A British manufacturer of a metal-on-metal component for an artificial hip has voluntarily withdrawn the metal liner (or cup) from the market, as some patients were forced to have the liner removed after complaining of infections, fractures and dislocations.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…
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,…
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…
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.
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…
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.
The FDA has announced that it will hold an advisory panel on June 27-28 to gather input from scientists, researchers , patients and medical practitioners to help regulators decide whether to impose new testing standards and review requirements before a medical devide is sold in the U. S. This panel is in response to mounting…
The Gynecare Prolift was introduced in March 2005 by J&J, however the U.S. FDA did not learn about the Prolift until 2007 when J&J was seeking approval for a related product. There are currently more than 550 lawsuits against J&J alleging injuries caused by vaginal mesh implants.
A British review of larger diameter metal on metal hip implants found, “unequivocal evidence that metal-on-metal stemmed prostheses are associated with higher failure rates than other types, and that the use of large head sizes, and use of these prostheses in younger women, is associated with a particularly high rate of early revision surgery.”
The publication Consumer Reports has been long known for it’s reviews of products including automobiles and home appliances, but has now taken on medical devices. Consumer Reports President, Jim Guest wrote an email to 1 Million Americans earlier this year stating, “The implant that fixed your knee or your heart may actually be a ticking…