MENTOR Smooth Round Moderate Profile 3501660Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,972 adverse event reports that list this exact device (DI 00081317001270), received between Jan 30, 2018 and Sep 23, 2026 — classified as 1,956 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (1,486 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 1,972 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Material Rupture

  It was reported that a patient underwent primary breast augmentation with two 375cc MENTOR Smooth Round Moderate Profile saline breast prostheses. Post-operatively, the patient was diagnosed, via virtual examination, with left breast implant deflation. As a result, the patient underwent breast implant removal surgery on(b)(6)2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50871905 ↗
• InjurySep 22, 2026Material Rupture

  It was reported that a patient underwent primary breast augmentation with two 375cc MENTOR Smooth Round Moderate Profile saline breast prostheses. Post-operatively, the patient was involved in an auto-accident and was diagnosed with left breast implant deflation. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Crushing Injury; Deformity/ Disfigurement

  MAUDE report 50857862 ↗
• InjurySep 17, 2026Material Rupture

  It was reported that a 58-year-old female patient underwent a breast augmentation revision with a 375cc MENTOR Smooth Round Moderate Profile saline breast prosthesis and experienced a deflation on the left side post-operatively, which was diagnosed with a physical exam. As a result, the patient underwent explantation on (b)(6) 2026, and replaced with a 450cc MENTOR Smooth Round Moderate Plus Profile saline breast prosthesis.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50806132 ↗
• InjuryAug 28, 2026Material Rupture

  It was reported that a patient with Saline MENTOR Smooth Round Moderate Profile breast implants experienced deflation on the right side post-operatively, which was confirmed during a physical exam. As a result, the patient is scheduled for removal on (b)(6)2026.The reported implantation date is prior to the device manufacture date. If additional information is received regarding the correct date of implantation or device lot number, a supplemental report will be submitted.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50507248 ↗
• InjuryAug 25, 2026Material Rupture

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50439062 ↗
• InjuryAug 25, 2026Material Rupture

  It was reported that a patient underwent a primary breast augmentation procedure with a MENTOR Smooth Round Moderate Profile saline breast prosthesis that deflated post implantation. Deflation of the patient¿s left breast prosthesis was reported. As a result, the patient underwent explantation.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50436974 ↗
• InjuryMay 22, 2026Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 320CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT AND BILATERAL IMPLANT MALPOSITION AS THEY WERE LATERALLY DISPLACED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON MARCH 31, 2026. FURTHERMORE, DURING THE REVISION SURGERY, THE LEFT CAPSULE WAS OBSERVED TO BE A BAKER GRADE I-II CAPSULAR CONTRACTURE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25258029 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH MENTOR SMOOTH ROUND MODERATE PROFILE, 375CC SALINE IMPLANTS DEVELOPED BILATERAL CUTANEOUS CONTOUR DEFORMITIES AFTER THE PROCEDURE. THE PHYSICAL EXAMINATION DIAGNOSED THE ISSUE. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Wrinkling

  MAUDE report 25165485 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH MENTOR SMOOTH ROUND MODERATE PROFILE, 375CC SILICONE IMPLANTS DEVELOPED BILATERAL CUTANEOUS CONTOUR DEFORMITIES AFTER THE PROCEDURE. THE PHYSICAL EXAMINATION DIAGNOSED THE ISSUE. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Wrinkling

  MAUDE report 25165333 ↗
• InjuryMay 4, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS THAT BOTH DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS INITIALLY REPORTED. IT WAS LATER REPORTED THAT BOTH OF THE PATIENT¿S BREAST PROSTHESES ARE ¿LEAKING¿. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2026-04341 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25072826 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV 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.

  Patient problems: Capsular Contracture

  MAUDE report 24944604 ↗
• InjuryApr 21, 2026Material Rupture

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

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24942296 ↗
• InjuryApr 21, 2026Material Rupture

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

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24942225 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24756676 ↗
• InjuryMar 25, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 375CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A DEFLATED LEFT IMPLANT. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS YET TO BE CONDUCTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24683369 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 375CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES EXPERIENCED BILATERAL BREAST CYSTS AND BREAST PAIN POST-OPERATIVELY. THE PATIENT UNDERWENT SURGICAL INTERVENTION VIA BIOPSY TO TREAT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Cyst(s); Pain

  MAUDE report 24630168 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT, IMPLANTED WITH TWO 375CC MENTOR SMOOTH ROUND, MODERATE PROFILE SALINE, BREAST PROSTHESES, EXPERIENCED BILATERAL BREAST CYSTS AND BREAST PAIN POST-OPERATIVELY. THE PATIENT UNDERWENT SURGICAL INTERVENTION VIA BIOPSY TO TREAT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Cyst(s); Pain

  MAUDE report 24627480 ↗
• InjuryMar 12, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 375CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT IMPLANT DURING AN IN-OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR SALINE IMPLANTS ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24586678 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN ON THE LEFT AND BAKER GRADE 3 ON THE RIGHT) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH 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 RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24564949 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN ON THE LEFT AND BAKER GRADE 3 ON THE RIGHT) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH 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 SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24564946 ↗
• InjuryFeb 27, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. THE REPLACEMENT DEVICES WERE TWO MENTOR SALINE BREAST PROSTHESES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24471375 ↗
• InjuryFeb 13, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ALONG WITH DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2026. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24337339 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ALONG WITH DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2026. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24337335 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, THE LEFT BREAST PROSTHESIS IS PALPABLE AND HAS PALPABLE LUMPS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Mass; Capsular Contracture

  MAUDE report 24308806 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. ADDITIONALLY, THE LEFT BREAST PROSTHESIS IS PALPABLE AND HAS PALPABLE LUMPS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24308804 ↗

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