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Defective medical devices are not limited to those implanted in a patient's body. Patients who must use canes, wheelchairs, or other devices to get around are susceptible to a whole array of device warnings and risks that other Americans are not. According to The Baltimore Sun, it is imperative to maintain wheelchairs and walkers as you would a car, as a lack of proper maintenance can result in unsafe conditions such as broken or bent parts. If the device is broken, it can result in the requirement of extra energy to get around, more pain, or—worst-case scenario—a devastating accident that can result in hospitalization.

The onus of maintaining these devices is not, however, solely the responsibility of the patient. Sometimes these devices, and machinery used in conjunction with them, are not properly built or vetted before it is put on the market. One such incident occurred earlier this year, when a California-based manufacturer was ordered to pay a $1.75 million civil penalty for continuing to sell faulty wheelchair lifts. The lifts were recalled by the National Highway Traffic Safety Administration (NHTSA), according to an agency report, as they had been labeled as potential fire hazards. Even after the recall was announced, the manufacturer, Rincon Corporation, continued selling the lifts to the public.

More than 4,000 Rincon lifts had been sold to manufacturers of buses and vans to help meet the transportation needs of wheelchair-bound patients. The recall was first announced in September 2012 because the lifts contained a defective cable determined to increase the risk of starting a fire. When the NHTSA followed up with the van and bus companies in 2013 to make sure that Rincon had informed them of the recall, the administration found that though Rincon had stopped producing the defective lifts it had not stopped selling them. Rincon later reported that it had sold 356 defective lifts after the recall had been issued.

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When most patients go in for surgery—especially serious surgeries like knee replacements—they are not concerned with the materials that doctors use. Most patients trust that their doctor is the expert, and will do what is necessary to ensure that the patient can recover quickly and well. Yet sometimes shady business deals are at fault for surgeries gone wrong, and doctors are helpless to remedy them. Such is the case with a device that until very recently was used to aid with knee replacement surgery, the OtisKnee, distributed by OtisMed Corporation.

In December, according to The New York Times, the former CEO of OtisMed pled guilty in a New Jersey federal court to criminal charges of distributing adulterated medical devices. The OtisKnee was not cleared by the Food and Drug Administration before OtisMed began to distribute and sell the device to American hospitals, and 18,000 of the adulterated devices were sold and distributed between 2006 and 2009. The device was marketed as one that would speed knee surgery and aid in patient recovery, but many patients experienced the exact opposite. In one case, a woman experienced intense and lasting pain after the surgery, and ended up having to have a second knee replacement. Another patient said that the revelation that the device that had been used was likely at fault for her persisting knee problems made her feel like she “had been a guinea pig.”

The Times reports that had it not been for a whistleblower, presumably at OtisMed, the public may never have been made aware that this device was being distributed without FDA approval. Knee replacements are the most common elective surgery performed in the U.S.—roughly 700,000 such operations are performed annually. The FDA medical device approval process is long and arduous, and can cost thousands of dollars for the company attempting to have a single device approved. According to the Times, OtisMed, a California-based start-up, saw an opening in a crowded market. While doctors and other experts say that the device is a good idea, because it was not fully vetted by the FDA, it was never decided if the device was actually able to perform the function it purported to do.

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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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