To the members of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee:

I am a 9/11 and Breast Cancer Survivor. I recently completed my 12th surgery. I advocate with many other survivors. 

We write to you on behalf of women currently suffering from and those who will be diagnosed with Breast Cancer, to express our unwavering support for your positive recommendation to the U.S. Food and Drug Administration’s (FDA) for approval of the Ice Cure Cryoablation System for the treatment of early-stage, low-risk breast cancer. 

This is a non-invasive option. The procedure is done in the office, with no need for hospitalization or complex anesthesia. It also costs thousands less than a lumpectomy. 

For breast cancer survivors, many had successful treatment with lumpectomy or other surgical alternatives. However, treatment has not been without drawbacks.

Some experience fears related to the surgical procedure, sometimes causing them to delay treatment. Many experience post-surgery anxiety and depression. It is a tough recovery with post-operative nausea, pain, and fatigue that interrupts lives. Some have to return for a second surgery for re-excision. Women often deal with the impact of a poor cosmetic outcome.  Most have lingering issues with body image following lumpectomy and an overall decline in their well-being and quality of life. Some struggle with lasting mental health issues.

 Most simply would have liked to have had the option to avoid surgery and post-surgical recovery.

We believe patients deserve the right to choose the best treatment in discussions with their physicians. We believe women deserve a minimally invasive alternative, that provides the same benefit without the drawbacks of surgery or general anesthesia.  

Patients should be able to weigh the options and choose if surgical or non-surgical treatment of breast cancer, is right for them.

We urge you to consider our appeal to make this treatment option available to breast cancer patients in the United States.

To learn about Ice Cure, click here:  https://www.icecure-medical.com/

Video on the procedure here: https://youtu.be/ach8k2R7LfU?si=H4iI23IetVCb2YBo

We do not ask for donations.

Important Update: on November 7th, the FDA voted for initial approval. Bring us to the finish line. Change Breast Cancer Treatment in our Nation!

Respectfully.

Anne Marie Principe, 9/11 Survivor, Breast Cancer Survivor and Advocate.

Fmr. Congresswoman Carolyn Maloney

Dr. Tulio Ramírez. MD FAA, cardiologist, and internist

Ivonne Sanchez, 9/11 (ret)FDNY EMT Responder