FDA Grants Marketing Approval to AeroForm Tissue Expansion Device for Patients Following Mastectomy

Binita Ashar, MD

The FDA has approved the marketing of AeroForm, a new system for soft tissue expansion in 2-stage breast reconstruction following mastectomy, and in the treatment of underdeveloped breasts and soft tissue deformities.

Manufactured by AirXpanders, AeroForm is a balloon-like wireless tissue expander for patients who choose to have reconstructive surgery following a mastectomy. The device has a soft, expandable polymer shell and is gradually filled with saline or air.

The marketing approval was based on results from a clinical trial of 99 patients using the AeroForm expander and 52 patients using the saline expander. The results showed that 96.1% of the patients using AeroForm expanders and 98.8% of the patients using saline expanders were able to have their breast tissue expanded and exchanged to a breast implant. The overall time needed for tissue expansion was lower with AeroForm, with tissue expansion occurring at an average of 21 days in the AeroForm group versus 46 days for the saline control.

The most common adverse events seen in the study were necrosis, seroma, post-operative wound infection, and procedural pain. Patients using the AeroForm device did not report any serious adverse events.

The FDA reviewed the data for the AeroForm system through the de novo premarket review pathway for novel, low- to moderate-risk devices for which there is no legally marketed predicate device to which to claim substantial equivalence.

“This tissue expander may result in fewer office visits for patients by allowing a patient to partially control their breast tissue expansion,” Binita Ashar, MD, director of the Division of Surgical Devices at the FDA’s Center for Devices and Radiological Health, said in a statement. “Patients need to speak with their surgeons about what type of tissue expander is appropriate for them and the benefits and risks of using an expander following their mastectomy.”

Tissue expanders are typically used prior to breast reconstruction to cause breast tissue and muscle to stretch over time, which creates a space, or “pocket,” for the breast implant.

The AeroForm expander includes a sterile implant with an outer shell made of silicone and a remote dosage controller. The expander contains a reservoir of compressed carbon dioxide, while the controller is a hand-held device that communicates with the receiving antenna and electronics located in the expander to release carbon dioxide and gradually inflate the expander. The controller is pre-programmed to release a small amount of carbon dioxide once every 3 hours, up to 3 times per day.

While saline-filled tissue expanders are typically expanded by a surgeon and require a needle to pierce the skin and inject saline into the expander through a port or injection area, the AeroForm tissue expander does not require a needle, and allows the patient to have control over slowly expanding the device at home.

A surgeon must determine whether a patient is a suitable candidate for treatment with the AeroForm. Patients must not have any residual tumor at the expansion site and must not undergo magnetic resonance imaging (MRI) while the device is in place. Patients with another electronic implant, such as a pacemaker, defibrillator, or neurostimulator device, are not eligible for treatment with the AeroForm tissue expander.