Here are MedTruth's major takeaways from "The Bleeding Edge" documentary:
1. Medical Devices Are Poorly Tested and Regulated
In 1976, the Medical Device Regulation Act, also known as Medical Device Amendments, ushered in the modern method of medical device regulation. The Bleeding Edge outlines the current system and shows how the outdated process doesn’t work well for medical device regulation.
There are various arms of the U.S. Food and Drug Administration, with a dedicated division specifically intended to regulate the safety of medical devices. Medical devices are approved through two processes: a post-market approval (PMA) or a 510(k) clearance.
David Kessler, the former FDA commissioner from 1990-1997, is a former agency staff member speaking out to highlight the issues in the regulatory process.
“When it comes to medical devices, we built a system that doesn’t work,” Kessler said in "The Bleeding Edge."
The vast majority of devices are approved through the 510(k) process, meaning they're regarded as substantially equivalent to other devices. Substantial equivalence indicates the devices don't need clinical testing.
When a 510(k) process is used, the predicate device may have failed. But it can still be used as a basis to allow another device to enter the market.
“That provision, which was meant as an exception, in essence, is a loophole,” Kessler said. “It became the rule, so that the vast majority of devices today regrettably are regulated under this framework.”
With a PMA, medical devices are regarded as a new product and clinical testing is required. However, 70 percent of biomedical research is funded by the manufacturer.
In the film, it's suggested that manufacturers have an influence on the outcome or perception of the trials. The film illustrates this with the case of Essure by interviewing women who were a part of the clinical trial. They stated that their reported experiences with the permanent birth control device had been altered in the trial results, making the device appear safer than it is.
Another issue is the reporting of medical device adverse events. When there's a problem with a medical device, companies are required to report it to the FDA. But the agency's Manufacturer and User Facility Device Experience (MAUDE) system, which houses adverse events for medical devices, is based on self-reporting.
"There is a system for reporting complications, but there’s tremendous underreporting because it’s a voluntary system," Kessler said.
Though its mandatory for manufacturers, importers and device user facilities to report problems, reporting from health care professionals, patients and consumers is voluntary. There are potentially a lot more unreported adverse events, according to the film. The adverse event database may only include the tip of the iceberg.
2. Physicians Don’t Receive Enough Education
Doctors have a lot on their plate, and they may view the safety of products entering the market as the FDA's responsibility. Physicians receive little to no education about many new products, but they’re often prompted to begin using "new" and "innovative" devices.
In "The Bleeding Edge," an example of the lack of training for new devices was illustrated with the da Vinci Surgery system. The da Vinci Surgery system is a medical device designed to allow physicians to perform surgery from a remote console. Though it was initially submitted for PMA approval, it was approved through the 510(k) process.
Intuitive Surgical, the da Vinci Surgery system manufacturer, said training would be provided with the machine but later scaled back the training requirements following approval. Physicians only underwent a short training before purchasing and utilizing it.
"I was told that it takes 10 cases to get good at robotics," Dr. Robert Poston, a da Vinci cardiac surgeon, said in the film.
"I know now, in retrospect, that I didn't really start to feel comfortable until I was about two or three hundred cases. In other words, that area where you would call yourself proficient."
Additionally, when something goes wrong, patients may find it difficult to find a doctor trained to perform removal or revision surgeries. In the case of Essure birth control, many physicians weren’t trained on how to remove the device.
Women with complications had trouble finding doctors who could safely help them recover. It became even more difficult in cases where the device coils had fractured and migrated through the body. Physicians also need more information about how medical devices are inserted, as some doctors put more than five Essure coils into some women, according to Angie Firmalino, founder of the Essure Problems advocacy group.
The film fiercely encourages physicians to get more involved with medical device safety, becoming actively engaged and involved in understanding new and existing devices.
3. Manufacturers and Industry Have A Profit-Driven Mindset
The way money is transferred between medical device manufacturers, lobbying groups like AvMed, and physicians is brought to light in the film, highlighting a number of questionable allowances within the industry.
Some opinions expressed in the film indicate the FDA, captured by industry, isn’t doing enough to protect public health. The film suggests this may be partially affected by conflicts of interests between the agency and medical device companies.
Various FDA staff members have previously worked for medical device companies, or go on to work in the industry. The argument is that the rotating door of staff provides medical device companies with the ability to get around FDA regulations.
This is only exacerbated by President Trump's moves to cut regulations, perpetuating the mindset that regulation is bad and that loosening the system is beneficial.
The film plays a slideshow of FDA staff who are affiliated with medical device companies, highlighting the faces of Commissioner Henney, Commissioner McClellan, Commissioner Crawford, Commissioner Von Eschenbach, Commissioner Hamburg and Commissioner Califf.
“We can no longer rely on the medical device companies to do what’s in the best interest of the patient, and we can no longer rely on the FDA to properly regulate these devices,” said Dr. William Kuo, Stanford Health Care.
The system may fail patients in the rush to push a new and innovative device to market. When companies are driven by profits, they’re more likely to commit negligence.
4. Patients Should Always Do Research and Ask Questions
Manufacturer marketing frames new technologies as superior and innovative. However, the film draws attention to the fact that new may also equate to unproven.
With an understanding of how the regulatory system works, patients have a responsibility to research each medical device. They should check to see if each device has associated side effects or a Black Box warning to generate an understanding of how the device the body can react to the device.
Doctors have a responsibility to explain options and potential side effects, and patients should know if revision or removal surgeries have ever been performed. The physician doing the work should be able to describe a clear plan for what happens if a device fails or causes complications.
Additionally, patients should ask doctors how many times they've implanted a medical device. A second opinion is always a great idea, too.
With the release of "The Bleeding Edge," essential public health knowledge is finally hitting the mainstream.