NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MX-410550Recalls & reported problems
Allergan, Inc. · STYLE 410, MX, 550G 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.
Quick summary
This Allergan Natrelle 410 silicone breast implant is a textured, shaped implant. The 24 reports describe ruptures and hardening or tightening around the implant, sometimes with fluid buildup, pain and infection, and mention no deaths and 24 injuries. It has 1 open recall started in July 2019 about a higher incidence of a type of lymphoma linked to textured breast implants.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10888628003774), received between May 13, 2019 and Oct 15, 2025 — classified as 24 injuries.
The most frequently reported specific device problem is “Material Rupture” (7 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 Rupture7
- Device Appears to Trigger Rejection6
- Adverse Event Without Identified Device or Use Problem5
- Patient-Device Incompatibility4
- Migration3
Patient problems
- Capsular Contracture10
- Failure of Implant9
- Seroma5
- Unspecified Infection3
- Breast Mass1
- Injury1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "TEXTURED IMPLANTS AND IS CONCERNED THEY MIGHT BE CAUSING PAIN" AND "TENDERNESS TO PALPITATION AT THE INFRA MAMMARY CREASE". LATER HEALTHCARE PROFESSIONAL REPORTED "RECALL". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURED IMPLANT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL NOT BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23280512 ↗InjuryApr 4, 2023Device 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 16676171 ↗InjuryJan 13, 2023Material Rupture; Material Rupture
COMPANY REPRESENTATIVE REPORTED AN UNKNOWN SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16157137 ↗InjuryJan 13, 2023Material Rupture; Material Rupture
COMPANY REPRESENTATIVE REPORTED AN UNKNOWN SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16157026 ↗InjuryJan 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryJan 11, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
THE EVENT OF RIGHT SIDE RUPTURE WAS CONFIRMED NOT TO HAVE OCCURRED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 16141674 ↗InjuryNov 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT CALLED AND REPORTED "BILATERAL BREAST INFECTION, BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, BILATERAL FLUID AROUND THE IMPLANTS, BILATERAL REDNESS, BILATERALLY THEIR BREASTS ARE HUGE AND HOT, BILATERALLY THEIR BREAST ARE ENORMOUS, BILATERAL BREAST SORENESS, THE LEFT SIDE IS SOLID AS A ROCK, THEY HAVE HAD THE FLU, THEY HAVE BEEN SICK" AGAINST THE RIGHT DEVICE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Seroma; Unspecified Infection
MAUDE report 15831631 ↗InjuryNov 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE "BREAST INFECTION, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, FLUID AROUND THE IMPLANT, REDNESS, THEIR BREAST IS HUGE AND HOT, THEIR BREAST IS ENORMOUS, BREAST SORENESS, SOLID AS A ROCK, THEY HAVE HAD THE FLU, THEY HAVE BEEN SICK." PATIENT ADDITIONALLY REPORTED "BREAST CANCER" WHICH IS NOT RELATED TO THE DEVICE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Seroma; Unspecified Infection
MAUDE report 15831630 ↗InjuryOct 27, 2022Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE AND TEXTURED EXCHANGE DUE TO CONCERN WITH PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15686374 ↗InjuryJul 13, 2022Migration; Migration
LEGAL REPRESENTATIVE REPORTED "SIGNIFICANTLY INCREASED RISK OF DEVELOPING CANCER, EMOTIONAL DISTRESS INCLUDING FEAR AND ANXIETY OF DEVELOPING CANCER, ACCUMULATION OF FOREIGN AND ADULTERATED SILICONE PARTICLES IN THEIR BODIES, INCLUDING THE RESULTING INFLAMMATION, CELLULAR DAMAGE, AND SUBCELLULAR DAMAGE, PAST AND FUTURE MEDICAL EXPENSES, PHYSICAL PAIN AND SUFFERING FROM EXPLANTATION" AGAINST NATRELLE 133 PLUS TISSUE EXPANDER AND NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS STYLE MX. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15008152 ↗InjuryJul 12, 2022Migration; Migration
LEGAL REPRESENTATIVE REPORTED SIGNIFICANTLY INCREASED RISK OF DEVELOPING CANCER, EMOTIONAL DISTRESS INCLUDING FEAR AND ANXIETY OF DEVELOPING CANCER, ACCUMULATION OF FOREIGN AND ADULTERATED SILICONE PARTICLES IN THEIR BODIES, INCLUDING THE RESULTING INFLAMMATION, CELLULAR DAMAGE, AND SUBCELLULAR DAMAGE, PAST AND FUTURE MEDICAL EXPENSES, PHYSICAL PAIN AND SUFFERING FROM EXPLANTATION" AGAIST NATRELLE 133 PLUS TISSUE EXPANDER AND NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS STYLE MX. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14992871 ↗InjuryJan 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13359701 ↗InjuryJun 22, 2021Material Rupture; Material Rupture
InjuryMar 17, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PAIN" AND EXCHANGE DUE TO PATIENT'S CONCERN WITH THE PRODUCT. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED "DISPROPORTION AND DEFORMITY", "FLATTENING AND LOSS OF PROJECTION" AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11507692 ↗InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE ""PAIN SENSATION", "HARDENING", "ENLARGEMENT", "LUMP" AND "LIQUID FOUND". DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 10544460 ↗InjuryJun 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED A LEFT SIDE "BREAST HARDENING" AND A EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10167924 ↗InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "INFECTED SEROMA" AND EXCHANGE DUE TO CONCERN WITH TEXTURED PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma; Unspecified Infection
MAUDE report 9947822 ↗InjuryFeb 19, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "MALPOSITION AND CONTRACTURE", BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9727497 ↗InjuryJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "LATE SEROMA". DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 9642924 ↗InjurySep 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED A RIGHT SIDE ¿PAIN¿, ¿BREAST CANCER TWICE¿, ¿LUMP UNDER MY ARMPIT¿, AND ¿IMPLANT ITSELF IS HARD, NOT LIKE IT WAS BEFORE¿. DEVICE REMAINS IMPLANTED.
Patient problems: Breast Mass; Pain; Swollen Lymph Nodes
MAUDE report 9068503 ↗InjurySep 12, 2019Material Rupture; Material Rupture
ALLERGAN SALES REPRESENTATIVE REPORTED RUPTURE ON AN UNKNOWN SIDE ON BEHALF OF HEALTHCARE PROVIDER. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9017353 ↗InjuryAug 22, 2019Migration; Migration
HEALTHCARE PROFESSIONAL REPORTED LEFT-SIDE "IMPLANT MIGRATION." DEVICE WAS EXPLANTED.
Patient problems: Injury
MAUDE report 8919960 ↗InjuryMay 15, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8614193 ↗InjuryMay 13, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8603327 ↗
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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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