H-CENTRAL COAST

Jun 10, 2011 1:40 PM by Carina Corral

Local thermographer responds to FDA warning about misleading women

The Food and Drug Administration has warned a local thermographer against making misleading claims to women.

You may recall, KSBY News ran a story last month about Central Coast Thermography, which offers a no-contact, non-invasive way to screen for breast cancer.

A week after our story aired, the FDA released an alert stating thermography is not an alternative to mammography and it had a specific warning for Gaea Powell who runs Central Coast Thermography.

Thermography sounds good on the surface: being able to use a heat-sensing camera to detect irregularities, even tumors, in the breast. The problem is there are no cases studies or scientific evidence to prove it works.

The FDA's alert sent out last week raises concern that women will believe "misleading claims about thermography and not receive needed mammograms."

Back in January, it sent a warning letter directly to Central Coast Thermography stating that it is in violation of the Federal Food, Drug, and Cosmetic Act for "marketing the FLIR Telethermographic camera for uses which have not received marketing clearance or approval."

"What happened was some of the local radiologists contacted the FDA because we weren't even on their radar and demanded some type of action be taken," said Gaea Powell, owner of Central Coast Thermography.

She had to stop marketing the FLIR Telethermographic camera as an alternative to mammograms. According to the warning letter "it's only been approved for use as an adjunct to other clinical diagnostic procedures."

"I had to change some of my the wording on my website and replace the commercial without the camera being promoted," said Powell, who still stands by the technology and said she has hundreds of patients who do, too.

However, in a previous interview, a local radiologist said it gives women a false sense of security. "We stopped doing it because there's no science behind the technology," said Dr. Fred Vernacchia of San Luis Diagnostic Center.

Powell said she sent a letter to the FDA about the changes she made to bring her into compliance, but she has yet to hear back.

An FDA spokesperson told KSBY News in an email that "the FDA is considering this matter closely."

As this controversy heats up all sides do agree on one thing: decisions on breast health should always be made with a doctor.

Click here to view the FDA alert sent out.

Click here to view the warning letter sent to Central Coast Thermograph.

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