49-YEAR-OLD FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 525CC MENTOR SMOOTH ROUND SPECTRUM AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE; DIAGNOSED VIRTUALLY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17851147 ↗
• InjuryAug 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND SPECTRUM 525CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA AN 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 17484618 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 525CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED PTOSIS ON THE RIGHT SIDE POST-OPERATIVELY. THE PATIENT UNDERWENT A MASTOPEXY AND HAD THE DEVICE EXPLANTED ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17100916 ↗
• InjuryMay 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 51-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 525CC MENTOR SMOOTH ROUND SPECTRUM 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 UNDERWENT EXPLANTATION ON (B)(6), 2023.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 16903755 ↗
• InjuryMay 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 34-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 525CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16855247 ↗
• InjuryMay 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 525CC MENTOR SMOOTH ROUND SPECTRUM 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: Deformity/ Disfigurement

  MAUDE report 16846053 ↗
• InjuryMar 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 50-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 525CC MENTOR SMOOTH ROUND SPECTRUM 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: Deformity/ Disfigurement

  MAUDE report 16462155 ↗
• InjuryJan 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 525CC MENTOR SMOOTH ROUND SPECTRUM SALINE PROSTHESIS. POST-OPERATIVELY, THE PATIENT HAD AN IN-OFFICE VISIT WITH THEIR HEALTH PROFESSIONAL WHO UTILIZED MAGNETIC RESONANCE IMAGING TO DIAGNOSE A DEFLATED RIGHT BREAST PROSTHESIS. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 525CC MENTOR SMOOTH ROUND SPECTRUM SALINE PROSTHESIS ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13388832 ↗
• InjuryDec 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SMOOTH ROUND SPECTRUM, 525CC SALINE BREAST IMPLANT EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH UNKNOWN MENTOR SILICONE IMPLANTS ON (B)(6) 2021. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12916944 ↗
• InjuryDec 2, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SMOOTH ROUND SPECTRUM, 525CC SALINE BREAST IMPLANT EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH UNKNOWN MENTOR SILICONE IMPLANTS ON (B)(6) 2021. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12916943 ↗
• InjuryMay 26, 2021Material Rupture; Connection Problem; Material Rupture; Connection Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 525CC MENTOR SMOOTH ROUND SPECTRUM SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AFTER THE DEVICE WAS EXPLANTED IT WAS PLACED ON THE STERILE TABLE AND IMMEDIATELY DEFLATED DUE TO WHAT APPEARED TO BE A FAULTY VALVE. THE DEVICE WAS REPLACED WITH AN UNSPECIFIED MENTOR SALINE PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11891509 ↗
• InjuryDec 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 CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND SPECTRUM 525CC BREAST IMPLANTS AND EXPERIENCED BILATERAL BREAST PAIN, CUTANEOUS CONTOUR DEFORMITY ON THE RIGHT SIDE, AND 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. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Pain; Wrinkling

  MAUDE report 11049447 ↗
• InjuryDec 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND SPECTRUM 525CC BREAST IMPLANTS AND EXPERIENCED BILATERAL BREAST PAIN, CUTANEOUS CONTOUR DEFORMITY ON THE RIGHT SIDE, AND 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. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Pain

  MAUDE report 11049431 ↗
• InjuryJul 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD HISPANIC FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 525CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES, SUFFERED LEFT BREAST IMPLANT DEFLATION, POST-PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10303467 ↗
• InjuryMay 29, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND SPECTRUM 525CC AND SUFFERED FROM DEFLATION ON THE RIGHT BREAST IMPLANT. 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 10102931 ↗
• InjuryMar 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 525CC MENTOR SMOOTH ROUND SPECTRUM PROSTHESIS AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED WOUND INFECTION. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 525CC MENTOR SMOOTH ROUND SPECTRUM PROSTHESIS (CATALOG #: 3501485, SERIAL #: (B)(4)) ON (B)(6) 2018.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9833263 ↗
• InjuryJan 7, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 525CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS ON THE RIGHT BREAST, SUFFERED RIGHT BREAST IMPLANT DEFLATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9560054 ↗

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