NATRELLE Silicone-Filled Breast Implants 110-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10888628002227), received between May 15, 2019 and Sep 9, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Material Rupture” (15 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Material Rupture

  Healthcare professional reported "Seroma", "Periprosthetic fluid" and "Rupture" against the left side. The device was explanted.

  Patient problems: Seroma

  MAUDE report 50691940 ↗
• InjuryJul 29, 2026Material Rupture

  Healthcare professional reported Rupture. This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50074012 ↗
• InjuryFeb 2, 2026Material Rupture

  PATIENT REPORTED A "RUPTURE" AND "SEIZURES". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24240767 ↗
• InjuryJan 9, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT EXCHANGES FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT AND CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24030153 ↗
• InjuryNov 5, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "GROSS RUPTURE OF IMPLANT BAG" DIAGNOSED VIA MRI. HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE OF IMPLANT¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED. DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23480200 ↗
• InjuryAug 26, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "BAKER GRADE III CAPSULAR CONTRACTURE, POSSIBLE LEAKING MAMMARY IMPLANT AND TEXTURED MAMMARY IMPLANT ". THIS RECORD IS FOR THE "RIGHT" SIDE. THE DEVICE REMAINS IMPLANTED

  Patient problems: Capsular Contracture

  MAUDE report 22898074 ↗
• InjuryAug 22, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22873164 ↗
• InjuryJun 5, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE, FOLDS, LUMP AND SEROMA" CONFIRMED VIA MRI. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Seroma

  MAUDE report 22148229 ↗
• InjuryAug 13, 2024Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE.

  Patient problems: Capsular Contracture

  MAUDE report 19976609 ↗
• InjuryAug 7, 2024Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 19934446 ↗
• InjuryMay 21, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "STYLE 110 TEXTURED IMPLANTS" AND "BAKER GRADE III CONTRACTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 19365592 ↗
• InjurySep 7, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15375150 ↗
• InjuryMay 25, 2022Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE "I HAVE BEEN HAVING PERSISTENT PAIN AND THE DOCTOR TOLD ME THERE WAS SCAR TISSUE AND THAT I NEEDED A BIOPSY." LATER, PATIENT REPORTED, "RUPTURE" AND "EXCHANGE FROM A TEXTURED TO SMOOTH BREAST IMPLANT DUE TO CONCERN WITH THE PRODUCT." THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14501270 ↗
• InjuryMay 3, 2022Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE EXPLANT OF TEXTURED DEVICE DUE TO THEIR CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL ADDED, "HOLE, NON-SPECIFIC". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14271382 ↗
• InjurySep 17, 2021Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL LATER CONFIRMED RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 12489523 ↗
• InjuryApr 28, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11742228 ↗
• InjuryFeb 26, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE, G3." DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11388158 ↗
• InjuryMay 15, 2019Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  PATIENT REPORTED RIGHT SIDE "BROKEN INSIDE." PATIENT STATED ITS "LEAKING INSIDE [THEIR] BODY", "THREE FAKE VEINS COMING FROM UNDER THE IMPLANTS", "THE IMPLANT IS MOVING AROUND EVERYWHERE". PATIENT REPORTED FEELING "DIZZY AND FOGGY", "AREA SEEMS DEFLATED AND IS TINGLY". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant; Seroma

  MAUDE report 8613499 ↗

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