Tagged Articles

tissue damage 27 articles

ASR Metal Hip Implant Has Failure Rate of Up to 50 percent Within Six Years

According to an article published by BMJ, ASR metal-on-metal hip implants such as the designs made by DePuy Orthopaedics, a subsidiary of Johnson & Johnson, are shown to have a failure rate of up to 50 percent within six years. “Metal on metal joints are designed to harness naturally occurring lubricating fluids from the native hip,” the article reads. “As wear debris is generated, hip joints become filled with high concentrations of chromium and cobalt. This leads to a chain of events culminating in extensive soft tissue necrosis and disruption of bone. The metallic ions then diffuse into the blood stream.” But the ... Read More

Hospira recalls injectable anesthetic Lidocaine due to particles floating in solution

Hospira, Inc., is recalling one lot of its injectable drug Lidocaine because of a confirmed report of discolored solution with visible particles floating in it as well as particulate embedded in the molded glass container. Hospira has identified the particulate as iron oxide, and said it is due to a supplier’s glass defect. Hospira is working with its supplier on implementing corrective and preventative actions. To date, no adverse events have been reported related to this recall, however if patients are injected with the particles – depending on the particle size and number – it could block administration of the ... Read More

Another recall issued for Hospira injectable anesthetic drug

Hospira is recalling one lot of 0.5% Marcaine (Bupivacaine Injection) after a customer reported seeing particles embedded in the glass vial as well as floating within the solution. Marcaine is an injectable anesthetic used to deaden feeling in the body prior to surgeries, childbirth and dental procedures. This is the fourth injectable anesthetic Hospira has recall in recent months due to vials contaminated with particle matter, and one of numerous products recalls the company has issued in the past six months. The latest recall involves one lot of 0.5 % Marcaine Bupivacaine Injection, 30 mL, single-dose vial – preservative free ... Read More

Hospira recalls one lot of high blood pressure treatment Labetalol

Hospira Inc. has issued a nationwide recall for one lot of the beta blocker Labetalol Hydrochloride injection used to treat high blood pressure due to foreign matter floating in the solution. This is Hospira’s fifth recall of injectable solutions in four weeks due to contaminated solution. The latest recall was initiated after embedded particulate were seen within the glass vials and visible particles floating in the solution. The embedded particulate was identified as stainless steel and the floating particulate as iron oxide. The particles may block the solution of the drug during administration, which could cause a delay in therapy. However, ... Read More

Johnson and Johnson to pay $2.5 billion to resolve thousands of ASR metal hip lawsuits

Johnson & Johnson will pay more than $2.5 billion to resolve more than 7,500 lawsuits involving defective ASR metal-on-metal hip implants made by its subsidiary DePuy Othopaedics. DePuy issued a worldwide recall on an estimated 93,000 of its ASR all-metal hip replacement systems in 2010 after reports that the devices were failing at a faster than expected rate. Traditional hip implants can last 20 years or more before needing to be replaced. However, a large number of DePuy’s ASR devices were failing in five years or less. Unlike traditional hip implants that are made with ceramic or plastic parts, the ... Read More

UK’s National Health Service bans metal-on-metal hip implants

The United Kingdom National Health Service is banning surgeons from using metal-on-metal hip replacement systems in patients, based on guidance issued from consumer health watchdog the National Institute for Health and Care Excellence (NICE). The consumer health advocacy group developed the guidelines after investigations and research into the all-metal implants, which were found to have a startling high premature failure rate. Traditional hip implants are made with plastic or ceramic parts and generally last about 25 years before needing to be replaced. In the past decade, medical device manufacturers introduced all-metal artificial hips, assuming the devices would hold up better ... Read More

Bayer markets Mirena-like IUD for adolescents despite Mirena IUD injury lawsuits

A new intrauterine device is being marketed in the United States with sexually active adolescents in mind. Skyla, made by Bayer Healthcare, is raising concerns among some experts not because it is geared toward younger women, but because some IUDs, especially the Mirena, also made by Bayer, have been associated with injuries, some of which have been serious. Skyla is a new version of Bayer’s Mirena. Both deliver a steady dose of the hormone levonorgestrel, but Skyla is smaller than the Mirena, lasts up to three years as opposed to five years with Mirena, and contains less of the hormone ... Read More

New IUD insertion device aims to cut down on uterine perforation

New Orleans-based company Bioceptive has created a device that it says makes the insertion of intrauterine devices – or IUDs – simpler, thus cutting down on the technical training required for health providers. The inserter automates some of the insertion process and allows the health care provider to guide the IUD into the intended place and reduce the chance of uterine perforation. IUDs tear through the uterine wall about once or twice for every 1,000 insertions, and the risk is even greater when the device is inserted by an inexperienced health care provider. Women who have had fewer children also ... Read More

Researchers: More studies needed to determine long-term cancer risk with all-metal hip implants

Researchers are recommending long-term studies be done on patients with metal-on-metal hip replacement systems to determine whether corroding implants cause cancer. The recommendation was made following a study in which researchers found no increase in cancer in a seven-year period in people with all-metal hip implants. Traditional hip implants are made with plastic or ceramic parts, but in the past decade many manufacturers of these medical devices began making the devices with all metal parts. The metal hips were thought to be more durable and thus ideal for younger and more active patients. However, they devices were found to fail prematurely ... Read More

Judge denies metal hip maker’s request to dismiss lawsuit in multidistrict litigation

A lawsuit in a multidistrict litigation (MDL) will move forward against Biomet Inc. over its allegedly defective metal-on-metal hip implant after an Indiana federal judge declined the company’s request for dismissal. Biomet argued that the claim against the company was preempted by federal law because the device was approved for use as part of a clinical investigation to determine safety and efficacy. The lawsuit was filed by Leslie Caccia who claimed he received a defective M2A-Magnum hip replacement system, made by Biomet. The complaint states the device damaged bone and tissue surrounding Caccia’s implant and he required multiple revision surgeries ... Read More