According to a systematic review published online September 9th in the BMJ, there is no evidence to support the use of 5 newer joint replacement devices compared to analogous products that have been on the market longer. In fact, the risk of undergoing revision surgery is higher with some of the newer systems.
The study was led by Marc J. Nieuwenhuijse, MD, PhD from the Patient Centered Comparative Effectiveness Program and US Food and Drug Administration Medical Device Epidemiology Science and Infrastructure Center, Department of Public Health, Weill Cornell Medical College, New York, City; the Department of Orthopaedics, Leiden University Medical Center, the Netherlands; and the Office of Surveillance and Biometrics, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD. He and his colleagues wrote that “[N]ew technologies are being introduced to the commercial market without sufficient high quality evidence for improved benefit over existing, well proven, and safe alternative implant solutions…[T]he status quo regarding the introduction of new device technologies is not acceptable.” Continue reading
Kenneth Feinberg, the attorney overseeing the General Motors compensation fund, has so far linked 19 deaths to a serious flaw with the ignition switches, a higher number than the 13 deaths GM had acknowledged in crashes resulting from the switch problem.
The fund has received 125 death claims and 320 injury claims in the five weeks it has been operating. Feinberg has found 31 claims eligible for compensation, CNN Money reports. Continue reading
Workers at hydraulic fracturing – fracking – oil and gas sites are routinely exposed to high levels of benzene, according to a study by the National Institute for Occupational Safety and Health (NIOSH).
The agency, part of the Centers for Disease Control and Prevention (CDC), recommends that workers limit their benzene exposure to an average of 0.1 of a part per million during their shift. But when the researchers measured airborne benzene workers would be exposed to when they opened hatches on tanks at well sites, 15 of 17 samples exceeded that amount, the Los Angeles Times reports. Benzene levels at the wells “reached concentrations that, depending on the length of exposure, potentially pose health risks for workers,” the researchers wrote in the Journal of Occupational and Environmental Hygiene. Workers must open the hatches one to four times per hour to inspect and measure the contents. Continue reading
Over-the-counter (OTC) acne treatments are widely available and frequently used, but the U.S. Food and Drug Administration (FDA) has warned that some may lead to life-threatening allergic reactions.
Signs of an allergic reaction include tightness in the throat, difficulty breathing, feeling faint, swelling of the eyes, face, lips or tongue and hives or itching in the area where the treatment was used. Consumers should stop using the product and seek medical attention immediately if they experience a reaction. Continue reading
The DePuy Pinnacle bellwether trial continues, as DePuy witnesses continue to testify. The trial, which began on September 2nd in the U.S. District Court for the Northern District of Texas in Dallas before U.S. District Judge Ed Kinkeade, is expected to last 6 to 8 weeks. Nine people, 5 women and 4 men, are on the jury. Continue reading
The U.S. Food and Drug Administration (FDA) just announced that Publix has issued a recall of its private label jalapeno bagels: Publix Jalapeno Bagels.
The Publix Jalapeno Bagels were sold in the stores’ self-service bins or in the artisan cases in the stores’ bakery departments. The recalled bagels may contain pieces of glass and small stones. The product supplier advised Publix of the potential product hazard. Continue reading
A West Virginia jury has reached a $3.27 million verdict in a federal bellwether product liability case brought over the Ethicon transvaginal TVT-O sling. Transvaginal mesh implants are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI); Ethicon is a unit of Johnson & Johnson.
The jury ordered that Ethicon must pay the multi-million compensatory damages amount in a case that included allegations that the its TVT-O transvaginal sling was defectively designed. Allegations also included that Ethicon neglected to warn the public about the device’s potential risks, wrote Law360. Although punitive damages have not been awarded, the jury found in favor of the plaintiff on all counts: Strict liability, design defect, failure to warn, and negligence. Continue reading
A group of lawmakers, first responders, and community and labor leaders gathered at Ground Zero on September 8 to begin an effort to reauthorize the James Zadroga 9/11 Health and Compensation Act for another 25 years.
The Zadroga Act was passed in December 2010 to provide medical treatment and compensation for 9/11 first responders, recovery workers and volunteers, and community survivors. Later this month, U.S. Senators Kirsten Gillibrand and Chuck Schumer will introduce the Zadroga Act reauthorization to extend the programs through 2041. Continue reading
The popular erectile dysfunction drug, Viagra (sildenafil citrate), has been associated with increased risks for the skin cancer, melanoma. Viagra is manufactured by Pfizer Inc. and is a phosphodiesterase (PDE) 5A inhibitor (PDE5A) that is typically used in the treatment of erectile dysfunction (ED). The drug received U.S. Food and Drug Administration (FDA) approval in 1998.
The research revealed that men who used Viagra and other sildenafil drugs were 84 percent likelier to receive a melanoma diagnosis. Melanoma is the deadliest of the skin cancers and, according to a prior The Associated Press report, more than three-quarters of all deaths related to skin cancer involve melanoma and approximately one person dies from melanoma every hour in the United States. Continue reading