MENTOR Smooth Round High Profile 3503630Recalls & reported problems

Summary

The FDA's MAUDE database contains 218 adverse event reports that list this exact device (DI 00081317001706), received between Jan 25, 2018 and Sep 18, 2026 — classified as 213 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (138 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 218 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Material Rupture

  It was reported that a female patient underwent unspecified Breast Augmentation with MENTOR Smooth Round High Profile, 630cc Saline implants, subsequently the patient experienced left sided deflation. As a result, the patient scheduled for removal surgery on (b)(6), 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50818990 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 630CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS EXPERIENCED PTOSIS ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25032278 ↗
• InjuryMar 31, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 630CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT DEFLATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24738764 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 72-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 630CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST-OPERATIVELY. THE PATIENT DESCRIBED THE BREAST TO BE "REALLY HARD", PAINFUL, AND ONE SIDE BEING SMALLER THAN THE OTHER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24394947 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 72-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 630CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST-OPERATIVELY. THE PATIENT DESCRIBED THE BREAST TO BE "REALLY HARD", PAINFUL, AND ONE SIDE BEING SMALLER THAN THE OTHER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24394945 ↗
• InjuryFeb 18, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 630CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24379033 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 630CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT LEAK. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24264397 ↗
• InjuryFeb 3, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT GEL BREAST PROSTHESES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24251337 ↗
• InjuryDec 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND HIGH PROFILE BREAST IMPLANTS EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23830726 ↗
• InjuryDec 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 630CC MENTOR SMOOTH ROUND HIGH PROFILE 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 SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23687277 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH IMPLANTATION OF A 630CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH REPORTED HAVING BREAST CANCER OF AN UNDISCLOSED SIDE. NO FURTHER DETAILS WERE PROVIDED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. AS THE AFFECTED SIDE WAS NOT PROVIDED, THE LOT/SERIAL NUMBERS FOR BOTH PRODUCTS ARE BEING PROVIDED AS LEFT IMPLANT - LOT NUMBER: 9827568 / SERIAL NUMBER: (B)(6) AND RIGHT IMPLANT - LOT NUMBER: 9813544 / SERIAL NUMBER: (B)(6). THE CATALOG NUMBER IS THE SAME FOR BOTH DEVICES. FOLLOW-UPS WERE NOT PERFORMED PER THE PATIENT'S REQUEST.

  Patient problems: Breast Cancer

  MAUDE report 23319307 ↗
• InjurySep 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 630CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH PICTURE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23039815 ↗
• InjurySep 9, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A SALINE MENTOR SMOOTH ROUND HIGH PROFILE BREAST IMPLANT (L) AND AN UNSPECIFIED MENTOR SALINE BREAST IMPLANT (R) EXPERIENCED BILATERAL DEFLATION ALONG WITH CAPSULAR CONTRACTURE BAKER GRADE IV ON THE RIGHT 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. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 23009296 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR SMOOTH ROUND HIGH PROFILE, 630CC SILICONE PROSTHESIS EXPERIENCE LEFT SIDED CAPSULAR CONTRACTURE UNKNOWN GRADE POST PROCEDURE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 22752779 ↗
• InjuryAug 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 55-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 630CC MENTOR SMOOTH ROUND HIGH PROFILE 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 22687142 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND HIGH PROFILE 630CC SALINE BREAST PROSTHESIS DEVELOPED ¿WEIRD¿ FEELINGS IN HER RIGHT BREAST POST IMPLANTATION. ADDITIONALLY, THE PATIENT¿S RIGHT BREAST FEELS HEAVIER, AND THE BREAST APPEARS LARGER THAN THE OTHER. THE PATIENT SUFFERED FROM POSSIBLE TRAUMA FROM A CAR ACCIDENT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 22522475 ↗
• InjuryJul 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 630CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST IMPLANT DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22468417 ↗
• InjuryJun 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 630CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A 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.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22125286 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT A 630CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BEING USED IN A BREAST AUGMENTATION REVISION WAS FOUND TO BE LEAKING AT THE FILL TUBE DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED A BACKUP DEVICE, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091743 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR SMOOTH ROUND HIGH PROFILE 630CC SALINE PROSTHESES EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE, RIGHT SIDED LOCATION, AND A LEFT SIDED ANISOMASTIA POST PROCEDURE. THIS WAS ACCOMPANIED BY BILATERAL PAIN. THERE WAS SWELLING ON THE RIGHT SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Local Reaction

  MAUDE report 22014275 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR SMOOTH ROUND HIGH PROFILE 630CC SALINE PROSTHESES EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE, RIGHT SIDED LOCATION, AND A LEFT SIDED ANISOMASTIA POST PROCEDURE. THIS WAS ACCOMPANIED BY BILATERAL PAIN. THERE WAS SWELLING ON THE RIGHT SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 22014263 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 2 ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 21708997 ↗
• InjuryMar 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 630CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESIS EXPERIENCED A 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.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21561224 ↗
• InjuryMar 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 630CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MAMMOGRAM, WITH LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21517400 ↗
• InjuryJan 23, 2025Migration; Migration

  A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND HIGH PROFILE 630CC SALINE PROSTHESIS EXPERIENCED LEFT-SIDED DEFLATION POSTOPERATIVELY, DIAGNOSED DURING AN IN-OFFICE EXAMINATION. SUBSEQUENTLY, SHE WAS FOUND TO HAVE BILATERAL MALPOSITION, NECESSITATING SURGICAL INTERVENTION. ON (B)(6) 2024, THE PATIENT UNDERWENT CAPSULORRAPHY ON THE LEFT SIDE AND CAPSULOTOMY ON THE RIGHT, FOLLOWED BY BILATERAL REPLACEMENTS USING CAT 3503630, LOT NUMBERS 9958401 ON THE RIGHT AND 9730811 FOR THE LEFT SIDE. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21217533 ↗

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