After the jubilation of beating cancer, many women who seek breast reconstruction have another journey to complete. Before they can receive a permanent breast implant, they must first undergo a process to create the space to house the new implant – a process which can be uncomfortable at times and may take many months.
“Traditionally, women undergoing breast reconstruction have had to endure a long process of inconvenient and sometimes uncomfortable saline injections every 2 to 3 weeks to create a pocket for the permanent implant following a mastectomy,” said Jeffrey Ascherman, MD, Site Chief, Division of Plastic Surgery, NewYork-Presbyterian/Columbia. According to some women, this process can also involve a significant time burden, since they must visit their doctor’s office every few weeks for an average of four to six months.
Dr. Ascherman is now the first physician in the United States to be enrolling patients in a study of a new, needle-free tissue expansion method that may allow women to achieve the same preparation for reconstructive surgery in a much easier manner.
The clinical trial at NewYork-Presbyterian/Columbia, which was the first center in the U.S. to receive Institutional Review Board (IRB) approval for the trial, involves a novel, needle-free tissue expansion method that eliminates the need for frequent saline injections and office visits. This investigational method first requires implantation of a normal-sized tissue expander device. Once at home, the patient uses a remote-control device to release small amounts of compressed carbon-dioxide from a valve in the expander. In a recent study of the device in Australia, the daily expansion resulted in creation of a pocket in an average of 15 days that was comparable to those created after several months of saline injections. Patients can use the new needle-free technology while at home, at their own pace and comfort level.
The randomized controlled clinical study is designed to directly compare the outcomes of traditional saline expansion method to the investigational, remote-controlled tissue expander. NewYork-Presbyterian/Columbia is the only hospital in New York, and one of only approximately ten hospitals in the U.S., to participate. The U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to conduct the study, and the trial has received approval for enrollment by the Columbia University Medical Center IRB.
Eligible patients include non-obese women between 18 – 65 years of age who do not smoke, have not had previous tissue expansion or radiation therapy, and who want breast reconstruction with tissue expansion after mastectomy.
For more information about this trial, see clinicaltrials.gov.
To inquire about enrolling in this study, or to refer a patient, please contact:
Jeffrey Ascherman, M.D.
Site Chief, Division of Plastic Surgery
NewYork-Presbyterian Hospital/Columbia University Medical Center
Tel: (212) 305-9612
*This blog post was originally published at Columbia University Department of Surgery Blog*