MENTOR SILTEX CONTOUR PROFILE Moderate 3542914Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00081317001881), received between Mar 7, 2018 and Feb 11, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Material Rupture” (20 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Material Rupture

  IT WAS REPORTED THAT A 58-YEAR-OLD BLACK FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 425CC MENTOR SILTEX CONTOUR PROFILE MODERATE 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: Crushing Injury; Deformity/ Disfigurement

  MAUDE report 24319230 ↗
• InjuryJul 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 55-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 425 CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE 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.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22427788 ↗
• InjuryFeb 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE, 425/475CC SALINE, BREAST IMPLANT EXPERIENCED LEFT-SIDED DEFLATION POSTOPERATIVE. THE PHYSICAL EXAMINATION DIAGNOSED THE ISSUE. AS A RESULT, PATIENT SCHEDULED FOR BILATERAL REPLACEMENT WITH CAT: SMHX630 ON AN UNSPECIFIED DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18749414 ↗
• InjuryMar 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 47-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 425CC MENTOR SILTEX CONTOUR PROFILE MODERATE 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 16497485 ↗
• InjuryApr 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 425CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION 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.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14089190 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 425CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE PROSTHESIS. POST-OPERATIVELY, THE PATIENT STATED SHE DEVELOPED CAPSULAR CONTRACTURE, BUT INFORMATION OF UNILATERAL OR BILATERAL AFFLICTION AND ANY BAKER GRADE RATINGS WERE NOT PROVIDED. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-01352 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 13485784 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 425CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE PROSTHESIS. POST-OPERATIVELY, THE PATIENT STATED SHE DEVELOPED CAPSULAR CONTRACTURE, BUT INFORMATION OF UNILATERAL OR BILATERAL AFFLICTION AND ANY BAKER GRADE RATINGS WERE NOT PROVIDED. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-01353 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 13485776 ↗
• InjuryNov 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 425/475CC MENTOR SILTEX CONTOUR PROFILE MODERATE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH ALLERGAN /NATRELLE SALINE DEVICES ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12840240 ↗
• InjuryJun 14, 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 REVISION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE 425CC AND SUFFERED FROM A LEFT SIDE DEFLATION AND SORENESS AND A BILATERAL ACQUIRED DEFORMITY OF THE RECONSTRUCTED BREASTS. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH NON-MENTOR DEVICES ALLERGAN BRAND 600CC ON (B)(6) 2021. THIS MEDWATCH IS FOR THE RIGHT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11996716 ↗
• InjurySep 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) AFRICAN AMERICAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE 425/475 SALINE PROSTHESIS EXPERIENCED LEFT SIDED PAIN AND RIGHT SIDED DEFLATION POST PROCEDURE. A PHYSICAL EXAMINATION WAS PERFORMED BY A PHYSICIAN AND DEFLATION WAS DIAGNOSED. AS A RESULT PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH CAT#: 3503380 ON (B)(6) 2020. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 10548093 ↗
• 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 AFRICAN AMERICAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE 425/475 SALINE PROSTHESIS EXPERIENCED LEFT SIDED PAIN AND RIGHT SIDED DEFLATION POST PROCEDURE. A PHYSICAL EXAMINATION WAS PERFORMED BY A PHYSICIAN AND DEFLATION WAS DIAGNOSED. AS A RESULT PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH CAT #: 3503380 ON (B)(6) 2020. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: No Code Available; Pain

