MENTOR SILTEX CONTOUR PROFILE High 3542713Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00081317001928), received between Jan 23, 2018 and Jan 3, 2024 — classified as 26 injuries.

The most frequently reported specific device problem is “Material Rupture” (21 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH AN UNKNOWN TEXTURED MENTOR SALINE PROSTHESIS EXPERIENCED LEFT-SIDED DEFLATION POST PROCEDURE. THE IMAGING EXAMINATION CONFIRMED THE ISSUE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18438290 ↗
• InjuryMay 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 450CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED THAT HER RIGHT BREAST IMPLANT HAD BURST AND HAD A LEAK. THE PATIENT CONSULTED WITH A MEDICAL PROFESSIONAL WHO DIAGNOSED HER WITH A DEFLATED RIGHT BREAST IMPLANT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14340694 ↗
• InjuryDec 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 350CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. IT WAS REPORTED THAT THE PATIENT FELL ON HER RIGHT BREAST. THE DEFLATION WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2022.

  Patient problems: Crushing Injury

  MAUDE report 12928909 ↗
• InjuryNov 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SILTEX CONTOUR PROFILE HIGH 450CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12906166 ↗
• InjuryJul 30, 2021Adverse 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 A 450CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESIS AND EXPERIENCED A DEVICE EXTRUSION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA AN OFFICE EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Pocket Erosion

  MAUDE report 12256695 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HISPANIC FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 450CC SALINE PROSTHESIS EXPERIENCED BLOOD WORK WAS WEIRD. UNABLE TO BREATHE. IBS, DRY EYE, BRAIN FOG, NIGHT SWEATS, SKIN ISSUES, DRY MOUTH, COUGHING, DRY EAVES, URINE SMELLS, DISCHARGING, ANXIETY, PROBLEMS WITH SLEEPING. RHEUMATOID ARTHRITIS, ACID REFLEX (GERD POST PROCEDURE. THE PATIENT STATED THAT SHE HAD COMPLICATED PREGNANCIES, MISCARRIAGE ABOUT 16 YEARS AGO, AND WITH NEXT CHILD, IT WAS ALSO A COMPLICATED PREGNANCY AND THOUGHT SHE WILL LOSE THE CHILD DUE TO HER KIDNEY COMPLICATIONS. THE NEXT PREGNANCY, CHILD HAD DOWN SYNDROME DUE TO BABY HAVING HEARTBEAT IR REGULATIONS WAS PREMATURE. PATIENT STATED LUMP ON THE BREAST. SHE HAD BILATERAL CAPSULECTOMIES, SHE ALSO HAD BILATERAL SEMI-DEFLATION LAST YEAR(2019) PERFORMED AND PATIENT HAD BURNING SENSATION AFTER THAT AND WENT TO SEE THE EXPLANT SURGEON WHO STATED IT WAS A WRONG THING TO DO, BECAUSE SALINE COULD HAVE REACHED YOUR BLOOD STREAM. PATIENT HAD DONE MANY TESTS AND SEEN MANY SPECIALISTS TO FIND OUT THE CAUSES OF ALL THESE ISSUES. MRI EXAMINATION ON (B)(6) 2019 CONFIRMED NO RUPTURES BUT BILATERAL CAPSULECTOM

  Patient problems: Autoimmune Reaction; Capsular Contracture; No Code Available

  MAUDE report 10667527 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HISPANIC FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 450CC SALINE PROSTHESIS EXPERIENCED BLOOD WORK WAS WEIRD. UNABLE TO BREATHE. IBS, DRY EYE, BRAIN FOG, NIGHT SWEATS, SKIN ISSUES, DRY MOUTH, COUGHING, DRY EAVES, URINE SMELLS, DISCHARGING, ANXIETY, PROBLEMS WITH SLEEPING. RHEUMATOID ARTHRITIS, ACID REFLEX (GERD POST PROCEDURE. THE PATIENT STATED THAT SHE HAD COMPLICATED PREGNANCIES, MISCARRIAGE ABOUT 16 YEARS AGO, AND WITH NEXT CHILD, IT WAS ALSO A COMPLICATED PREGNANCY AND THOUGHT SHE WILL LOSE THE CHILD DUE TO HER KIDNEY COMPLICATIONS. THE NEXT PREGNANCY, CHILD HAD DOWN SYNDROME DUE TO BABY HAVING HEARTBEAT IR REGULATIONS WAS PREMATURE. PATIENT STATED LUMP ON THE BREAST. SHE HAD BILATERAL CAPSULECTOMIES, SHE ALSO HAD BILATERAL SEMI-DEFLATION LAST YEAR(2019) PERFORMED AND PATIENT HAD BURNING SENSATION AFTER THAT AND WENT TO SEE THE EXPLANT SURGEON WHO STATED IT WAS A WRONG THING TO DO, BECAUSE SALINE COULD HAVE REACHED YOUR BLOOD STREAM. PATIENT HAD DONE MANY TESTS AND SEEN MANY SPECIALISTS TO FIND OUT THE CAUSES OF ALL THESE ISSUES. MRI EXAMINATION ON (B)(6) 2019 CONFIRMED NO RUPTURES BUT BILATERAL CAPSULECTOM

  Patient problems: Autoimmune Reaction; Capsular Contracture; No Code Available

  MAUDE report 10667515 ↗
• InjurySep 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A SALINE MENTOR SILTEX CONTOUR PROFILE HIGH 450 CC AND EXPERIENCED 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: No Code Available

  MAUDE report 10541414 ↗
• InjuryJul 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 450CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED 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 10279633 ↗
• InjuryJul 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 450CC TEXTURED MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST IMPLANT AND EXPERIENCED RIGHT-SIDED IMPLANT DEFLATION POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH LIKE DEVICE, CATALOG # 3542713, LEFT SERIAL # (B)(4) AND RIGHT SERIAL # (B)(4) ON (B)(6) 2009.

