The Bleeding Edge shows why FDA regulation needs to change

Reece Armstrong looks into Netflix's latest documentary, The Bleeding Edge and examines the FDA's regulatory approvals for medical devices and why it needs to change. 

“Everything we do is a means to the end of unleashing innovation to improve and save lives”.

These are the words spoken by Scott Whitaker, CEO of the Advanced Medical Technology Association (AdvaMed), at the beginning of The Bleeding Edge, Netflix’s latest documentary which looks into the scandals surrounding medical devices and the lives they have affected.

Writing about medical devices and the wider healthcare industry gives one a certain amount of insight into the regulations surrounding medical devices and the reasons why so many potentially ‘dangerous’ products are on the market.

Devices such as Essure, surgical mesh and hip implants, all of which we have featured, are explored in-depth in the documentary, which makes a commendable effort to bring the scandals into public conversation.

Whitaker’s words aren’t without truth, but the key word ‘innovation’ is inherently linked to the FDA’s approval process, or rather the industry’s insistence on getting devices to market at times when it can often appear to put patients at risk.

In fact, the FDA’s very foundations for getting medical devices to market seems to be mired in questionable regulations. The major culprit here is the 510(K) premarket submission, which allows device manufacturers to demonstrate a product’s safety and effectiveness based on it being ‘substantially equivalent’ to another product that is on the market.

In essence, this regulatory ‘loophole’ allows manufacturers to submit a device for approval without clinical trial data. When you consider the regulatory stages drug makers go through to get new pharmaceuticals approved, the fact that medical device makers can get approval based on equivalence seems ridiculous.  

Essure is the documentary’s main focus, and harrowing stories of numerous women who have suffered due to the device are captivatingly told. Stories of women who have suffered in their love lives, their employment and most of all their health provide explicit details into the ways that Essure has affected them.

Device manufacturer Bayer has pointed out that The Bleeding Edge paints a biased picture of its product. The company stated in a press release shortly after the documentary aired that, “the portrayal of Essure in The Bleeding Edge lacks scientific support, despite the fact that Bayer provided the producers with extensive scientific information on Essure before the completion of the film."

Bayer also points to its clinical trial data of Essure, which states that from two five-year studies, consisting of 643 women with the Essure implant, 99% stated they were comfortable with the device during follow ups.

However, digging a little deeper into an FDA review document for Essure shows otherwise. For instance, data from the Pivotal Study shows that on the day of placement, 161 women reported cramping, 70 reported pain, 59 reported nausea and 37 reported bleeding.

Clearly then, the device exhibited problems from the start; problems, which from the FDA’s review, that Bayer knew about.

It would be disingenuous to suggest that Essure hasn’t provided many women with a suitable means to permanent contraception. However, the company’s decision to stand by the efficacy of Essure - despite the 13,000 plus lawsuits relating to the device - seems duplicitous. And even when Bayer announced it would end sales of Essure in the US at the end of 2018, the company still stood by the device’s safety.

The Essure example isn’t the most grievous mistake of the FDA’s regulatory system though, as it could be argued that the device is supported by a wealth of clinical data.

The mesh scandal, which has cost Johnson & Johnson millions of pounds in lawsuits and has devastated thousands of women’s lives, could be argued to be a symptom of the FDA’s 510(k) regulatory pathway - The Bleeding Edge points out that all surgical mesh devices have been approved based on ‘equivalence’.

The other side of this argument rests in the devices being developed that could genuinely save lives. The FDA’s regulations, as relaxed as they appear, allow manufacturers to get devices to market and offer their devices to potentially improve and save a person’s life.

Unfortunately, without the clinical data to back up many of these devices, it’s likely that scandals such as those referenced in The Bleeding Edge will keep repeating themselves.

And judging by the FDA’s recent actions involving regulation, the agency is determined to further ease the approval process for medical device manufacturers. The FDA’s Medical Innovation Action Plan, announced in 2017, clarifies 510(K) requirements in an effort to ‘lower the barriers to innovation’ and bring ‘state-of-the-art medical technologies to the market faster’, according to FDA commissioner Scott Gottlieb.

Time will tell how the FDA handles medical device approvals. It’s dangerous to state that devices are a risk to patients, as the majority of them are intuitive, life-saving, or at least life-improving products that have been developed with what one assumes is a tremendous attention to detail.

But as Dr Michal Carome, director Public Citizen Health Research, says in The Bleeding Edge, “the regulation of medical devices has always been less than ideal,” and now, after so much public effort by campaign groups, it needs to change.