NATRELLE Silicone-Filled Breast Implants 110-420Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10888628002265), received between Nov 27, 2019 and Sep 25, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Material Rupture” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Material Rupture

  Patient problems: Breast Mass

  MAUDE report 50906174 ↗
• InjurySep 25, 2026Material Rupture

  Patient problems: Breast Mass

  MAUDE report 50906162 ↗
• InjurySep 15, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient problems: Capsular Contracture

  MAUDE report 50781690 ↗
• InjurySep 14, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture Grade III". This record is for the left side. Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50759169 ↗
• InjuryJul 16, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERNS WITH THE PRODUCT. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25842538 ↗
• InjuryJul 15, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERNS WITH THE PRODUCT. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25824449 ↗
• InjuryJun 29, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND REMOVAL AND EXCHANGE FROM TEXTURED TO SMOOTH DEVICES. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25651488 ↗
• InjuryApr 21, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH DEVICE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT" AND "RUPTURE" VIA CT SCAN. HEALTHCARE PROFESSIONAL LATER REPORTED "PAIN." DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 21877347 ↗
• InjuryApr 23, 2020Gel Leak; Material Rupture; Gel Leak; Material Rupture

  PATIENT REPORTED EXPERIENCING ¿PAIN THAT COMES AND GOES¿, ¿LUMPS UNDERNEATH BREAST AND ARMPIT, FEELS LIKE NODULES¿, ¿FIBROCYSTIC BREAST¿, ¿RIPPLING¿ AND ¿EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE THEIR CONCERN¿ WITH THE PRODUCT. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED "A SMALL AMOUNT OF SILICONE BLEED¿. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 9991920 ↗
• InjuryNov 27, 2019Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "PAIN" AND "CONCERN WITH THE PRODUCT." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND "ENLARGED LYMPH NODES." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9385264 ↗

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-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-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-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