The benefits and risks of mammography screening have long been debated in the scientific community. According to the National Cancer Institute, while screening may be effective in reducing the number of deaths from breast cancer through early detection of a cancerous tumor, it can, at the same time, cause harm to the woman who is participating. The most common limitations of breast cancer screening can include false-positives, overdiagnosis, false-negatives, discomfort, radiation risk, and anxiety.

Yet a new medical device approved in February by the U.S. Food and Drug Administration, may alleviate some of the risks posed by mammograms, according to the University of Rochester Medical Center (URMC). The device, which passed the FDA's most stringent premarket approval process, was developed by a URMC startup company, Koning.

The Koning Breast CT system is intended to diagnose cancer in women who have signs or symptoms of the disease, and those who have abnormal findings after a standard mammogram. As of right now, it is not intended to replace annual screenings, yet the use of the new device may help to alleviate the risks of overdiagnosis or false-positives. Because it is also the first breast imaging device that allows for a readable picture without compression of the breast tissue, the Koning Breast CT system is also a more comfortable procedure for patients undergoing treatment.

A breakthrough in the medical community came for migraine sufferers this November, according to MedicalXPress.com. A study from Case Western Reserve School of Medicine found that nerves in the brains of patients who suffered migraines show abnormalities of the “myelin sheath that serves as insulation around nerve fibers,” MedicalXPress.com reports. The study involved observing 15 patients who underwent a surgical treatment that attempted to reduce the negative effects of serious migraines, and included electron microscopy that assessed the structure of cell nerves in patient's brains. The study also examined the presence and function of cranial proteins in migraine patients.

Ultimately, the study found that patients whose myelin sheath was damaged were more likely to suffer migraines. As a result, one doctor in the study “developed migraine surgery techniques after noticing that some migraine patients had reduced headache activity after cosmetic forehead-lifting.” This type of cosmetic surgery removes some of the muscle and vessel tissue surrounding cranial nerves.

This is great news for people who suffer migraines because migraine drugs have long been very prone to negative side effects in patients. According to Healthline, painkillers, often prescribed and taken for migraines, can have severe side effects affecting the stomach and kidneys and can result in heart attack or stroke. Because these painkillers are so common, doctors sometimes neglect to make their patients aware of how serious of a drug they can be if misused.

Consumers and patients who have been in injured by defective devices or other unsafe products frequently report these issues to the FDA, as they should. Recent cases relating to defective medical devices as well as products outside the realm of healthcare demonstrate that while it's the federal government's job to investigate these claims and promote safe standards across the board, this process is often a lengthy one.

In some cases, manufacturers appear to act as if they can get away with unsafe products, leaving individuals at high risk while continuing to make a profit. In terms of medical devices, heart defibrillators, vaginal mesh implants, and knee and hip implants are just a few examples of products that were designed to help actually harming patients.

In the consumer sector, both GM and Toyota have recalled high numbers of automobiles after serious reports of driver injury and even death. In all these cases, the government frequently finds that the manufacturer knew about the dangers long before a recall or product fix was implemented.

More research has come out recently that links testosterone therapy to heart conditions. A study published in early January of this year found that men taking testosterone drugs faced a higher risk of heart attack for men over the age of 65. Men younger than 65 but with a history of heart problems also had higher risks for heart attacks, according to the study tracking 56,000 men. Serious medical complications from treatment or medical devices can cause an array of complications or injuries.

The study looked at men between 2008 and 2010, finding that the heart attack risk for men doubled when participating in testosterone therapy. Previous studies had only looked at older men using a high dosage of testosterone gel, although a November 2013 Veterans Affairs study also identified a 30 percent increase in heart attacks, death, and strokes for more than 1200 men taking the testosterone drug.

As a result of these studies, some researchers are urging that the FDA put new warning labels on the products so that more patients are aware of the increased risks. Presently, there are no explicit warnings of the increased heart attack risk for those using testosterone replacement therapy. Given that several studies have indicated a link with heart attacks and other conditions, it's likely a matter of time before the FDA requires some form of labeling regarding the issue. For some patients, though, this might be done too late, since testosterone therapy is still being given to men across the United States.

In recent months, the FDA has begun reviewing more information regarding Essure, a transcervical sterilization procedure for women. Essure is a Class III medical device that, according to the FDA, received a high level of review prior to marketing. The procedure had to be vetted through the pre-market approval process used by the FDA. This process includes reviewing data about product labeling materials and a scientific and regulatory review.

Although the FDA has received more reports of complications from women who have gone through the procedure, the federal agency still classifies the risk of adverse events as “low”. In addition to clinical studies, the FDA also reviews surveillance data sources post-market to determine how safe and effective a variety of medical devices are in practice.

Reports submitted to the FDA by consumers are helpful in identifying problems as soon as possible so that if defects or complications are a factor, other patients can be warned before being affected.