NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FX-410360Recalls & reported problems
Allergan, Inc. · STYLE, 410, FX, 360 G 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 38 adverse event reports, all describing injuries and no deaths. Most reports describe the scar tissue around the implant tightening and contracting so the breast becomes hard, firm and painful, sometimes with fluid buildup or a ruptured implant; a few mention a possible link to a rare breast implant-related lymphoma. One recall, started in July 2019 and still open, follows FDA notice of higher rates of that lymphoma with textured 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
- 39
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10888628002975), received between Jun 11, 2019 and Sep 14, 2026 — classified as 39 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (14 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
- Device Appears to Trigger Rejection14
- Material Rupture13
- Adverse Event Without Identified Device or Use Problem8
- Patient-Device Incompatibility5
Patient problems
- Capsular Contracture19
- Failure of Implant11
- Seroma6
- Unspecified Infection3
- Lymphoma1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture Baker grade III" and "exchange from textured implant to smooth". This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50755977 ↗InjuryAug 7, 2026Material Rupture
Healthcare Professional reported "had fallen over the weekend and sustained trauma¿, ¿implant was ruptured¿, ¿most likely her swelling is from the trauma and Hematoma¿, ¿swelling with firmness in the upper pole¿, "Breast Pain with Swelling" and "possible hematoma". This record is for the right side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50176874 ↗InjuryFeb 11, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURED", "RECALLED IMPLANT" AND LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24318236 ↗InjuryJun 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE GRADE IV RIGHT BREAST, RIGHT BREAST FIRM CAPSULE WITH IMPLANT SUPERIOR DISPLACEMENT AND DECREASED WIDTH OF BREAST MOUND. 410 TEXTURED IMPLANTS PLACED IN 2015, NOW CAUSING PAIN IN RIGHT BREAST". THIS RECORD IS FOR FOR THE "RIGHT" SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22126597 ↗InjuryNov 16, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryNov 16, 2023Material Rupture; Material Rupture
InjuryOct 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18043715 ↗InjuryMay 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16965994 ↗InjuryFeb 3, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERNS WITH THE PRODUCT WITH A RIGHT SIDE RUPTURE AND POSSIBLE BIA-ALCL". THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16299837 ↗InjuryJan 19, 2023Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16208481 ↗InjuryNov 17, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT, SWELLING AND PAIN". HEALTHCARE PROVIDER LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND WILL NOT BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 15821462 ↗InjuryNov 17, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT, SWELLING AND PAIN". HEALTHCARE PROFESSIONAL LATER REPORTED, CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15820652 ↗InjuryAug 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15147818 ↗InjuryAug 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15138260 ↗InjuryJul 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15103834 ↗InjuryMay 13, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III, AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14401060 ↗InjuryMay 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENTS CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14379445 ↗InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PERI-IMPLANT EFFUSION." ADDITIONAL EVENT OF SEVERE SCARRING AND INFLAMMATION WAS REPORTED. THE DEVICE WAS EXPLANTED.
Patient problems: Seroma
MAUDE report 14365330 ↗InjuryApr 12, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 14091208 ↗InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT" AND "FLUID BUILD UP IN THE LEFT SIDE CAVITY PER MRI AND SWELLING." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "POSITIVE ALCL DIAGNOSIS." CYTOLOGY REPORT PROVIDED "THE TUMOR CELLS ARE DIFFUSELY POSITIVE FOR CD45, CD3, CD30, AND GATA3, AND NEGATIVE FOR AE1/AE3 AND CK7." PATHOLOGICAL MARKER CONFIRMING ALK- HAS NOT BEEN RECEIVED. DEVICE HAS BEEN EXPLANTED.
Patient problems: Lymphoma; Seroma
MAUDE report 14053499 ↗InjuryOct 27, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 12708439 ↗InjuryApr 30, 2021Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE TENDERNESS. PATIENT ALSO REPORTED "CHRONIC HIGH FEVERS UP TO 105 DEGREES", FREQUENT HOSPITAL VISITS FOR BACTERIA INFECTIONS" AND HYPOTHYROIDISM. THESE EVENTS ARE NOT DEVICE RELATED. HEALTHCARE PROFESSIONAL REPORTED "DEFLATED IMPLANTS". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 11757871 ↗InjuryApr 30, 2021Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE TENDERNESS. PATIENT ALSO REPORTED "CHRONIC HIGH FEVERS UP TO 105 DEGREES", FREQUENT HOSPITAL VISITS FOR BACTERIA INFECTIONS" AND HYPOTHYROIDISM; THESE EVENTS ARE NOT DEVICE RELATED. HEALTHCARE PROFESSIONAL REPORTED "DEFLATED IMPLANTS". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 11757801 ↗InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "IMPLANT HAS BEEN REMOVED DUE TO INFECTION." THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 10683633 ↗InjuryOct 2, 2020Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE "RUPTURE". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 10621923 ↗
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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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