NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MX-410410Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10888628003743), received between May 30, 2019 and Aug 8, 2025 — classified as 30 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/DEFLATION". THIS RELATES TO THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22748913 ↗
• InjuryMay 6, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE DUE TO CONCERN WITH THE PRODUCT¿ AND "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21973693 ↗
• InjuryJun 12, 2023Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 17105162 ↗
• InjuryOct 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 15656460 ↗
• InjuryAug 17, 2022Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "PAIN" AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE "INTRACAPSULAR RUPTURE." PATIENT ADDITIONALLY REPORTED THE FOLLOWING EVENTS, WHICH ARE NOT DEVICE-RELATED: "ACUTE APPENDICITIS, GALLSTONE, BRAIN FOG, SINUS AND EAR INFECTIONS, FEVERS, ABDOMINAL PAIN, CYST IN ABDOMINAL AREA, BLADDER INFECTION, AND UTI". LATER, PATIENT REPORTED, "THEIR HAIR IS STARTING TO FALL OUT," WHICH IS NOT DEVICE-RELATED. PATIENT ALSO REPORTED THE FOLLOWING EVENTS, WHICH ARE NOT DEVICE-RELATED: "DEPRESSION, VERY FREQUENT HEADACHES AND MIGRAINES, NOSE BLEEDS, I BECAME INCREASINGLY OVERLY FATIGUED, FREQUENT FEVERS THAT WOULD SOMETIMES LAST FOR SEVERAL DAYS, FREQUENT FEVERS BETWEEN 100-102 DEGREES, INABILITY TO CONTROL MY BODY TEMPERATURE, PERSISTANT JOINT AND MUSCLE PAIN, RESPIRATORY DIFFICULTIES WHICH THEN REQUIRED AN INHALER AND FLONASE, CHRONIC DRY MOUTH AND EYES (ALTHOUGH ALWAYS HIGHLY HYDRATED), POOR MEMORY/CONCENTRATION, INSOMNIA. SWEATS AROUND THE CLOCK". THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15241325 ↗
• InjuryJun 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPRESENTATIVE REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, AND INCREASED RISK OF ALCL. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14880932 ↗
• InjuryJun 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE "MIDLINE LUMP AND TENDERNESS" AND "REMOVAL DUE TO CONCERNS WITH DEVICE". PATIENT REPRESENTATIVE ADDITIONALLY REPORTED "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN AND "INCREASED RISK OF ALCL". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14879773 ↗
• InjuryJun 22, 2022Material Rupture; Material Rupture

  PATIENT REPORTED "RUPTURE PER MRI" AGAINST RIGHT DEVICE AND "CONCERNS WITH THE PRODUCT" . THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant; Swollen Lymph Nodes/Glands

  MAUDE report 14775305 ↗
• InjuryJun 2, 2022Material Rupture; Material Rupture

  PATIENT REPORTED ACUTE APPENDICITIS, GALLSTONE, BRAIN FOG, SINUS AND EAR INFECTIONS, FEVERS, ABDOMINAL PAIN, CYST IN ABDOMINAL AREA, PAIN, BLADDER INFECTION, UTI, RIGHT SIDE RUPTURE, RIGHT SIDE SWELLING, FEELS COLD FLUID ON RIGHT SIDE, RIGHT SIDE HAS DROPPED, RIGHT SIDE FEELS WARMER, RIGHT SIDE REDNESS AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14581332 ↗
• InjuryMay 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 14459569 ↗
• InjuryMay 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 REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14342148 ↗
• InjuryApr 13, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14102439 ↗
• InjuryFeb 17, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. STATUS OF DEVICE UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13549639 ↗
• InjuryNov 7, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "CONCERN WITH THE PRODUCT" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 12761636 ↗
• InjuryJun 25, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE TEXTURE TO SMOOTH EXCHANGE DUE TO CONCERN WITH THE PRODUCT. PATIENT REPRESENTATIVE LATER REPORTED ¿CAPSULAR CONTRACTURE REQUIRING BILATERAL CAPSULOTOMY,¿ BAKER GRADE UNKNOWN, ¿INCREASED RISK ALCL,¿ AND ¿BREAST PAIN.¿ DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12071580 ↗
• InjuryJun 22, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE TEXTURE TO SMOOTH EXCHANGE DUE TO CONCERN WITH THE PRODUCT. PATIENT REPRESENTATIVE LATER REPORTED ¿CAPSULAR CONTRACTURE REQUIRING BILATERAL CAPSULOTOMY,¿ BAKER GRADE UNKNOWN, ¿INCREASED RISK ALCL,¿ AND ¿BREAST PAIN.¿ DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12044281 ↗
• InjuryApr 2, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "HARDENING, SWELLING, PAIN AND EXCHANGE. THE PATIENT WAS IMPLANTED JUST BEFORE TURNING( B)(6) YEARS OLD BUT STATED THAT THEY HAD "TUBULAR BREASTS" AND IT WAS DEEMED MEDICALLY NECESSARY BY THE PHYSICIAN AND THE PATIENT'S PSYCHIATRIST TO HAVE IMPLANTS PUT IN." HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 11607333 ↗
• InjuryMar 29, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED BILATERAL IMPLANT EXCHANGE DUE TO VOLUNTARY RECALL. ADDITIONALLY, HEALTHCARE PROVIDER ALSO REPORTED "DOUBLE BUBBLE," "LYMPHADENOPATHY/NEGATIVE FOR MALIGNANCY," AND "RUPTURED PRIOR TO EXPLANTATION." DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 11582734 ↗
• InjuryMar 3, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ¿BAKER IV ENCAPSULATION.¿ DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11407710 ↗
• InjuryMar 2, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ¿BAKER IV ENCAPSULATION.¿ DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11402682 ↗
• InjuryFeb 20, 2020Migration; Migration

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "PROLAPSE." ADDITIONALLY, PATIENT REPORTED "VERY MISSHAPEN RIGHT BREAST" AND "POCKET OF TISSUE OR FLUID UNDER THE RIGHT BREAST THAT LOOKED UNUSUAL AND VERY NOTICEABLE". DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 9733331 ↗
• InjuryJan 14, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTH PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV, AND PAIN. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9588512 ↗
• InjuryDec 30, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PATIENT¿S CONCERN WITH THE PRODUCT" AND "RUPTURE." ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED "CREASE/FOLDING OF IMPLANT." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9530593 ↗
• InjuryDec 20, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND REMOVAL DUE TO VOLUNTARY MARKET WITHDRAWAL. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9504987 ↗
• InjuryNov 7, 2019Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 9289911 ↗