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NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants LX-410255Recalls & reported problems

Allergan, Inc. · STYLE 410, LX, 255G BIOCELL |textured|contour|silicone · Class 3 · Implant

All models of Natrelle Breast Implants (1167)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888628003316), received between May 9, 2022 and Jun 10, 2022 — classified as 3 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

Device problems

  • Device Appears to Trigger Rejection3

Patient problems

  • Capsular Contracture3
  • Seroma1

Recent adverse event reports

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

  • InjuryJun 10, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    PATIENT REPORTED THAT "IMPLANTS SOFT ON THE OUTER EDGES AND FIRMER IN THE MIDDLE" AND "ONE IS HARD." HEALTHCARE PROFESSIONAL REPORTED EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT AND CAPSULAR CONTRACTURE, BAKER GRADE NOT SPECIFIED. AFFECTED SIDE IS RIGHT. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Patient problems: Capsular Contracture

    MAUDE report 14657008 ↗
  • InjuryJun 6, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    PATIENT REPORTED LEFT SIDE "IMPLANTS SOFT ON THE OUTER EDGES AND FIRMER IN THE MIDDLE" AND "ONE IS HARD". HEALTHCARE PHYSICIAN REPORTED VIA DT FORM "BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT", "CAPSULAR CONTRACTURE, BAKER GRADE NOT SPECIFIED". DEVICE HAS BEEN EXPLANTED.

    Patient problems: Capsular Contracture

    MAUDE report 14605763 ↗
  • InjuryMay 9, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    PATIENT REPRESENTATIVE REPORTED SWELLING TO LEFT BREAST, LEFT BREAST PAIN, HARDENING, COLD SENSATION, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND "SEROMAS". ADDITIONAL REPORT OF "SYMPTOMS CONSISTENT WITH ALCL,¿ ¿MENTAL ANGUISH,¿ ¿DISFIGUREMENT,¿ ¿INTERFERENCE WITH DAILY FUNCTIONS SUCH AS WORKING/SLEEPING/EXERCISING/OTHER ACTIVITIES INVOLVING THE LEFT ARM,¿ ¿NEGATIVE EFFECT ON INTIMACY AND SELF-IMAGE,¿ ¿OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING¿ AND PAINFUL REMOVAL PROCEDURES¿ WHICH WERE ALL DEEMED NOT DEVICE RELATED. THE DEVICE HAS BEEN EXPLANTED.

    Patient problems: Capsular Contracture; Seroma

    MAUDE report 14339509 ↗

Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices

All Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices →

Sources and updates

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