MENTOR Smooth Round SPECTRUM 3501430Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00081317001973), received between May 17, 2018 and Aug 20, 2025 — classified as 36 injuries.

The most frequently reported specific device problem is “Material Rupture” (27 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 34-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 225CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22856730 ↗
• InjuryOct 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 225CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES EXPERIENCED BILATERAL DEFLATIONS 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 20569019 ↗
• InjuryOct 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 225CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES EXPERIENCED BILATERAL DEFLATIONS 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 20569012 ↗
• InjuryJun 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH UNSPECIFIED MENTOR SALINE BREAST IMPLANTS AND EXPERIENCED BILATERAL DEFLATION 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. THIS REPORT IS FOR THE SECOND OF TWO DEVICES.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 19554234 ↗
• InjuryJun 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH UNSPECIFIED MENTOR SALINE BREAST IMPLANTS AND EXPERIENCED BILATERAL DEFLATION 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. THIS REPORT IS FOR THE FIRST OF TWO DEVICES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19553723 ↗
• InjuryJun 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR SMOOTH ROUND SPECTRUM 225CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN UNSPECIFIED BREAST PROSTHESIS ON (B)(6)2023.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 17210672 ↗
• InjuryJun 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 57-YEAR-OLD ASIAN FEMALE WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR SMOOTH ROUND SPECTRUM 225CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THE DEVICE BEGAN LEAKING ROUGHLY FOUR YEARS AGO AND NOW HAS COMPLETELY FLATTENED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17087735 ↗
• InjuryMay 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 225CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17033149 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 67-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 225CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES AND WAS DIAGNOSED WITH BREAST CANCER POST-OPERATIVELY. AT THIS TIME, THE RESULTS OF PATHOLOGY REPORT HAVE NOT BEEN PROVIDED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND BILATERAL MASTECTOMY ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Breast Cancer

  MAUDE report 16935638 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 67-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 225CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES AND WAS DIAGNOSED WITH BREAST CANCER POST-OPERATIVELY. AT THIS TIME, THE RESULTS OF PATHOLOGY REPORT HAVE NOT BEEN PROVIDED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND BILATERAL MASTECTOMY ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Breast Cancer

  MAUDE report 16934173 ↗
• InjuryMar 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 50-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 225CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16468676 ↗
• InjuryDec 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 225CC MENTOR SMOOTH ROUND SPECTRUM SALINE IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT INFORMED THEIR HEALTHCARE PROFESSIONAL THAT THE RIGHT BREAST IMPLANT WAS DEFLATING. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A MENTOR GEL IMPLANT ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13120143 ↗
• InjurySep 16, 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 BREAST RECONSTRUCTION WITH TWO 225CC MENTOR SMOOTH ROUND SPECTRUM PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (UNKNOWN GRADE) AND AUTOIMMUNE DISORDER POSTOPERATIVELY. THE PATIENT SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING JOINT PAIN (B)(6), MUSCLE PAIN (B)(6) 2020, WEAKNESS (B)(6) 2020, BREAST PAIN, ITCHING, JOINT STIFFNESS, FATIGUE, MUSCLE ACHE, PULSATION SENSATION, BRADYCARDIA, BURNING SENSATION, FINGER SWELLING, TINNITUS, EBV, VERTIGO, SWEATING, SLEEPING DIFFICULTY, DRY EYES, DRY MOUTH, METALLIC TASTE IN MOUTH, NOT ABLE TO FOCUS, WEIGHT LOSS, AND HEADACHES. THE PATIENT SATED THAT SHE WAS DIAGNOSED WITH FIBROMYALGIA ON (B)(6) 2021. NO DEVICE ISSUE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2021. THE PATIENT REPORTED THE EVENT TO FDA VIA MW5101770. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: Autoimmune Disorder; Capsular Contracture

