FDA Report on Surgical Mesh for Treatment of Pelvic Organ Prolapse and Stress Urinary Incontinence
FDA report: Surgical Mesh for Treatment of Women with Pelvic Organ Prolapse and Stress Urinary Incontinence
Drug, medical device trials that doctors rely on flawed, analysis shows
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…
FDA sees need to study metal hip implant effects on body
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…
FDA: Hip implant complaints increasing
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…
Metal hip replacement component taken off the market
A British manufacturer of a metal-on-metal component for an artificial hip has voluntarily withdrawn the metal liner (or cup) from the market, as some patients were forced to have the liner removed after complaining of infections, fractures and dislocations. The liner was part of Smith & Nephew’s R3 Acetabular System. According to Bloomberg Businessweek, about…
Important Reminder from FDA: Defective AEDs Recalled
The Food and Drug Administration is reminding owners of automatic external defibrillators (AEDs) to check whether their devices are subject to a Jaunary recall. Certain AEDs contain a defective component that could cause the AED to not delvier defibrillation. Because of the seriousness of this issue the agency has classified this recall as class I,…
First Vaginal Mesh Trial Set Against Bard
U.S. District Judge Joseph R. Goodwin in Charleston, West Virginia has set a February 5, 2013 trial date for the first of approximately 600 cases against Bard arising out of injuries as a result of the Avaulta device. The Bard cases have been consolidated with cases filed across the U.S. against Bard, Johnson & Johnson…
DePuy ASR Hip Case Set For Trial in Nevada
A trial has been set in Nevada state court for December 3, 2012. The case involves three plaintiffs alleging their DePuy ASR hip implants were defective. The case was filed in state court in Nevada because the distributor, Precision Instruments Inc. distributed the hips in Nevada.
Some GOOD news for Metal on Metal Hip recipients
Over the past several months we have passed along some very discouraging information about Metal-on-Metal hip prostheses. We are happy to have something positive to report: According to a published report in HealthDay News on April 3, 2012, “People with metal-on-metal hip replacements do not have an increased risk of cancer during the first seven…
British Agency Urges Ban on Metal Hip Combination
The U.K.’s Medicines and Healthcare products Regulatory Agency issued a statement urging surgeons to stop using a specific combination of Johnson & Johnson and Stryker metal hip devices due to unacceptably high rates of failure. The combination is Mitch TRH cup/heads and Accolade femoral stems.