MENTOR Smooth Round SPECTRUM 3501420Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00081317001966), received between Apr 3, 2018 and Mar 4, 2025 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT 175CC MENTOR SMOOTH ROUND SPECTRUM VALVE WAS REPORTEDLY DEFECTIVE (TUBING SEALED SHUT). THERE WERE NO PATIENT CONSEQUENCES OR ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21515796 ↗
• InjuryOct 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT AN 80-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 175CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT HAD ASYMMETRY OF THE LEFT BREAST AND WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT DURING A CONSULTATION WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A LEFT-SIDED 175CCMENTOR SMOOTH ROUND SPECTRUM ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15597328 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH 175CC MENTOR SMOOTH ROUND SPECTRUM SALINE IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL PAIN IN HER BREASTS AND OTHER UNSPECIFIED SYMPTOMS. AT THE TIME OF THIS REPORT, THE PATIENT HAS NOT CONSULTED WITH A HEALTHCARE PROFESSIONAL. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-11296 FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 15491375 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH 175CC MENTOR SMOOTH ROUND SPECTRUM SALINE IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL PAIN IN HER BREASTS AND OTHER UNSPECIFIED SYMPTOMS. AT THE TIME OF THIS REPORT, THE PATIENT HAS NOT CONSULTED WITH A HEALTHCARE PROFESSIONAL. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-11295 FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 15491354 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION, AS PART OF GLOW CLINICAL STUDY, WITH A (LEFT) 620CC MENTOR MEMORYSHAPE BREAST IMPLANT AND A (RIGHT) 175CC MENTOR SMOOTH ROUND SPECTRUM. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREASTS WRINKLING AND ALSO ASYMMETRY ON THE RIGHT BREAST. AS A RESULT, ON (B)(6) 2020, THE PATIENT UNDERWENT BILATERAL BREAST FAT GRAFTING. 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; Wrinkling

  MAUDE report 13428905 ↗
• InjurySep 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND SPECTRUM 175CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION AFTER FALLING POST PROCEDURE. THE DEFLATION WAS CONFIRMED THROUGH A PHYSICAL EXAMINATION AND MAGNETIC RESONANCE IMAGING. AS A RESULT, EXPLANT AND REPLACEMENT WITH MENTOR-SMOOTH ROUND SPECTRUM SALINE IMPLANTS WAS PERFORMED ON (B)(6) 2021. THE PATIENT IS STATED TO BE FULLY RECOVERED.

  Patient problems: Crushing Injury

  MAUDE report 12485785 ↗
• InjuryAug 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND SPECTRUM 175CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS 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 12271407 ↗
• InjuryJun 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 175CC MENTOR SMOOTH ROUND SPECTRUM. THE PATIENT NOTICED A CHANGE OF FULLNESS OF THE LEFT BREAST. LEFT BREAST DEFLATION WAS CONFIRMED VIA MAMMOGRAM PERFORMED ON (B)(6) 2019. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8708408 ↗
• InjuryJun 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT A MASTECTOMY PROCEDURE WITH A MENTOR SMOOTH ROUND SPECTRUM 175CC SALINE BREAST PROSTHESIS IS EXPERIENCING PAIN IN HER RIGHT BREAST. THE PATIENT REPORTED THAT THE SHE HAS HAD THE PAIN FOR A FEW MONTHS. IN ADDITION, THE PATIENT REPORTED SHE HAD A HEART TEST THAT SHOWED A SHADOW ON THE RIGHT BREAST AND THAT THE RIGHT BREAST LOOKS BOTCHED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Pain

  MAUDE report 8685319 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND SPECTRUM 175CC AND EXPERIENCED DEFLATION ON THE RIGHT BREAST IMPLANT AND BILATERAL PTOSIS. THE DEFLATION WAS CONFIRMED BY THE PHYSICAL EXAMINATION BY THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR BREAST IMPLANT SERIAL NUMBER (B)(4), LOT NUMBER 7569152 ON THE LEFT BREAST IMPLANT AND WITH SERIAL NUMBER (B)(4), LOT NUMBER 7569152 ON THE RIGHT BREAST IMPLANT ON (B)(6) 2018. THE PATIENT WAS IN A STABLE CONDITION AFTER SURGERY. THE PATIENT HAD NO COMPLICATIONS.

  Patient problems: No Code Available; Ptosis

  MAUDE report 7671176 ↗
• InjuryMay 29, 2018Material 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 175CC AND EXPERIENCED DEFLATION ON THE RIGHT BREAST IMPLANT. THE DEFLATION WAS CONFIRMED BY THE PHYSICAL EXAMINATION BY THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR BREAST IMPLANT OF UNKNOWN TYPE ON (B)(6) 2018.

  Patient problems: No Code Available; Ptosis

  MAUDE report 7551229 ↗
• InjuryApr 24, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY. PROCEDURE WITH A SALINE MENTOR SMOOTH ROUND SPECTRUM 175CC BREAST IMPLANT AND EXPERIENCED 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 7456774 ↗
• InjuryApr 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR SMOOTH ROUND SPECTRUM 175CC SALINE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY PHYSICAL EXAMINATION. PATIENT HAS NO SIDE EFFECTS OR ADVERSE EVENT FROM HER DEFLATED LEFT SALINE IMPLANT. AS A RESULT PATIENT IS SCHEDULED TO HAVE THE DEVICE EXPLANTED (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7419827 ↗
• InjuryApr 4, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND SPECTRUM 175CC POST OPERATIVELY ADJUSTABLE SALINE PROSTHESIS AND EXPERIENCED DEFLATION POST PROCEDURE. 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 7398114 ↗
• InjuryApr 3, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND SPECTRUM 175CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION WAS DIAGNOSED BY A DOCTOR EXAMINATION. 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 7394701 ↗

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