NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FF-410740Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE FF 740CC 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 is a Natrelle 410 silicone-filled breast implant from Allergan, a textured implant used to enlarge or reconstruct the breast. The 31 reports mostly describe the implant rupturing and being removed or replaced, along with fluid collection around it (seroma), tightening of the surrounding tissue (capsular contracture), swelling and redness. All 31 reports describe injuries; no deaths were reported. There is 1 open recall, started in July 2019, after FDA reported a higher rate of a rare immune-system cancer 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
- 31
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10888628002739), received between Jun 6, 2019 and Feb 6, 2026 — classified as 31 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
- Adverse Event Without Identified Device or Use Problem14
- Material Rupture11
- Device Appears to Trigger Rejection5
- Patient-Device Incompatibility3
Patient problems
- Seroma12
- Failure of Implant9
- Capsular Contracture8
- Edema3
- Lymphoma3
- Cellulitis2
- Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)1
- Breast Mass1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "EXCHANGE OF TEXTURED DEVICES DUE TO PRODUCT CONCERN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24280259 ↗InjuryFeb 6, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "EXCHANGE OF TEXTURED DEVICES DUE TO PRODUCT CONCERN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24280040 ↗InjuryFeb 5, 2026Device Appears to Trigger Rejection
PATIENT REPORTED "EXCHANGE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT", "PAIN" AND "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24273626 ↗InjuryFeb 5, 2026Device Appears to Trigger Rejection
PATIENT REPORTED "EXCHANGE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT", "PAIN" AND "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24273234 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT". HEALTHCARE PROFESSIONAL LATER REPORTED " BREAST PAIN, SWELLING, REDNESS". HEALTHCARE PROFESSIONAL LATER REPORTED "BREAST CANCER, DEFORMITY, CELLULITIS, EDEMA, SEROMA". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED. DEVICE WILL BE RETURNED.
Patient problems: Cellulitis; Seroma
MAUDE report 23302834 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "SWELLING AND RETRACTING AND EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT". HEALTHCARE PROFESSIONAL LATER REPORTED "BREAST PAIN AND REDNESS". HEALTHCARE PROFESSIONAL LATER REPORTED "BREAST CANCER, DEFORMITY, CELLULITIS, EDEMA, SEROMA AND AXILLARY MASS". THIS RECORD IS FOR THE RIGHT. DEVICE WAS EXPLANTED. DEVICE WILL BE RETURNED.
Patient problems: Breast Mass; Cellulitis; Seroma
MAUDE report 23279545 ↗InjuryJun 4, 2025Material Rupture; Material Rupture
PATIENT REPORTED "IMPLANT WERE RECALLED". HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE "RUPTURE". DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22147157 ↗InjuryNov 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III, SEROMA VOLUME UNKNOWN, AND A BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS." DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 18088593 ↗InjuryJul 5, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE VIA MRI. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17261608 ↗InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE "ALCL". PATIENT REPORTED "BREAST CANCER" WHICH IS NOT RELATED TO THE DEVICE. HEALTHCARE PROFESSIONAL REPORTED "BIA-ALCL" AND "400 ML SEROMA." PATHOLOGICAL MARKER CD30+ HAS BEEN RECEIVED. PATHOLOGICAL MARKER ALK- HAS NOT BEEN RECEIVED. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Lymphoma; Seroma
