FDA based its decision on the results of clinical trials involving 122 women with Stage 1 and Stage 2 breast cancer who were undergoing chemotherapy regimens that have been associated with hair loss. Two-thirds of the patients who used the DigniCap reported losing less than half their hair, the agency said.
“We are pleased to see a product for breast cancer patients that can minimize chemotherapy-induced hair loss and contribute to the quality of life of these individuals,” William Maisel, acting director of FDA's office of device evaluation, said in a statement. “Managing the side effects of chemotherapy is a critical component to overall health and recovery.”
Hair loss due to chemotherapy typically is temporary, but minimizing or relieving such side effects is considered a key part of overall treatment and can affect a patient's quality of life.
Despite Tuesday's approval, FDA made clear that DigniCap might not work with some chemotherapy regimens. It also noted such possible side effects as cold-induced headaches, neck and shoulder discomfort, chills and pain associated with wearing the cap for extended periods.
According to Dignitana's website, the device was developed more than a decade ago by Swedish oncology nurse Yvonne Olofsson, with help from the clinic where she worked. It has been tested on patients in Germany, Japan, Russia and various European countries, the company said, and was already approved for use in Europe.
Each medical facility providing the cap will set its own price for the treatment, Dignitana explains, though it is working to have insurers help cover that cost.
"Some carriers that cover the cost of wigs have considered scalp cooling similarly and provided some reimbursement," the company says on its site. "We believe this will become more standard practice over the next year or two."