“The Bleeding Edge” is a new documentary out on Netflix that examines the potential dangers of different medical devices and treatments. We are all aware of the dangers of human error as well as the failure of products to work as designed. This film, however, graphically details how medical devices in particular can be dangerous and yet less regulated than pharmaceuticals. The strength of the documentary message is getting coverage in the media.
Metal implants could lead to neurological problems
Horror stories from the documentary include those of women whose intestines fell out of their bodies after robotic surgery, but one to have the widest range of impact could be aimed at the hundreds of thousands of patients who use metal orthopedic devices. The metal on metal design and subsequent breakdown of these implants has caused elevated cobalt levels in the body that is believed to be the cause of neurological problems that include dementia or Parkinson’s-like symptoms.
Approval process to blame
The issue of these devices potentially causing dangerous medical issues is linked to the FDA’s 510(k) process for approving these new devices. Drugs are tested on humans, data is collected from testing and a panel of scientists from the FDA must sign off on final approval. Manufacturers of new medical devices, however, merely need to prove that they have created a something similar to a product already on the market (even if that product has been recalled).
Reason for hope
The documentary also lists some success stories. One inspiring example is a doctor who diagnosed the cobalt poisoning as the cause of his own neurological issues after his hip surgery led to a complete mental breakdown.
Another example is the protests organized against Bayer, who manufactured Essure birth control devices inserted into the fallopian tubes through the uterus. The product proved to be ineffective in some cases, and caused bleeding and discomfort in others. Thousands joined Facebook groups dedicated to the problems caused by Essure. There were also protests at corporate headquarters and at medical conferences. Essure is now off the market.
Sometimes medical malpractice suits are part of bigger lawsuits. However, they may be an issue specifically related to the health or injury of an individual. In either case, a law firm with experience in personal injury law can help resolve the matter and perhaps gain recompense for damages to you or a loved one.