The Bleeding Edge
by Karen Pecota

Academy Award nominated documentary filmmakers Amy Ziering and Kirby Dick switch gears from findings in their last two documentaries on sexual assault to issues with the modern technology featuring medical devices in The Bleeding Edge.

Ziering says, "Kirby and I like to investigate stories that aren't on anyone's radar. Kirby adds, "We decided to make this film after attending a Consumer's Union summit, where we learned that, for most moderate and high-risk medical devices, the FDA does not require any clinical testing in humans." Kirby continues, "It was shocking to learn that the medical device industry, a $400 billion industry (larger than Pharma), was able to get away with this lack of regulation." Adding, "And, the harm that dangerous devices are causing to millions of patients."

Stated by the documentarians in reference to the challenges of this investigation was that with the help of their producer Amy Herdy, they looked into more than 50 different medical devices. They had the difficult task to narrow their narrative down to only four very tragic testimonials but that are scientifically accurate.

The birth control device Essure was introduced and millions of women signed up for the procedure that promised no-fuss, permanent birth control. Dick and Ziering share three stories that represent reoccurring problems with the device from Angie Firmalino, a mail carrier in upstate New York, Gaby Avina a practicing nurse who had the implant herself and was the public face of the product including a website called "Ask Gaby"; and Ana Fuentes, a divorcee and a mother for four, now constantly I'll, who is faced with giving up her children to foster care in order to have a chance for a stable life again.

Dr. Stephen Tower, an orthopedic surgeon who fell in love with hip replacement surgeries while in medical school. When his own hip needed replacing he wanted the new chrome-cobalt artificial hip that had rave reviews. A year after surgery high levels of cobalt was poisoning his body. He suffered a nervous breakdown.

Tammy Jackson tried another product called a "vaginal mesh" for women's issues that involved implanting a resin wire mesh that scars into place. She's had nineteen surgeries to remove the mesh. She still has no remedy for her pain.

Award-winning medical Investigative journalist, former Knight Science fellow and author, Jeanne Lenzer (JenneLenzer.com) shares findings in her book The Dangers Within Us,  helped Dick and Ziering's investigative journey. Lenzer gives credence to their findings and talks candidly about the dangerous realities of modern medical devices.

As much as this film is for patients and consumers, Dick feels that because the regulation of medical devices is not taught in most medical schools their investigation is revelatory for doctors. Normally doctors are really excited to learn of the benefits of a medical device but often don't do the research necessary to decipher the pros and cons. If they would find that very little data is available for many of the devices they would concur that their patients would definitely be Guinea Pigs. 

Ziering shares, "We had a highly respected Doctor from a highly respected institution screen our film. He recognized me in the grocery store one day. He introduced himself and in revealed, "I have to tell you that your film changed the way I practice." Curious, she asked him to explain.

He continued, "Yeah, they send me these devices all the time, and in the past I always took it on face value that they had been studied and tested." Adding, "I recently was given one that I was told was safe to implant in infants, and having seen your film, I wrote back and asked for the study and what ages were tested." He was shocked by their response, "Oh, there's no study!" He queries them, "How on Earth can you tell me to put this in a newborn?" The company's response, "Oh, well, it seems to fine in kids 12-years-old and up." This doctor thanked Ziering and told her he would have never questioned the information without seeing her film."

Dick and Ziering's film with investigative research is trying to help consumers have a 'buyers beware" approach to the modern medical devices today. There are dangers that modern technology produces not to initially harm the public but who is going to try it out? We, the general public, need to be our own advocates, question the doctors, demand the stats on the studies, and seek out advocacy movements. Dick and Ziering encourage us to be informed and not take the latest and greatest device at face value because we do not want to be the modern technologies guinea pigs.