Natrelle® Style 133 Tissue Expanders 133MV-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888628004115), received between Oct 5, 2018 and Apr 28, 2022 — classified as 3 injuries.

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-2455-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPRESENTATIVE REPORTED "IF PATIENT KNEW OF THE SIGNIFICANT POTENTIAL HEALTH RISKS OF ALLERGAN¿S NATRELLE STYLE 410 FX IMPLANTS, THEY WOULD NEVER HAVE HAD ALLERGAN¿S BIOCELL PRODUCT IMPLANTED IN THEIR BODY. AS A RESULT OF THE IMPLANTATION OF ALLERGAN¿S DEFECTIVE NATRELLE STYLE 410 FX IMPLANT, PATIENT HAS SUFFERED PHYSICAL COMPLAINTS AND SYMPTOMS, ALL OF WHICH ARE CAUSALLY CONNECTED TO ALLERGAN¿S NATRELLE STYLE 410 FX IMPLANT. PATIENT HAS EXPERIENCED PAIN UNDER THEIR ARMPITS, UNDER AND ACROSS CHEST, BACKPAIN, PAIN WHEN TAKING DEEP BREATHS. DIFFICULTY WITH SEXUAL ACTIVITY, NUMBNESS, STIFFNESS, PULLING, ACHING, SHOOTING PAIN INTO THE ARMPITS, SHOULDER PAIN ,NECK PAIN, TINGLING AND NUMBNESS IN ARMS, HANDS, FINGERS, LOSS OF STRENGTH IN ARMS AND HANDS, DENTAL ISSUES, MUSCULO SKELETAL COMPLAINTS, REDNESS, SWELLING, SHOULDER PAIN, STIFFNESS. FORMATION OF SCARS AROUND THE INCISION, NERVE, BACK AND NECK PAIN, DIVOTS, SORENESS, FEVER, INFECTION AND DISCOMFORT. PATIENT ALSO SUFFERED FROM AND PRESENTLY SUFFERS GREAT FEAR THAT ALLERGAN¿S RECALLED AND DEFECTIVE NATRELLE STYLE 410 FX IMPLANT WILL RESULT IN THEM EXPERIENCING BIA-ALCL AND/OR DEATH." THE DEVICE HAS BEEN EXPLANTED. THIS RECORD

  Patient problems: Unspecified Infection

  MAUDE report 14240424 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPRESENTATIVE REPORTED "IF PATIENT KNEW OF THE SIGNIFICANT POTENTIAL HEALTH RISKS OF ALLERGAN¿S NATRELLE STYLE 410 FX IMPLANTS, THEY WOULD NEVER HAVE HAD ALLERGAN¿S BIOCELL PRODUCT IMPLANTED IN THEIR BODY. AS A RESULT OF THE IMPLANTATION OF ALLERGAN¿S DEFECTIVE NATRELLE STYLE 410 FX IMPLANT, PATIENT HAS SUFFERED PHYSICAL COMPLAINTS AND SYMPTOMS, ALL OF WHICH ARE CAUSALLY CONNECTED TO ALLERGAN¿S NATRELLE STYLE 410 FX IMPLANT. PATIENT HAS EXPERIENCED PAIN UNDER THEIR ARMPITS, UNDER AND ACROSS CHEST, BACKPAIN, PAIN WHEN TAKING DEEP BREATHS. DIFFICULTY WITH SEXUAL ACTIVITY, NUMBNESS, STIFFNESS, PULLING, ACHING, SHOOTING PAIN INTO THE ARMPITS, SHOULDER PAIN ,NECK PAIN, TINGLING AND NUMBNESS IN ARMS, HANDS, FINGERS, LOSS OF STRENGTH IN ARMS AND HANDS, DENTAL ISSUES, MUSCULO SKELETAL COMPLAINTS, REDNESS, SWELLING, SHOULDER PAIN, STIFFNESS. FORMATION OF SCARS AROUND THE INCISION, NERVE, BACK AND NECK PAIN, DIVOTS, SORENESS, FEVER, INFECTION AND DISCOMFORT. PATIENT ALSO SUFFERED FROM AND PRESENTLY SUFFERS GREAT FEAR THAT ALLERGAN¿S RECALLED AND DEFECTIVE NATRELLE STYLE 410 FX IMPLANT WILL RESULT IN THEM EXPERIENCING BIA-ALCL AND/OR DEATH." THE DEVICE HAS BEEN EXPLANTED. THIS RECORD

  Patient problems: Unspecified Infection

  MAUDE report 12590683 ↗
• InjuryOct 5, 2018No Apparent Adverse Event; No Apparent Adverse Event

  HEALTH PROFESSIONAL REPORTED PATIENT EXPERIENCED "CELLULITIS". THIS IS THE LEFT SIDE RECORD. DEVICE REMAINS IMPLANTED.

  Patient problems: Cellulitis

  MAUDE report 7939224 ↗