NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FM-410350Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10888628002852), received between May 20, 2019 and Sep 16, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Material Rupture” (7 reports).

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

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-2452-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50796448 ↗
• InjurySep 14, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular contracture" Baker Grade III. This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50753464 ↗
• InjuryDec 9, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE, SWELLING AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". PATIENT ALSO REPORTED "RUPTURE AND EXCHANGE DUE TO CONCERNS WITH THE PRODUCT". HEALTHCARE PROFESSIONAL LATER REPORTED "POSSIBLE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH DEVICE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT". PATIENT LATER REPORTED "CONTRACTION", "SEVERELY ENCAPSULATED", "PAIN, "I FEEL DIFFERENT", PATIENT DID NOT PROVIDE ANY BAKER GRADE. HEALTHCARE PROFESSIONAL LATER REPORTED "SIGNS OF RUPTURE: NO". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23759073 ↗
• InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE DUE TO CONCERNS WITH THE PRODUCT". PATIENT ALSO REPORTED "EXCHANGE DUE TO CONCERN WITH THE PRODUCT". HEALTHCARE PROFESSIONAL LATER REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DEVICE DUE TO THE PATIENT'S CONCERN". PATIENT LATER REPORTED "CONTRACTION", "SEVERELY ENCAPSULATED", "PAIN, "EXTREMELY UNCOMFORTABLE", "I FEEL DIFFERENT" AND PATIENT DID NOT PROVIDE ANY BAKER GRADE. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23758797 ↗
• InjuryMay 12, 2024Material Rupture; Material Rupture

  PATIENT REPORTED, "I AM CONCERNED AS I HAVE HAD BREAST TENDERNESS AND SOME SWELLING. I NEED TO KNOW WHAT TO DO FROM HERE AND WHAT TESTING NEEDS TO BE DONE." HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE "PATIENT'S CONCERN OF THE PRODUCT " AND "RUPTURE." HEALTHCARE PROFESSIONAL LATER REPORTED '"ANY CREASES" AND "HOLE IN RADIUS (EDGE)." DEVICE HAS BEEN EXPLANTED AND NOT REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 19295896 ↗
• InjuryApr 22, 2024Material Rupture; Material Rupture

  PATIENT REPORTED, "I AM CONCERNED AS I HAVE HAD BREAST TENDERNESS AND SOME SWELLING. I NEED TO KNOW WHAT TO DO FROM HERE AND WHAT TESTING NEEDS TO BE DONE." HEALTHCARE PROFESSIONAL LATER REPORTED "PATIENTS CONCERN OF THE PRODUCT" AND "RUPTURE". DEVICE HAS BEEN EXPLANTED. THIS IS THE RIGHT SIDE RECORD.

  Patient problems: Failure of Implant

  MAUDE report 19153432 ↗
• InjuryDec 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED " CAPSULAR CONTRACTURE BAKER GRADE III". HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE IV" AND " IMPLANTS WELDED TO CAPSULE AND SEROUS FLUID". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 18411643 ↗
• InjuryApr 26, 2023Material Rupture; Migration; Material Rupture; Migration

  PATIENT REPORTED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE AND IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16820540 ↗
• InjuryFeb 14, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND LEFT SIDE REMOVAL OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16371454 ↗
• InjuryApr 28, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN/ANXIETY WITH THE PRODUCT. PATIENT REPRESENTATIVE REPORTED "PAIN, RUPTURE, AND SWELLING OF THE BREAST." PATIENT REPRESENTATIVE ADDITIONALLY REPORTED "DEPRESSION" NOT RELATED TO THE DEVICE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 14240440 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPRESENTATIVE REPORTED LEFT SIDE SUBSEQUENT SURGERIES AND MEDICAL PROCEDURES, PAIN AND SUFFERING, SCARING AND DISFIGUREMENT. THE PATIENT WAS DIAGNOSED WITH BIA-ALCL. PATHOLOGICAL MARKER CD30+ AND ALK- HAS NOT BEEN RECEIVED. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Lymphoma

  MAUDE report 13285206 ↗
• InjuryOct 26, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT" AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10733894 ↗
• InjuryJul 28, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT" AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10335585 ↗
• InjuryMay 20, 2019Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 8624848 ↗