“Let's continue to improve lives by unleashing innovation.” That’s how a new Netflix documentary ‘The Bleeding Edge’, on the medical device industry in the United States, starts. At a conference for industry manufacturers, a presenter can be seen giving a pep talk to leading companies to “unleash” medical innovation in this age of technological advancement.
And unleash innovation, they did. Unbridled, unethical and unregulated. That’s what the terrifying documentary reveals, as it goes into the dark underbelly of the $400 billion industry through stories of victims of faulty medical devices. These are not the stories of just a rare case here and an isolated case there. These are hundreds of thousands of patients who have suffered because of this ‘unleashed innovation’.
While the documentary focuses on what is happening in the US, the story isn’t any different, only if worse, in India and across the globe.
The Johnson & Johnson’s faulty hip implants fiasco that affected 4,700 patients and even took lives in India is a fitting example of the phenomenon that the film exposes.
These faulty devices were also implanted in patients in Australia, US, UK, Canada and Brazil.
Similarly, the 1 hr 40 minute-long documentary gives the example of birth control devices, hip implants, vaginal mesh, robotic surgery and breast implants gone woefully wrong.
Intestines falling out of bodies, paranoia, neurological disorders, unbearable pain, bleeding and even deaths – this is how the devices have wreaked havoc in patients’ lives.
The Fault in Medical Devices
Essure, a birth control device by Bayer, was implanted in thousands of women for over a decade. In several cases, the device not just failed to achieve its objective, but also introduced severe complications in women’s bodies like heavy continuous bleeding and pain. Patients who spoke in the film recount how it handicapped them physically, mentally or socially.
A mother of four lost her job and her husband because of ill health triggered by the device, and had to eventually put her kids in a foster home. Another woman lost all hopes of ever having sexual intimacy with her partner again.
What’s more scary is that doctors didn’t know how to remove the device. The manual told them how to shoot it up the uterus, but nothing on how to take it out. This resulted in the implant either getting stuck, or broken pieces of the metal strewn in women’s uteri as attempts were made to remove the device.
The faulty J&J metal-on-metal hip implants led to chemicals seeping into the patients’ bloodstreams causing complications. The film shows this as well. The chemicals gave birth to psychological symptoms and neurological disorders.
Another major culprit was robotic surgery. Some women who underwent hysterectomy through robotic surgeries, which weren’t performed correctly, had their intestines falling out of their bodies.
What Fed the Monster?
Other than the testimonies of affected patients, doctors afflicted by the effects of some devices, scientists aware of the abhorrent impact and authorities concerned for patient safety have all come forward.
So, how did this snowball into a problem of catastrophic levels? Why were medical devices whose safety and efficacy were unknown put in people’s bodies? Why was there such disregard for human lives?
Lack of regulations, loopholes in law, the nexus between hospitals and manufacturers and people in power protecting the interests of companies rather than patients are to be blamed, shows the film.
The US Food and Drug Administration’s (FDA) regulations for medical devices are not stringent. There are two ways a device can be approved by the FDA – either under the premarket approval (PMA) or the 510(k) process. The former is more strict than the latter, but is still not as robust as the process for drug approval.
The latter, a huge loophole, is also one under which majority of devices are approved. It says that a device doesn’t even need to undergo the process of approval if it can be established that it is similar to a product already in the market.
The situation in India is even more gruesome. For imported devices, they have to be FDA approved or adhere to European standards. And for Indian devices, there is no concrete law.
Only recently, they’ve introduced some rules under the Indian Certification of Medical Devices Scheme (ICMED), but they’re not compulsory. And there’s no liability on the manufacturer. In addition, whatever little regulation is there, it is only for 23 devices. So, hundreds of unapproved devices plague the market.
What about the faulty devices brought to light in the film? The J&J hip implants have already been globally recalled.
The FDA, even after seeing the cases of several women who suffered because of Essure, refused to take it off the market saying that the “benefits outweigh the risks”. This is after European countries banned the product. Later, in July this year, Bayer announced it would stop selling Essure at the end of 2018. Not because they accepted the product may be faulty, but because of “business reasons”.
Attacking the film, the company said women in the US are not inclined to buy it because of “inaccurate and misleading publicity about the device”.
While the recall of the device comes as a success, the public, lawmakers and medical community need to push for change in industry regulations for lasting effect.
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