FDA
FDA Each of the three women who spoke before me at the Food and Drug Administrations’s advisory council panel that was assessing cryoablation as a means of curing cancer, had breast cancer, l also had breast cancer.

However, unlike me, they had had surgeries and in some cases horrific results of surgeries before surviving the disease. The doctor who was the first to speak was also a cancer survivor, but cautioned against approval of this non-invasive means of curing cancer because it had not been tested on people of all ages, just a limited group and she was fearful of promoting how great it is, could result in it being used in some women for whom it might not work.

As I listened to her three minutes of testimony, I wondered if as a doctor she had ever guaranteed any medicine or that any surgery would positively work.

One woman whose first cancer was identified in 2012 and was treated with surgery, sought out a different option on her own when diagnosed again in 2021.

On her own, she found a doctor who did cryoablation, simply freezing the tumor with a frozen needle, had it done and described her success and happiness.

The third woman who spoke learned about cryoablation from a friend. But she had undergone a lumpectomy in 2023 and described in painful detail, the drains and pumps she needed afterwards, the pain med she had to take, her first painful shower, and as she described it the ‘butchering’ of her body.

Dr. Kenneth Tomkovich M.D.

As I finished my three minutes extolling every benefit of cryoablation absent any pain, medicine, treatments, or slowing down of my busy life, the panel called for the final speaker, Dr. Ken Tomkovich, the radiologist who had done my cryoablation at Centra State’s Women’s Center.

So happy to see him eight years after his magic worked on me, I drew laughter from the panel as I called out, “I know that man!” And the two of us hugged in the middle of the room before Dr. Tomkovich took the stand.

He told of his quarter of a century of experience in radiology, his 20 years with cryoablation, and his belief that of all his experiences , cryoablation is “one of the best I’ve ever done.” He talked about how cryoablation offered personalized care with no sledge hammer methods, and how the ice itself provided the anesthesia to avoid pain, and best of all the zero side effects of the procedure.

Dr. Tomkovich went one further….he called each of us who had opted to be part of the trial and have him do the cryoablation, heroes. He told the panel he wanted to thank each of us who had put our trust and confidence in him, and said how proud he was of all his patients. It’s the first time I’ve ever been praised and thanked for taking the easiest way out. 

I also haven’t figured out why approval for the procedure by the FDA is taking so long.

Cyroablation has been approved for prostate cancer since the 1990s and has long since proven itself successful. Today it is also used, in addition to prostate cancer, against eye, liver and kidney diseases.

Why should so simple, so effective, so painless and medicine free procedure take so long to be approved for breast cancer?

The FDA is continuing to take comments, approvals, or information on cryoablation through December 9 and has already voted to recommend this wonderful procedure to the Food and Drug Administration. You can send letters advocating the approval to this LINK   or by writing

Center for Devices and Radiological Health, Food and Drug Administration

10903 New Hampshire Ave., Bldg. 66, Rm. 5214

Silver Spring, MD 20993-0002

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