By Alida Almonte-Giannini
The Food and Drug Administration (FDA) is proposing to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The intention is to modernize the regulations by incorporating current science and mammography best practices. These updates would notify women with dense breasts about their increased cancer risk and shortcomings of mammography alone. The proposal will update mammography regulations for the first time in two decades, and while these recommendations may seem new, they have been in place at Mercy Medical Center in Rockville Centre, New York since 2013.
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In early 2018, Mercy added VolparaDensity to its Breast Cancer Screening Program, which ensures that each patient receives an objective measure of breast density. Each patient's density is reviewed in conjunction with their Breast Cancer Risk Assessment to create a customized screening program.
Mercy is currently the only hospital on Long Island to offer VolparaDensity and the only in New York to offer LumaGem Molecular Breast Imaging — a supplementary screening modality for women with dense breast, significantly increasing early detection in women. Unlike prior nuclear breast imaging technologies, LumaGem's newly configured detectors assist in the discovery of small breast cancers with minimal radiation exposure. In fact, MBI helps uncover 400 percent more invasive cancers than a digital mammography alone.
MBI has proven to be as effective, or more, as a secondary screening method, compared to full-field ultrasound or MR, with far fewer false positives. Clinical research shows use of MBI reduces the need for tissue biopsies by 50 percent, compared to other modalities. MBI is also more comfortable and better tolerated by most patients than conventional mammography or MR.
Dr. Conellia Ha, Mercy Medical Center's director of radiology, welcomes this new federal recommendation. Together with her team at Mercy, Dr. Ha is an early adopter of recommendations and new modalities to assist in the detection of breast cancer.
"In anticipation of the changing landscape of breast imaging and recognizing the need for customized breast cancer screenings, the Department of Radiology at Mercy has been proactive in taking preemptive measures to stay ahead of the curve, utilizing groundbreaking solutions like VolparaDensity and state-of-the-art technology like the MBI. In keeping with Mercy's commitment to providing the latest tools, we will shortly transition to the Tyrer-Cruzick 8 Risk Assessment Model, rather than the Gail Model, which incorporates breast density," said Dr. Ha.
Tyrer-Cuzick estimates the likelihood of a woman developing breast cancer over the course of her lifetime, which is critical to helping assess prevention and planning.
Grants like Pink Aid help support breast health services for the uninsured and underinsured on Long Island. This year's Pink Aid grant, for $30,000, supports complimentary breast cancer screenings, breast biopsies and secondary screenings like the MBI at Mercy Medical Center.
MBI technology costs the patient around $450 and is not always covered.
MBI was donated to Mercy Medical Center by the Friends of Mercy Medical Center, an organization of men dedicated to volunteering their time and efforts to raise funds for the advancement of medical and surgical care for the patients at Mercy.
About the author: Alida Almonte-Giannini is public and community relations director for Mercy Medical Center.