NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MX-410620Recalls & reported problems
Allergan, Inc. · STYLE 410, MX, 620G 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 textured silicone gel breast implant appears in 27 adverse event reports, all describing injuries and no deaths. Most reports describe the scar tissue tightening around the implant (capsular contracture), causing pain and firmness, along with implant rupture, fluid collections, and in one case a patient's immune system reacting to the implant. One recall remains open, started in July 2019 over FDA information on higher rates of a rare lymphoma (BIA-ALCL) 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
- 26
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10888628003781), received between May 29, 2019 and May 6, 2024 — classified as 26 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (9 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 Rejection9
- Adverse Event Without Identified Device or Use Problem7
- Patient-Device Incompatibility6
- Material Rupture5
- No Apparent Adverse Event1
Patient problems
- Capsular Contracture14
- Failure of Implant4
- Pain3
- Seroma3
- Unspecified Infection2
- Foreign Body Reaction1
- No Clinical Signs, Symptoms or Conditions1
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE "BREAST PAIN." DEVICE WAS EXPLANTED. HEALTHCARE PROFESSIONAL LATER REPORTED PAIN, "APPEARS BIGGER" AND "CURRENT IMPLANTS HAVE BEEN RECALLED". HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 19250411 ↗InjuryApr 18, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE "BREAST PAIN." DEVICE REMAINS IMPLANTED. HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE PAIN, CAPSULAR CONTRACTURE BAKER GRADE III, "APPEARS BIGGER" AND "CURRENT IMPLANTS HAVE BEEN RECALLED".
Patient problems: Capsular Contracture
MAUDE report 19130155 ↗InjuryAug 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND REPLACEMENT FROM TEXTURED TO SMOOTH DUE TO THE PATIENT CONCERN OF THE IMPLANT. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17437991 ↗InjuryAug 1, 2023Device Appears to Trigger Rejection; No Apparent Adverse Event; Device Appears to Trigger Rejection; No Apparent Adverse Event
PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND REPLACEMENT FROM TEXTURED TO SMOOTH DUE TO THE PATIENT CONCERN OF THE IMPLANT. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 17437844 ↗InjuryApr 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
COMPANY REPRESENTATIVE REPORTED THE LEFT SIDE "PATIENT SAYS THAT SHE WILL HAVE THE IMPLANTS REMOVED BECAUSE SHE IS HAVING ISSUES." PATIENT REPRESENTATIVE LATER REPORTED " PLAINTIFF UNDERWENT PAINFUL REMOVAL PROCEDURES AS WELL AS TREATMENT, THERAPY, RECOVERY, AND EXPENSE ASSOCIATED WITH THE REMOVAL OF THE BIOCELL TEXTURED BREAST IMPLANT DUE TO FEAR OF ALCL, TO REDUCE RISK OF ALCL, AND DUE TO SYMPTOMS CONSISTENT WITH ALCL AND FEAR OF ALCL INCLUDING: MENTAL ANGUISH, INCREASED RISK OF ALCL, EVALUATION FOR ALCL, EXPLANT, RECONSTRUCTION, SEROMAS, PHYSICAL PAIN, SCARRING AND DISFIGUREMENT. PLAINTIFF EXPERIENCED BREAST SWELLING, SEROMA, HEAT SENSATIONS, BREAST PAIN, CAPSULAR CONTRACTURE, AND SIGNIFICANT WEIGHT LOSS OR GAIN. ADDITIONALLY, PLAINTIFF SUFFERED AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING EMOTIONAL DISTRESS AND ANXIETY, AS WELL AS LOSS OF QUALITY OF LIFE AND DEPRESSION; AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVERE AND ONGOING. PLAINTIFF HAS NOT BEEN DIAGNOSED WITH BIA-ALCL DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 16702516 ↗InjuryOct 6, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ANXIETY AND RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15550503 ↗InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. PATIENT REPORTED "POCKETS OF SEROMA FLUID". DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 14274736 ↗InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. PATIENT ADDITIONALLY REPORTED "POCKETS OF SEROMA FLUID". DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 13258624 ↗InjuryDec 10, 2021Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE, AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED "EXPOSED IMPLANT," "UNSPECIFIED OPEN WOUND OF LEFT BREAST" AND "CHRONIC INFLAMMATION." DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Foreign Body Reaction; Wound Dehiscence
MAUDE report 12978901 ↗InjuryJul 14, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12170370 ↗InjuryJul 14, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12169346 ↗InjuryApr 14, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS, DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11666060 ↗InjuryMar 16, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN IMPLANT EXCHANGE DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11495630 ↗InjuryOct 13, 2020Material Rupture; Material Rupture
DEVICE HAS BEEN EXPLANTED AND DISCARDED AFTER SURGERY.
Patient problems: Failure of Implant
MAUDE report 10670969 ↗InjurySep 23, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10574727 ↗InjurySep 22, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL CONFIRMED CAPSULAR CONTRACTURE, BAKER GRADE IV.
Patient problems: Capsular Contracture
MAUDE report 10568158 ↗InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED REASON FOR RIGHT SIDE DEVICE REMOVAL AS "INFECTION." DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 10513267 ↗InjurySep 3, 2020Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE IMPLANT "WAS HARD AND RUPTURED." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10489524 ↗InjuryAug 31, 2020Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE IMPLANT WAS HARD AND RUPTURED. DEVICE HAS BEEN EXPLANTED
Patient problems: Failure of Implant
MAUDE report 10471091 ↗InjuryMay 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED REASON FOR DEVICE REMOVAL WAS "PAIN." DEVICE HAS BEEN EXPLANTED.
Patient problems: Pain
MAUDE report 10017586 ↗InjuryApr 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "HAD TO HAVE IMPLANT REMOVED DUE TO AN INFECTION THAT WAS SO SEVERE THEY WERE NEAR DEATH." DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Unspecified Infection
MAUDE report 9957495 ↗InjuryJan 29, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PATIENT¿S CONCERN WITH THE PRODUCT", CAPSULAR CONTRACTURE, BAKER GRADE III, AND PAIN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9642808 ↗InjuryDec 19, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNSPECIFIED. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9497203 ↗InjuryDec 11, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND "PATIENT¿S CONCERN WITH THE PRODUCT." DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9451820 ↗InjuryMay 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PAIN." THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Pain
MAUDE report 8650693 ↗
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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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