News tagged with 'Medical Devices and Implants'

The Food and Drug Administration (FDA) announced that Abbott Laboratories, Inc., has initiated a worldwide recall of 32 lots of laboratory kits used to diagnose gonorrhea. The kits have been shown to be unreliable because they may give false negative results. These test kits were distributed to hospitals and laboratori

The U.S. Food and Drug Administration (FDA) has become aware of a possible association between cochlear implants, devices containing electrodes which are positioned in the cochlea (inner ear) to activate auditory nerve fibers allowing for transmission of sound signals to the brain, and the occurrence of bacterial menin

A Texas jury recently awarded a Harris County man $3.1 million in a product liability lawsuit involving three technological companies. In October 1997, Mohammad Tamoozi underwent brain surgery to remove a tumor. During the procedure, the neurosurgeon, Dr. Robert Levinthal, used an image-guided surgical navigation sys

A Federal jury recently awarded $225,000 to a Florida man who received a defective prosthetic knee device. Joel Tuitt suffered from degenerative arthritis in his left knee, the results of a slip-and-fall accident in 1996. To help prevent further injury, doctors decided in February 1999 to install a Duracon unicompart

According to Abbott Laboratories Inc., the U.S. Food and Drug Administration (FDA) has found that one of the pharmaceutical maker's manufacturing plants does not meet quality and safety standards. A spokesperson for Abbott said the company has not thoroughly reviewed the report on the Lake County, Illinois facility bu

A group of parents in Georgia who claim their children developed autism from exposure to mercury in dental fillings and vaccines filed eleven lawsuits in an Atlanta court last week. Several major corporations and drug companies, including Johnson & Johnson, GlaxoSmithKline and the American Dental Association (ADA), we

Sulzer Orthopedics Inc.'s $1 billion settlement proposal is "fair, adequate and reasonable," U.S. District Judge Kathleen M. O'Malley decided Wednesday. The company, which is a subsidiary of Switzerland's Sulzer Medica, offered the amount to settle thousands of lawsuits stemming from the recalls of the company's popul

Japan's Olympus Optical Co. has announced another recall of more than 14,000 bronchoscopes. The decision comes less than two days after Johns Hopkins Hospital informed 415 patients that bronchoscopes made by Olympus' subsidiary, New York-based Olympus America, may have given them a rare, but fatal, lung infection. Ho

After Sulzer Medica initially refused to increase its $783 million offer to settle thousands of lawsuits stemming from the recent recalls of the company's popular hip and knee replacement devices, company officials announced this week that Sulzer has agreed to a revised $1 billion settlement. Sulzer recalled over 17,5

What is BioGlue? BioGlue is an animal-based sealant that is made of a bovine serum albumin (a cow protein) and a chemical called glutaraldehyde. How does BioGlue work? The cow protein and the chemical join in the patient's tissue to seal the area, like a glue. This product can also seal non-tissue material

Health officials investigating the mysterious deaths of three Minnesota men who died after undergoing elective knee surgery made a stunning discovery last week when they found that one of the men may have contracted a fatal infection from donor tissue taken from a cadaver. Doctors report that the 23-year-old man, who

Cryolife reported this week that the company received approval from the Food and Drug Administration (FDA) to market Bioglue, a surgical adhesive used for suture line, bypass, and abdominal aortic sealing. The approval comes several weeks after a Baylor College of Medicine study found that the adhesive could lead to c

The Minnesota State Health Department has lifted a suspension on all elective knee surgeries that was imposed after three men mysteriously died last month. The State's epidemiologist concluded last week that such operations were safe and could resume as normal. Brian Lykins, 23, and Wayne Hulterstrum, 78, died Novemb

Swiss medical device maker Sulzer Medica announced that it would not increase the company's $783 million settlement offer proposed to resolve nearly 1,800 lawsuits stemming from the December 2000 recall of its popular Sulzer hip replacement device. The announcement comes the day before three judges in a U.S. Federal Co

A California based health care company that produces blood glucose monitoring systems for diabetics has settled a class-action lawsuit for $45 million. Lifescan, a subsidiary of Johnson & Johnson, was facing a nationwide class-action suit filed on behalf of hundreds of thousands of diabetics alleging the company marke