NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants MF-410640Recalls & reported problems
Allergan, Inc. · NATRELLE 410 STYLE MF 640CC 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 silicone-filled breast implant from Allergan has 34 adverse event reports, all describing injuries and no deaths. Most reports describe the scar tissue tightening around the implant (capsular contracture), swelling and fluid buildup, and implant rupture, along with a few reports of swelling lymph nodes and a rare lymphoma of the implant capsule. One open recall, started in July 2019, followed updated FDA safety information on higher rates of that 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
- 34
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10888628003521), received between Jun 6, 2019 and Aug 9, 2025 — classified as 34 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (8 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 Problem12
- Device Appears to Trigger Rejection8
- Material Rupture8
- Patient-Device Incompatibility7
- Device Handling Problem1
Patient problems
- Capsular Contracture15
- Failure of Implant6
- Seroma4
- Lymphoma3
- Unspecified Infection3
- Inflammation2
- Swollen Lymph Nodes/Glands2
- Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "SWELLING LYMPH NODES AND PAIN". THIS RELATES TO THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Swollen Lymph Nodes/Glands
MAUDE report 22766572 ↗InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED RIGHT SIDE "SWELLING LYMPH NODES AND PAIN". DEVICE REMAINS IMPLANTED.
Patient problems: Swollen Lymph Nodes/Glands
MAUDE report 22734125 ↗InjuryApr 30, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryApr 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL LATER REPORTED A CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN DISCARDED.
Patient problems: Capsular Contracture
MAUDE report 19188720 ↗InjuryAug 3, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO CONCERN WITH THE PRODUCT, "A LUMP ON LEFT BREAST", "LEFT TRANSAXILIARY IS NUMB", "CHEST PAIN", AND "FEELS SOMETHING MOVING DOWN LEFT ARM." PATIENT ADDITIONALLY REPORTED "CANCER SURVIVOR"; THIS IS NOT DEVICE RELATED. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15161344 ↗InjuryAug 3, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE EXCHANGE OF TEXTURED BREAST IMPLANT DUE TO CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15161269 ↗InjuryJul 8, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT¿S REPRESENTATIVE REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, AND INCREASED RISK OF ALCL. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14959606 ↗InjuryFeb 23, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "CONFIRMED ALCL." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED RIGHT SIDE RUPTURE, AND SEROMA. PATHOLOGICAL MARKER CD30+ HAS BEEN RECEIVED. PATHOLOGICAL MARKER ALK- HAS NOT BEEN RECEIVED. THE DEVICE REMAINS IMPLANTED.
Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Lymphoma; Seroma
MAUDE report 13585062 ↗InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT LEFT SIDE LYMPHEDEMA, PAIN, SWELLING, AND ¿LEARNED ABOUT THE ALLERGAN RECALL ONLINE¿. IN ADDITION THE PATIENT REPORTED THE FOLLOWING EVENTS, WHICH ARE DEEMED NOT RELATED TO THE DEVICE: C DIFF, SEPSIS AND HEMORRHAGIC COLITIS, LUMP, WEAKNESS, CHRONIC DEBILITATING FATIGUE, FIBROMYALGIA, GERD, OSTEOPENIA, ANEMIA, INCONTINENCE, BREAST IMPLANT ILLNESS, HASHIMOTOS, ASTHMA, CHRONIC BRONCHITIS, MEMORY PROBLEMS/LOSS OF CONCENTRATION, HEAT/COLD INTOLERANCE, BLOATING, CONSTANT NOISE/RINGING IN EARS, WEIGHT GAIN, RESTLESS LEGS, ANXIETY, PERIPHERAL NEUROPATHY." DEVICE REMAIN IMPLANTED.
