The FDA has issued a warning stemming from improperly maintained electrical dental equipment. The poorly maintained equipment can result in third degree burns. In fact, some of the patients even needed to undergo plastic surgery as a result. One of the main reason for the alert directed at dental professionals was that the burns may become apparent only after tissue damage has occurred...
The US Supreme Court announced it will decide a case regarding whether federal regulation of pharmaceutical companies preempts state law. The case the Court will decide arises from a products liaiblity lawsuit against Pfizer's Warner-Lamber unit involving its Rezulin diabetes drug. The FDA ordered Rezzulin off the market in March 2000 because it was linked to hundreds of deaths and cases of...
The FDA is recalling the MRL/Welch Allyn AED 20 Automatic External Defibrillator that is used by emergency personnel in hospitals, at fire stations and other risk management departments to treat heart attack victims. The defective equipment may show an error message (Defib Comm) which can result in the medical personnel giving improper treatment. Hospitals, fire departments, and ambulance...
A recent study concerning the utilization of cardiac stents has found that the stents are no more effective than medcines in preventing future heart attacks. However, the study was funded in part by pharmaceutical companies. This brings up a broader ethical issue concerning the objectivity of medical research, especially when that research is funded by organzations or companies that have a...
After the third day of Transcather Cardiovascular Therapeutics show, the results are still mixed regarding the safety of drug coated heart stents. The stents, manufactured by Boston Scientific's Taxus and Johnson & Johnson's Cypher, many experts agreed, there appears to be a long-term clotting risk compared with the use of older bare metal stents. Even some physicians have been reluctant in...
A leading stent manufacturer has admitted that there is an increased clot risk for those with Boston Scientific's cardiac stent. It is the first acknowledgment by a stent maker of an increased risk of the dangerous side effect of stents, which are small wire-mesh tubes used to keep previously clogged arteries open. Drug-coated stents, which are coated with medicine to prevent the growth of...
According to a study published in The Journal of the American Medical Association, malfunctions in implantable cardioverter defibrillators, or ICDs, are on the rise. The device is designed to keep the heart pumping properly and efficiently. Between 1990 and 2002, a total of 2.25 million pacemakers and 415,780 ICDs were implanted in the U.S. Of the implanted pacemakers, 8,834 (4.6 per 1,000)...
The first Guidant defective defibrillator trial has been postponed because one of the witnesses is unavailable due to the Passover holiday. The judge has said that the case will most likely resume in July.
An expert panel commissioned by Guidant Corporation to assess its handling of problems with cardiac medical devices cited the company for failure to properly assess patient safety. The commission noted that Guidant's decisions were guided by statistical projections provided by engineers rather than medical data provided by doctors. The group urged Guidant to create an outside panel of...
According to a report published in the NY Times, Guidant Corporation has issued a warning to doctors about possible battery defects in two of its implantable defibrillator devices. The devices in question, the Contak Renewal 3 RF and Renewal 4 RF cardiac defibrillators, have not been implanted in any patients thus far. Guidant said the FDA may classify the warning as a product recall.
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