NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MF-410255Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10888628003446), received between Aug 12, 2020 and Sep 25, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Material Rupture” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906209 ↗
• InjuryFeb 17, 2026Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24368788 ↗
• InjuryNov 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV, DOUBLE CAPSULE AND RECALLED IMPLANT (410)". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED. DEVICE IS IN TRANSIT TO MANUFACTURER.

  Patient problems: Capsular Contracture

  MAUDE report 23500918 ↗
• InjuryNov 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV, DOUBLE CAPSULE AND RECALLED IMPLANT (410)". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED. DEVICE IS IN TRANSIT TO MANUFACTURER.

  Patient problems: Capsular Contracture

  MAUDE report 23496679 ↗
• InjuryMar 30, 2023Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 16650018 ↗
• InjuryNov 4, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "TEXTURED" AGAINST LEFT DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15736059 ↗
• InjuryOct 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. PATIENT ADDITIONALLY REPORTED "FIRMNESS, AND HARDNESS", THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15633937 ↗
• InjuryOct 19, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND " TEXTURED IMPLANTS." DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15633090 ↗
• InjuryJul 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT. HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15080276 ↗
• InjuryMay 20, 2022Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE, EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT, "ABNORMAL LEFT AXILLARY LYMPH NODE FINDING," AND "ALCL." PATIENT ALSO REPORTED "NAUSEOUS" AND "JOINTS HURT"; THESE EVENTS ARE NOT RELATED TO THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE AND "ABNORMAL LEFT AXILLARY LYMPH NODE AND PROMINENT FOLDING ALONG THE EDGE OF THE LEFT IMPLANT." PATHOLOGICAL MARKERS CONFIRMING ALCL HAVE NOT BEEN RECEIVED. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Lymphoma; Swollen Lymph Nodes/Glands

  MAUDE report 14463157 ↗
• InjuryApr 1, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED FOR RIGHT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PATIENT CONCERN WITH THE PRODUCT" AND "RUPTURE". THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 13972576 ↗
• InjuryJan 26, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "PATIENT CONCERN WITH THE PRODUCT" AGAINST RIGHT DEVICE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 13358303 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "SWELLING, BREAST ENLARGEMEN, ACUTE AND CHRONIC INFLAMMATORY CELLS AND SEROMA." DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 11826563 ↗
• InjuryMar 28, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE II AND IMPLANT EXCHANGE FROM TEXTURED DUE TO CONCERN OF THE PRODUCT. HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV AND IMPLANT EXCHANGE FROM TEXTURED DUE TO CONCERN OF THE PRODUCT. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11580436 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT." PATIENT REPORTED "A SEVERE REACTION" AND "MULTIPLE INSTANCES OF ANAPHYLAXIS." THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11317794 ↗
• InjuryFeb 2, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT." PATIENT REPORTED "A SEVERE REACTION" AND "MULTIPLE INSTANCES OF ANAPHYLAXIS." THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11267144 ↗
• InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED AN UNKNOWN SIDE OF "EXPERIENCING SYMPTOMS" AND "EXPERIENCING PERSISTENT PAIN OVER THE PAST 3 MONTHS." HEALTHCARE PROVIDER ADDITIONALLY REPORTED LEFT SIDE PAIN, SWELLING AND "SMALL AMOUNT OF FLUID BUT NOTHING SIGNIFICANT." THIS RECORD WILL BE FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 10740991 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPRESENTATIVE REPORTED "REMOVAL OF IMPLANTS DUE TO FEAR ALCL."

  Patient problems: Unspecified Infection

  MAUDE report 10655772 ↗
• InjuryAug 12, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "SWELLING, INCREASE IN SIZE OF IMPLANT, 40CC'S OF FLUID", EXCHANGE DUE TO THE PATIENTS CONCERN WITH THE PRODUCT AND "RUPTURED NOTICED DURING SURGERY." DEVICE WAS EXPLANTED.

  Patient problems: Seroma

  MAUDE report 10399881 ↗