NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FF-410290Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10888628002654), received between May 30, 2019 and Jul 27, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Migration

  Healthcare professional reported "Implant bottoming out". This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50035015 ↗
• InjuryJul 8, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE DUE TO CONCERN WITH THE PRODUCT. PATIENT REPRESENTATIVE ADDITIONALLY REPORTED "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN AND "INCREASED RISK OF ALCL", SIDE NOT SPECIFIED. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14959562 ↗
• InjuryJul 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTH PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANT DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. LATER, PATIENT REPRESENTATIVE REPORTED, "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN REQUIRING BILATERAL CAPSULECTOMY, CELLULITIS AND ABSCESS OF THE BREAST, AND INCREASED RISK OF ALCL." THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Abscess; Capsular Contracture; Cellulitis

  MAUDE report 14885758 ↗
• InjuryJun 22, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CONCERN WITH THE PRODUCT" AS WELL AS A POSSIBLE LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12044128 ↗
• InjuryFeb 3, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE "III/IV." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11273607 ↗
• InjuryNov 18, 2020Material Rupture; Material Rupture

  ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED DOUBLE CAPSULE WITH A "SMALL AMOUNT OF FLUID". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant; Seroma

  MAUDE report 10864513 ↗
• InjuryNov 13, 2020Material Rupture; Material Rupture

  PATIENT REPORTED "LEFT SIDE RUPTURE AND EXCHANGE DUE TO CONCERN WITH THE PRODUCT¿. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10838205 ↗
• InjuryDec 30, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND PATIENT'S CONCERN WITH THE PRODUCT.

  Patient problems: Failure of Implant

  MAUDE report 9532642 ↗
• InjuryJul 19, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE II-III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8808230 ↗
• InjuryJul 18, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED A LEFT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV AND PAIN. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8805343 ↗
• InjuryMay 30, 2019Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEVICE WAS "BROKEN". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8655076 ↗