NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FF-410375Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE FF 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 breast implant is a soft, shaped breast implant made by Allergan. The 36 reports mostly describe implants that rupture or leak, with the surrounding scar tissue tightening around the implant and fluid collecting near it, sometimes requiring removal and replacement. All 36 reports describe injuries, and no deaths were reported. One open recall, started in July 2019, followed FDA notice of a higher rate of a rare breast implant-related lymphoma in patients 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
- 36
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10888628002678), received between May 14, 2019 and Mar 26, 2026 — classified as 36 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (18 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 Rejection18
- Material Rupture10
- Patient-Device Incompatibility7
- Adverse Event Without Identified Device or Use Problem2
- No Apparent Adverse Event1
Patient problems
- Capsular Contracture24
- Failure of Implant7
- Seroma7
- No Clinical Signs, Symptoms or Conditions2
- Abscess1
- Cellulitis1
- Erosion1
- Swollen Lymph Nodes1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
InjuryMar 26, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "BILATERAL RUPTURES." THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699647 ↗InjuryMar 26, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698864 ↗InjuryFeb 17, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE", "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" AND "FLUID HAS ALSO BEEN IDENTIFIED ON ONE SIDE VIA IMAGING". THIS RECORD IS FOR LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24363867 ↗InjuryOct 30, 2025No Apparent Adverse Event; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "REMOVAL OF TEXTURED DEVICE DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT" AND "LATE ONSET SEROMA". THE DEVICE WAS EXPLANTED.
Patient problems: Seroma
MAUDE report 23431282 ↗InjurySep 10, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURE¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23016003 ↗InjuryAug 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "SEROMA" AND LATER REPORTED "COLLAPSED CAPSULAR TISSUE MEASURING 0 CM IN RECONSTRUCTED DIAMETER, FIBROPLASIA, SCLEROSIS, FIBROSIS AND CALCIFICATION." AFFECTED SIDE IS RIGHT. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 22738499 ↗InjuryJul 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17429080 ↗InjuryJul 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17428186 ↗InjuryMay 29, 2023Material Rupture; Material Rupture
THE DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Failure of Implant
MAUDE report 17017353 ↗InjuryMay 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE NO COMPLAINT AGAINST DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16989035 ↗InjuryMar 9, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULE APPEARED TO BE GRADE II-III AND NO RUPTURE WAS FOUND. AS NOTED IN THE OPERATIVE REPORT, PERIPROSTHETIC FLUID ON THE RIGHT SIDE WAS ASPIRATED AND SENT FOR CYTOLOGY. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Failure of Implant; Seroma
MAUDE report 16516708 ↗InjuryDec 16, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE THAT WAS NOTICED DURING EXPLANT SURGERY. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16000524 ↗InjuryJul 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPRESENTATIVE REPORTED "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN AND "INCREASED RISK OF ALCL." DEVICE REMAINS IMPLANTED. THIS RECORD REPRESENTS THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 15051896 ↗InjuryJul 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTH PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANT DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. LATER PATIENT REPRESENTATIVE REPORTED, "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN REQUIRING BILATERAL CAPSULECTOMY, CELLULITIS AND ABSCESS OF THE BREAST, AND INCREASED RISK OF ALCL." THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Abscess; Capsular Contracture; Cellulitis
MAUDE report 14885361 ↗InjuryOct 29, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "EXCHANGE OF TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT AND CAPSULAR CONTRACTIVE, BAKER IV." DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12722212 ↗InjuryOct 26, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV AND "EXCHANGE OF TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT." ADDITIONAL EVENT WAS REPORTED "EVIDENCE OF OLD BLOOD HEMATOMA". DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12696273 ↗InjuryOct 1, 2021Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE REMOVAL DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED. HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE.
Patient problems: Failure of Implant
MAUDE report 12565715 ↗InjuryApr 7, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PATIENT'S CONCERN WITH THE PRODUCT" AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED AND CONFIRMED BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11628013 ↗InjuryApr 7, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT AND CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11627500 ↗InjuryApr 2, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "VERY CONCERNED WITH A TEXTURED IMPLANT", "ROTATED 45 DEGREE IN A CLOCKWISE POSITION", "DEFORMITY OF RECONSTRUCTED BREAST", "ANIMATION DEFORMITY ON THE LEFT LATERAL ASPECT OF BREAST", "LEFT IMPLANT HAS BEEN EXTRUDING", AND "A SMALL DEGREE OF SEROMA WHICH IS CULTURED AND WE CAN ALSO OBSERVE INSIDE THE STRETCHING OF THE LATERAL POCKET A LITTLE BIT." DEVICE HAS BEEN EXPLANTED.
Patient problems: Erosion; Seroma
MAUDE report 11609713 ↗InjuryFeb 26, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED A "PSEUDOCYST." DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 11387079 ↗InjuryFeb 10, 2021Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE EXCHANGE DUE TO CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "TORN AND RUPTURED." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11308200 ↗InjuryFeb 8, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PAIN", CAPSULAR CONTRACTURE, BAKER GRADE IV, AND "PATIENT'S CONCERNS WITH THE PRODUCT." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11294524 ↗InjuryFeb 8, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PAIN", CAPSULAR CONTRACTURE, BAKER GRADE IV, AND "PATIENT'S CONCERNS WITH THE PRODUCT." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11294410 ↗InjuryJan 6, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11124646 ↗
Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices
- MENTOR MemoryGel Breast Implant 3503501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,167 reports
- MENTOR MemoryGel Breast Implant 3504001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,130 reports
- MENTOR MemoryGel Breast Implant 3504004BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,012 reports
- MENTOR MemoryGel Breast Implant 3504504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,754 reports
- MENTOR MemoryGel Breast Implant 3503001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,752 reports
- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
- MENTOR MemoryGel Breast Implant 3504501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,690 reports
- MENTOR MemoryGel Breast Implant 3503251BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,684 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page