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.Īnd 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 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. The other side of this argument rests in the devices being developed that could genuinely save lives. 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 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. 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. However, the company’s decision to stand by the efficacy of Essure - despite the 13,000 plus lawsuits relating to the device - seems duplicitous. It would be disingenuous to suggest that Essure hasn’t provided many women with a suitable means to permanent contraception. 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.Ĭlearly then, the device exhibited problems from the start problems, which from the FDA’s review, that Bayer knew about. However, digging a little deeper into an FDA review document for Essure shows otherwise. 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."īayer 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. 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.ĭevice manufacturer Bayer has pointed out that The Bleeding Edge paints a biased picture of its product. 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.Įssure is the documentary’s main focus, and harrowing stories of numerous women who have suffered due to the device are captivatingly told. In essence, this regulatory ‘loophole’ allows manufacturers to submit a device for approval without clinical trial data. 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 fact, the FDA’s very foundations for getting medical devices to market seems to be mired in questionable regulations. 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. 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.ĭevices 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. 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. “Everything we do is a means to the end of unleashing innovation to improve and save lives”.
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