Natrelle 133S Tissue ExpandersRecalls & reported problems across all models
Allergan, Inc. · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 319
- Deaths reported
- 0
- Injuries reported
- 281
- Recalls
- 0
We found 25 models of Natrelle 133S Tissue Expanders by Allergan, Inc. in the FDA's device registry (GUDID). Together they are named in 319 adverse event reports in the FDA's MAUDE database, received between May 31, 2019 and Sep 30, 2026 — classified as 281 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (176 reports).
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
Most reported Natrelle 133S Tissue Expanders problems
Device problems
- Fluid/Blood Leak176
- Adverse Event Without Identified Device or Use Problem64
- Break31
- Deflation Problem13
- Improper or Incorrect Procedure or Method8
- Device Appears to Trigger Rejection6
- Device Handling Problem6
- Material Rupture6
Patient problems
- Failure of Implant210
- Unspecified Infection58
- No Clinical Signs, Symptoms or Conditions19
- Seroma17
- Necrosis7
- Wound Dehiscence7
- Cellulitis5
- No Patient Involvement5
Natrelle 133S Tissue Expanders models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Natrelle 133S Tissue Expanders 133S-MX-13-TExpander, Skin, Inflatable39 reports
- Natrelle 133S Tissue Expanders 133S-MV-13-TExpander, Skin, Inflatable30 reports
- Natrelle 133S Tissue Expanders 133S-MV-15-TExpander, Skin, Inflatable29 reports
- Natrelle 133S Tissue Expanders 133S-MX-15-TExpander, Skin, Inflatable28 reports
- Natrelle 133S Tissue Expanders 133S-MV-14-TExpander, Skin, Inflatable26 reports
- Natrelle 133S Tissue Expanders 133S-MX-14-TExpander, Skin, Inflatable25 reports
- Natrelle 133S Tissue Expanders 133S-MX-12-TExpander, Skin, Inflatable18 reports
- Natrelle 133S Tissue Expanders 133S-MV-16-TExpander, Skin, Inflatable15 reports
- Natrelle 133S Tissue Expanders 133S-FX-13-TExpander, Skin, Inflatable13 reports
- Natrelle 133S Tissue Expanders 133S-MX-16-TExpander, Skin, Inflatable13 reports
- Natrelle 133S Tissue Expanders 133S-FV-14-TExpander, Skin, Inflatable12 reports
- Natrelle 133S Tissue Expanders 133S-FX-14-TExpander, Skin, Inflatable12 reports
- Natrelle 133S Tissue Expanders 133S-FV-13-TExpander, Skin, Inflatable10 reports
- Natrelle 133S Tissue Expanders 133S-MV-12-TExpander, Skin, Inflatable9 reports
- Natrelle 133S Tissue Expanders 133S-FX-12-TExpander, Skin, Inflatable8 reports
- Natrelle 133S Tissue Expanders 133S-FV-12-TExpander, Skin, Inflatable7 reports
- Natrelle 133S Tissue Expanders 133S-SX-13-TExpander, Skin, Inflatable4 reports
- Natrelle 133S Tissue Expanders 133S-FX-15-TExpander, Skin, Inflatable4 reports
- Natrelle 133S Tissue Expanders 133S-FV-16-TExpander, Skin, Inflatable3 reports
- Natrelle 133S Tissue Expanders 133S-MV-11-TExpander, Skin, Inflatable3 reports
- Natrelle 133S Tissue Expanders 133S-SX-15-TExpander, Skin, Inflatable3 reports
- Natrelle 133S Tissue Expanders 133S-MX-11-TExpander, Skin, Inflatable3 reports
- Natrelle 133S Tissue Expanders 133S-FV-11-TExpander, Skin, Inflatable2 reports
- Natrelle 133S Tissue Expanders 133S-SV-14-TExpander, Skin, Inflatable2 reports
- Natrelle 133S Tissue Expanders 133S-FX-11-TExpander, Skin, Inflatable1 report
Recent Natrelle 133S Tissue Expanders adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "Infection" and "Seroma". This record is for the left side. Device was explanted.
Patient problems: Seroma; Unspecified Infection
MAUDE report 50945682 ↗InjurySep 29, 2026Detachment of Device or Device Component
Sales representative reported "Expander came apart inside the patient". This record is for an unknown side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935111 ↗InjurySep 21, 2026Fluid/Blood Leak
Healthcare professional, through company representative, reported: "tissue expander was not expanding in office. We removed the expander and found there was a small hole on the posterior side, causing it to leak". This record is for an unknown-side device. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838932 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Impaired Healing; Unspecified Infection
MAUDE report 50699888 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "delayed wound healing" and "infection". This record is for left side. The device was explanted.
Patient problems: Impaired Healing; Unspecified Infection
MAUDE report 50699510 ↗InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "She felt heat and felt the expander move so the MRI was aborted. She subsequently developed worsening mastectomy flap necrosis requiring explant of the tissue expander". This record is for the left side. The device was explanted.
Patient problems: Necrosis
MAUDE report 50599301 ↗InjuryJul 27, 2026Difficult to Open or Remove Packaging Material
Healthcare professional, through sales representative, reported "defect where it was stuck to itself". The device was not implanted. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50038374 ↗InjuryJul 27, 2026Fluid/Blood Leak
Healthcare Professional reported through sales representative "several holes in it". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50037813 ↗MalfunctionJul 14, 2026Contamination
Healthcare professional, through sales representative, reported "a hair was in one of the products upon opening it". The device was not implanted. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25813146 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED ¿PATIENT REACTION¿. LATER HEALTHCARE PROFESSIONAL REPORTED ¿INFECTED SEROMA AROUND THE IMPLANT¿. LATER HEALTHCARE PROFESSIONAL REPORTED ¿FINEGOLDIA MAGNA¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Bacterial Infection; Seroma
MAUDE report 25459260 ↗InjuryJun 6, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED ¿HAD AN OPEN WOUND", "MY BODY REJECTED THE IMPLANT", AND "MY BODY WENT SCEPTIC¿. LATER PATIENT PRESENTED OPERATIVE NOTES REPORTING "DELAYED WOUND CLOSURE", "SOFT TISSUE INFECTION", AND "COPIOUS AMOUNT OF INFECTED SEROMA". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Seroma; Unspecified Infection; Wound Dehiscence
MAUDE report 25419580 ↗InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "INFECTION AND WOUND PROBLEMS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Impaired Healing; Unspecified Infection
MAUDE report 25103779 ↗InjuryApr 10, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "SPONTANEOUS RUPTURE". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE STATUS IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845123 ↗InjuryApr 9, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "HAD SPONTANEOUS RUPTURE". LATER, PATIENT REPORTED "RUPTURED", "500 EXPANDER EXPANDED TO 570". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24827461 ↗InjuryMar 31, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED THROUGH COMPANY REPRESENTATIVE "RUPTURE". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24746920 ↗
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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