Stephen Tower and Metal-on-Metal Artificial Hips As a former FDA commissioner noted in the documentary, “we built a system that doesn’t work.”ĭr.
If this sounds loony, then you are paying attention. Check out this site for many articles on the MoM artificial hip.Īccording to The Bleeding Edge, in some cases a new medical device is approved under 510(k) because of its substantial equivalence to an existing product that has been recalled because of health concerns. The FDA has explained that, under 510(k), it does not look at the safety of the underlying medical device rather, it simply examines whether the new product is “substantially equivalent” to the predicate product. Turns out, in many cases the MoM construction allowed metals to grind and be released into the blood and tissue of patients, causing all kinds of problems, from severe leg pain to neurological symptoms. Because the MoM hip was “substantially equivalent” to previous artificial hip systems, the FDA permitted several device companies to manufacture and sell MoM artificial hips. One of the best examples of this 510(k) failure is the metal-on-metal (MoM) artificial hip. This may sound benign–after all the products are equivalent–but it has allowed many inadequately tested and dangerous devices to hit the market. Under 510(k), a medical device company may avoid clinical testing and the “Pre-Market Approval” process if the company can show that the new device is “substantially equivalent” to a similar device already approved and on the market. The worst of these loopholes is the 510(k) process, which I have written about extensively on this site. However, over the years certain loopholes in the MDA have allowed medical device companies to run amuck.
The 1976 Medical Device Amendments Act (“MDA”) was a positive step forward for regulating medical devices and for protecting human health. And it may have you writing your member of congress. It’s one thing to hear that the Essure birth control device has injured thousands of women it’s quite another when you see a woman on screen explain how she has given up on her hope to find love because she can no longer have intercourse due to permanent internal injuries. It is a tragic story, particularly when the film takes a close look at many of the actual victims of these harmful medical devices. It examines the two main causes permitting the manufacture and sale of defective medical devices: corporate greed and inadequate FDA oversight. The Bleeding Edge is a remarkable film investigating the public health crisis caused by our current medical device industry. And if you are interested in this subject, you must see the new Netflix documentary The Bleeding Edge. If you are reading this sentence then you discovered my site because of your interest in medical devices and the problems they can cause. And some have caused massive human suffering: neurological problems, sexual dysfunction, immobility, infertility, headaches, pain, even death.
These devices include artificial hips, hernia mesh, IUDs, IVC filters, and others. For more than three years I have been writing about the dangers of certain implanted medical devices.
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