The DePuy metal-on-metal hip replacements have affected many citizens and often left them with serious and life-threatening complications. These implants suffer an extremely high failure rate, which is projected to be around 80% at just 8 years after surgery. The complications of a metal-on-metal hip replacement can be extremely severe.…
The Stryker Corporation is a leading manufacturer of medical devices. However, even Stryker could not avoid blame in the ongoing metal-on-metal hip replacement issue. Earlier this month, Stryker stated that it is issuing a voluntary recall of two of its hip replacement products: the Rejuvenate Modular hip replacement and the…
Although the recall on Johnson & Johnson’s metal-on-metal DePuy hip replacement was in August of 2010, the problems are far from over. Johnson & Johnson created the Pinnacle hip replacement as a second generation of DePuy, and it has already begun suffering similar results to its predecessor. According to Fox…
The FDA has recently proposed a new method of identifying and tracking medical devices. Under this system, most medical devices would be inscribed with a “unique device identifier”, or UDI. This code would contain product information including manufacturer, expiration and other device specifics. High risk medical devices are the first…
Transvaginal mesh is a surgically implanted device designed to help with problems of organ prolapse (or “falling out”) and bladder incontinence. This mesh is a synthetic material which acts as a reinforcing sling around the intended organs. Such mesh has been used with some success in other surgeries, but has…
The Medtronic Infuse Bone Graft is a bone growth stimulator used during surgery. “Infuse” is a bone morphogenetic protein, a genetically engineered form of a naturally occurring protein. It is applied in liquid form via sponge; it is meant to grow into bone in order to facilitate re-growth and replace…
Intuitive Surgical, Inc.’s da Vinci Surgical System is the target of several recent lawsuits beginning in Alabama, Mississippi and New York. This device was cleared by the FDA in 2000 and claims to be a much-desired minimally invasive alternative to traditional surgery. The da Vinci robot performs surgery through a…
Recent reports have shown that the FDA is stepping up in strengthening the approval and research of post-approval drug safety. The administration has created a post market drug safety program that has shown to be extremely effective. The Center for Drug Evaluation and Research (CDER), the administration’s program, focuses on…
The FDA has recently been receiving a lot of attention for something other than a recall or warning; the health experts are facing pressure on approving medical devices at a faster rate. The majority of approvals can take years, and when life threatening or extremely painful health problems are at…
Metal-on-metal hip replacement systems continue to receive criticism as experts across the world encourage doctors to stop using these defective systems. Due to the full metal design of these replacement systems, the implant is known to shed tiny pieces of metallic ions that lead to a high risk of causing…