NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MF-410375Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE MF 375CC 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 Natrelle 410 textured silicone gel-filled breast implant from Allergan appears in 35 adverse event reports, all describing injuries and no deaths. Most describe the implant rupturing or leaking, sometimes with pain or hardening of the surrounding tissue, and several implants were removed or replaced. One open recall, started July 2019, relates to FDA information on a higher rate of a rare lymphoma in patients with 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
- 35
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10888628003477), received between May 30, 2019 and May 26, 2026 — classified as 35 injuries.
The most frequently reported specific device problem is “Material Rupture” (11 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 Rupture11
- Adverse Event Without Identified Device or Use Problem8
- Device Appears to Trigger Rejection8
- Patient-Device Incompatibility7
- Failure to Osseointegrate2
- No Apparent Adverse Event1
Patient problems
- Capsular Contracture15
- Failure of Implant11
- Seroma4
- Granuloma3
- Unspecified Infection3
- No Clinical Signs, Symptoms or Conditions2
- Fluid Discharge1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 25284051 ↗InjuryMay 26, 2026Material Rupture
The device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25279615 ↗InjuryOct 22, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE", "PAIN" AND "TEXTURED TO SMOOTH DUE TO PATIENT'S CONCERN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23361514 ↗InjuryOct 20, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED/ACTUAL RUPTURE/DEFLATION, CHANGE SHAPE/SIZE/STYLE" AND "OPERATION-CAPSULECTOMY/CAPSULOTOMY (LEFT) [AN]: YES" VIA NBIR. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23334137 ↗InjuryOct 15, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED/ACTUAL RUPTURE/DEFLATION, CHANGE SHAPE/SIZE/STYLE" AND "OPERATION-CAPSULECTOMY/CAPSULOTOMY (RIGHT) [AX]: YES" VIA NBIR. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23305921 ↗InjuryApr 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV WITH PAIN. LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III." THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21864455 ↗InjuryApr 17, 2025Material Rupture; Material Rupture
PATIENT REPRESENTATIVE REPORTED ON BEHALF OF PATIENT A RIGHT SIDE RUPTURE. PATIENT ALSO MENTIONED AT TIME OF IMPLANTATION PATIENT HAD BREAST CANCER. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21859840 ↗InjuryFeb 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED. THIS RECORD RELATES TO THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 21390143 ↗InjuryFeb 7, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE II AND POSSIBLE RUPTURE. THE DEVICE REMAINS IMPLANTED. THIS RECORD RELATES TO THE LEFT SIDE.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 21331631 ↗InjuryJan 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21241153 ↗InjuryJan 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21240845 ↗InjuryOct 22, 2024Material Rupture; Material Rupture
InjuryJun 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, PAIN, AND EXCHANGE DUE TO PATIENT'S CONCERN WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17186856 ↗InjuryMar 10, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND "CONCERNS ABOUT POSSIBILITY OF ALCL." THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16524997 ↗InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE INFECTION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Unspecified Infection
MAUDE report 15199170 ↗InjuryJul 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III, AGAINST RIGHT SIDE DEVICE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15108381 ↗InjuryOct 8, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL LATER REPORTED CONCERN WITH PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12599765 ↗InjurySep 22, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 12516519 ↗InjurySep 22, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 12512345 ↗InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PAIN AND DISCOMFORT" AND IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED "FIBROCONNECTIVE TISSUE WITH FOREIGN BODY GRANULOMATOUS REACTION CONSISTENT WITH CAPSULE." DEVICE HAS BEEN EXPLANTED.
Patient problems: Granuloma
MAUDE report 11505707 ↗InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT AND "BREAST PAIN". HEALTHCARE PROFESSIONAL REPORTED "FIBROCONNECTIVE TISSUE WITH FOREIGN BODY GRANULOMATOUS REACTION CONSISTENT WITH CAPSULE." DEVICE HAS BEEN EXPLANTED.
Patient problems: Granuloma
MAUDE report 11464029 ↗InjuryJan 27, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED REASON FOR LEFT SIDE DEVICE REMOVAL WAS NOTED AS ¿BAKER IV CAPSULAR CONTRACTURE ALSO WANTED EXCHANGE TO SMOOTH DEVICE IMPLANT INTACT¿. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11236284 ↗InjuryJan 11, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE, "SEROMA FLUID," AND EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 11148949 ↗InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED HAVING "A LUMP OR THICKENING IN OR NEAR THE BREAST OR IN THE UNDERARM AREA." PATIENT THEN REPORTED A RIGHT SIDE "SARCOID" AND "NON-CACIATED GRANULOMATOUS INFLAMMATION." PATIENT ADDITIONALLY REPORTED HAVING "RAYNAUD'S PHENOMENON;" THIS EVENT IS NOT RELATED TO THE DEVICE. DEVICE REMAINS IMPLANTED.
Patient problems: Granuloma
MAUDE report 11095363 ↗InjurySep 18, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE EXCHANGE OF IMPLANT DUE TO VOLUNTARY RECALL AND RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10552966 ↗
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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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