MENTOR SILTEX CONTOUR PROFILE SPECTRUM 3542511Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00081317002130), received between Jun 11, 2018 and Sep 18, 2023 — classified as 15 injuries.

The most frequently reported specific device problem is “Material Rupture” (14 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT DEFLATION. THE BREAST LOOKED DIFFERENT. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17762788 ↗
• InjuryDec 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 65-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY PROCEDURE WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 275CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR SMOOTH ROUND SPECTRUM 375CC SALINE BREAST PROSTHESIS ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15921247 ↗
• InjuryJun 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 72-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 275CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REPORTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14743610 ↗
• InjuryAug 17, 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 WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION SURGERY WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM, 275CC BREAST IMPLANT EXPERIENCED RIGHT-SIDED BREAST MASS AND WRINKLING POST PROCEDURE. THE PATIENT STATED THAT SHE HAD A LITTLE NODULE ON TOP OF HER SCAR, SOME BUMPS, AND SHE IS CONCERNED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Mass; Wrinkling

  MAUDE report 12332150 ↗
• InjuryDec 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 275CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM PROSTHESIS (RIGHT) AND A 275CC MENTOR SILTEX CONTOUR PROFILE HIGH PROSTHESIS (LEFT) AND EXPERIENCED BILATERAL DEFLATION, LEFT-SIDED PARESTHESIA, AND RIGHT-SIDED BREAST PAIN POSTOPERATIVELY. INITIALLY, THE PATIENT REACHED OUT TO MENTOR STATING THAT SHE EXPERIENCED RIGHT-SIDED DEFLATION AND LEFT-SIDED NERVE DAMAGE. THE PATIENT HAD A CONSULTATION WITH HER PHYSICIAN AND STATED THAT SHE EXPERIENCED RIGHT-SIDED DEFLATION AND BREAST PAIN/DISCOMFORT. IN ADDITION, THE PATIENT¿S PHYSICIAN NOTED THAT SHE HAD A HISTORY OF THE LEFT BREAST IMPLANT WITH SUBSEQUENT SURGICAL TREATMENT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020. AT THIS TIME OF REPORT, THE DATE OF EXPLANTATION FOR THE LEFT-SIDED DEVICE IS UNKNOWN AND IS ESTIMATED AS (B)(6) 2020 BASED ON AVAILABLE INFORMATION. FOLLOW-UP IS STILL IN PROGRESS. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: Pain

  MAUDE report 10945560 ↗
• InjuryOct 1, 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 CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM 275CC AND EXPERIENCED AUTOIMMUNE SYMPTOMS INCLUDING FATIGUE, WEIGHT GAIN, THYROID PROBLEMS, DRY SKIN, HAIR LOSS, HEADACHES, VISION CHANGE, HIGH BLOOD PRESSURE, AND ANXIETY. 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 DEVICE.

  Patient problems: Autoimmune Reaction

  MAUDE report 9141674 ↗
• InjuryOct 1, 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) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM 275CC AND EXPERIENCED AUTOIMMUNE SYMPTOMS INCLUDING FATIGUE, WEIGHT GAIN, THYROID PROBLEMS, DRY SKIN, HAIR LOSS, HEADACHES, VISION CHANGE, HIGH BLOOD PRESSURE, AND ANXIETY. 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 DEVICE.

  Patient problems: Autoimmune Reaction

  MAUDE report 9141672 ↗
• InjurySep 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 275CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE RIGHT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNKNOWN DATE.

  Patient problems: No Code Available

  MAUDE report 9088077 ↗
• InjuryAug 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH A 275CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM SALINE ON THE LEFT SIDE AND AN UNSPECIFIED MENTOR SALINE IMPLANT ON THE RIGHT SIDE, SUFFERED BILATERAL DEFLATION POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 8931589 ↗
• InjuryJul 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD PATIENT WITH UNKNOWN SEX, RACE AND ETHNICITY UNDERWENT UNSPECIFIED BREAST SURGERY WITH 275CC MENTOR SILTEX CONTOUR PROFILE SPECTRUM AND WAS PRESENTED WITH LEFT SIDE BREAST IMPLANT 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 8804189 ↗
• InjuryNov 14, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A SALINE MENTOR SILTEX CONTOUR PROFILE SPECTRUM 275CC AND EXPERIENCED DEFLATION ON THE RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH UNKNOWN TISSUE EXPANDER ON (B)(6) 2018. THERE WERE NO COMPLICATIONS.

  Patient problems: No Code Available

  MAUDE report 8070720 ↗
• InjuryNov 12, 2018Material 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 SPECTRUM 275CC BREAST IMPLANT AND EXPERIENCED BILATERAL PAIN AND DEFLATION. 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: Pain

  MAUDE report 8060974 ↗
• InjuryNov 12, 2018Material 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 SPECTRUM 275CC BREAST IMPLANT AND EXPERIENCED BILATERAL PAIN AND DEFLATION. 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: Pain

  MAUDE report 8060955 ↗
• InjuryJun 11, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM 275CC SALINE BREAST PROSTHESES THAT BOTH DEFLATED AFTER IMPLANTATION. PATIENT REPORTED THAT HER IMPLANTS LOST VOLUME AND WERE FLATTENING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 7589818 ↗
• InjuryJun 11, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR SILTEX CONTOUR PROFILE SPECTRUM 275CC SALINE BREAST PROSTHESES THAT BOTH DEFLATED AFTER IMPLANTATION. PATIENT REPORTED THAT HER IMPLANTS LOST VOLUME AND WERE FLATTENING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 7589813 ↗

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