MENTOR SILTEX CONTOUR PROFILE SPECTRUM 3542515Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00081317002178), received between Mar 22, 2018 and May 14, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Material Rupture” (18 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Material Rupture

  IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 650CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) AND DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026, AND REPLACED WITH A 550CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 25167455 ↗
• InjurySep 11, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND SKIN REACTION 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; Local Reaction

  MAUDE report 23031194 ↗
• InjuryOct 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH UNSPECIFIED MENTOR SALINE BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17950913 ↗
• InjuryOct 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. A DISCREPANCY WAS OBSERVED WHEN THE INFORMATION REPORTED INCLUDED A DATE OF IMPLANTATION THAT OCCURRED PRIOR TO THE MANUFACTURING DATE OF THE BREAST IMPLANT. AS THIS IS NOT POSSIBLE, MENTOR ASSOCIATES WILL REACH OUT FOR FURTHER INFORMATION. IF NEW INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17932671 ↗
• InjuryApr 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 41-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 650CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST IMPLANT DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL AS THE RIGHT BREAST WAS SMALLER. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 800CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16708854 ↗
• InjuryFeb 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 650CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM PROSTHESIS AND EXPERIENCED LEFT-SIDED DEFLATION POSTOPERATIVELY. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13545538 ↗
• InjuryJul 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH A 650CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM BREAST IMPLANT EXPERIENCED RIGHT SIDED BREAST PAIN AND DEFLATION POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Pain

  MAUDE report 12147966 ↗
• InjuryFeb 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT UNSPECIFIED BREAST RECONSTRUCTION WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 650CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. THE REPORT INDICATED THAT ULTRASOUND NEEDLE BIOPSY AND AXILLARY LYMPH NODES ON THE LEFT AND IMPLANT ON THE LEFT SIDE HAS BURST AND THE SILICONE HAS BEEN IN THE BODY AND NEEDS TO BE REMOVED IMMEDIATELY. PATIENT HAS PAIN. THE DOCTOR PERFORMED ENORMOUS TESTS AND THEY CAME BACK NEGATIVE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. NO FURTHER INFORMATION WAS PROVIDED REGARDING THIS CASE. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED, AND NOTES WILL BE UPDATED NOTE: THE OUTER SHELL OF THE IMPLANT MADE FROM GEL.

  Patient problems: Granuloma; Pain

  MAUDE report 11386908 ↗
• InjuryJan 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH 650CC TEXTURED MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST IMPLANT EXPERIENCED LEFT-SIDED IMPLANT DEFLATION POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANTS, 440CC ON THE LEFT (LEFT CATALOG # SMPX440 AND LOT-SERIAL # (B)(4)) AND 605CC ON THE RIGHT (RIGHT CATALOG # SMPX605 AND LOT-SERIAL # (B)(4)) ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11233429 ↗
• InjuryJan 11, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A (B)(4) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH 650CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST PROSTHESIS AND EXPERIENCED A PAINFUL 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: Pain

  MAUDE report 11151929 ↗
• InjuryJan 1, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 650CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM AND WAS PRESENTED WITH BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE DEVICE WILL BE EXPLANTED ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9537159 ↗
• InjuryDec 27, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH TWO 650 CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST PROSTHESES, SUFFERED LEFT BREAST IMPLANT DEFLATION, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9527888 ↗
• InjuryAug 30, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 650CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. THE PATIENT REPORTED THAT HER LEFT BREAST PROSTHESIS WAS LEAKING, VERY PAINFUL, AND HAD A BAD SMELL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 650CC GEL BREAST PROSTHESIS ON (B)(6) 2015.

  Patient problems: No Code Available

  MAUDE report 8950992 ↗
• InjuryMay 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SILTEX CONTOUR PROFILE SPECTRUM 650CC AND EXPERIENCED DEFLATION ON THE RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT WILL UNDERGO REMOVAL ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8577643 ↗
• InjuryMay 1, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM 650CC SALINE PROSTHESIS EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. RIGHT SIDED DEFLATION WAS DIAGNOSED THROUGH MAGNETIC RESONANCE IMAGING ON (B)(6) 2019. LEFT SIDED DEFLATION WAS DISCOVERED DURING THE EXPLANT SURGERY ON (B)(6) 2019. THE DEVICES WERE REPLACED WITH 755CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT RELATES TO THE LEFT PROSTHESIS. SEE 1645337-2019-10887 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: No Code Available

