Consumers may not realize it, but the U.S. Food and Drug Administration (FDA) currently has no way to track problems with medical devices and drugs that go wrong other than voluntary reporting. Unlike other countries that have drug and device registries, the FDA has an absolute head-in-the sand approach to […]
Category: Defective Medical Devices
The Food and Drug Administration (FDA) held a meeting this week to consider whether the 510(k) approval process for medical devices is keeping the public safe while balancing the need of industry to get innovative products to the market faster and easier. “External stakeholders” were invited and helped set the […]
The Biomet MDL (multidistrict litigation) was established for the organization and litigation of individual personal injury lawsuits against Biomet in the fall of 2012. In February of this year, the MDL contained 132 individual lawsuits. The count now stands upwards of 180 individual lawsuits, and it is still growing every […]
In a 1993 published study, 148 retrieved modular hip prostheses of mixed titanium cobalt and chromium were examined to determine if they had corroded while implanted in humans. Significant corrosion was observed and it didn’t matter whether the hips were metal or a combination of metal and ceramic or other […]
Public Broadcasting should be commended for trying to explain a very important issue that most Americans do not understand – until it happens to them. A “Need to Know” broadcast, explores the mysterious world of medical devices. Most Americans imagine their Food and Drug Administration (FDA) is protecting them from […]
The American Urogynecologic Society (AUGS) has issued a position statement that pushes back against any restrictions to ban surgical options for the treatment of pelvic organ prolapse (POP), including transvaginal surgical mesh cleared for use by the U.S. Food and Drug Administration (FDA). The AUGS position states that it is […]
First Coast News in Jacksonville recently aired a story about four women who had the misfortune of being implanted with surgical mesh, three to treat pelvic organ prolapse or incontinence and one for hernia repair. Unfortunately, all of them had a very bad outcome. “The pain was severe enough that […]
The Food and Drug Administration is curious whether robotic surgery is helping patients or raising the cost of healthcare. Intuitive Surgical’s da Vinci robot is the subject of an FDA survey that has been sent to key hospitals that belong to a product safety network overseen by the FDA. Surgeons […]
He is a billionaire who loves a good stock, but apparently Johnson & Johnson is not among them. Berkshire Hathaway founder, Warren Buffett, decided to drop 34% of his stock in Johnson & Johnson (JNJ) during the fourth quarter of 2012, according to reports. Buffett has been selling off JNJ […]
A patient with a metal-on-metal or any hip replacement that causes symptoms or problems requires that the individual become his/her own best advocate. First, make an appointment with an orthopedic surgeon for evaluation which includes not just a physical exam but an examination of fluid around the joint/ soft tissue […]