MAUDE report 15298459 ↗InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE DUE TO PATIENT'S CONCERN WITH THE PRODUCT. PATIENT REPRESENTATIVE REPORTED "AS PART OF A RECONSTRUCTIVE PROCEDURE, PLAINTIFF HAD A RIGHT BREAST IMPLANT PERFORMED IN 2017 WITH AN ALLERGAN BIOCELL PRODUCT, THE NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE FILLED BREAST IMPLANT, IN BREAST. SINCE THAT TIME, PLAINTIFF HAS EXPERIENCED PAIN AND A COLLECTION OF FLUID IN RECONSTRUCTED BREAST, WHICH REQUIRED MEDICAL TREATMENT. AROUND THE TIME OF ALLERGAN USA, INC.'S 2019 RECALL OF ITS TEXTURED BREAST IMPLANTS, THE PLAINTIFF WAS EXPERIENCING PAIN, SWELLING AND FLUID COLLECTION AROUND IMPLANT, THEREFORE PATIENT CONTACTED A PHYSICIAN ABOUT CONDITION WHEREIN THE DECISION WAS MADE TO HAVE BIOCELL NATRELLE 410 DEVICE EXPLANTED. AFTER CONSULTING WITH TREATING PHYSICIANS, PLAINTIFF HAD NATRELLE 410 DEVICE EXPLANTED AND REPLACED AT OWN EXPENSE. EVEN WITH THE BREAST IMPLANT BEING REMOVED, PLAINTIFF WILL REMAIN AT RISK FOR DEVELOPING BIA-ALCL AND WILL REQUIRE REGULAR, INVASIVE, AND COSTLY MONITORING FOR THE CONDITION. PLAINTIFF HAS BEEN BE FORCED TO EXPEND SUBSTANTIAL SUMS FOR THE REMOVAL OF THE RECALLED IMPLANTS, FOR SURGICAL AND DIAGNOS
Patient problems: Seroma
MAUDE report 14596798 ↗InjuryJan 20, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13309120 ↗InjuryNov 12, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV, "ANY CREASE" AND TEXTURED DEVICES DUE TO PATIENT'S CONCERN. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED LEFT SIDE SEROMA. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 12804932 ↗InjuryApr 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE "CHEST PAIN", ¿TIGHTNESS IN BOTH SIDES¿, "NUMBNESS" AND "ITCHING." PATIENT ADDITIONALLY REPORTED "BRAIN FOG" WHICH IS NOT DEVICE RELATED. HEALTHCARE PROFESSIONAL REPORTED "FLUID" AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO PATIENT CONCERN WITH THE PRODUCT." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "EASY BRUISING" AND "HEADACHES" WHICH ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 11608864 ↗InjuryFeb 8, 2021Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANT DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL ALSO REPORTED SEROMA-LATE AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 11298606 ↗InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED RIGHT SIDE "REACTIVE FLUID", "A FEW LYMPH NODES 6 MILLIMETERS IN SIZE ON THE RIGHT BREAST", " AND "DOCTOR SUSPECTS "LYMPHOMA." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED SWELLING OF THE NECK ON THE RIGHT SIDE" AND "WOUND HEMATOMA" NOT RELATED TO THE DEVICE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 10891375 ↗InjurySep 10, 2020Material Rupture; Material Rupture
PATIENT REPORTED ¿RIGHT SIDE IMPLANT REMOVAL¿. ADDITIONALLY, PATIENT REPORTED "PAIN, LEAKING, FELL ILL THE WHOLE TIME, FELT VERY SICK, CHRONIC PAIN IN BREAST COULDN'T EVEN WEAR BRA THEY WERE SO PAINFUL, NOTICED DIFFERENCE IN SHAPE". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10514556 ↗InjuryJul 27, 2020Material Rupture; Material Rupture
InjuryFeb 27, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT ADDITIONALLY REPORTED ¿TERRIBLE PROBLEMS, FLUID RETENTION, LIKE REJECTION".
Patient problems: Capsular Contracture
MAUDE report 9767101 ↗InjuryFeb 27, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
ADDITIONALLY, PATIENT REPORTED "TERRIBLE PROBLEMS, FLUID RETENTION, LIKE REJECTION".
Patient problems: Capsular Contracture
MAUDE report 9765272 ↗InjuryFeb 11, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9694861 ↗InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE "FLUID BUILDING UP", "EXCHANGE OF TEXTURED IMPLANTS DUE TO CONCERN WITH THE PRODUCT" AND "DISCOMFORT." DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 9694793 ↗InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED RIGHT SIDE "SWELLING LYMPH NODES UNDER ONE ARM, PAIN, HARDNESS," AND "EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT." THE DEVICE REMAINS IMPLANTED.
Patient problems: Swollen Lymph Nodes
MAUDE report 9547961 ↗InjuryOct 24, 2019Material Rupture; Material Rupture
HEALTH PROFESSIONAL REPORTED A RIGHT SIDE RUPTURE AND "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9236132 ↗InjuryOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPRESENTATIVE LATER REPORTED "INCREASED RISK FOR DEVELOPING BIA-ALCL" AND "PAIN AND SUFFERING." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Edema
MAUDE report 9176163 ↗
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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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