After a British study found poor results from hip resurfacing on some men and on women in general, researchers say the technique shouldn’t be used on women and men should be evaluated carefully before having resurfacing. Researchers said resurfacing and metal-on-metal bearings should be examined closely before new implant technology is released. Hip resurfacing has…
The bad news is that nearly 123 million medical devices, from ultrasound gels to hip implants, were recalled in the last quarter. According to ExpertRecall, a company that tracks recalls, while the number of recalled devices has dropped from the previous quarter, the number of units that were affected topped the 100 million mark for…
A U.S. District Court judge in Ohio has scheduled the first bellwether trial for lawsuits filed against DePuy Orthopaedics, Inc., alleging defects in the metal-on-metal ASR hip replacement system. A bellwether trial is used for multiple lawsuits with common complaints. The Ohio trial is set for May 2013. Attorneys were ordered to submit four trial…
The U.S. Food and Drug Administration sent a warning letter to medical device maker Medtronic, saying it lacks adequate complaint procedures and its response to complaints and an FDA investigation were inadequate. Medtronic manufactures implantable drug infusion systems, deep brain stimulation systems, spinal cord neurostimulation systems, nerve monitoring products and other neurological medical/surgical products. The…
The U.S. Food and Drug Administration recommends that patients with Riata or Riata ST heart defibrillator implants have X-rays or other scans to check for abnormalities in the lead insulation. The manufacturer, St. Jude Medical of Minnesota, recalled the leads in November 2011 due to premature erosion of the insulation around the electrical conductor wires.…
A California woman was awarded $5 million and her husband $500,000 after a jury found that transvaginal mesh manufacturer C.R. Bard Inc.’s negligence caused the woman’s injuries including incontinence and chronic pain. The jury ruled on July 23, 2012, that Bard was 60 percent responsible and the surgeon 40 percent responsible for negligent handling of…
FDA report: Surgical Mesh for Treatment of Women with Pelvic Organ Prolapse and Stress Urinary Incontinence
A new analysis concluded that many of the reports that are conducted on new drugs and medical devices come from studies conducted on a small number of patients in clinical trials with less-than-reliable methods and, often, missing data! Dr. Robert Califf of the Duke Translational Medicine Institute in Durham, N.C., told Reuters Health that these…
U.S. Food and Drug Administration staff have sent word to agency advisers meeting this week that there should be more and consistent tests to study the effect of metal in hip implants on surrounding body tissue. The staff said these tests might help lower high failure rates on implants made by Johnson & Johnson and…
As the U.S. Food and Drug Administration prepares to examine how safe metal-on-metal hip implants are, the agency released a report saying it received more than 16,800 reports of adverse events associated with the devices from 2000-2011. Complaints increased after Johnson & Johnson began recalling its ASR hip implants in 2010, according to Bloomberg News. More…