  MAUDE report 8570830 ↗
• InjuryMay 1, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM 650CC SALINE PROSTHESIS EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. RIGHT SIDED DEFLATION WAS DIAGNOSED THROUGH MAGNETIC RESONANCE IMAGING ON (B)(6) 2019. LEFT SIDED DEFLATION WAS DISCOVERED DURING THE EXPLANT SURGERY ON (B)(6) 2019. THE DEVICES WERE REPLACED WITH 755CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT RELATES TO THE RIGHT PROSTHESIS. SEE 1645337-2019-10886 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: No Code Available

  MAUDE report 8570829 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) AFRICAN AMERICAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM 650CC SALINE BREAST IMPLANTS WHICH PATIENT REPORTED THAT HER BREAST FEELS LIKE THEY ARE PULLING APART, SHE FEELS DIZZY FOR A LONG PERIOD OF TIME, AND SHE HAS PASSED OUT TWO TIMES, IT SEEMS LIKE HER HEART IS HARD TO BEAT, AFTER IMPLANTATION. 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.

  Patient problems: No Code Available; Pain

  MAUDE report 8561247 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) AFRICAN AMERICAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM 650CC SALINE BREAST IMPLANTS WHICH PATIENT REPORTED THAT HER BREAST FEELS LIKE THEY ARE PULLING APART, SHE FEELS DIZZY FOR A LONG PERIOD OF TIME, AND SHE HAS PASSED OUT TWO TIMES, IT SEEMS LIKE HER HEART IS HARD TO BEAT, AFTER IMPLANTATION. 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.

  Patient problems: No Code Available; Pain

  MAUDE report 8561206 ↗
• InjuryJan 21, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 650CC AND EXPERIENCED DEFLATION OF THE LEFT BREAST TISSUE EXPANDER. AS A RESULT, THE PATIENT HAD UNDERGONE EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8264446 ↗
• InjurySep 12, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM, 650CC SALINE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. 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 7869120 ↗
• InjuryAug 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA FDA MEDWATCH MW5077747 THAT A FEMALE PATIENT OF UNKNOWN AGE UNDERWENT BREAST RECONSTRUCTION WITH A SALINE MENTOR SILTEX CONTOUR PROFILE SPECTRUM 650 CC AND EXPERIENCED CHANGE IN HER DIGESTIVE SYSTEM, JOINT PAIN, RINGING IN EARS, ITCHING, BREAST PAIN AND A COUGH DUE TO NEWLY DIAGNOSED ASTHMA. AS A RESULT, THE PATIENT UNDERWENT REMOVAL OF THE IMPLANTS ON (B)(6) 2018. THERE WAS NO PRODUCT ISSUE, SUCH AS DEFLATION REPORTED. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE. THIS IS FOR THE RIGHT SIDE IMPLANT, SEE MANUFACTURER REPORT NUMBER 1645337-2018-05085 FOR CONTRALATERAL PROSTHESIS.

  Patient problems: No Code Available; Pain

  MAUDE report 7802315 ↗
• InjuryAug 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA FDA MEDWATCH MW5077747 THAT A FEMALE PATIENT OF UNKNOWN AGE UNDERWENT BREAST RECONSTRUCTION WITH A SALINE MENTOR SILTEX CONTOUR PROFILE SPECTRUM 650CC AND EXPERIENCED CHANGE IN HER DIGESTIVE SYSTEM, JOINT PAIN, RINGING IN EARS, ITCHING, BREAST PAIN AND A COUGH DUE TO NEWLY DIAGNOSED ASTHMA. AS A RESULT, THE PATIENT UNDERWENT REMOVAL OF THE IMPLANTS ON (B)(6) 2018. THERE WAS NO PRODUCT ISSUE, SUCH AS DEFLATION REPORTED. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE. THIS IS FOR THE LEFT SIDE IMPLANT, SEE MANUFACTURER REPORT NUMBER 1645337-2018-05086 FOR CONTRALATERAL PROSTHESIS.

  Patient problems: No Code Available; Pain

  MAUDE report 7802285 ↗
• InjuryMar 22, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY PROCEDURE WITH A SALINE MENTOR SILTEX CONTOUR PROFILE SPECTRUM 650CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT HAS UNDERGONE EXPLANTATION ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7364397 ↗

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