NATRELLE Silicone-Filled Breast Implants 120-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10888628002593), received between Apr 7, 2014 and Sep 28, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Material Rupture” (17 reports).

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

3 other recalls cover devices cleared under the same FDA submission (P020056); 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.

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-2454-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922833 ↗
• InjurySep 15, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "Capsular contracture Baker grade IV", "Rupture", "Deformity". This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50773685 ↗
• InjurySep 8, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Pain", "Capsular Contracture Baker grade Unknown" and "Exchange from textured to smooth breast implants". This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50674106 ↗
• InjuryAug 19, 2026Material Rupture

  Healthcare professional reported "exchange from textured to smooth" and "rupture". Later, healthcare professional reported "Fear ALCL". Later, healthcare professional reported "the inner silicone touched the patient" and "the problem was with the shell". This record is for the left side. The device was explanted.

  Patient problems: Anxiety

  MAUDE report 50331140 ↗
• InjuryAug 19, 2026Material Rupture

  Healthcare professional reported "exchange from textured to smooth" and "rupture". Later, healthcare professional reported "Fear ALCL". This record is for the right side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50331139 ↗
• InjuryJul 20, 2026Material Rupture

  Healthcare professional reported "rupture" and "lumps". This record is for the left side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25879642 ↗
• InjuryMar 17, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD REMAINS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24619392 ↗
• InjuryMar 12, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD REMAINS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24587385 ↗
• InjuryJan 6, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTH PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III-IV. A DIFFERENT HEALTHCARE PROFESSIONAL LATER ALSO REPORTED A CAPSULAR CONTRACTURE BAKER GRADE NOT PROVIDED AND A RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21085863 ↗
• InjurySep 14, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED AGAINST RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT AND THEN LATER REPORTED RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15417557 ↗
• InjuryAug 17, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15241704 ↗
• InjuryAug 17, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15241548 ↗
• InjuryJul 11, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "PATIENTS CONCERNS" AGAINST LEFT DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE RUPTURE THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 14978701 ↗
• InjuryMay 5, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PATIENT'S CONCERN WITH THE DEVICE AND RUPTURE. HEALTHCARE PROFESSIONAL ADDED "HOLE, NON-SPECIFIC". THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14290687 ↗
• InjuryMay 5, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PATIENT'S CONCERN WITH THE DEVICE, AND RUPTURE. HEALTHCARE PROFESSIONAL ADDED "HOLE, NON-SPECIFIC". THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14289346 ↗
• InjuryAug 23, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12356228 ↗
• InjuryDec 11, 2020Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10993482 ↗
• InjuryNov 4, 2019Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9271445 ↗
• InjurySep 6, 2019Material Rupture; Material Rupture

  PATIENT REPORTED A LEFT SIDE RUPTURE WITH "BUBBLES." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8972059 ↗
• InjuryAug 5, 2019Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND A RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8861334 ↗
• InjuryAug 2, 2019Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND A RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8856929 ↗
• InjuryApr 7, 2014Patient-Device Incompatibility; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED A CASE OF LATE SEROMA AND LYMPHOMA. IN F/U WITH THE NURSE, INFO WAS RECEIVED THAT THE PT PRESENTED WITH A LEFT SIDE LATE SEROMA. SHE WAS TAKEN TO SURGERY AND THE SEROMA WAS EVACUATED. THE DEVICE WAS REINSERTED. THE NURSE DID NOT HAVE THE SERIAL NUMBERS FOR THIS DEVICE, BUT IT WAS NOTED THAT IT WAS A STYLE120-600 ALLERGAN DEVICE. THE PT HAD HER ORIGINAL AUGMENTATION IN 2007, EXACT DATE UNK. THE DEVICES WERE STYLE15-304. THEY WERE REMOVED AND REPLACED WITH THE 120-600 THAT SHE HAS IN PLACE NOW. THE REASON FOR REMOVAL AND REPLACEMENT OF THE 15-304 WAS A SIZE EXCHANGE. THE PT HAS NOT BEEN EXPLANTED. THE NURSE WAS TO SEND OVER THE CYTOLOGY ON THIS CASE AS SHE WAS NOT FAMILIAR WITH HOW TO READ THE HISTOLOGY/CYTOLOGY RESULTS. SHE WAS ALSO FAX OVER THE OP REPORT WITH THE REMAINDER OF THE DEVICE INFO. TO DATE, THE MEDICAL RECORDS HAVE NOT BEEN RECEIVED. ONCE RECEIVED, ANY NEW INFO WILL BE SUBMITTED.

  Patient problems: Anaplastic Large Cell Lymphoma; Capsular Contracture; Lymphoma; Seroma

  MAUDE report 3761522 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020056. One submission often covers many models, so check the product and lot details in each record.

• Z-0701-2020 · Nov 6, 2019 · Terminated
  Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 762
• Z-0700-2020 · Nov 6, 2019 · Terminated
  Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod
• Z-2453-2019 · Jul 24, 2019 · Open, Classified
  Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TR