FDA Revisits Breast Implant Safety Over New Concerns of Risk

Henrietta Brewer
March 30, 2019

"Given that more than half of women over the age of 40 in the US have dense breasts, helping to ensure patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an important part of a comprehensive breast health strategy". Nuclear medicine equipment service provider since 1975.

The Food and Drug Administration is proposing rules that would require mammogram providers to notify women if they have dense breast tissue.

The density language is part of a proposed rule under which the FDA would amend mammography regulations outlined in the Mammography Quality Standards Act (MQSA).

Additionally, both healthcare professionals and patients will receive more detailed lay summary letters that include information about the mammography facility, which can aid in communications after the examination.

Doctors say tumors are more hard to detect in mammogram images of dense tissue.

The FDA announced today that it is working to update mammography regulations, expanding the amount of information that mammography facilities must give patients and healthcare professionals.

Since 1992, the FDA has been responsible for quality of care at facilities that conduct mammograms including accreditation, certification, inspection and enforcing standards. It is also an additional risk factor for breast cancer, which is the leading cancer among women. "What's important for the patient to understand is. what they may do in addition to mammography to find some cancers that might be masked by the dense breast tissue and therefore might not be found until a later time", Margolies said. "The FDA plays a unique and meaningful role in the delivery of quality mammography to help patients get accurate screening to identify breast health problems early, when they can be effectively addressed", said Dr. Scott Gottlieb, outgoing FDA commissioner, in a prepared statement March 27.

According to the National Cancer Institute (NCI), approximately 12.4 percent of women will be diagnosed with breast cancer at some point during their lifetime. "Only three dozen states have laws involving breast density notifications but the new law would make this nationwide".

Alas, there have been some cases of cancer associated with breast implants. A recent study backed by the American College of Radiology suggested women in states with these laws were more likely than women in states without requirements to have learned of their breast tissue type from a mammogram results letter (60% versus 48%) and more likely to discuss supplemental screening with a doctor (67% versus 53%). "We're committed to making sure patients have access to high quality mammography". Cappello died in November 2018 of complications from breast cancer that was not detected on her original mammogram due to breast density.

Yep. The FDA also proposed changes to expand the language used to classify mammography findings.

"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". It said that in 2018, more than 260,000 women in the US were diagnosed with breast cancer and more than 40,920 women died of the disease. This "better positions the agency to enforce and take action", said Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health.

The proposed changes have a 90-day public comment period, which is followed by changes based on those comments, before it's reviewed one last time and becomes finalized.

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