MENTOR CPX 2 Breast Tissue Expander 3546213Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00081317002260), received between May 29, 2018 and May 15, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR CPX 2 BREAST TISSUE EXPANDER 450CC DEVICE THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE LEFT SIDE TISSUE EXPANDER WAS DETECTED BY BOTH ULTRASOUND AND MRI. IN ADDITION, A SILICONE INFILTRATION IN THE AXILLARY LYMPH NODE WAS CONFIRMED BY A CORE BIOPSY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019.

  Patient problems: Granuloma; No Code Available

  MAUDE report 8612966 ↗
• InjuryMay 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED (VIA FDA MEDWATCH) THAT A FEMALE PATIENT OF UNKNOWN AGE WHO UNDERWENT BREAST PROSTHESES IMPLANTATION WITH MENTOR SALINE IMPLANTS ON (B)(6) 2004 REPORTED BREAST IMPLANT ILLNESS. THE PATIENT REPORTED THAT SHE HAS BEEN FEELING TERRIBLE FOR THE LAST 10+ YEARS, AND HAS SEEN MULTIPLE DOCTORS, HAS HAD MULTIPLE IMAGING, TESTING, AND PHYSICAL THERAPY BUT HER SYMPTOMS REMAIN UNRESOLVED. THE PATIENT REPORTS BONE PAIN, NECK AND BACK PAIN, BRAIN FOG, SEVERE FATIGUE, IMPAIRED CONCENTRATION AFFECTING DRIVING, STOMACH AND DIGESTIVE ISSUES, EYE PROBLEMS, POOR LIBIDO, AND DEPRESSION. ALL THE TESTS COME BACK NEGATIVE FOR LYME DISEASE. THE PATIENT REPORTED THAT ONE PHYSICIAN BELIEVES SHE HAS FIBROMYALGIA AND ANOTHER SAID SHE MAY HAVE BEGINNING STAGES OF OSTEO-ARTHRITIS. THE PATIENT REPORTS HER QUALITY OF LIFE IS VERY POOR AND THAT SHE EATS HEALTHY, TAKES VITAMINS, BUT HAS DIFFICULTY EXERCISING DUE TO PAIN AND FATIGUE. THE PATIENT DID RESEARCH AND BELIEVES IT IS BREAST IMPLANT ILLNESS. THE PATIENT CANNOT AFFORD TO GET THEM REMOVED BUT IS TIRED OF FEELING SICK. NO PRODUCT ISSUE, SUCH AS DEFLATION, WAS REPORTED. SEE MANUFACTURER REPORT NUMBER 1645337-2018-03281 FOR CONTRALATERAL PROSTHESI

  Patient problems: Autoimmune Reaction; No Code Available

  MAUDE report 7550661 ↗