  MAUDE report 12485327 ↗
• InjurySep 16, 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 BREAST RECONSTRUCTION WITH TWO 225CC MENTOR SMOOTH ROUND SPECTRUM PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (UNKNOWN GRADE) AND AUTOIMMUNE DISORDER POSTOPERATIVELY. THE PATIENT SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING JOINT PAIN ((B)(6) 2020), MUSCLE PAIN ((B)(6) 2020), WEAKNESS ((B)(6) 2020), BREAST PAIN, ITCHING, JOINT STIFFNESS, FATIGUE, MUSCLE ACHE, PULSATION SENSATION, BRADYCARDIA, BURNING SENSATION, FINGER SWELLING, TINNITUS, EBV, VERTIGO, SWEATING, SLEEPING DIFFICULTY, DRY EYES, DRY MOUTH, METALLIC TASTE IN MOUTH, NOT ABLE TO FOCUS, WEIGHT LOSS, AND HEADACHES. THE PATIENT SATED THAT SHE WAS DIAGNOSED WITH FIBROMYALGIA ON (B)(6) 2021. NO DEVICE ISSUE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2021. THE PATIENT REPORTED THE EVENT TO FDA VIA MW5101770. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

  Patient problems: Autoimmune Disorder; Capsular Contracture

  MAUDE report 12485318 ↗
• InjurySep 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD A 225CC MENTOR SMOOTH ROUND SPECTRUM SALINE PROSTHESIS PLACED EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, REPLACEMENT WITH A NEW 225CC MENTOR SMOOTH ROUND SPECTRUM SALINE PROSTHESIS WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12411253 ↗
• InjuryApr 19, 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 HISPANIC FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH TWO 225CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES, SUFFERED LEFT BREAST PAIN, POST-PROCEDURE. THE LEFT BREAST IS DESCRIBED TO FEEL LIKE A HOT SHARP SWORD, THROBBING, AND HAS HEATING PAD SENSATION. THE PATIENT IS UNABLE TO MOVE THE LEFT BREAST, LEAN FORWARD, HAVE PHYSICAL THERAPY OR LAY ON THE RIGHT SIDE OF THE BODY DUE TO STABBING PAIN. BOTH IMPLANTS ARE ALSO REPORTED TO BE ENGORGED AND HEAVY. THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO THE PAIN. 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: Capsular Contracture; Local Reaction; Paresthesia

  MAUDE report 11690965 ↗
• InjuryApr 19, 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 HISPANIC FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST AUGMENTATION WITH TWO 225CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES, SUFFERED LEFT BREAST PAIN, POST-PROCEDURE. THE LEFT BREAST IS DESCRIBED TO FEEL LIKE A HOT SHARP SWORD, THROBBING, AND HAS HEATING PAD SENSATION. THE PATIENT IS UNABLE TO MOVE THE LEFT BREAST, LEAN FORWARD, HAVE PHYSICAL THERAPY OR LAY ON THE RIGHT SIDE OF THE BODY DUE TO STABBING PAIN. BOTH IMPLANTS ARE ALSO REPORTED TO BE ENGORGED AND HEAVY. THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO THE PAIN. 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: Capsular Contracture; Local Reaction; Paresthesia

  MAUDE report 11690953 ↗
• InjuryJan 26, 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 HISPANIC FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION REVISION WITH TWO 225CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES, SUFFERED A LEFT BREAST IMPLANT THAT HAS FLIPPED, EXCRUCIATING PAIN AND A BREAST DESCRIBED AS HARD AS A ROCK. THE PATIENT HAS CONSULTED WITH A MEDICAL PROFESSIONAL, HOWEVER, AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 11231253 ↗
• InjuryNov 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT, WHO UNDERWENT BREAST RECONSTRUCTION WITH A 225CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESIS ON THE LEFT SIDE, SUFFERED LEFT BREAST IMPLANT DEFLATION, POST-PROCEDURE. THE DEFLATION WAS DIAGNOSED VIA VISUAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND BILATERAL REPLACEMENT WITH TWO UNSPECIFIED MENTOR SALINE BREAST PROSTHESES ON (B)(6) 2020. THE PATIENT WAS IN STABLE CONDITION AFTER THE SURGERY.

