Clinical trial tests breast reconstruction technology – Featured Sun Sentinel Article

Article by Rhonda Weiss – Special Correspondent
Published in the Sun Sentinel on October 21, 2015

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Underway in Fort Lauderdale is the second phase of a clinical trial for a procedure that seeks to reduce the amount of time and pain experienced by breast cancer patients undergoing reconstructive surgery. It is one of only seven such trials in the country and the only one in Florida.

Physicians Laura Sudarsky and Tracey H. Stokes, of eSSe Plastic Surgery and Broward Health Imperial Point, are currently screening patients to participate in the continued trial for the AeroForm expander, which allows patients to use a wireless remote control to gradually self-administer small amounts of compressed carbon-dioxide to stretch the skin and tissue at the site of a mastectomy to ready it for a permanent implant. This differs from the traditional expanding device that involves the weekly injection of saline solution in increasingly larger amounts at a doctor’s office.

The AeroForm expander eliminates the weekly visits and use of needles, and the gradual expansion is less likely to cause patients to experience muscle spasms, said Kathryn Kelley, senior director of clinical affairs for AirXpanders, the medical device company in Palo Alto, Calif., that designed and manufactures it.

“The stretch isn’t done all at once. It’s gradual,” she said, adding that it can be used at home. “They can control the rate of expansion. That is a big benefit to the patients.”

Jan Themann of Plantation participated in the first phase of the trial and said she would recommend the procedure, which is currently awaiting FDA approval in the United States. She said her experience with the device lasted about two weeks, a much shorter period than the sometimes months-long process needed when using a traditional saline expander.

With all of the time and stress related to the treatment of breast cancer, beginning when she was diagnosed in December, Themann said it was a benefit to be able to use the AeroForm at home at her own pace.

“The waiting, the stress of waiting in the doctors’ office – I spent so much time making appointments and having to go to them,” Themann said. “Not having to go to the doctors’ office was huge.”

The two Fort Lauderdale physicians first became involved with the trial after Sudarsky read about it and requested to take part. Kelley said participating doctors must be board certified in plastic surgery and be experienced with two-stage breast reconstruction. The two-stage procedure consists of one surgery to insert a tissue expander followed by a second surgery to replace it with a permanent breast implant after the expander has done its job.

“The excitement of being part of the trial, for the patients and for us, is to be able to evaluate a new device going forward,” Sudarsky said.

The data from the first phase of the trial is being reviewed and will be presented in Boston during the October meeting of the American Society of Plastic Surgery. Approval from the FDA generally takes about six months, Kelley said, and the application was submitted in August. The device has already been approved for commercial use in Australia, where similar trials in 2009, 2011 and 2012 showed improved timing over the traditional method.

“We’ve been able to show that it’s faster. It’s faster to complete the expansion. It’s faster to complete the reconstruction,” Kelley said.

For the second phase of the trial, Sudarsky said her office will be accepting 10 patients and already has three. Those interested in taking part should visit the website or call the office.

The first phase of the trial was randomized, meaning some patients received the new device, while others were treated using the traditional method. But, Sudarsky said, all participants in the second phase will receive the AeroForm.

Themann said she feels lucky to have been part of the trial that enabled her to use this new technology. “I would absolutely recommend it, simply because of the ease of use,” she said. “The learning curve was ridiculously simple.”

She also appreciated the ability to feel more active in her treatment.

“I just felt as if I were more in control,” she said. “I felt I had more control over what was going on with my body.”

Call 954-533-1671, or contact EssePlasticSurgery.com / breast-reconstruction-clinical-study.