# Breast tissue expanders (saline and carbon dioxide)

Source: https://onco.cc/technologies/breast-tissue-expanders/  
OnCo record `breast-tissue-expanders` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A temporary empty implant placed at mastectomy and gradually filled over weeks to stretch the skin, so that a permanent implant can be put in later.

## Summary

Saline tissue expanders are cleared in the United States under product code LCJ. Current examples include AbbVie's Natrelle 133S (K254126, 16 January 2026), Mentor's CPX4 Plus Enhance (K241918, 2 August 2024) and PliaForm with suture tabs (K242963, 24 April 2025), Sientra's AlloX2 Pro (K214124, 8 June 2023) and Motiva's Flora SmoothSilk expander (K211676, 13 October 2023). AeroForm, made by AirXpanders, took a different approach: it was filled with carbon dioxide from a canister inside the device, released by a remote controller, and was granted De Novo classification as a carbon dioxide gas controlled tissue expander (DEN150055, 21 December 2016, product code PQN). Textured Natrelle expanders were part of the 2019 BIOCELL recall described on the breast implants record.

## Fields

- Kind: Technology
- Status: standard-of-care
- Last checked: 2026-11-04
- Also known as: Tissue expander; Natrelle 133; Mentor CPX4; PliaForm; AlloX2; Motiva Flora; AeroForm
- Tags: devices-gaps-2026-11
- Principle: A silicone shell with an integrated or remote injection port is filled stepwise with saline through the skin (or with carbon dioxide released from an internal reservoir) to stretch the overlying skin and muscle.
- Since: 2016
- Strengths: Creates space for an implant when skin is tight after mastectomy; Can be kept in place through radiotherapy in some pathways
- Limitations: A second operation is needed to exchange for an implant; Infection and expander loss

## Sources

- FDA 510(k) K254126: Natrelle 133S tissue expanders (16 January 2026): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254126
- FDA 510(k) K241918: Mentor CPX4 Plus Enhance (2 August 2024): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241918
- FDA 510(k) K242963: Mentor PliaForm (24 April 2025): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242963
- FDA 510(k) K214124: Sientra AlloX2 Pro (8 June 2023): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K214124
- FDA 510(k) K211676: Motiva Flora SmoothSilk tissue expander (13 October 2023): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211676
- FDA De Novo DEN150055: AeroForm tissue expander system: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN150055

## Connected records

- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/)
- fronts: [Devices & Physical Therapies](https://onco.cc/fronts/devices/), [Surgery & Interventional](https://onco.cc/fronts/surgery/)
- technologies: [Acellular dermal matrices and meshes in implant reconstruction](https://onco.cc/technologies/acellular-dermal-matrix-breast/), [Breast implants for reconstruction (silicone gel, saline and shaped cohesive gel)](https://onco.cc/technologies/breast-implants/), [Breast reconstruction: implant and autologous, immediate and delayed, and what women report afterwards](https://onco.cc/technologies/rejuv-recon-breast/)
- companies: [AbbVie (incl. ImmunoGen, Capstan)](https://onco.cc/companies/abbvie/), [Establishment Labs (Motiva)](https://onco.cc/companies/establishment-labs/)
- terms: [Breast reconstruction](https://onco.cc/terms/breast-reconstruction/)

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