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HeartStart MRx Defibrillator Recalled for Defective Part

The United States Food and Drug Administration (FDA) recently issued a recall for the Philips HeartStart MRx defibrillator because it contains a faulty part that can put patients at risk of serious injury and death.

The defective medical device was recalled after it was determined that a glass tube inside the defibrillator has tiny cracks that allow gases to escape and cause the device to malfunction. These cracks also allow electrical surges to cross the defibrillator's resistors, potentially damaging them and causing the device to fail while it is in automated external defibrillator (AED) mode. When the device fails in this mode, it can still be operated manually. Healthcare providers who have the defibrillator are urged to have the defective glass tube repaired to prevent patient injuries and deaths. In their uncorrected state, these defibrillators can fail at any time.

When a patient is injured by a defective medical device, he or she may seek compensation for his or her damages through a defective medical device claim. When a victim dies from a defective medical device, his or her loved ones may seek compensation for damages through a wrongful death claim.

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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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In mid-January the U.S. Food and Drug Administration approved a first-of-its-kind device to treat obesity, according to a FDA press release. The device, known as the Maestro Rechargeable System, realigns nerve pathways between the brain and the stomach. It's the first FDA-approved device to fight obesity since 2007, and is approved for patients who have a body mass index of 35 to 45, with at least one other obesity-related condition. One such condition would be Type 2 diabetes. The system consists of a rechargeable electrical pulse generator, leads, and electrodes that are implanted surgically into the abdomen. Safety trials consisted of 233 patients, in which 157 received the device and 76 in a control group who did not. Though there were some adverse effects observed, the FDA sponsored a survey that found that patients with severe obesity would be willing to accept the dangers for the weight loss it promised.

There are several devices to help fight obesity that have been on the market for years, including those that tie off the passageways to the stomach. Some of these devices require that the patient eat very slowly, or that he takes very small bites. Many of these devices came under fire by the FDA for safety concerns. One well-publicized event was the discontinuation of the manufacture of one of these devices for teenagers after two percent of patients who were using them experienced severe side effects. According to the National Institutes of Health, a significant number of patients surveyed in a trial of obesity-reducing devices experienced negative side effects.

Only time will tell if the recently approved device will have a similarly bad track record. If you or someone you know has experienced negative side effects or long-term health problems because of an obesity device, you may be eligible for compensation. Do not go through it alone. Contact an experienced Chicago defective medical device attorney today.

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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