Medicine

FDA seeks to step up mammography oversight, info sharing

FDA seeks to step up mammography oversight, info sharing

All U.S. women getting mammograms would receive information about breast density, which can sometimes make cancer harder to spot, under a government proposal released Wednesday.

FDA said technological developments, like the first approval of a 3D mammography system in 2011, and more advanced understanding of breast anatomy and cancer risk factors prompted the amendments. In addition to this, though, another 100,000 women undergo breast reconstruction following cancer surgery.

Several dozen states, including MI, already have similar laws.

But the FDA's proposal, if finalized, would apply to all states and set minimum standards for the information disclosed.

Yep. The FDA also proposed changes to expand the language used to classify mammography findings. Mammograms of dense breasts-breasts with a higher proportion of fibroglandular tissue compared to fatty tissue-can be hard to interpret because the dense tissue can obscure signs of breast cancer and lower the sensitivity of the image.

The FDA's proposals would amend regulations issued under the Mammography Quality Standards Act passed by Congress in 1992. Furthering this and to improve communication with providers, the agency has also proposed expanding the categories used to classify mammography findings, now labeled as "negative", "benign", "probably benign", "suspicious", "highly suggestive of malignancy" or "incomplete: need additional imaging evaluation". "We are dedicated to working across the agency and with stakeholders to provide patients with tools and information to fight breast cancer effectively", said the FDA's principal deputy commissioner Amy Abernethy, MD, PhD, in a statement.

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Another addition would require that facilities deliver medical reports to healthcare providers for patients whose summaries are classified as either suspicious or highly suggestive of malignancy within a specific timeframe, aiming for earlier definitive tissue diagnosis and start of treatment while minimizing patient anxiety. Most of these confirmed cancer cases-known as breast implant-associated anaplastic large cell lymphoma-are only known to involve a very specific type of implant that has a textured surface and are created to reduce scar tissue and slippage.

Beyond this, the proposed amendments also call for distribution of additional detailed information regarding mammogram facilities to both patients and providers, as a way to help the post-exam process run smoother.

However, one breast cancer expert noted that many women are already being informed about their breast density. Population-attributable risk proportion of clinical risk factors for breast cancer.

"We found that dense breast notification laws were associated with small increases in cancer detection", said lead study author Susan Busch of the Yale School of Public Health in New Haven, Connecticut.

"It is extremely important that the dissemination of information to patients and referring providers ... is done right, to allow for an informed conversation between patients and their physicians on the appropriate steps to take in the patients' breast care regimen should dense breast tissue be identified". The National Cancer Institute estimates 12.4% of women will be diagnosed with breast cancer in their lifetime. "This is meant to help ensure important information that could affect decisions about patient care-such as the potential need for further evaluation or a repeat of a mammogram-is communicated as quickly as possible".

The FDA has made a draft of the proposed amendment available for public comment for 90 days.