Natrelle INSPIRA Breast Implants TRF-450Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty TRF-450 Full profile BIOCELL |textured|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · Natrelle INSPIRA Breast Implants (197)
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 INSPIRA textured silicone gel breast implant appears in 34 adverse event reports, all describing injuries and no deaths. Most reports describe the scar tissue tightening around the implant (capsular contracture), often severe enough to need removal or replacement, along with rupture, fluid collection, and swollen lymph nodes; some patients also mention fear of lymphoma and emotional distress. One recall, still open, was started in July 2019 over updated FDA information on higher rates 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
- 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 10888628008342), received between May 29, 2019 and May 15, 2025 — classified as 34 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (12 reports).
1 FDA recall record name this device's identifier, 1 still open.
3 other recalls cover devices cleared under the same FDA submission (P020056); they may or may not involve this specific model.
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-2453-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Appears to Trigger Rejection12
- Patient-Device Incompatibility11
- Material Rupture10
- Adverse Event Without Identified Device or Use Problem3
- No Apparent Adverse Event1
Patient problems
- Capsular Contracture22
- Failure of Implant10
- Seroma4
- Swollen Lymph Nodes4
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE "REPLACEMENT FROM TEXTURED TO SMOOTH DUE TO THE PATIENT'S CONCERN OF THE PRODUCT AND DOUBLE CAPSULE". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". DEVICE HAS BEEN EXPLANTED, NOT REPLACED, AND DISCARDED.
Patient problems: Capsular Contracture
MAUDE report 22027128 ↗InjuryNov 16, 2023Material Rupture; Material Rupture
PATIENT REPORTED, LEFT SIDE EXCHANGE, DUE TO PATIENT¿S CONCERNS WITH THE PRODUCT. PAIN, AND "APPEARANCE CHANGE". PATIENT ALSO REPORTED, "THERE MAY BE RUPTURE". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 18146767 ↗InjuryApr 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 16787749 ↗InjuryApr 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKERS GRADE 4." DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16785917 ↗InjuryApr 7, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE." HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16702310 ↗InjuryApr 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPRESENTATIVE REPORTED LEFT SIDE "FEAR OF ALCL", "MENTAL ANGUISH", ¿SUFFERED AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING EMOTIONAL DISTRESS", "ANXIETY¿, "PTSD", "CAPSULAR CONTRACTURE" BAKER GRADE UNSPECIFIED, "SEROMAS", ¿LOSS OF QUALITY OF LIFE¿ AND ¿DEPRESSION¿. NON-DEVICE RELATED EVENTS OF "CHRONIC HEADACHE¿ AND "CHRONIC INSOMNIA¿ WERE ALSO REPORTED. UNKNOWN TREATMENT AND THERAPIES WERE NOTED. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 16681740 ↗InjuryApr 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPRESENTATIVE REPORTED RIGHT SIDE "FEAR OF ALCL", "MENTAL ANGUISH", ¿SUFFERED AGGRAVATION OF UNDERLYING CONDITIONS INCLUDING EMOTIONAL DISTRESS", "ANXIETY¿, "PTSD", "RIGHT ENCAPSULATED BREAST, CAPSULAR CONTRACTURE" BAKER GRADE UNSPECIFIED, "SEROMAS", ¿LOSS OF QUALITY OF LIFE¿ AND ¿DEPRESSION¿. NON-DEVICE RELATED EVENTS OF "CHRONIC HEADACHE¿ AND "CHRONIC INSOMNIA¿ WERE ALSO REPORTED. UNKNOWN TREATMENT AND THERAPIES WERE NOTED. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 16681588 ↗InjuryApr 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT." PATIENT LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16668201 ↗InjuryMar 29, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16639969 ↗InjuryMar 1, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16459565 ↗InjuryFeb 14, 2023Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 16374766 ↗InjuryNov 28, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15874792 ↗InjuryNov 22, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15847144 ↗InjuryJul 19, 2022Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE CONCERNS WITH TEXTURED IMPLANT. HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15057782 ↗InjuryMay 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH AND CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14481636 ↗InjuryMay 13, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE SORENESS AND THE IMPLANT IS "TIGHT." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED BILATERAL EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. PATIENT LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11822258 ↗InjuryMay 13, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "CAPSULAR CONTRACTURE GRADE III", "DEFORMED", "PAIN", "FIRM".
