MENTOR SILTEX CONTOUR PROFILE SPECTRUM 3542512Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00081317002147), received between Apr 17, 2019 and Oct 6, 2023 — classified as 20 injuries.

The most frequently reported specific device problem is “Material Rupture” (15 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 24-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 350CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17887368 ↗
• InjurySep 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 75-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 350CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. IT WAS REPORTED THAT THERE IS LESS FLUID IN THE LEFT BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17674610 ↗
• InjuryApr 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 350CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT DEFLATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16744714 ↗
• InjuryApr 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 350CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM ON BOTH SIDES AND EXPERIENCED BILATERAL BREAST IMPLANT DEFLATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16744522 ↗
• InjuryJun 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 350CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14854176 ↗
• InjuryMar 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT (B)(6) OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 350CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT WILL UNDERGO REMOVAL AND A PLANNED REPLACEMENT WITH MENTOR GEL IMPLANTS ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT BREAST IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-02669 FOR THE CONTRALATERAL EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement

  MAUDE report 13727029 ↗
• InjuryMar 10, 2022Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF AN UNKNOWN SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE IV CAPSULAR CONTRACTURE OF THE RIGHT BREAST. AS A RESULT, THE PATIENT WILL UNDERGO REMOVAL AND A PLANNED REPLACEMENT WITH MENTOR GEL IMPLANTS ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT BREAST IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-02670, FOR THE CONTRALATERAL EVENT.

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

  MAUDE report 13726949 ↗
• InjuryDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH A 350CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM EXPERIENCED LEFT SIDED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, PARATHESIA AND A SKIN REACTION POST PROCEDURE. PATIENT WAS EXPERIENCING AN ITCH AND DISCOMFORT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture; Paresthesia; Skin Inflammation/ Irritation

  MAUDE report 13091065 ↗
• InjuryNov 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 350CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM AND EXPERIENCED LEFT SIDE BREAST IMPLANT DEFLATION, AND CAPSULAR CONTRACTURE; LEFT SIDE BAKER GRADE UNKNOWN POSTOPERATIVELY. CT SCAN SHOWED IMPLANT WAS LEAKING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 12844375 ↗
• InjurySep 3, 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 RACE FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 350CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING FEELING TIRED AND WINDED POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12423708 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA FRENCH HEALTH AUTHORITY ANSM THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A 350CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST PROSTHESIS ON (B)(6) 1997. ON (B)(6) 2016, THE PATIENT UNDERWENT A TOTAL CAPSULECTOMY AND REPLACEMENT WITH AN UNSPECIFIED SEBBIN GROUP IMPLANT (CATALOG # LSA SL 280, LOT # FH00436), WHICH IS STILL IMPLANTED AT THE TIME OF THIS REPORT. THE EXPLANTED MENTOR DEVICE WAS FOUND INTACT AND IT IS CURRENTLY UNKNOWN WHY THE PATIENT HAD THE DEVICE EXPLANTED. ON OR AROUND (B)(6) 2020, THE PATIENT EXPERIENCED A THICKENED RIGHT AXILLARY NODE WHICH MEASURED 9MM AND A RIGHT PERIPROSTHETIC LYMPHOCELE. THE PATIENT UNDERWENT A LYMPH NODE BIOPSY AND WAS CD30+/ALK-, SUSPICIOUS FOR ANAPLASTIC LARGE-CELL LYMPHOMA. THE CYTOLOGY RESULTS FOR THE RIGHT-SIDED PERIPROSTHETIC LYMPHOCELE FLUID SHOWED SUSPICIOUS ATYPICAL CD30+/EMA+ CELLS. THE PATIENT IS SCHEDULED FOR EXPLANTATION AROUND (B)(6) 2021. AT THE TIME OF DIAGNOSIS, THE PATIENT HAD NOT HAD A MENTOR DEVICE IMPLANTED FOR OVER FOUR YEARS. HOWEVER, THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. SHOULD MORE INFORMATION BE MADE AVAILABLE, A SUPPLEMENTAL

  Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Seroma; Swollen Lymph Nodes/Glands

  MAUDE report 11634992 ↗
• InjuryDec 9, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM, 350CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. A PHYSICAL EXAMINATION WAS PERFORMED BY A PHYSICIAN AND DEFLATION WAS DIAGNOSED. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: LEFT REPLACED WITH SMPX-270, SN#: (B)(4), AND RIGHT REPLACED WITH SMPX-270, AND SN#:(B)(4) 0N (B)(6) 2020.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 10977086 ↗
• InjuryApr 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH 350CC TEXTURED MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST IMPLANT HAS EXPERIENCED POSTOPERATIVE RIGHT-SIDED IMPLANT DEFLATION, CONFIRMED BY A PHYSICIAN. 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 9960293 ↗
• InjuryMar 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 350CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. 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 9848686 ↗
• InjuryFeb 19, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD AFRICAN AMERICAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 350CC AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. 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 9727947 ↗
• InjuryFeb 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 350CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST IMPLANT EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9710261 ↗
• InjuryNov 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH AN 350CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE BILATERAL DEFLATION. THE DIAGNOSIS WAS CONFIRMED BY A PHYSICIAN UPON EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2019 AND REPLACED WITH UNSPECIFIED BREAST IMPLANTS. THIS REPORT IS FOR THE PATIENT'S LEFT-SIDED DEVICE.

  Patient problems: No Code Available

  MAUDE report 9377815 ↗
• InjuryAug 28, 2019Material Rupture; Material Rupture

  IN 1999, THE PATIENT HAD UNDERGONE PRIMARY PROCEDURE: IMPLANTATION OF MENTOR SALINE IMPLANTS , CATALOG NUMBER 3542512, MENTOR SILTEX CONTOUR PROFILE SPECTRUM 350CC IN 2002, ONE IMPLANT RUPTURED AND ONE IMPLANT WAS REMOVED AND REPLACED WITH A MENTOR SALINE IMPLANT, CATALOG NUMBER 3542512, MENTOR SILTEX CONTOUR PROFILE SPECTRUM 350CC . THIS EVENT WAS REPORTED IN ASR-Q3-10-31-2017. IN 2004 , THE PATIENT EXPERIENCED ONE IMPLANT RUPTURE AND BOTH IMPLANTS WERE REMOVED AND REPLACED WITH MENTOR SALINE IMPLANTS , CATALOG NUMBER 3542712, MENTOR SILTEX CONTOUR PROFILE SPECTRUM 350CC. THIS EVENT WAS REPORTED IN ASR-Q3-10-31-2017 REPORT. IN 2016 , THE PATIENT EXPERIENCED ONE IMPLANT RUPTURE. NO REMOVAL NOR REPLACEMENT OF IMPLANTS. IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION OF UNKNOWN TYPE WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM 350C AND EXPERIENCED DEFLATION ON THE RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2017. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR PSR REFERENCE NUMBER IP-00015869. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 8939337 ↗
• InjuryJul 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 350CC AND EXPERIENCED RIGHT SIDE DEFLATION. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 350CC ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8783453 ↗
• InjuryApr 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST AUGMENTATION WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM 350CC SALINE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. AS A RESULT PATIENT HAD THE DEVICE REMOVED AND REPLACED WITH SERIAL NUMBER (B)(4), CATALOG NUMBER 3341152 ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8524364 ↗

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