Patient problems: Swelling/ Edema
MAUDE report 12711061 ↗InjuryAug 20, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND EXCHANGE DUE TO THE CONCERN WITH PRODUCT. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 12347559 ↗InjuryAug 19, 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 12345928 ↗InjuryJun 25, 2021Material Rupture; Device Handling Problem; Material Rupture; Device Handling Problem
PATIENT REPORTED VIA REGULATORY AGENCY A RIGHT SIDE RUPTURE. THE DEVICE WAS REPORTED TO BE IMPLANTED AFTER ITS EXPIRATION DATE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 12067109 ↗InjuryJun 23, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 12052057 ↗InjuryApr 14, 2021Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT AND RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 11666045 ↗InjuryMar 26, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPRESENTATIVE REPORTED PATIENT EXPERIENCED ¿CAPSULAR CONTRACTURE,¿ BAKER GRADE NOT PROVIDED, ¿ANXIETY,¿ ¿CHRONIC PAIN¿ ¿HEAT SENSATION,¿ ¿RASHES,¿ ¿ITCHING¿ AND ¿SWELLING.¿ PATIENT REPRESENTATIVE ALSO REPORTED PATIENT ¿SUFFERED PERSONAL INJURIES AND RELATED DAMAGES,¿ ¿DEPRESSION,¿ ¿CHRONIC INSOMNIA,¿ ¿NAUSEA ON AN ONGOING BASIS,¿ ¿PANIC DISORDER, PTSD, SIGNIFICANT WEIGHT GAIN, IRRITABLE BOWEL, CHRONIC HEADACHES, CHRONIC GASTROINTESTINAL UPSET AND REFLUX¿ AND ¿DISFIGUREMENT, DISABILITY;¿ THESE EVENTS NOT RELATED TO THE DEVICE. DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 11575079 ↗InjuryMar 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED A PATIENT WITH LEFT SIDE SEROMA (300CC). FLUID WAS ASPIRATED AND CYTOLOGY NOTED THAT THE FLUID WAS "CONSISTENT WITH BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA." WHILE THE MARKER OF CD30+ HAS BEEN REPORTED, THE MARKER OF ALK- HAS NOT. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Lymphoma; Seroma
MAUDE report 11563578 ↗InjuryJan 26, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEVICE REMOVAL DUE TO RECALL. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11229944 ↗InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED THEY "BEEN HAVING BREAST PAINS", "FLUID AROUND BREASTS AND UNDER [THEIR] ARMS". PATIENT ADDITIONALLY REPORTED [THEIR] BREATHING HAS BEEN FUNNY", HAD A BLOOD CLOT IN [THEIR] NECK, AND [THE PATIENT] HAS BEEN FIGHTING TWO TYPES OF CANCER¿, "NECK WAS REAL, REAL SWOLLEN AND COULDN'T DO MUCH"; THESE EVENTS ARE UNRELATED TO THE DEVICE. DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.
Patient problems: Seroma
MAUDE report 10643577 ↗InjuryApr 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT REPORTED THEY EXPERIENCED THE EVENT OF ¿BIOCELL IMPLANTS REMOVED 3 YEARS AGO BECAUSE THEY GOT INFECTED WITHIN 6 MONTHS AFTER IMPLANTATION¿. DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 10012285 ↗InjuryApr 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED "AN INFECTION OF A RARE BUG THOUGHT TO HAVE COME FROM A SHOWER HEAD, HEMATOMA, AND SURGERIES REQUIRING SKIN GRAFTS TO THE AREA". DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.
Patient problems: Complaint, Ill-Defined; Unspecified Infection
MAUDE report 10003512 ↗InjuryApr 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED A PATIENT WITH "BREAST IMPLANT¿ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA;" PATHOLOGY HAS NOT BEEN RECEIVED AND THE MARKERS OF CD30+ AND ALK- HAVE NOT BEEN REPORTED/CONFIRMED. THE DEVICE WAS PLACED IN A BIOLOGICALLY MALE PATIENT. AFFECTED SIDE IS LEFT. THE DEVICE REMAINS IMPLANTED.
Patient problems: Lymphoma
MAUDE report 9991656 ↗InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE "SWELLING AND HOT" AND CONCERNS WITH TEXTURED IMPLANT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Inflammation; Irritation
MAUDE report 9897302 ↗InjuryMar 25, 2020Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE "COLLAPSED". PATIENT ALSO REPORTED "HAIR WAS FALLING OUT", "BODY ATTACKED JOINTS AND HAIR GROWTH", "DIAGNOSED WITH ALOPECIA UNIVERSALIS", "HAD TO TAKE AN IMMUNE SUPPRESSOR", "HAIR FALLS OUT EVERY FEW MONTHS", "SUPPOSED TO BE IN MENOPAUSE, BUT LEVELS WERE THAT OF SOMEONE IN THEIR FIRST TRIMESTER", AND "HAD TO HAVE AN OOPHORECTOMY AND HYSTERECTOMY"; THESE ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9878191 ↗InjuryFeb 11, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9693907 ↗InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE "FLUID BUILD UP" AND "CONCERN WITH THE PRODUCT." DEVICE REMAINS IMPLANTED.
Patient problems: Seroma
MAUDE report 9677055 ↗
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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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