Health Care

FDA Says Breast Density Must Be Reported to Women During Mammograms

FDA Says Breast Density Must Be Reported to Women During Mammograms”

Under new guidelines, USA women undergoing mammograms would receive extra information about breast density, which can sometimes make cancer harder to spot.

"We're trying to facilitate a conversation about breast cancer screening between the patient and their healthcare professional", he said. Nuclear medicine equipment service provider since 1975.

Centers that provide mammograms to screen for breast cancer will have to tell women whether they have dense breast tissue, which can increase the risk of cancer and mask tumors, the Food and Drug Administration announced in a proposed rule on Wednesday.

The proposal would amend the Mammography Quality Standards Act of 1992 (MQSA), which authorizes agency oversight over mammography facilities, and would "better position FDA to enforce the MQSA regulations and take action when violations are found", according to the agency.

Among other changes, the FDA wants information about breast density in both the mammography lay summary letter given to patients and in the medical report provided to referring physicians. It also can make it harder for health care providers to see malignancies on mammograms.

The issue has become increasingly important amid findings that dense breasts raise a woman's risk of developing breast cancer.

Breast density information is not new to mammography reporting but remains important for patients and clinicians, according to a statement from the American College of Radiology (ACR).

Visitors walk past a sculpture of a pink ribbon installed to promote the "Pink Ribbon" breast cancer awareness campaign at Cheonggye Stream in central Seoul October 5, 2011.

More than three dozen states already have laws involving breast-density notifications. In turn, this would result in more informed decision-making - especially when it comes to breast cancer diagnoses. Women with dense tissue are often advised to have other screening tests in addition to mammograms, such as ultrasound or M.R.I. scans.

"We believe the proposed rule would help empower patients and healthcare professionals by proposing improvements to the information facilities communicated to them, helping to facilitate the sometimes hard conversations about potential risks for breast cancer", FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said in a statement. "We look forward to working with FDA through the details of this process to ensure that any updates to FDA regulations improve patient care and efficiency of care provided". It said that in 2018, more than 260,000 women in the USA were diagnosed with breast cancer and more than 40,920 women died of the disease.

The proposed amendments to MQSA would also help the FDA crack down on mammogram facilities and ensure that they are following quality standards.

The FDA can directly notify patients and their healthcare professionals, should facilities be unwilling or unable to do so, that mammography at a facility did not meet quality standards and that re-evaluation or repeat of the mammogram at another certified facility may be needed.

The U.S. Office on Women's Health has more about mammography.

The FDA is taking comment on the proposed rule for 90 days after it is published March 28 in the Federal Register.



Like this

loading...
loading...

Latest


29 March 2019
Rivers on Mars Formed Over a Billion Years Ago
In the river basins for which there are the most data, Mars' rivers were about two times wider than those on Earth . The team was puzzled by an exciting detail since it seems that Mars became a desert at a surprisingly rapid rate.

29 March 2019
How many cigarettes in a bottle of wine?
Drinking half a bottle of wine a night carries the same cancer risk as smoking up to three cigarettes a day, a study estimates. The study only considered cancer risk, and not the risks of other health conditions, such as heart disease.

29 March 2019
Turkey president blames West for currency rate fluctuations
Turkey plans to buy 100 F-35s and some Turkish pilots already started training with counterparts in the US. Officials with the Pentagon and the Turkish embassy declined to comment.

29 March 2019
Dutch art detective unearths stolen Picasso painting
It was yet another success for Brand, who hit the headlines last year for returning a stolen 1,600-year-old mosaic to Cyprus. Buste de Femme was first painted in 1938, and is now thought to be worth US$28 million.

29 March 2019
UPS teams up with Matternet to deliver medical supplies | Logistics
The new drone delivery system would allow, for faster and more efficient transportation of goods including same-day delivery. It was called unmanned aircraft system integration pilot program (IPP) in which Matternet had conducted test flights too.

29 March 2019
HMD Attaches A Release Date To Nokia X71 And Its 48MP Camera
During this launch event, the company is going to unveil its new smartphone named with Nokia X71 . Second, the front camera of the device will be embedded in the upper left corner of the screen.

29 March 2019
Spanish Court Issues Int'l Arrest Warrant for North Korean Embassy Attackers
The Mexican citizen said he had carried out the raid voluntarily and he did not identify his companions, the court document said. In Spain, the High Court has the power to investigate criminal offences, after which formal accusations are launched.

29 March 2019
Kohli miffed as umpire misses last ball no ball
He said that he went through the last ball in slow motion and could confirm that umpire Ravi wasn't looking at Malinga's foot. In reply, RCB's top order started solidly as Parthiv Patel (31 from 22) and Kohli (46 from 32) set a strong platform.

29 March 2019
A's acquire DH/1B Morales from Blue Jays
Morales, 35, is expected to play first base while Gold Glover Matt Olson recovers from a broken hamate bone in his right hand. Almost $50-million of Toronto's payroll for the 2019 season is going towards players no longer with the club.

29 March 2019
Petra Kvitova 'glad it's over' after attacker sentenced
A man who stabbed two-time Wimbledon champion Petra Kvitova in her home was sentenced to eight years in prison on Tuesday. She added that she had offered Zondra money to leave, eventually giving him 10,000 Czech crowns (£341; $440).