LIPSG, South Nassau Enrolling Mastectomy Patients into Clinical Study

South Nassau Communities Hospital and Long Island Plastic Surgical Group, PC (LIPSG) are enrolling mastectomy patients into a clinical study designed to evaluate a new tissue expansion method for those who choose to undergo breast reconstruction.

This randomized, controlled clinical study is designed to directly compare the outcomes of the traditional saline tissue expansion method to an investigational, remote-controlled, needle-free, carbon dioxide-based tissue expansion system known as The AeroForm™ Patient Controlled Tissue Expander System.

Tissue expansion is a process required to stretch the skin and tissue at the site of a mastectomy so that a standard saline or silicone breast implant can be placed.

“Traditionally, women undergoing breast reconstruction have had to endure a long process of inconvenient and often painful weekly inflations using conventional saline expanders to create a pocket for a standard implant following a mastectomy,” said Kaveh Alizadeh, MD, president of Long Island Plastic Surgical Group.

“This investigational system eliminates the need for saline injections by allowing the patient to trigger the release of small amounts of compressed carbon-dioxide through the valve of a tiny chamber located inside the expander. The patient uses the remote control to gradually inflate the investigational expander in small, pre-set amounts on a daily basis at home, eliminating the need for weekly doctor visits.”

During a clinical study in Australia, the average expansion time associated with the remote-controlled tissue expander was 15 days, a fraction of the time required using traditional expanders which can take months to achieve full expansion.

The current standard of care in tissue expansion involves implanting a saline expander under the skin and pectoral muscle following a mastectomy procedure. The patient returns to her doctor weekly for saline injections, which many patients say is the most painful, difficult part of the reconstruction process. The traditional saline process can take as long as five to six months, Dr. Alizadeh explained.

Maureen Cori, a 48-year old mother of two from Woodmere, underwent a double mastectomy after hearing that she had breast cancer. After her mastectomies, Cori decided to pursue breast reconstruction, which involved expanding her breasts over time with traditional saline expanders.

“I faced so many complications with saline expanders at the outset,” Cori said. “I developed infections and my surgeon had to remove both expanders shortly after they were initially implanted. It was also a constant challenge for my surgeon to inject the saline during my weekly follow-up appointments.”

Cori believes that a product like AeroForm holds promise as an alternative choice for women who choose breast reconstruction in the future.

“This is an important study for women’s health because it gives the patient the opportunity to control the expansion,” she said. “Everyone has different pain thresholds. With AeroForm, the expansion process can be managed with significantly less discomfort and because there are no injections, risk of infection is decreased. I believe it is critical that we find more options for women during this challenging and emotional time.” 

South Nassau Communities Hospital, Long Island Surgical Group, P.C. and other hospitals across the U.S. are participating in the study. Enrollment will continue until a total of 92 AeroForm expanders and 46 saline expanders have been implanted in patients around the country.

AeroForm will be evaluated based on its ability to successfully and safely expand the tissue to the point that the expander can be replaced with a standard breast implant. Secondary measurements will include the average number of days needed to achieve the desired expansion, total reconstruction time, pain and patient satisfaction. 

The AeroForm Patient Controlled Tissue Expander was designed and manufactured by AirXpanders, a medical device company in Palo Alto, CA. The U.S. Food and Drug Administration (FDA) has granted AirXpanders an Investigational Device Exemption (IDE) to conduct the study and it has been approved for enrollment at Long Island Plastic Surgical Group and South Nassau by an Institutional Review Board (IRB).

For more information on the study, visit clinicaltrials.gov. If you or someone you know is interested in joining the study, please call 516-504-3014.