NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants LX-410625Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888628003392), received between Oct 25, 2019 and Mar 1, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 1, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT REPRESENTATIVE REPORTED PATIENT UNDERWENT ¿REMOVAL OF LEFT IMPLANT AND DESIRE DUE TO FEAR OF ALCL, TO REDUCE RISK OF ALCL, AND DUE TO SYMPTOMS CONSISTENT WITH ALCL AND FEAR OF ALCL: MENTAL ANGUISH AND FEAR OF ALCL, EVALUATION FOR ALCL, INCREASED RISK OF ALCL,¿ ¿SUFFERS FROM SERIOUS EMOTIONAL DISTRESS INCLUDING ANGUISH, FRIGHT, HORROR, NERVOUSNESS, GRIEF, ANXIETY, AND WORRY OF BIA-ALCL,¿ ¿AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING BUT NOT LIMITED TO ANXIETY,¿ ¿TISSUE DAMAGE,¿ ¿SEROMA,¿ ¿SWELLING,¿ ¿INFECTION,¿ ¿RASHES,¿ ¿ITCHING,¿ PAIN¿ AND ¿CRAMPING,.¿ PATIENT REPRESENTATIVE ALSO REPORTED PATIENT ¿SUFFERED PERSONAL INJURIES AND RELATED DAMAGES,¿ ¿DISFIGUREMENT,¿ ¿OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING,¿ ¿PANIC DISORDER, POST-TRAUMATIC STRESS,¿ ¿AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING BUT NOT LIMITED TO SIGNIFICANT WEIGHT LOSS, ULCER, GI UPSET,¿ ¿AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING BUT NOT LIMITED TO DIARRHEA ON AN ONGOING BASIS,¿ ¿AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING BUT NOT LIMITED TO INSOMNIA,¿ ¿AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING BUT NOT LIMITED TO DEPRESSION,¿ ¿AGGRAVATION OF UNDERLYING CONDITIO

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 11396261 ↗
• InjuryJan 20, 2020Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE "RUPTURE OF THE INNER CAPSULE," "FLUID AND SWELLING IN UPPER PART OF CHEST," ON UNSPECIFIED SIDE, AND REMOVAL DUE TO CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 9606899 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT SIDE "FLUID AND SWELLING IN UPPER PART OF CHEST" AND "REMOVAL DUE TO CONCERN WITH THE PRODUCT". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 9240209 ↗