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The Bleeding Edge Chronicles Medical Device Complications

Medical Device Complications

Have you heard of the documentary, The Bleeding Edge? It chronicles the unnecessary pain and suffering of patients caused by complications of medical devices that received little or no testing.

Available on Netflix, this documentary is extremely powerful. It is worth taking the time to watch and share with everyone you know especially if you will be undergoing an expensive or risky medical procedure.

Watch the trailer.


Examples of Medical Device Complications

One of the examples discussed is Essure, a permanent birth control device that claims to be 99% effective at preventing pregnancy. Several women, including Angie Firmalino, founder of the Facebook group called Essure Problems, discuss their experiences and how it has affected their lives. In her specific case, the device had dislodged and migrated to her uterus. When it was removed, it left behind metal fragments that ravaged her reproductive system.

The good news is that on July 20, 2018, Bayer announced that it would discontinue sales of its Essure in the United states after December 31.

Another example is vaginal mesh. This is commonly used in gynecological surgeries even though the FDA didn’t require human studies before approving it. The mesh becomes rigid and almost impossible to remove. While mesh lawsuits have cost Johnson & Johnson (the manufacturer) $300 million in the last decade, revenues were $683 billion during the same period.

Dr. Stephen Tower, an orthopedic surgeon who himself had received a metal-on-metal hip replacement, talks about his experience – the tremors, the cognitive issues and psychological problems caused by metal getting into his tissue and bloodstream. He talks about “systemic” damage caused by metal traveling through the bloodstream to different body systems and is investigating issues affecting the brain.

Read our blogs on metal-on-metal hip replacements.

Questions? Our knowledgeable staff is available at (877) 284-6600.


Safety Precautions

At the end of the documentary, it lists several safety precautions to take.

  • Research any new device that will be used on or in you. New is not necessarily better.
  • Get a second opinion for any risky or expensive procedure.
  • Ask your surgeon how many procedures he/she has performed.
  • Have a friend or family member be your advocate while you’re in the hospital.
  • To see if your doctor has been paid by a medical device company, go to openpaymentsdata.cms.gov.

Need Legal Advice?

There are many complications that can occur from medical devices. If you have suffered a serious complication due to a medical device, contact one of our attorneys for a free, no-obligation review of your situation.

Contact us


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