Natrelle Style 133 Tissue Expanders with Suture TabsRecalls & reported problems across all models
Allergan, Inc. · 42 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Natrelle Style 133 Tissue Expanders with Suture Tabs model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 107
- Deaths reported
- 0
- Injuries reported
- 86
- Recalls
- 1
We found 42 models of Natrelle Style 133 Tissue Expanders with Suture Tabs by Allergan, Inc. in the FDA's device registry (GUDID). Together they are named in 107 adverse event reports in the FDA's MAUDE database, received between Aug 8, 2017 and Dec 31, 2025 — classified as 86 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (59 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Natrelle Style 133 Tissue Expanders with Suture Tabs recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 24, 2019Open, 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-2457-2019 · Root cause: Unknown/Undetermined by firm · names 42 of these models · Recall details · FDA record ↗
Most reported Natrelle Style 133 Tissue Expanders with Suture Tabs problems
Device problems
- Fluid/Blood Leak59
- Adverse Event Without Identified Device or Use Problem17
- Improper or Incorrect Procedure or Method10
- Break8
- Device Contamination with Chemical or Other Material5
- No Apparent Adverse Event3
- Patient-Device Incompatibility3
- Device Appears to Trigger Rejection2
Patient problems
- Failure of Implant63
- Unspecified Infection15
- No Patient Involvement8
- No Known Impact Or Consequence To Patient5
- Capsular Contracture4
- No Consequences Or Impact To Patient4
- Injury3
- Cellulitis2
Natrelle Style 133 Tissue Expanders with Suture Tabs models
42 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MX-13-TExpander, Skin, Inflatable1 recall16 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MV-14-TExpander, Skin, Inflatable1 recall13 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MX-14-TExpander, Skin, Inflatable1 recall11 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MX-15-TExpander, Skin, Inflatable1 recall9 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MV-13-TExpander, Skin, Inflatable1 recall6 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MX-12-TExpander, Skin, Inflatable1 recall6 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133FX-13-TExpander, Skin, Inflatable1 recall5 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MV-16-TExpander, Skin, Inflatable1 recall5 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133FV-15-TExpander, Skin, Inflatable1 recall4 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133FX-15-TExpander, Skin, Inflatable1 recall4 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MV-15-TExpander, Skin, Inflatable1 recall4 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MX-11-TExpander, Skin, Inflatable1 recall4 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133FX-12-TExpander, Skin, Inflatable1 recall3 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MX-16-TExpander, Skin, Inflatable1 recall3 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133FV-14-TExpander, Skin, Inflatable1 recall2 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133FX-14-TExpander, Skin, Inflatable1 recall2 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MV-12-TExpander, Skin, Inflatable1 recall2 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133SX-15-TExpander, Skin, Inflatable1 recall2 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133FV-12-TExpander, Skin, Inflatable1 recall1 report
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133FX-16-TExpander, Skin, Inflatable1 recall1 report
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133SV-13-TExpander, Skin, Inflatable1 recall1 report
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133SV-15-TExpander, Skin, Inflatable1 recall1 report
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133SX-12-TExpander, Skin, Inflatable1 recall1 report
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133SX-13-TExpander, Skin, Inflatable1 recall1 report
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133FV-11-TExpander, Skin, Inflatable1 recall0 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133FV-13-TExpander, Skin, Inflatable1 recall0 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133FV-16-TExpander, Skin, Inflatable1 recall0 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133FX-11-TExpander, Skin, Inflatable1 recall0 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133LV-11-TExpander, Skin, Inflatable1 recall0 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133LV-12-TExpander, Skin, Inflatable1 recall0 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133LV-13-TExpander, Skin, Inflatable1 recall0 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133LV-14-TExpander, Skin, Inflatable1 recall0 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133LV-15-TExpander, Skin, Inflatable1 recall0 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133LV-16-TExpander, Skin, Inflatable1 recall0 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MV-11-TExpander, Skin, Inflatable1 recall0 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133SV-11-TExpander, Skin, Inflatable1 recall0 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133SV-12-TExpander, Skin, Inflatable1 recall0 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133SV-14-TExpander, Skin, Inflatable1 recall0 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133SV-16-TExpander, Skin, Inflatable1 recall0 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133SX-11-TExpander, Skin, Inflatable1 recall0 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133SX-14-TExpander, Skin, Inflatable1 recall0 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133SX-16-TExpander, Skin, Inflatable1 recall0 reports
Recent Natrelle Style 133 Tissue Expanders with Suture Tabs adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED ¿HAD THE NATRELLE 133MX-13T TISSUE EXPANDER IN PRIOR TO HER IMPLANTS. SHE HAS WITHIN THE LAST YEAR BEEN DIAGNOSED WITH CHRONIC LYMPHATIC LEUKEMIA¿ AND ¿HAD THE EXPANDERS IN FOR A LITTLE BIT LONGER PERIOD DUE TO AN INFECTION¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. UNKNOWN IF DEVICE WILL BE RETURNED.
