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When discussing the safety of medical devices or prescription drugs, it is not uncommon to hear about various recalls and safety alerts being issued. The announcement of a safety recall by manufacturers or government regulators may seem extremely ominous, but it is important to understand that a recall does not necessarily mean a product cannot be used at all. There are various types and levels of recalls, and the action required by each is often dependent on the danger related to the particular device or drug.

Recall Classes

The United States Food and Drug Administration (FDA) maintains three separate classes of recalls to be used appropriately based on the level of risk associated with the recalled item. A recall is categorized by the FDA as one of the following:

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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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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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It has been several years since Michigan-based medical device manufacturer Stryker issued a voluntary recall of their Rejuvenate and ABH II modular-neck stem metal hip replacements, according to the U.S. Food and Drug Administration. The recall was made after many patients complained that the hip replacement was defective, causing them more pain and suffering than before the implant was surgically inserted. The main issue with the device is that it was found to be subject to a high rate of corrosion at the neck junction.

In November of last year, an agreement was reached in New Jersey that determined that the manufacturer would pay an average of $300,000 per implant in individual lawsuits brought against it. In some cases, depending if the patient is deceased, the payout may be less. In other cases, in which the pain and suffering is determined to be extreme, the payout may be more. The company, in total, would payout $1.4 billion in settlement claims, though the claim must be filed by an individual patient, even in this mass tort case.

If you have experienced pain or suffering because of a Stryker hip implant, the first step is to seek legal counsel. The next is to enroll in the Settlement Program. Enrollment opened on January 16 of this year, and is open until March 2. If you do not enroll in the Settlement Program before March 2, you will not be eligible to receive compensation. The fact that you enrolled in the claims process, however, does not guarantee that you will receive payment either. If you did not register for the settlement by December of last year, it is possible that you are not eligible to enroll. If this is the case for you, it is imperative that you speak with an attorney right away.

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