  Patient problems: No Code Available

  MAUDE report 10268615 ↗
• InjuryFeb 12, 2020Adverse 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 A MENTOR SILTEX CONTOUR PROFILE HIGH 450CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2019.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9702117 ↗
• InjuryFeb 3, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH MENTOR SILTEX CONTOUR PROFILE HIGH 450CC AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9660775 ↗
• InjuryJan 27, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH 450CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST IMPLANTS AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION. THE DIAGNOSIS WAS CONFIRMED BY A PHYSICIAN UPON EXAMINATION. AS A RESULT, THE PATIENT'S IMPACTED DEVICE WAS EXPLANTED ON (B)(6) 2020.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9633502 ↗
• InjuryNov 1, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 450CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST IMPLANT EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH A 420CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANT ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9269458 ↗
• InjurySep 6, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 450CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST PROSTHESES, SUFFERED RIGHT SIDE DEFLATION, POST-OPERATIVELY. 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 8972093 ↗
• InjurySep 6, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION SURGERY WITH TWO 450CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST IMPLANTS EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. THE BILATERAL DEFLATION WAS DIAGNOSED BY A PHYSICIAN. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2019. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS. SEE 1645337-2019-18459 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: No Code Available

  MAUDE report 8971750 ↗
• InjurySep 6, 2019Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION SURGERY WITH TWO 450CC MENTOR SILTEX CONTOUR PROFILE HIGH SALINE BREAST IMPLANTS EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. THE BILATERAL DEFLATION WAS DIAGNOSED BY A PHYSICIAN. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2019. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS. SEE 1645337-2019-18458 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: No Code Available

  MAUDE report 8971749 ↗
• InjuryJun 25, 2019Adverse 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 UNDERWENT AN UNKNOWN BREAST RECONSTRUCTION SURGERY WITH MENTOR SILTEX CONTOUR PROFILE HIGH 450CC SALINE BREAST IMPLANTS WHICH THE PATIENT WAS NOT ABLE TO USE HER LEFT ARM AFTER THE IMPLANTATION, FEW YEARS LATER PATIENT BELIEVES IMPLANT IS PULLING A MUSCLE IN HER LEFT ARM . SHE ALSO STATED SHE HAS A HARD BALL IN CHEST. HER DOCTOR MENTIONED IMPLANTS NEEDS TO BE REMOVED AS SOON AS POSSIBLE, BECAUSE OF THE ARTICLE REGARDING BIA-ALCL. NO DIAGNOSE HAS BEEN ADVISED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Mass; Capsular Contracture; Local Reaction; Pain

  MAUDE report 8730775 ↗
• InjuryJun 14, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR SILTEX CONTOUR PROFILE HIGH 450CC SALINE PROSTHESES RIGHT SIDED DEFLATION AND PAIN POST PROCEDURE. AS A RESULT, THE DEVICES WERE EXPLANTED ON (B)(6) 2019. BOTH DEVICES OF THE SAME LOT NUMBER WERE RETURNED TO MENTOR AND FOUND TO HAVE BEEN DEFLATED THROUGH ANALYSIS ON (B)(6) 2019. THEREFORE, MENTOR IS CONSERVATIVELY GOING TO REPORT BOTH DEVICES AS THE IMPACTED PRODUCT, AS THERE IS NO WAY TO DETERMINE WHICH DEVICE IS THE IMPACTED PRODUCT. ONE OF THESE DEVICES HAD BEEN PREVIOUSLY REPORTED PREVIOUSLY UNDER 1645337-2019-10972. THIS REPORT RELATES TO THE SECOND DEVICE THAT COULD POTENTIALLY BE THE IMPACTED PRODUCT AS DETERMINED THROUGH FAILURE ANALYSIS ON (B)(6) 2019.

  Patient problems: No Code Available; Pain

  MAUDE report 8700692 ↗
• InjuryMay 2, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 450CC SALINE PROSTHESIS RIGHT SIDED DEFLATION AND PAIN POST PROCEDURE. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2019.

  Patient problems: Pain

  MAUDE report 8575076 ↗
• InjuryApr 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A SALINE MENTOR SILTEX CONTOUR PROFILE HIGH 450CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE RIGHT SIDE. DEFLATION WAS CONFIRMED BY PHYSICIAN DURING AN EXAM. 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 8540481 ↗
• InjuryApr 2, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 450CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE RIGHT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 400 CC GEL BREAST PROSTHESES ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8474194 ↗
• InjuryMay 22, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SILTEX CONTOUR PROFILE HIGH 450CC 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 7535609 ↗
• InjuryMay 15, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX CONTOUR PROFILE HIGH 450CC SALINE BREAST PROSTHESIS. LEFT BREAST PROSTHESIS DEFLATION WAS DETERMINED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7515376 ↗
• InjuryApr 11, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX CONTOUR PROFILE HIGH 450 CC SALINE PROSTHESIS. DEFLATION ON THE LEFT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE VIA PHYSICAL EXAMINATION AND MAMMOGRAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANT DATE.

  Patient problems: No Code Available

  MAUDE report 7421119 ↗

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