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Patients concerned about Medtronic Sprint Fidelis leads

Patients who have been implanted with [Medtronic Sprint Fidelis Leads] are understandably concerned after learning that the leads have been linked to five fatalities. Some patients have undergone risky surgeries in order to have the leads removed after they malfunctioned. Meanwhile, [lawsuits] have been filed on behalf of patients who were injured by fractured leads. The leads were implanted into hundreds of thousands of patients who are now at risk of serious injury if their Sprint Fidelis Lead malfunctions. All unused leads were recalled by Medtronic on October 15, although Medtronic is actually referring to the recall as a “voluntary ... Read More

NorCal man blames MRI dyes for illness

An elderly man has sued several major health companies, claiming the dyes used to scan his failing kidneys caused a rare, painful and incurable disease. Peter Gerber, 72, of San Rafael, contends that injections of dyes containing the heavy metal gadolinium caused him to develop nephrogenic systemic fibrosis, or NSF. Also known as nephrogenic fibrosing demopathy, the disease can thicken the skin, stiffen joints, restrict movement and potentially lead to death if it affects internal organs. Only about 215 cases have been reported worldwide, all involving people with kidney disease. No cures have been reported but some patients have seen ... Read More

History of hernia patch raises questions on implant recalls

How do makers of implanted medical devices react when one of their products starts breaking? One answer can be found in the case of a hernia repair device made by a subsidiary of C. R. Bard Inc. In late 2005, the company sent out a recall, urging doctors to stop using some versions of the product because a plastic component could break and cut through a patient’s internal organs and tissue. At the time, Bard executives said they knew about some serious injuries potentially caused by the device, which is known as the Kugel patch. Since then, the Food and ... Read More

Medtronic recall exposes gaps in medical safety

In late January, something unsettling happened at the Minneapolis Heart Institute. On two successive days, patients came to the clinic after their heart defibrillators had jolted them with huge, unnecessary and painful electric shocks. One 65-year-old woman said she’d been zapped 14 times in an hour. Doctors checked the hospital’s records and discovered four similar cases had occurred in recent months. Each stemmed from a broken wire — called a lead — that tells a defibrillator when to send an electric shock to a malfunctioning heart. All six cases involved the Sprint Fidelis 6949, manufactured by Medtronic Inc., a leading ... Read More

A new concern for end-stage renal disease patients

Nephrogenic systemic fibrosis (NSF) is a new fibrotic skin disease entity that was first recognized in 1997 in 15 patients receiving hemodialysis. Early reports noted that NSF closely resembled scleromyxedema, but had a number of differentiating features. The entity was initially termed nephrogenic fibrosing dermopathy, and a case definition was established based on its characteristic clinical and histopathologic features. The name was later changed to NSF in view of the systemic nature of the disorder and recognition of the role circulating fibrocytes play in mediating NSF. Underlying renal impairment is a prerequisite for the diagnosis of NSF, and 90% of ... Read More

Ortho Evra lawsuit settled for $1.25m as J&J tries to avoid public trials

Ortho Evra manufacturer, Johnson & Johnson, recently settled a lawsuit with the family of a 14-year-old girl killed by the defective birth control patch. The case is just one of many Ortho Evra lawsuits settled by Johnson & Johnson prior to going trial. It likely hints at the company’s desire to avoid trials where its actions -or lack thereof – regarding safety problems with the defective Ortho Evra birth control patch could be called into question. When Ortho Evra was introduced in 2002, Johnson and Johnson touted the once-weekly patch as a convenient alternative to daily oral contraceptive pills. The ... Read More

J&J pays $1.25m to settle lawuit over death of 14-year-old

Johnson & Johnson agreed to pay $1.25 million to settle a lawsuit over the death of a 14-year-old girl who used the company’s Ortho Evra birth-control patch, according to court records. The confidential agreement involved Alycia Brown, a resident of LaCrosse, Wisconsin, who suffered two blood clots in her lungs on May 7, 2004, after using the patch for several weeks. J&J, the world’s largest maker of health-care products, faces lawsuits by 2,400 of the 5 million women who used the patch. Most claim they suffered strokes or clots in their legs or lungs. The company settled dozens of cases ... Read More

Gadolinium MRI contrast agents linked to Nephrogenic Systemic Fibrosis

Gadolinium based MRI contrast agents and Nephrogenic Systemic Fibrosis/ Nephrogenic Fibrosing Dermopathy (NSF/NFD) have been linked in yet another study. This time, researchers in Scotland have confirmed that gadolinium based contrast agents used in MRI’s are strongly associated with the onset of this often fatal disorder in people suffering from pre-existing kidney disease. Their findings only add to the growing body of evidence that shows a strong connection between NSF/NFD and gadolinium based contrast agents that are often used in MRIs. The Scottish gadolinium MRI contrast agent study looked at 1,826 patients who underwent renal replacement therapy at two Glasgow ... Read More

Heart device recall poses a quandary for patients

On Sunday when Medtronic warned physicians to stop using a potentially faulty wire attached to its heart defibrillators, the company also advised patients to consult their doctors. On Monday, anxious patients were doing just that, causing some doctors’ offices to be flooded with calls as people tried to determine whether they might have the defective models. The risk of a defective wire is low. Medtronic said that about 2.3 percent of the estimated 235,000 patients with the defective wire, or 4,000 to 5,000 people, would experience a lead fracture within 30 months of implantation. But learning through tests that one’s ... Read More

MRI contrast agents get strong kidney-risk warning

Certain contrast agents used in magnetic resonance imaging — gadolinium-based products made by Bayer AG, GE and others — will now carry the U.S. Food and Drug Administration’s strongest, “black box” warning. The FDA’s move on Friday finalizes its announcement in May that it would add the labeling warning to the MRI contrast agents. The final warning notes that the agent boosts the risk of a potentially fatal side effect in patients with certain kidney and liver conditions. The skin disease called nephrogenic systemic fibrosis, or NSF, can occur in some patients, the companies said in a joint letter to ... Read More