  MAUDE report 10548043 ↗
• InjurySep 8, 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 PRIMARY BREAST AUGMENTATION WITH A 425/475CC MENTOR SILTEX CONTOUR PROFILE MODERATE ON BOTH SIDES AND EXPERIENCED FATIGUE, INFLAMMATION, IBS, TUMORS WITH SURGERIES TO REMOVE TUMORS, BRAIN FOG, TINNITUS LOSS OF HEARING, IMBALANCE FALLING ISSUES, RHEUMATOID JOINT ACHES SWELLING, PAIN IN CHEST ARMS, FALLING ASLEEP ON KNEES, SLEEP DISORDERS, DRY PAINFUL EYES & MOUTH, DEPRESSION ANXIETY PANIC ATTACKS PTSD, SMELL THINGS THAT AREN'T PRESENT, DERCUMS DISEASE & THAT REQUIRED 16 SURGERIES TO REMOVE TUMORS, STAGE II LIPODEMA & HAS TO DO THERAPY SURGERIES, ENDOMETRIOSIS, PCOS, INFERTILITY ISSUES, FOOD INTOLERANCE'S, SHINGLES, VERTIGO, NAUSEA VOMITING, RESTLESS LEG DISORDER, TACHYCARDIA, TREMORS, MIGRAINES, MUSCLE PAIN & WEAKNESS, HAIR LOSS, ACID REFLEX, CRACKED HEELS, CHOKING ISSUES, WEIGHT GAIN, NIGHT SWEATS, SHORTNESS OF BREATH, SCALLOP TONGUE FISSURED TONGUE ULCERS ON TONGUE, LOW GRADE FEVER, EYES ARE GOOPED SHUT, PINK EYE, POST NASAL DRIP, ORAL ALLERGIES SYNDROME, BOILS, TMJ, CARPOOL TUNNEL, PAIN BREAST AND ARMPITS POSTOPERATIVELY. AS A RESULT, THE DEVICES WILL BE EXPLANTED ON (B)(6) 2020. THIS REPORT IS FOR THE PATI

  Patient problems: Breast Mass; No Code Available

  MAUDE report 10505150 ↗
• InjurySep 8, 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 PRIMARY BREAST AUGMENTATION WITH A 425/475CC MENTOR SILTEX CONTOUR PROFILE MODERATE ON BOTH SIDES AND EXPERIENCED FATIGUE, INFLAMMATION, IBS, TUMORS WITH SURGERIES TO REMOVE TUMORS, BRAIN FOG, TINNITUS LOSS OF HEARING, IMBALANCE FALLING ISSUES, RHEUMATOID JOINT ACHES SWELLING, PAIN IN CHEST ARMS, FALLING ASLEEP ON KNEES, SLEEP DISORDERS, DRY PAINFUL EYES & MOUTH, DEPRESSION ANXIETY PANIC ATTACKS PTSD, SMELL THINGS THAT AREN'T PRESENT, DERCUMS DISEASE & THAT REQUIRED 16 SURGERIES TO REMOVE TUMORS, STAGE II LIPODEMA & HAS TO DO THERAPY SURGERIES, ENDOMETRIOSIS, PCOS, INFERTILITY ISSUES, FOOD INTOLERANCE'S, SHINGLES, VERTIGO, NAUSEA VOMITING, RESTLESS LEG DISORDER, TACHACARDIA, TREMORS, MIGRAINES,MUSCLE PAIN & WEAKNESS, HAIR LOSS, ACID REFLEX, CRACKED HEELS, CHOKING ISSUES, WEIGHT GAIN, NIGHT SWEATS, SHORTNESS OF BREATH, SCALLOP TONGUE FISSURED TONGUE ULCERS ON TONGUE, LOW GRADE FEVER, EYES ARE GOOPED SHUT, PINK EYE, POST NASAL DRIP, ORAL ALLERGIES SYNDROME, BOILS, TMJ, CARPOOL TUNNEL, PAIN BREAST AND ARMPITS POSTOPERATIVELY. AS A RESULT, THE DEVICES WILL BE EXPLANTED ON (B)(6) 2020. THIS REPORT IS FOR THE PATIE

  Patient problems: Breast Mass; No Code Available

  MAUDE report 10505120 ↗
• InjuryAug 5, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 425/475CC MENTOR SILTEX CONTOUR PROFILE MODERATE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY DUE TO CHEST INJURY. HEALTH PROFESSIONAL STATED THAT PER PATIENT, HER SON KNOCKED INTO HER CHEST AND THEN SHE NOTICED FLAT SIDE. AS A RESULT, THE PATIENT WILL UNDERGO EXPLANTATION AND REPLACEMENT ON (B)(6) 2020. ORDER WAS PLACED FOR CATALOG NUMBER 3505004.

