NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FF-410595Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10888628002715), received between Jul 23, 2019 and Jun 11, 2026 — classified as 28 injuries.

The most frequently reported specific device problem is “Material Rupture” (12 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN", "SWELLING" AND "THE FLUID WAS EXTRACTED AND TESTED BUT THERE WAS NO INFECTION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25473818 ↗
• InjuryOct 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 23330243 ↗
• InjuryJul 17, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 22535792 ↗
• InjuryJul 8, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 22442652 ↗
• InjuryJul 6, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 22408652 ↗
• InjuryMay 15, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16930012 ↗
• InjuryMay 15, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16929981 ↗
• InjuryJan 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "ALCL FOUND ON POST OP PATHOLOGY", "RECURRENT SEROMA FORMATION", "LEFT RECONSTRUCTED BREAST WITH CAPSULAR CONTRACTURE GRADE 4", "BILATERAL IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". . HISTOPATHOLOGICAL MARKERS CD30+ AND ALK- HAVE BEEN RECEIVED. THE DEVICE HAS BEEN EXPLANTED AND REPLACED. TREATMENT: DEVICE EXPLANT, "LEFT CAPSULECTOMY ... ROBOTIC ASSISTED LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL REPAIR OF INCISIONAL HERNIA WITH MESH" AND "ROUGHLY 550 CC SEROMATOUS FLUID WAS REMOVED".

  Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Capsular Contracture; Seroma

  MAUDE report 16143281 ↗
• InjuryDec 22, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ALLERGAN DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 16040431 ↗
• InjuryDec 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16026671 ↗
• InjuryDec 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING "LEFT SIDE REMOVAL WAS ¿CAPSULAR CONTRACTURE¿ BAKER GRADE, UNKNOWN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16010730 ↗
• InjuryDec 9, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15955814 ↗
• InjurySep 8, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROVIDER REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15380179 ↗
• InjuryAug 15, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CONTRACTURE," BAKER GRADE UNKNOWN AND "TEXTURED IMPLANTS" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15230232 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "BREAST IMPLANT- ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA". THE DEVICE REMAINS IMPLANTED. HISTOPATHOLOGICAL MARKERS WERE NOT REPORTED.

  Patient problems: Lymphoma

  MAUDE report 15084870 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPRESENTATIVE REPORTED THE PATIENT WORRIED ABOUT THE RISKS THEY FACE WITH BIOCELL TEXTURED BREAST IMPLANTS AND BIA-ALCL. THE PATIENT SUFFER FROM MENTAL STRESS, ANXIETY, WORRY, HUMILIATION, FEAR, CONCERN AND OTHER PERSONAL AND FINANCIAL HARDSHIP DUE TO THE CONTINUOUS FEAR OF BIA-ALCL RETURNING AND AFTERMATH FROM THE SUFFERING OF BIA-ALCL. PATHOLOGY HAS NOT BEEN RECEIVED AND THE MARKERS OF CD30+ AND ALK- HAVE NOT BEEN REPORTED OR CONFIRMED. THE PATIENT UNDERWENT A REMOVAL OF THEIR POTENTIALLY CANCER CAUSING BREAST IMPLANT IN THE LEFT SIDE.

  Patient problems: Lymphoma

  MAUDE report 13284387 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED RIGHT SIDE "PAIN, HARDNESS," AND "INNER ITCHING BAND FROM THE MIDDLE OF THE BACK TO THE BREAST." HEALTHCARE PROFESSIONAL REPORTED "SEROMA." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 11616470 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED "RED BREAST" AND "HAD AN INFECTION THAT WOULD NOT GO AWAY WITH ANTIBIOTICS UNTIL THE IMPLANTS WERE REMOVED." DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 10790953 ↗
• InjurySep 28, 2020Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 10593389 ↗
• InjuryAug 19, 2020Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE "DEFLATING" AND "REDNESS AROUND THERE, IT LOOKED LIKE RASH." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10424616 ↗
• InjuryAug 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10420568 ↗
• InjuryJul 7, 2020Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "PAINFUL BY THE ARMPIT", "LOOKING LIKE THEY'RE DEFLATING" AND "REDNESS AROUND THERE, IT LOOKS LIKE RASH.". DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10240630 ↗
• InjuryApr 5, 2020Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE POSSIBLE RUPTURE, "FEELS LIKE IT'S TORN APART, PIECES ARE FLOATING, LOOKS AND FEELS LUMPY", HEALTHCARE PROFESSIONAL LATER REPORTED PATIENT WAS CONCERNED WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9927053 ↗
• InjuryApr 5, 2020Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE POSSIBLE RUPTURE, "LOST SHAPE, BOTTOMED OUT, PAINFUL AND COMING OUT UNDERNEATH MUSCLE BUT NOT THROUGH SKIN". ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED "PATIENT'S CONCERN WITH THE PRODUCT". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9927048 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "DUE TO PAIN IN BREAST". THE DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Pain

  MAUDE report 9689138 ↗