NATRELLE Silicone-Filled Breast Implants 115-586Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888628002463), received between May 6, 2022 and Sep 14, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Rupture” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Material Rupture

  Healthcare professional reported "Rupture" and "exchange from textured to a smooth". This record is for the right side. Device was explanted and replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752884 ↗
• InjuryApr 6, 2026Material Rupture

  PATIENT REPORTED "RUPTURE" "EXCHANGE DUE TO CONCERN WITH THE PRODUCT". PATIENT ADDITIONALLY REPORTED "GENERALLY FEELING UNWELL"; THIS EVENT IS NOT RELATED TO THE DEVICE. PATIENT REPRESENTATIVE REPORTED "PLAINTIFF WAS IMPLANTED WITH BIOCELL DEVICES, WHICH PLAINTIFF CONTENDS CAUSED INJURIES. MANUFACTURING DEFECT, FAILURE TO WARN, BREACH OF EXPRESS WARRANTY, NEGLIGENCE, AND CONSUMER FRAUD. PATIENT HAS NOT BEEN DIAGNOSED WITH BIA-ALCL". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Malaise

  MAUDE report 24795471 ↗
• InjuryAug 12, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "TEXTURED IMPLANTS". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED. HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV", "RUPTURE" AND "FLUID ACCUMULATION".

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 22786519 ↗
• InjuryMay 6, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPRESENTATIVE REPORTED "LEFT CAPSULAR CONTRACTURE REQUIRING BILATERAL CAPSULOTOMIES AND INCREASED RISK OF ALCL. PATIENT HAS NOT BEEN DIAGNOSED WITH BIA-ALCL." THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14309492 ↗

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