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Many more revision surgeries occur in patients with all-metal hip implants

Nearly 75 percent of revision surgeries to remove and replace a hip replacement within five years of initial implantation occur in patients who received a metal-on-metal device, according to a Canadian study. Researchers pored through data involving 60,000 hip replacements performed across Canada between 2003 and 2011. They found that the need for revision surgery was greater in patients who had large-diameter modular metal-on-metal implants compared to patients who had more common plastic devices. Traditional hip replacement systems are made with ceramic or plastic parts, and can last 20 years or more before needing to be replaced. In the past ... Read More

Corroding metal on artificial hip caused patient neurological symptoms

When orthopedic surgeon Stephen Tower realized in 2006 that in order to continue his recreational cycling he needed hip replacement surgery, he picked the newest and seemingly most durable hip implant on the market at the time – a metal-on-metal device made by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. The hip implant was specifically marketed to younger, active patients like Stephen. However, after a year Stephen was having pain in his hip and balance issues that caused him to crash his bike. Within the next year, he began experiencing more problems – ringing in his ears, sleep apnea, ... Read More

British MPs call for criminal inquiry into toxic DePuy hip implants

British MPs have called for an investigation into DePuy Orthopaedics after testimony from a U.S. court case revealed that the medical device company continued to sell defective artificial hip implants despite knowing for at least three years they were toxic to patients. DePuy, a subsidiary of Johnson & Johnson, recalled the ASR hip replacement system and hip resurfacing system after mounting reports that the device was failing at a higher than expected rate. The recall affected an estimated 93,000 people worldwide. The DePuy device was made to be more durable with all-metal parts, as opposed to plastic or ceramic parts ... Read More

Anemia drug for kidney patients pulled from market following deaths, hypersensitivity reactions

Omontys (peginesatide), an injection made by Takeda Pharmaceuticals and used to treat anemia due to chronic kidney disease in patients on dialysis, is being recalled and removed from the market because of serious hypersensitivity reactions, including anaphylaxis, some of which have been fatal. About 0.02 percent of patients died after receiving a first dose of Omontys. The reported hypersensitivity reactions occurred within 30 minutes after administration of the drug. There have been no reports of hypersensitivity reactions following subsequent dosing, or in patients who have completed their dialysis session. Since the drug was introduced, more than 25,000 patients have received ... Read More

Hip implant failures more likely in women than men

Women are more likely to need revision surgery to remove and replace their artificial hips than men, according to a study published in JAMA Internal Medicine. The study, funded by the Food and Drug Administration (FDA) focused on the high number of failure rates in hip replacement systems. Researchers found that regardless of the type of hip implant used, hip replacements in women were more than 30 times more likely to fail than those implanted in men. Research involved more than 35,000 people who received hip replacement surgeries from one of 46 different hospitals in the Kaiser Permanente health system. ... Read More

New consortium aims to improve safety of medical devices

The Food and Drug Administration (FDA) has caught much flack in the past couple years over its medical device approval process, with critics arguing that not enough effort is made to ensure the safety and efficacy of devices before they hit the market. In response, a new consortium of leaders from industry, academia and government agencies was formed to help guide the advancement of medical device regulatory science. The Medical Device Innovation Consortium (MDIC), is a public-private partnership with the FDA’s Center for Devices and Radiological Health (CDRH). FDA Commissioner Dr. Margaret Hamburg called the formation of the consortium a ... Read More

International safety alert issued on metal hip device

Medsafe, New Zealand Medicines and Medical Devices Safety Authority, has issued an international safety alert on the Durom Acetabular Cup, an artificial hip device that was discontinued by its manufacturer in June 2011. The device has been failing at a higher than expected rate, causing some patients to undergo revision surgery to have their defective hip implants removed and replaced. The Durom Acetabular Cup, made by Zimmer Inc., is designed with metal-on-metal parts, just like the DePuy Orthopaedics ASR XL Acetabular hip replacement system and resurfacing system. The Depuy device was recalled by DePuy Orthopaedics, a subsidiary of Johnson & Johnson, ... Read More

Knee, hip replacement surgery puts older adults at risk for heart attack

People who are older than 60 who undergo knee or hip replacement surgery are at risk of having a heart attack in the weeks immediately following surgery, a new study shows. One in 200 older patients experience a heart attack in the six weeks following hip surgery, and 1 in 500 experience a heart attack in the six weeks following knee surgery. Elderly patients over the age of 80 are at greater risk. The study does not prove the surgeries cause heart attacks, but doctors speculate the stress of undergoing surgery and the disruption of the flow of blood and oxygen ... Read More

Medical experts petitioned FDA to ban transvaginal mesh

“All too frequently, industry knowingly targets less experienced surgeons, knowing that these mesh have not, and will never be, accepted by more experienced surgeons who are fully aware of their inherent risk without benefit.” Daniel Elliott, a urologic surgeon at the Mayo Clinic in Rochester, Minn., wrote the statement in a public letter last August, speaking out against transvaginal mesh, a surgical mesh device used in the repair of common pelvic organ disorders such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). One common repair method is the surgical insertion of surgical mesh through the vagina. It acts ... Read More

FDA warns of potentially fatal heart rhythm abnormalities with anti-nausea drug for cancer patients

Zofran (ondansetron), a drug used to treat nausea and vomiting in cancer patients undergoing chemotherapy, may cause a potentially fatal heart rhythm, the Food and Drug Administration (FDA) warns. Preliminary results from a study on the 32 mg single intravenous dose of Zofran and its generic counterparts found that the drug may affect electrical activity of the heart, known as QT interval prolongation, which could predispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes. As a result, the 32 mg single intravenous dose will be removed from the Zofran drug label. Lower doses ... Read More