Breast Reconstruction May Be More Comfortable With New Tissue Expander Under Study
03/29/2013

Campbell, CA plastic surgeon Dr. Kamakshi Zeidler says a remote-controlled breast tissue expansion system could help mastectomy patients prepare for breast reconstruction with less pain while gaining more control over the process.

Online PR News – 29-March-2013 – Campbell, CA – Campbell, CA - A clinical study is evaluating a new tissue expansion method for mastectomy patients who are planning to undergo breast reconstruction. The device, The AeroForm(TM) Patient Controlled Tissue Expander was designed and manufactured by AirXpanders, a medical device company in Palo Alto, Calif.

"Traditionally, women undergoing breast reconstruction have to endure a long process of inconvenient and often painful inflations using conventional saline expanders to create a pocket for a permanent implant following a mastectomy," says Kamakshi Zeidler, MD. “The remote controlled expanders may offer an alternative to traditional expanders, which require doctors to place a needle into the breast area every few weeks and inject saline into the implant to increase its size.”

Dr. Zeidler and a patient are seen in this recent story on KTVU 2 News in San Francisco: http://youtu.be/z9s6BqodeM4

The aim of the study is to evaluate an investigational, remote-controlled, needle-free, carbon dioxide-based system as compared to a traditional saline expander. Tissue expansion is a process required to stretch the skin and tissue at the site of a mastectomy so that a permanent breast implant can be placed.

This investigational, remote-controlled system eliminates the need for saline injections by using internal, compressed carbon-dioxide that is gradually released through a small internal valve to fill the expanders. “They are used to stretch out scar tissue over time to create space for reconstructive implants,” says Dr. Zeidler. The patient will be able to use the remote control to inflate the expander in small pre-set amounts on a daily basis at home, eliminating the need for weekly doctor visits and allowing the patient to control the pace at which they expand in her chest. Dr. Zeidler says patients usally introduce three small doses a day, which are less likely to cause pain. “I like the fact that I can do this at my own pace and have control over the process,” says one patient who is participating in the study. When enough space is created, the doctor can remove the expanders and insert permanent implants to restore breast contours.

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 bolus saline injections, which many patients say is the most painful, difficult part of the reconstruction process, according to Dr. Zeidler.

“This randomized controlled clinical study is designed to directly compare the outcomes of tissue expansion of the traditional saline expansion method to the investigational, remote-controlled tissue expander,” says Dr. Zeidler. The device is being evaluated based on its ability to successfully and safely expand the tissue to the point that the expander can be replaced with a permanent 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 U.S. Food and Drug Administration (FDA) has granted AirXpanders an Investigational Device Exemption (IDE) to conduct the study. Women in the San Jose / Silicon Valley area who are interested in joining the study may call the office of Dr. Kamakshi Zeidler in Campbell, CA at 408-559-7177. Visit www.zeidlermd.com

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About Kamakshi Raimondo Zeidler, M.D.

AESTHETIC AND RECONSTRUCTIVE PLASTIC SURGERY
EDUCATION & TRAINING:

STANFORD UNIVERSITY
CLINICAL INSTRUCTORSHIP MICROSURGERY FELLOWSHIP

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
PLASTIC AND RECONSTRUCTIVE SURGERY RESIDENCY

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
POSTDOCTORAL RESEARCH FELLOWSHIP

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
GENERAL SURGERY RESIDENCY

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
DOCTOR OF MEDICINE
ALPHA OMEGA ALPHA

UNIVERSITY OF MELBOURNE, AUSTRALIA
SOCIELOGICAL RESEARCH

RICE UNIVERSITY
BACHELOR OF ARTS BIOLOGY