Articles Posted in Medical Devices

Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are not easy subjects for women to talk about. SUI and POP are often the outcomes of weakening muscle tension caused by age or child birth. Stress urinary incontinence is triggered by the weakening of the pelvic muscles, and it can lead an involuntary loss of urine that results from physical activity. Pelvic Organ Prolapse is a condition where a pelvic organ drops and the bulges against the walls of the vagina often protruding outside the vagina.
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As women age, they sometimes suffer from a condition called pelvic organ prolapse (“POP”). Some doctors have treated this condition with a medical device called a surgical mesh. These surgical mesh devices – made from the same material as Rubbermaid storage containers – have never been tested on patients. Unfortunately, these untested devices have been found to erode patients’ insides, which can result in constant pain and additional operations.
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In two reviews, two studies and an editorial appearing in a special issue of The Spine Journal today, a group of spinal specialists directly rebuke the research of other spinal surgeons that has supported the widespread use of a Medtronic bone growth product called Infuse. More specifically, the specialists chastise those researchers who received millions of dollars from Medtronic and allegedly failed to report serious complications and side effects that affected patients receiving the Medtronic Infuse bone graft product during clinical trials. Ultimately, the specialists have found the clinical research to be both misleading and biased. Early access to these reports spurred the U.S. Senate Finance Committee to announce last week that it was conducting a formal investigation into whether doctors with financial ties to the Medtronic were aware of but didn’t report potentially serious complications including male sterility, infection, bone loss and unwanted bone growth.
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Although not yet part of a product-wide recall like the DePuy Orthopedic’s metal-on-metal ASR XL Acetabular System and ASR Hip Resurfacing System, Stryker’s Cormet metal-on-metal hip system and DePuy’s metal-on-metal Pinnacle hip may also cause metalosis, a potentially dangerous and serious condition caused by the metal components of these products grinding up against each other – causing microscopic metal ions (cobalt and chromium) to break off into the surrounding tissues and bloodstream. These hip devices have been implanted in hundreds of thousands of patients over the past several years and their early high failure rates seem like only part of the problem. Perhaps the bigger concern should be this risk of blood toxicity and chromium and cobalt poisoning – the potential adverse effects of which are still being investigated but include soft tissue damage, bone loss and inflammatory reactions. In addition, studies have shown that elevated level may potentially have harmful effects on immunity, reproduction, kidney function, the nervous system and carcinogenisis.
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We can now add low magnesium levels to the growing list of side effects caused by Proton Pump Inhibitors (PPIs), like Nexium, Prilosec, Prevacid and Protonix. While PPIs do an incredible job of controlling chronic acid reflux, many researchers now believe that they may also increase your risk of contracting pneumonia, developing bone fractures, (also, see my blog from last Spring), and increasing your risk of a heart attack if taken with a drug like Plavix. It seems as if every couple months, a new warning is issued by the FDA concerning these products.
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Urinary Stress Incontinence (“USI”) and Pelvic Organ Prolapse (“POP”) are relatively common but treatable medical conditions. USI is the loss of bladder control which affects many older women and women following childbirth. POP is a weakening of the muscles and ligaments that support organs like the bladder and uterus and has the potential to be very serious. Traditionally, doctors treated these conditions without mesh in a procedure called an abdominal sacrocpopexy which uses the patient’s own ligaments to support weakened muscles. More recently, an increasing number of gynecological and urological surgeons have been using vaginal mesh and sling devices. It was thought that transvagnial mesh would lead to better outcomes; however, a recent study concluded that not only was this traditional surgery just as effective as the mesh, but there were significantly more complications and side effects as a result of using mesh.
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The recent failures and recalls of the Durom Cup hip implant and DePuy’s ASR hip system, including the ASR XL Acetabular system and the ASR Hip Resurfacing System, have brought the efficacy of hip implants into the public spotlight. It should be no surprise then that the failures of yet another hip implant are coming into focus.
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The Zimmer NexGen knee is a ‘high-flex’ porous femoral component that attaches to the bottom of the thighbone instead of using cement to keep the knee replacements in place. Beginning in April, 2010, surgeons began calling for recalls of the devices, based on a dangerously high failure rate, resulting in revision surgeries or close monitoring for radiographic loosening of the knees.
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Yesterday, the FDA issued a safety alert for Bard Recovery and Bard G2 filters, inferior vena cava (IVC) filters, manufactured by C.R. Bard. These filters are small devices that are implanted in to the inferior vena cava, the main blood vessel that returns blood from the lower half of the body, to prevent pulmonary embolism. The filters prevent blood clots from reaching the lungs where they would become fatal. Over the last five years, there have been 921 adverse event reports involving IVC filters – 328 cases where the device migrated in the body, 146 cases involving a detachment of a device component, 70 cases involving perforation, and 56 cases where the filter fractured. According to the FDA, many of these events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of a blood clot or pulmonary embolism has subsided.
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On April 30, 2010, the FDA ordered Baxter Healthcare Corp. to recall and destroy all of its more than 200,000 Baxter Colleague Infusion Pumps due to Baxter’s longstanding failure to correct serious safety problems with the Infusion pumps. These pumps are medical devices designed to deliver fluids, nutrients and medication to patients in a controlled manner. They are widely used by health care practitioners in order to more accurately deliver medications to patients. More than 500 deaths and 56,000 adverse events associated with these infusion pumps have been reported to the FDA in the last five years.
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