  Patient problems: Capsular Contracture; Injury; No Code Available

  MAUDE report 10367917 ↗
• InjuryJul 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE 425CC AND SUFFERED FROM A LEFT SIDE DEFLATION AND SORENESS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement; Pain

  MAUDE report 10246101 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA MEDWATCH FORM 070028-2020-01 THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR SILTEX CONTOUR PROFILE MODERATE 425CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT AND BILATERAL CAPSULAR CONTRACTURE. THE PATIENT EXPERIENCED DIASTASIS RECTI. THE PATIENT HAD A HISTORY OF BREAST CARCINOMA, BILATERAL MASTECTOMIES. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR BREAST IMPLANT OF UNKNOWN TYPE ON (B)(6) 2019.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9617886 ↗
• InjuryJan 7, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR SILTEX CONTOUR PROFILE MODERATE 425CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR BREAST IMPLANT OF UNKNOWN TYPE ON (B)(6) 2019.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9559386 ↗
• InjurySep 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 425CC MENTOR SILEX CONTOUR PROFILE MODERATE SALINE BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE LEFT-SIDED DEFLATION. 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 8957015 ↗
• InjuryJun 24, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE 425CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE LEFT BREAST PROSTHESIS WAS REPORTED. 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 8727825 ↗
• InjuryFeb 27, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SILTEX CONTOUR PROFILE MODERATE 425CC 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 8374981 ↗
• InjuryFeb 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX CONTOUR PROFILE MODERATE 440CC SALINE BREAST IMPLANTS WHICH THE RIGHT SIDE DEFLATED AFTER IMPLANTATION. AS A RESULT PATIENT HAD THE DEVICE EXPLANTED AND REPLACED WITH THE SAME MENTOR DEVICE ON (B)(6) 2019. THE PATIENT DID NOT EXPERIENCE ANY ACCOMPANYING SYMPTOMS, WAS NOT HOSPITALIZED, AND HAS SINCE FULLY RECOVERED.

  Patient problems: No Code Available

  MAUDE report 8366094 ↗
• InjuryNov 2, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH MENTOR SILTEX CONTOUR PROFILE MODERATE 425CC SALINE BREAST PROSTHESES. DEFLATION OF THE RIGHT BREAST PROSTHESIS WAS IDENTIFIED BY VISUAL EXAMINATION. AS A RESULT, THE PATIENT WAS SCHEDULED FOR REMOVAL ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8035127 ↗
• InjuryJun 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX CONTOUR PROFILE MODERATE 425CC SALINE PROSTHESES. BILATERAL SKIN RIPPLING AND DEFLATION OF THE BREAST PROSTHESES WERE DIAGNOSED POST PROCEDURE THROUGH A PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANT DATE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 7620994 ↗
• InjuryJun 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX CONTOUR PROFILE MODERATE 425CC SALINE PROSTHESES. BILATERAL SKIN RIPPLING AND DEFLATION OF THE BREAST PROSTHESES WERE DIAGNOSED POST PROCEDURE THROUGH A PHYSICAL EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANT DATE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Wrinkling

  MAUDE report 7620577 ↗
• InjuryMar 22, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX CONTOUR MODERATE PROFILE 425CC SALINE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH IMPLANTS AS FOLLOW: LEFT: CATALOG NUMBER: 350-4001BC, SERIAL NUMBER: (B)(4), RIGHT: CATALOG NUMBER: 350-4001BC, SERIAL NUMBER: (B)(4)ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7364350 ↗

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