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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.

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Sometimes a medical device meant to provide relief for patients suffering and expedite healing causes more pain than relief. One of these devices is known as a pain pump, most commonly used in patients recovering from shoulder surgery after a serious shoulder injury. According to the New York Times, these devices became popular in the late 1990s because they allowed patients to leave the hospital earlier while they received narcotic painkillers for recovery through the pump. While the pain pumps had received clearance from the U.S. Food and Drug Administration, the FDA had never cleared the devices for use in joints.

It was not long until several young patients returned to their surgeons suffering from chondrolysis, a rare ailment in which the cartilage dies, precipitating the painful condition of a bone grinding on an adjacent bone. One orthopedic surgeon told the Times that he had lost many hours of sleep trying to figure out what was causing the chondrolysis before several medical studies identified pain pumps as a likely culprit.

Throughout 2010 and 2011, hundreds of lawsuits were filed against the manufacturer of one widely implemented pain pump, I-Flow Corporation. The company was ordered to pay millions of dollars in settlements to patients who had experienced negative side effects, many who had to have shoulder joints entirely replaced. The FDA issued a warning discouraging the use of pain pumps in joints, and required manufacturers of anesthetics to change labels, encouraging doctors not to use such anesthetics through pain pumps.

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Though the manufacturer has come under fire for defective devices in the past, this year the da Vinci Sp Intuitive single port robot system used in surgical procedures is expected to hit the consumer market, according to MedGadget.com. The system is designed to allow for single-incision surgeries, and is a competitor to manufacturing giant Titan. The system was first introduced as a prototype more than five years ago, but only received approval from the U.S. Food and Drug Administration (FDA) last year.

The first da Vinci Intuitive surgical robot was introduced more than a decade ago. When the company first went public, 15 years ago, it posted $10 million in annual sales, though the robot had only been used on 600 patients worldwide. The machine was thought by the medical professional community to be a great symbol of technological surgical advance, and, according to ModernHealthcare.com, “one of the most coveted status symbols of 21st-century medicine.” Yet the $2.3 million machine caused serious side effects and even injury in several patients, due to a disregard for patient safety on the part of the manufacturer and aggressive marketing tactics that often preceded patient testing.

As of 2013, according to ModernHealthcare.com, da Vinci was facing 25 product liability lawsuits. Many of the lawsuits allege that the manufacturer failed to properly train surgeons on how to use the innovative machine, and instead pushed through patents and marketing efforts before hospitals were equipped enough to handle the new technology.

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Lupron is a hormonal regulator that has several dangerous, if not oft-publicized side effects of which every patient should be aware. The drug is prescribed to help slow early-onset puberty in teenagers, to men who exhibit signs of prostate cancer, and to help treat women with endometriosis, a rare condition in which the lining of the uterus grows outside the actual uterus. According to the U.S. Food and Drug Administration (FDA), the first adverse reaction to Lupron was discovered in 2012, after marketing of the drug had already began, and consisted of a rarely-reported complication of the liver. Six months later, the FDA reported that Lupron could result in lung complications and disease, and one year later, the FDA found serious complications of the drug that could lead to liver injury or convulsions, such as those experienced by patients who suffer from epilepsy.

Most patients take Lupron in the form of a daily shot, according to WebMD. In children, dosage is based on weight and what type of therapy for which the drug is being administered. One easy test to see if the drug is defective is to check the liquid for particles or discoloration, according to WebMD. The site of the injection should be changed periodically, so as not to overload one particular area with too much of the drug at any given time.

Regardless of where or how it is injected, however, Lupron can have deadly side effects. According to Wellsphere.com, one doctor advised that the drug should be pulled from the market as early as 2008. The doctor alleged that the manufacturing company of Lupron did not adequately study the possible side effects of the drug before approving it for consumer use. In 2009, the pharmaceutical company agreed to pay $875 million “to settle claims that it paid kickbacks to doctors to promote Lupron,” Wellsphere.com reports. More than 12,000 reports of Lupron's negative side effects have been reported to the FDA, resulting in more 1,100 deaths.

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Last year, a Supreme Court ruling came down that will affect thousands of Americans, even if they were not aware of the ruling. Building on a ruling that declared manufacturers of medical devices could, in some cases, enjoy immunity status if the device turned out to be defective, last year's case determined that no patient could challenge a manufacturer in state court if it had been approved at the federal level. According to Forbes, the ruling is a big win for medical product manufacturers and a loss for American consumers.

The ruling, which, according to Forbes, outlines that “state lawsuits claiming drugmakers failed to adequately design their medicines cannot proceed because they are pre-empted by federal law,” was based on a 2004 incident in which a New Hampshire woman was left unable to see, work, or eat without a feeding tube. The woman had taken a generic non-steroidal anti-inflammatory, but later developed Stevens-Johnson Syndrome and toxic epidermal necrolysis. A lower court ruling awarded her $21 million in damages. The manufacturer of the drug, Mutual Pharmaceutical, argued that the decision should be overturned because the FDA had already approved the drug.

Mutual pointed to a 2011 ruling which determined that generic drugs were not required to change product labeling if alerted to side effects of which they were not previously aware.

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