Natrelle 133S Tissue Expanders 133S-MX-11-TRecalls & reported problems
Allergan, Inc. · Natrelle TE Smooth 133S-MX-11-T (US) · Class U · Implant
All models of Natrelle Breast Implants (1167) · Natrelle 133S Tissue Expanders (25)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888628044173), received between Sep 25, 2020 and Oct 18, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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, 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.
Most reported problems
Device problems
- Patient-Device Incompatibility2
- Break1
- Fluid/Blood Leak1
Patient problems
- Failure of Implant2
- Foreign Body Sensation in Eye2
- Unspecified Infection2
- Wound Dehiscence2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 18, 2022Break; Break
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "THAT LIQUID WAS COMING OUT OF A SMALL PUNCTURE IN THE IMPLANT". DEVICE STATUS IS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15629067 ↗InjurySep 25, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HOSPITAL SALES REPRESENTATIVE REPORTED " REVISION IS THE RESULT OF REMOVAL OF AN INFECTED TISSUE EXPANDER." HEALTHCARE PROVIDER ALSO REPORTED ¿WOUND DEHISCENCE AND EXPOSURE" . DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.
Patient problems: Foreign Body Sensation in Eye; Unspecified Infection; Wound Dehiscence
MAUDE report 10590605 ↗InjurySep 25, 2020Fluid/Blood Leak; Patient-Device Incompatibility; Fluid/Blood Leak; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL INDICATED THAT THE EVENTS OF WOUND DEHISCENCE AND EXPOSURE WERE NOT DUE TO OR CAUSED BY THE DEVICE; "UNCERTAIN ETIOLOGY" NOTED AS CAUSE. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED VIA REGULATORY AGENCY LEFT SIDE "RUPTURE" AND HEMATOMA.
Patient problems: Failure of Implant; Foreign Body Sensation in Eye; Unspecified Infection; Wound Dehiscence
MAUDE report 10587007 ↗
Other Expander, Skin, Inflatable devices
- B.BRAUN 7B3050B. Braun Medical Inc. · EXPANDER, SKIN, INFLATABLE1 recall40 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549314Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE1 recall22 reports
- MENTOR CPX4 PLUS, Smooth, Medium Height SCPX146MHMentor Texas L.P. · Expander, skin, inflatable1 recall18 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MX-13-TAllergan, Inc. · Expander, Skin, Inflatable1 recall16 reports
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC135UHMentor Texas L.P. · Expander, skin, inflatable1 recall14 reports
- MENTOR ARTOURA PLUS, Smooth, High Profile SDC150HMentor Texas L.P. · Expander, skin, inflatable1 recall14 reports
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC120UHMentor Texas L.P. · Expander, skin, inflatable1 recall14 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MV-14-TAllergan, Inc. · Expander, Skin, Inflatable1 recall13 reports
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
- 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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