NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MM-410360Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE MM 360CC 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
- 19
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10888628003644), received between Sep 25, 2019 and Jun 10, 2026 — classified as 19 injuries.
The most frequently reported specific device problem is “Material Rupture” (8 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.
Reports received per month
Recalls naming this device
- 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
- Material Rupture8
- Adverse Event Without Identified Device or Use Problem4
- Patient-Device Incompatibility4
- Device Appears to Trigger Rejection3
Patient problems
- Capsular Contracture7
- Failure of Implant6
- Unspecified Infection4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026Material Rupture
PATIENT REPORTED "RUPTURE¿ AND ¿EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25461624 ↗InjuryJun 10, 2026Material Rupture
PATIENT REPORTED ¿LEAKING¿, ¿RUPTURE¿ AND ¿EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25461310 ↗InjuryJun 9, 2026Device Appears to Trigger Rejection
PATIENT REPORTED "APPARENTLY HAVE THE RECALLED GUMMY BEARS IN MY CHEST, AND I HAVE BEEN HAVING PROBLEMS WITH THEM FOR YEARS¿AND LATER REPORTED "PAIN AND LUMPS ON THE INSIDE AND A RASH AND SMALL BUMPS ON THE OUTSIDE" . LATER PATIENT REPORTED "APPARENTLY THEY ARE ENCAPSULATED", BAKER GRADE WAS NOT PROVIDED. THIS RECORD IS FOR THE LEFT-SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25445489 ↗InjuryJun 9, 2026Device Appears to Trigger Rejection
PATIENT REPORTED "APPARENTLY HAVE THE RECALLED GUMMY BEARS IN MY CHEST, AND I HAVE BEEN HAVING PROBLEMS WITH THEM FOR YEARS¿ AND LATER REPORTED "PAIN AND LUMPS ON THE INSIDE AND A RASH AND SMALL BUMPS ON THE OUTSIDE". LATER PATIENT REPORTED "APPARENTLY THEY ARE ENCAPSULATED", BAKER GRADE WAS NOT PROVIDED. THIS RECORD IS FOR THE RIGHT-SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25444774 ↗InjuryNov 7, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT", DEVICE FOUND TO BE RUPTURED WHEN RECEIVED. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. DEVICE WAS RETURNED.
Patient problems: Failure of Implant
MAUDE report 23500023 ↗InjurySep 12, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE" AND "IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT" CONFIRMED WITH CT SCAN . THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23040308 ↗InjuryMay 16, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "TRIPLE THE SIZE OF THE RIGHT BREAST AND EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT ". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURED ". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22035133 ↗InjuryNov 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 18192626 ↗InjuryAug 22, 2023Material Rupture; Material Rupture
InjuryFeb 20, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16403280 ↗InjuryDec 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11040513 ↗InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED THAT THEY HAD THE IMPLANTS PLACED IN 2016 AND THEY WERE REMOVED IN 2017 DUE TO AN "INFECTION", AT THE ADVICE OF THEIR ONCOLOGIST. DEVICE WAS EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 10791953 ↗InjurySep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPRESENTATIVE REPORTED REMOVAL DUE TO ¿CAPSULE EXCISION DUE TO AN INFECTION,¿ PATIENT EXPERIENCED ¿DEBILITATING PHYSICAL PAIN AND MENTAL SUFFERING,¿ ¿MENTAL STRESS, ANXIETY, WORRY, HUMILIATION, FEAR, AND OTHER PERSONAL ¿ HARDSHIP DUE TO THE CONTINUOUS FEAR OF BIAALCL,¿ ¿SUFFERED, OR WILL SUFFER, PAINFUL REMOVAL PROCEDURES TO MITIGATE THE RISK OF DEVELOPING BIA-ALCL, AS WELL AS ANY TREATMENT, THERAPY, RECOVERY, ¿ ASSOCIATED WITH THE REMOVAL OF THE BIOCELL TEXTURED BREAST IMPLANTS, THE POTENTIAL FOR THE DEVELOPMENT OF BIA-ALCL, AND ANY CONDITION OR SYMPTOMS ASSOCIATED WITH BIA-ALCL OR THE PREVENTION OF THAT ISSUE¿ AND ¿SUFFERED EMOTIONAL DISTRESS, ANXIETY¿ LOSS OF QUALITY OF LIFE.¿ PATIENT REPRESENTATIVE ALSO REPORTED PATIENT EXPERIENCED "DEPRESSION" AND "DISABILITY;" THESE EVENTS ARE NOT RELATED TO THE DEVICE. DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Unspecified Infection
MAUDE report 10568594 ↗InjuryJun 11, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryJun 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10137768 ↗InjuryApr 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT REPORTED THEY EXPERIENCED THE EVENT OF ¿IMPLANTS REMOVED AROUND TWO MONTHS FOLLOWING IMPLANTATION DUE TO INFECTION¿. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 10011996 ↗InjuryApr 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED HAVING LEFT SIDE IMPLANT "REMOVED AROUND TWO MONTHS FOLLOWING IMPLANTATION DUE TO INFECTION". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 10011984 ↗InjuryOct 10, 2019Material Rupture; Material Rupture
InjurySep 25, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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