Two New Warnings Issued By The FDA

Two New Warnings Issued By The FDA
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True, in 2019, the month of February contained only 28 days. Still, the FDA did not shrink from carrying out all of its duties during that short month. In fact, during the month of February, the FDA issued two warnings about devices that have been used to detect breast cancer. The first warning came in response to a tactic used by one distributor of thermography equipment. That distributor had claimed that its company’s thermography package could function as a stand-alone screener.

Authorities at the FDA did not hesitate to dispute that claim. Those same experts said that thermography devices have failed to demonstrate the ability to function as an effective screening tool, regardless of the condition that doctors strive to detect. Indeed, the FDA’s warning also included strong support for mammography, which can detect breast cancer so effectively that its results have allowed screened women with a detected malignancy to increase their chances for survival.

The second warning concerned more than the methods used for detecting breast cancer It also related to the procedures used to deal with malignant breast tissue. Currently, some medical facilities have chosen to use robotically assisted surgical devices, when attempting to treat or prevent the development of breast cancers.

The FDA’s strong statement represented an effort to clarify the meaning of certain preliminary tests. Those tests had produced limited and unsubstantiated evidence that robotically assisted surgical devices could be used to treat or prevent breast or cervical cancers. The government agency wanted to make clear the significance of the limited amount of test findings.

Such findings should not be viewed as an endorsement of any surgeon’s attempt at using a robotic device when performing a mastectomy. By the same token, the preliminary data does not support the practice of using such a device as a screening tool. The traditional treatment and screening methods offer the best guarantee of long-term survival for the women that have utilized those same traditional techniques.

The agency’s warnings do not rule out the possibility that such techniques could prove quite effective in the future. Meanwhile though, engineers and scientists must work together, in order to improve upon the existing technology. Then, hopefully, women will have more options available to them, when seeking to detect any signs of a malignancy in breast or cervical tissue, or when electing to undergo a treatment for cancer in either of those two regions of their body.


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