NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FX-410315Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10888628002968), received between Aug 22, 2019 and Sep 27, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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 27, 2026Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50909693 ↗
• InjuryAug 5, 2026Material Rupture

  Healthcare professional reported "implant rupture". This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50145342 ↗
• InjuryDec 4, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15912554 ↗
• InjuryAug 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15262884 ↗
• InjuryJul 8, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PHYSICIAN REPORTED VIA DEVICE TRACKING RIGHT SIDE EXCHANGE DUE TO "TEXTURED SHAPED". PATIENT REPRESENTATIVE REPORTED "CAPSULAR CONTRACTURE [BAKER GRADE UNSPECIFIED] AND INCREASED RISK OF ALCL". THE DEVICE WAS REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 14958543 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED ON THE LEFT SIDE "HER IMPLANT WAS HARD, BLACK, WITH RED LINES AND AN ABSCESS". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Abscess; Necrosis

  MAUDE report 9739961 ↗
• InjuryJan 7, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9560786 ↗
• InjuryDec 11, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTION BAKER GRADE III, IMPLANT IS IN HIGHER POSITION THAN THE OTHER DUE TO THE CAPSULAR CONTRACTURE AND REMOVAL DUE TO VOLUNTARY RECALL. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9454786 ↗
• InjuryDec 10, 2019Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 9446369 ↗
• InjurySep 27, 2019Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 9131393 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED WITH ANTIBIOTICS THREE TIMES FOR INFECTION. PATIENT REPRESENTATIVE REPORTED ¿HAD A NIPPLE DISCHARGE WHICH HAS RESOLVED SINCE SECOND COURSE OF ANTIBIOTICS,¿ AND PATHOLOGY RESULTS CONFIRMED "ABUNDANT ACUTE INFLAMMATION PRESENT SUGGESTIVE OF ABSCESS." PATIENT REPRESENTATIVE ALSO REPORTED PATIENT WAS ¿CONSTANTLY FATIGUED¿ AND ¿HAVING MEMORY PROBLEMS;" THESE EVENTS ARE NOT RELATED TO THE DEVICE.

  Patient problems: Abscess; Seroma; Unspecified Infection

  MAUDE report 9101306 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED WITH ANTIBIOTICS THREE TIMES FOR INFECTION. PATIENT REPRESENTATIVE REPORTED ¿HAD A NIPPLE DISCHARGE WHICH HAS RESOLVED SINCE SECOND COURSE OF ANTIBIOTICS." PATIENT REPRESENTATIVE ALSO REPORTED PATIENT WAS ¿CONSTANTLY FATIGUED¿ AND ¿HAVING MEMORY PROBLEMS," THESE EVENTS ARE NOT RELATED TO THE DEVICE.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 9098978 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PAIN" AND "POSSIBLE AUTOIMMUNE DISEASE." DEVICE REMAINS IMPLANTED.

  Patient problems: Pain

  MAUDE report 8978082 ↗
• InjuryAug 22, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, AND PAIN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8922952 ↗