Patient problems: Capsular Contracture
MAUDE report 11821105 ↗InjuryJan 21, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPRESENTATIVE REPORTED PATIENT EXPERIENCED ¿CAPSULAR CONTRACTURE,¿ BAKER GRADE UNKNOWN, ¿LOSS OF ENJOYMENT OF LIFE,¿ ¿SIGNIFICANTLY INCREASED RISK OF DEVELOPING CANCER, EMOTIONAL DISTRESS INCLUDING FEAR AND ANXIETY OF DEVELOPING CANCER, ACCUMULATION OF FOREIGN AND ADULTERATED SILICONE PARTICLES IN THEIR BODIES, INCLUDING THE RESULTING INFLAMMATION CELLULAR DAMAGE, AND SUBCELLULAR DAMAGE,¿ ¿PHYSICAL PAIN AND SUFFERING¿ AND ¿RIPPLING.¿ PATIENT REPRESENTATIVE ALSO REPORTED PATIENT ¿SUFFERED PERSONAL INJURIES AND RELATED DAMAGES,¿ ¿HIGH BLOOD PRESSURE¿ AND ¿DISFIGUREMENT;¿ THESE EVENTS ARE NOT RELATED TO THE DEVICE. DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 11211048 ↗InjuryNov 13, 2020Device Appears to Trigger Rejection; Patient-Device Incompatibility; Device Appears to Trigger Rejection; Patient-Device Incompatibility
PATIENT REPRESENTATIVE REPORTED RIGHT SIDE "PAINFUL REMOVAL PROCEDURES AS WELL AS TREATMENT, THERAPY, RECOVERY, AND EXPENSE ASSOCIATED WITH THE REMOVAL OF THE BIOCELL TEXTURED BREAST IMPLANTS 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 PAIN, SEVERE PAIN FROM RIGHT SHOULDER/NECK TO RIGHT HAND, TIGHTNESS IN RIGHT BREAST, THICK SCARRING NEAR RIGHT UNDER ARMPIT AND BILATERAL BREASTS, CAPSULAR CONTRACTURE IN RIGHT BREAST, EXCRUCIATING PAIN IN JOINTS, MUSCULAR TWITCHING IN RIGHT BREAST AND SHOULDER, CHRONIC EAR INFECTIONS/SINUS INFECTIONS/SWOLLEN LYMPH NODES IN THROAT AND NECK, RINGING IN EARS, CHRONIC BLOATING AND STOMACH DISCOMFORT, CHRONIC AND DEBILITATING HEADACHES, COGNITIVE DYSFUNCTION AND MEMORY LOSS, STUTTERING, CHRONIC FATIGUE, RASHES ON BREASTS, BRUISING AND SKIN IRRITATION, INDENTATIONS TO CHEST, SKIN IRRITATIONS AND REDNESS ON SHOULDERS AND CHEST, ASYMMETRY, EXTREME HARDENING OF BREASTS, SEROMAS, DOUBLE ENCAPSULATIONS, LIMITED PHYSICAL MOBILIT
Patient problems: Capsular Contracture; Seroma
MAUDE report 10837198 ↗InjuryNov 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED A LEFT SIDE EXCHANGE FROM A TEXTURED TO SMOOTH IMPLANT DUE TO CONCERN WITH THE PRODUCT AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10820560 ↗InjuryNov 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED RIGHT SIDE "EXCHANGE FROM A TEXTURED TO SMOOTH IMPLANT DUE TO CONCERN WITH THE PRODUCT" AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10816618 ↗InjurySep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PATIENT'S CONCERN WITH THE PRODUCT" AND SEROMA. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 10567575 ↗InjuryAug 31, 2020Material Rupture; Material Rupture
PHYSICIAN REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 10471890 ↗InjuryJan 8, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED VIA REGULATORY AGENCY RIGHT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE IV", "PAIN", AND ¿ENLARGED LYMPH NODES THROUGHOUT CHEST AND ABDOMEN TO PELVIS." THE PATIENT ADDITIONALLY REPORTED "ISSUES WITH ARMS¿, ¿SKIN, RASHES¿ AND ¿RANGE OF MOTION¿, ¿ENLARGED LYMPH NODES THROUGHOUT ABDOMEN TO PELVIS¿, ¿CHRONIC FATIGUE¿, ¿INFLAMMATION ARTHRITIS OR RHEUMATOID ARTHRITIS¿, ¿JOINT PAIN¿, ¿EYES AND VISION HAVE CHANGED¿, ¿GET SICK EASILY¿, MEMORY AND FOCUS ISSUES¿, ¿CANNOT KEEP UP¿, AND ¿LOST SOME HAIR IN PATCHES¿; THESE EVENTS ARE NOT DEVICE RELATED. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Swollen Lymph Nodes
MAUDE report 9565594 ↗InjuryJan 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT REPORTED VIA REGULATORY AGENCY "GRADE 4 CAPSULAR CONTRACTURE, PAIN," AND "ENLARGED LYMPH NODES THROUGHOUT MY CHEST AND ABDOMEN TO MY PELVIS." PATIENT ADDITIONALLY REPORTED "ISSUES WITH MY ARMS, SKIN, RASHES AND RANGE OF MOTION, CHRONIC FATIGUE, INFLAMMATION ARTHRITIS OR RHEUMATOID ARTHRITIS, JOINT PAIN, MY EYES AND VISION HAVE CHANGED, GET SICK EASILY, MEMORY AND FOCUS ISSUES, CANNOT KEEP UP, AND LOST SOME HAIR IN PATCHES;" THESE EVENTS ARE NOT DEVICE RELATED. THE DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.
Patient problems: Capsular Contracture; Swollen Lymph Nodes
MAUDE report 9554142 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P020056. One submission often covers many models, so check the product and lot details in each record.
- Z-0700-2020 · Nov 6, 2019 · TerminatedNatrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod
- Z-0701-2020 · Nov 6, 2019 · TerminatedNatrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 762
- Z-2454-2019 · Jul 24, 2019 · Open, ClassifiedNatrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-
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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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