MENTOR SILTEX CONTOUR PROFILE Moderate 3542915Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00081317001898), received between Jun 27, 2018 and Nov 25, 2024 — classified as 18 injuries.

The most frequently reported specific device problem is “Material Rupture” (13 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE, 525/575 CC, SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20773135 ↗
• InjuryJan 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 525CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON AN UNKNOWN SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE PATIENT REPORTED TWO DEVICE SERIAL NUMBERS, HOWEVER, IT IS UNKNOWN WHICH SERIAL NUMBER BELONGS TO THE IMPACTED SIDE. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18540646 ↗
• InjuryJul 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESIS AND EXPERIENCED BILATERAL DEFLATIONS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17289203 ↗
• InjuryJun 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17185335 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE, 525/575CC, SALINE BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE UNKNOWN POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13696589 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE, 525/575CC, SALINE BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE GRADE UNKNOWN POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 13696505 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020 A MENTOR SILTEX CONTOUR PROFILE MODERATE BREAST PROSTHESIS WAS RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB WITH NO ACCOMPANYING INFORMATION. THE DEVICE COULD NOT BE ASSOCIATED WITH AN EXISTING COMPLAINT. HOWEVER, IT IS LIKELY THAT THIS DEVICE WAS EXPLANTED FROM A PATIENT. MEANING THAT A SURGICAL INTERVENTION RELATED TO THIS DEVICE WAS PERFORMED.

  Patient problems: No Code Available

  MAUDE report 9825624 ↗
• InjuryFeb 10, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH UNSPECIFIED MENTOR BREAST IMPLANTS AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED NIPPLE AREA PAIN AND DEFLATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Pain

  MAUDE report 9690646 ↗
• InjuryJan 22, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH AN UNKNOWN SALINE IMPLANTS TEXTURED (TEARDROP) AND SUFFERED FROM BILATERAL CAPSULAR CONTRACTURE, BILATERAL RUPTURE, AUTOIMMUNE REACTION. THE PATIENT SUFFERED FROM HARDENING OF BREASTS, HEALTH COMPLICATIONS, HYSTERECTOMY DUE TO UTERINE TUMOR, THREE BRAIN TUMORS, CROHN'S DISEASE, BRAIN FOG, LETHARGIC WITH NO ENERGY, CHEST PAIN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: Autoimmune Reaction; Capsular Contracture

  MAUDE report 9615675 ↗
• InjuryJan 22, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH AN UNKNOWN SALINE IMPLANTS TEXTURED (TEARDROP) AND SUFFERED FROM BILATERAL CAPSULAR CONTRACTURE, BILATERAL RUPTURE, AUTOIMMUNE REACTION. THE PATIENT SUFFERED FROM HARDENING OF BREASTS, HEALTH COMPLICATIONS, HYSTERECTOMY DUE TO UTERINE TUMOR, THREE BRAIN TUMORS, CROHN'S DISEASE, BRAIN FOG, LETHARGIC WITH NO ENERGY, CHEST PAIN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: Autoimmune Reaction; Capsular Contracture

  MAUDE report 9615674 ↗
• InjuryJan 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH AN UNKNOWN TEXTURED SILTEX MENTOR PROSTHESIS IN 2002 EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, THE DEVICE WAS REPLACED WITH A MENTOR SILTEX ROUND MODERATE PROFILE 300CC SALINE PROTHESIS. THIS WAS THE SECOND IN A SERIES OF THREE DEFLATIONS. THE OTHER TWO EVENTS WERE REPORTED UNDER 1645337-2020-00755 AND 1645337-2020-00781.

  Patient problems: No Code Available

  MAUDE report 9596407 ↗
• InjuryJan 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A A SALINE ROUND ULTRA HIGH PROFILE TEXTURED 600CC AND EXPERIENCED DEFLATION AND BREAST PAIN ON THE LEFT BREAST IMPLANT. THE PATIENT NOTICED THAT THE LEFT SIDE LOOKS LIKE IT IS FLAT AND A LITTLE SORE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Pain

  MAUDE report 9596376 ↗
• InjuryJan 15, 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 MENTOR SMOOTH ROUND SALINE IMPLANTS 700CC AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS. THE PATIENT SUFFERED FROM CHEST PAIN, SLEEPING ISSUES, ISSUES WITH SWALLOWING FOODS, STOMACH ISSUES, MIGRAINES, EYES SWELL, SKIN RASHES. THE PATIENT HAS A HISTORY OF BILATERAL HYPOMASTIA. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 9590862 ↗
• InjuryJan 15, 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 MENTOR SMOOTH ROUND SALINE IMPLANTS 700CC AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS. THE PATIENT SUFFERED FROM CHEST PAIN, SLEEPING ISSUES, ISSUES WITH SWALLOWING FOODS, STOMACH ISSUES, MIGRAINES, EYES SWELL, SKIN RASHES. THE PATIENT HAS A HISTORY OF BILATERAL HYPOMASTIA. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 9590847 ↗
• InjuryJan 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 525CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESES, SUFFERED LEFT BREAST IMPLANT DEFLATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available; Pain

  MAUDE report 9537915 ↗
• InjuryApr 22, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE 525/575CC PROSTHESIS AND EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, THE DEVICE WAS REPLACED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8536954 ↗
• InjuryMar 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR OLD HISPANIC FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 525CC MENTOR SILTEX CONTOUR PROFILE MODERATE SALINE BREAST PROSTHESES, EXPERIENCE RIGHT SIDE DEFLATION POST-OPERATIVELY. PATIENT INITIALLY OBSERVED THE DEFLATION AND WAS LATER ON CONFIRMED VIA ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8453227 ↗
• InjuryJun 27, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD CAUCASIAN FEMALE UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE MODERATE 525CC SALINE PROSTHESIS. ON (B)(6) 2018 RIGHT SIDED DEFLATION WAS OBSERVED. AS A RESULT, BILATERAL PROSTHESIS REMOVAL WITHOUT REPLACEMENT WAS PERFORMED ON (B)(6) 2018. THE RIGHT IMPLANT WAS CONFIRMED TO BE COMPLETELY DEFLATED DURING THE REPLACEMENT SURGERY. THERE WERE NO PROCEDURAL COMPLICATIONS, AND THE PATIENT AWOKE IN STABLE CONDITION.

  Patient problems: No Code Available

  MAUDE report 7644030 ↗

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