NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FF-410535Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10888628002708), received between May 14, 2019 and Sep 25, 2026 — classified as 33 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.

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 33 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 50904064 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED "IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT" AND "WHEN THEY LAY ON THEIR BACK TO SLEEP THEIR HEART STARTS POUNDING AND WAKES THEM FROM THEIR SLUMBER WHICH IS NOT RELATED TO THE DEVICE". ADDITIONALLY REPORTED WAS CONTRALATERAL SIDE "SWELLING, HARDNESS, ITCHING, PAIN". HISTOPATHOLOGICAL MARKERS CD30+ AND ALK- HAVE NOT BEEN RECEIVED FOR THIS SIDE, HENCE THE REPORT OF ALCL HAS NOT BEEN CONFIRMED. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)

  MAUDE report 24326789 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED "SWELLING", "HARDNESS", "ITCHING", "PAIN", "IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT", "30 CC OF FLUID EXTRACTED" AND "THE END RESULTS IS THOUGHT TO BE A MALIGNANT TRANSFORMATION OF T-CELLS WHICH BECOMES ALK" "IT SAYS NEGATIVE" "AND CD30 IS POSITIVE". HISTOPATHOLOGICAL MARKERS CD30+ AND ALK- HAVE NOT BEEN RECEIVED, HENCE THE REPORT OF ALCL HAS NOT BEEN CONFIRMED. ADDITIONALLY PATIENT REPORTED "WHEN THEY LAY ON THEIR BACK TO SLEEP THEIR HEART STARTS POUNDING AND WAKES THEM FROM THEIR SLUMBER"; THIS EVENT IS NOT DEVICE RELATED. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)

  MAUDE report 24275141 ↗
• InjuryNov 6, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE OF BREAST IMPLANT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23489959 ↗
• InjurySep 15, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE" AND "BIOCELL TEXTURED IMPLANT". PATIENT LATER REPORTED "RUPTURE AND RECALL IMPLANT". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23053775 ↗
• InjuryJul 7, 2025Material Rupture; Material Rupture

  PATIENT REPORTED A LEFT SIDE RUPTURE CONFIRMED VIA MRI. HEALTHCARE PROVIDER CONFIRMED. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22417545 ↗
• InjuryJun 16, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "RUPTURE" AND "REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22211906 ↗
• InjuryAug 10, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE PAIN AND RIGHT SIDE IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. HEALTHCARE PROFESSIONAL ALSO REPORTED RIGHT SIDE IMPLANT RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17503130 ↗
• InjuryJun 28, 2023Material Rupture; Material Rupture

  COMPANY REPRESENTATIVE REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17218711 ↗
• InjuryMay 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16918041 ↗
• InjuryOct 19, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN REPORTED LEFT SIDE LATE SEROMA AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. THE DEVICE HAS BEEN REPLACED.

  Patient problems: Inflammation; Seroma

  MAUDE report 15631877 ↗
• InjuryAug 29, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AGAINST RIGHT DEVICE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15317414 ↗
• InjuryJun 10, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROVIDER REPORTED A LEFT SIDE "BREAST SEROMA/PERI-IMPLANT EFFUSION" "UNSPECIFIED LUMP IN THE LEFT BREAST, LOWER INNER QUADRANT" NOT DEVICE RELATED. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 14659066 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROVIDER REPORTED A RIGHT SIDE SEROMA. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 14658880 ↗
• InjuryApr 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CONCERN WITH THE PRODUCT, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, AND "ANY CREASES". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14163343 ↗
• InjuryMar 22, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE AND EXCHANGED FROM TEXTURED TO SMOOTH DUE TO PRODUCT CONCERN. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 13848136 ↗
• InjuryDec 6, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "PATIENT'S CONCERN WITH PRODUCT" AGAINST RIGHT DEVICE. PHYSICIAN REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12939629 ↗
• InjuryDec 3, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "PATIENT'S CONCERN WITH PRODUCT" AGAINST LEFT DEVICE. ADDITIONALLY REPORTED WAS CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 12923842 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT SIDE "BODY DRAMATICALLY CHANGED", "INFLAMMATION AND SWELLING IN THEIR BREAST, ARMS, AND LEGS". LATER PATIENT REPORTED ¿SWELLING,¿ "BRUISING, DISCOLORED CIRCLES THAT ARE RED WHERE THE IMPLANT IS," ¿WRINKLED APPEARANCE OF THE IMPLANT,¿ AND ¿SWOLLEN LYMPH NODES OFF AND ON.¿ THE DEVICE REMAINS IMPLANTED.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 11616091 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL STATED THAT "THE PATIENT HAS A CONFIRMED ALCL DIAGNOSIS" AND REPORTED A SMALL AMOUNT OF PERI-IMPLANT FLUID; PATHOLOGY HAS NOT BEEN RECEIVED AND THE MARKERS OF CD30+ AND ALK- HAVE NOT BEEN REPORTED OR CONFIRMED. ADDITIONALLY NOTED WAS PATIENT'S CONCERN WITH THE PRODUCT AS WELL AS PATIENT FEELING A LUMP FOR TWO TO THREE MONTHS WITH A LITTLE PAIN. AFFECTED SIDE IS LEFT. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Lymphoma; Seroma

  MAUDE report 11590520 ↗
• InjuryMar 19, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 11525675 ↗
• InjuryFeb 3, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RIGHT-SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT". HEALTHCARE PROFESSIONAL LATER REPORTED A RIGHT SIDE RUPTURE AND "ANY CREASES". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11274165 ↗
• InjuryFeb 2, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11266846 ↗
• InjuryOct 13, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND "EXCHANGE DUE TO CONCERN WITH PRODUCT". HEALTHCARE PROFESSIONAL ALSO REPORTED IMPLANT "HAS FLIPPED", "SUPERIOR MALPOSITION" DUE TO CAPSULAR CONTRACTURE WHICH IS NOT DEVICE RELATED. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10670710 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 9865448 ↗