  Patient problems: No Code Available

  MAUDE report 10880368 ↗
• InjurySep 17, 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 WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 225CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES, SUFFERED RIGHT BREAST IMPLANT DEFLATION, RIGHT BREAST INFECTION AND LEFT BREAST CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN, POST-PROCEDURE. DUE TO EXPERIENCING BREAST PAIN, THE PATIENT HAD MAMMOGRAPHY DONE ON (B)(6) 2020 AND THIS IS WHEN THE RIGHT BREAST IMPLANT COLLAPSE AND PERI-IMPLANT FLUE COLLECTION WAS DIAGNOSED. ON (B)(6) 2020, A DIAGNOSIS OF THE RIGHT BREAST INFECTION AND DEFLATION WAS GIVEN BY THE PATIENT'S HEALTHCARE PROFESSIONAL. THE PATIENT BELIEVES THAT DUE TO A PREVIOUS CAPSULAR CONTRACTURE (TAKEN OUT IN 2015) THAT THEY EXPERIENCED, THE IMPLANT DEFLATED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT EXPLANTATION ON (B)(6) 2020. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10550268 ↗
• InjuryJul 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 225CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES, SUFFERED RIGHT BREAST IMPLANT DEFLATION AND RIGHT BREAST INFECTION, POST-PROCEDURE. DUE TO EXPERIENCING BREAST PAIN, THE PATIENT HAD MAMMOGRAPHY DONE ON (B)(6) 2020 AND THIS IS WHEN THE RIGHT BREAST IMPLANT COLLAPSE AND PERI-IMPLANT FLUE COLLECTION WAS DIAGNOSED. ON (B)(6) 2020, A DIAGNOSIS OF THE RIGHT BREAST INFECTION AND DEFLATION WAS GIVEN BY THE PATIENT'S HEALTHCARE PROFESSIONAL. THE PATIENT BELIEVES THAT DUE TO A PREVIOUS CAPSULAR CONTRACTURE (TAKEN OUT IN 2015) THAT THEY EXPERIENCED, THE IMPLANT DEFLATED. AS A RESULT, THE PATIENT WAS SCHEDULED FOR IMPLANT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10267912 ↗
• InjuryDec 6, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND SPECTRUM 225CC SALINE PROSTHESIS EXPERIENCED SPONTANEOUS LEFT SIDED DEFLATION POST PROCEDURE. THE PATIENT RECEIVED AN OFFICIAL MEDICAL DIAGNOSIS FOR THE DEFLATION. AS A RESULT, REPLACEMENT WITH MENTOR GEL IMPLANTS WAS PERFORMED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9428410 ↗
• InjuryOct 31, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SMOOTH ROUND SPECTRUM 225CC BREAST IMPLANT AND EXPERIENCED RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ON THE LEFT SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9261008 ↗
• InjurySep 3, 2019Material Rupture; Material Rupture

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR ASR REFERENCE NUMBER (B)(4). ON (B)(6) 2019, MENTOR CONFIRMED THAT ASR SUBMISSION REFERENCE NUMBERS (B)(4) WERE DUPLICATED. THIS FILE HAS BEEN UPDATED TO CONTAIN ALL OF THE MOST CURRENT AND CORRECT INFORMATION, AND FINAL REPORTING/DOCUMENTATION OF THIS EVENT WILL TAKE PLACE IN THIS COMPLAINT FILE, MANUFACTURER'S REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR 225CC SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT THAT DEFLATED POSTOPERATIVELY. AS A RESULT, THE PATIENT HAD THE DEVICE EXPLANTED AND REPLACED WITH AN UNSPECIFIED IMPLANT ON (B)(6) 2017.

  Patient problems: No Code Available

  MAUDE report 8956431 ↗
• InjuryJul 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A SALINE MENTOR SMOOTH ROUND SPECTRUM 225 CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8761027 ↗

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