FDA Approves AeroForm Tissue Expander for Breast Reconstruction After Mastectomy
The FDA has approved AeroForm, a balloon-like wireless tissue expander, for patients who choose to have reconstructive surgery following a mastectomy or for those with underdeveloped breasts and soft tissue deformities.
Devices like AeroForm are utilized before breast reconstruction to stretch breast tissue and muscle to create space for the implant. The FDA approved the AeroForm system under the de novo premarket review pathway, which is intended for novel, low- to moderate-risk devices for patients who do not have other approved options.
“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.”
The approval was based on results from a clinical trial known as XPAND, which included 99 patients using the AeroForm expander and 52 patients using a saline expander. In the AeroForm expander arm, expansion was performed gradually at 30 cc/day. Those in the saline control group received the standard course of percutaneous injections.
The results showed that 96.1 percent of the patients using AeroForm expanders and 98.8 percent of the patients using saline expanders were able to have their breast tissue expanded and exchanged to a breast implant. Moreover, the overall time needed for tissue expansion was lower with AeroForm. Tissue expansion occurred at an average of 21 days in the AeroForm group versus 46 days for saline group.
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 AeroForm has provided the patients in this trial with a faster and more convenient form of tissue expansion versus saline devices,” said lead investigator Jeffrey Ascherman, MD, chief of the division of plastic surgery at Columbia University, said in a statement. “A hidden benefit of this device is the fact that the patient can play an active role in recovering her body after breast cancer. My patients have thoroughly enjoyed this role and I am confident that this will appeal to many women across the United States and around the world when widely available.”
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.