Patient problems: Unspecified Infection
MAUDE report 23933103 ↗InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
PATIENT REPORTED ¿HAD THE NATRELLE 133MX-13T TISSUE EXPANDER IN PRIOR TO HER IMPLANTS. SHE HAS WITHIN THE LAST YEAR BEEN DIAGNOSED WITH CHRONIC LYMPHATIC LEUKEMIA¿ AND ¿HAD THE EXPANDERS IN FOR A LITTLE BIT LONGER PERIOD DUE TO AN INFECTION¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. UNKNOWN IF DEVICE WILL BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 23933058 ↗InjuryNov 3, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE CONFIRMED VIA ULTRASOUND. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 18063408 ↗InjurySep 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE "CLINIC TOLD HER SHE HAS CAPSULAR CONTRACTURE ON THE LEFT IMPLANT." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17737931 ↗InjuryJan 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND "WHITE BLOOD CELL COUNTS LOWER THAN NORMAL." THE DEVICE HAS BEEN EXCHANGED.
Patient problems: Capsular Contracture
MAUDE report 13193470 ↗InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED LEFT SIDE "PAIN" AND "SWELLING" AND DEVICE WAS IMPLANTED FOR LONGER THAN 6 MONTHS. PATIENT ADDITIONALLY REPORTED INFECTION. DEVICE WAS EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 11490000 ↗InjuryOct 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "I HAD TWO REPLACEMENT IMPLANTS (TISSUE EXPANDERS) AND ONE HAD FAILED. THE PATIENT WAS CONCERNED WITH GETTING LUMPY SORE SPOT. THE RIGHT BREAST IMPLANT IS THE ONLY ONE I HAD FOR ONE YEAR AND IT DEVELOPED AN ENORMOUS SEROMA (80 MLS OF FLUID WAS DRAINED). IT WAS LIKE A SEVERE INFECTION AND THE CULTURES WERE NEGATIVE. THE INFECTION GOT SO BAD AND THE DRAINAGE WAS HORRIBLE STUFF THAT HAD TO REMOVED." THIS RECORD IS FOR THE RIGHT SIDE.
Patient problems: Seroma; Unspecified Infection
MAUDE report 10704788 ↗InjuryOct 9, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
HEALTH PROFESSIONAL REPORTED A RIGHT SIDE "500CC AIR"; USE ERROR DURING IMPLANT PROCEDURE. IT IS UNKNOWN IF THE DEVICE HAS BEEN EXPLANTED OR REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 10656336 ↗InjuryOct 9, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
HEALTH PROFESSIONAL REPORTED A LEFT SIDE "500CC AIR"; USE ERROR DURING IMPLANT PROCEDURE. PLACEMENT OF DEVICE IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 10656275 ↗InjurySep 29, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE". THE EXPANDER WAS IMPLANTED FOR MORE THAN SIX MONTHS. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10601223 ↗InjuryMay 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "INFECTION". DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 10017757 ↗MalfunctionMar 27, 2020Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED LEFT SIDE "LEAK". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9891016 ↗InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED AN UNKNOWN SIDE FOR A TISSUE EXPANDER "FEELING SICK IN MAY, SEVERE FATIGUE. NAUSEA I VOMITING. HOT/COLD SPELLS, TEMPERATURES, LOSS OF APPETITE, OVERALL FEELING VERY BAD," "RECEIVE LAB WORK MULTIPLE TIMES, ALL SHOWING I HAD AN INFECTION," "WAS DIAGNOSED WITH SEVERE SEPSIS, SEPTIC SHOCK, AND WAS TAKEN TO SURGERY FOR IMMEDIATE REMOVAL OF MY IMPLANTS AND EXPANDERS." THIS RECORD WILL BE FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 9889764 ↗InjuryFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "TISSUE FAILURE/NECROSIS". DEVICE HAS BEEN EXPLANTED.
Patient problems: Necrosis
MAUDE report 9665802 ↗InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTH PROFESSIONAL REPORTED A LEFT SIDE "TISSUE FAILURE/NECROSIS". DEVICE HAS BEEN EXPLANTED.
Patient problems: Necrosis
MAUDE report 9647844 ↗
Other Allergan, Inc. products
- Natrelle Breast Implants1,167 models · 38,972 reports · 7 recalls
- Natrelle INSPIRA Breast Implants197 models · 15,057 reports · 1 recall
- NATRELLE Saline-Filled Breast Implants103 models · 7,892 reports · 1 recall
- Natrelle Inspira SoftTouch Breast Implants195 models · 6,571 reports · 1 recall
- NATRELLE Silicone-Filled Breast Implants128 models · 4,507 reports · 1 recall
- Natrelle Inspira Cohesive Breast Implants192 models · 2,949 reports · 1 recall
- JUVEDERM ULTRA XC3 models · 550 reports
- JUVEDERM ULTRA PLUS XC2 models · 324 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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