NATRELLE Silicone-Filled Breast Implants 110-330Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10888628002234), received between Sep 26, 2019 and Sep 16, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Material Rupture” (16 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Material Rupture

  Patient reported: "rupture". This record is for the right-side device. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790643 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED RAYNAUD¿S PHENOMENON. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Pallor

  MAUDE report 24304461 ↗
• InjuryJan 14, 2026Material Rupture

  PATIENT REPORTED "EXCHANGE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT" AND "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24067130 ↗
• InjuryDec 25, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED THROUGH COMPANY REPRESENTATIVE "RUPTURED IMPLANT". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23892658 ↗
• InjuryDec 25, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED THROUGH COMPANY REPRESENTATIVE "RUPTURED IMPLANT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23892638 ↗
• InjuryNov 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23600762 ↗
• InjuryNov 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23600756 ↗
• InjuryNov 3, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RECALLED IMPLANTS TEXTURED", "RUPTURED IMPLANT" AND "BREAST PAIN, GREATER ON THE RIGHT, CONCERN FOR IMPLANT INTEGRITY" AND " INTRACAPSULAR NEEDLE RUPTURE. "CONFIRM WITH MAMMOGRAM. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23452485 ↗
• InjuryOct 6, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENTS CONCERN WITH THE PRODUCT". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NONABBVIE.

  Patient problems: Failure of Implant

  MAUDE report 23228465 ↗
• InjuryOct 3, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENTS CONCERN WITH THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED WITH NONABBVIE.

  Patient problems: Failure of Implant

  MAUDE report 23211189 ↗
• InjuryOct 25, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED AN EVENT OF LEFT SIDE RUPTURE AND "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT". DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15668570 ↗
• InjuryApr 28, 2022Material Rupture; Material Rupture

  HEALTHCARE PROVIDER REPORTED A RIGHT SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14230255 ↗
• InjurySep 17, 2021Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE RUPTURE. HEALTHCARE PROFESSIONAL LATER CONFIRMED RUPTURE. THE DEVICE HAS BEEN REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 12488319 ↗
• InjuryDec 21, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE, LUMPS AND EXCHANGE DUE TO CONCERN WITH THE PRODUCT. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11048143 ↗
• InjuryDec 15, 2020Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL ALSO REPORTED "ABDOMINAL PAIN"; THIS IS NOT DEVICE RELATED. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 11010547 ↗
• InjuryApr 10, 2020Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9947713 ↗
• InjuryJan 31, 2020Material Rupture; Material Rupture

  ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "ISSUE OF IMPLANT BOTTOMING OUT AND LATERAL DISPLACEMENT". DEVICE HAS BEEN EXPLANTED AND DISCARDED AFTER SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 9652446 ↗
• InjuryJan 6, 2020Material Rupture; Migration; Material Rupture; Migration

  PATIENT REPORTED RIGHT-SIDE "IMPLANT IN RIGHT BREAST IS RUPTURED" AND "GEL FROM IMPLANT IS IN LYMPH NODES.¿ DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9555059 ↗
• InjuryNov 29, 2019Material Rupture; Material Rupture

  PATIENT REPORTED EXPERIENCING ISSUES: "FLUID BUILD UP" AND "THEIR IMPLANT MAY BE LEAKING." THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Seroma

  MAUDE report 9391686 ↗
• InjurySep 26, 2019Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  PATIENT REPORTED "IMPLANT IN LEFT BREAST IS HARDENED," AND "GEL FROM IMPLANT IS IN LYMPH NODES.¿ HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9123140 ↗

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