Natrelle 133 Plus Tissue Expanders 133P-MX-12-TRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888628010154), received between Dec 10, 2019 and Jan 30, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 24, 2019Class IOpen, Classified

   The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

   Z-2456-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

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.

• InjuryJan 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED ¿SHE HAS PAIN ALL THE TIME AND SHE HASN'T SLEPT THROUGH THE NIGHT SINCE THEY WERE IMPLANTED. SHE CAN'T LIE ON HER BACK AT ALL. SHE SAID SHE HAS SHOOTING PAIN IN HER LEFT BREAST AND HER RIGHT BREAST LOOKS LIKE THREE QUARTERS OF A BREAST WITH A FLAT BOTTOM. SHE SAID HER RIGHT BREAST IS HARD AS A ROCK. SHE HAS NIPPLE DISCHARGE, BREASTS LOOK EXTREMELY DEFORMED AND MISSHAPEN TO THE POINT THEY DON'T EVEN LOOK LIKE BREASTS; THEY USED TO LOOK LIKE BREASTS BUT NOW THEY LOOK LIKE BOXES BECAUSE THE BOTTOMS ARE COMPLETELY FLAT." PATIENT ADDITIONALLY REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV." THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16263521 ↗
• InjuryDec 10, 2019Fluid/Blood Leak; Fluid/Blood Leak

  PATIENT REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9444337 ↗