For the purposes of this article and because, well, we are PlasticsToday, I will limit the scope to advances in the world of medical polymers. “But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.”Įnough sturm und drang, though-in 2018, as in every year that I’ve been alive, there were countless examples of the medtech industry applying advanced technologies to saving lives and improving quality of life. “That doesn’t mean the products are unsafe,” FDA stressed in the statement. In a statement issued the day after media outlets began reporting on the Implant Files, FDA recognized that allowing medical device manufacturers to rely on comparative testing against “predicate” devices that may be more than 10 years old is not advancing medical technology. The agency itself has tacitly acknowledged that it can do a better job regulating medical devices and has proposed a modernization of the approval process. FDA’s 510(k) process lets low- to medium-risk devices on the market as long as the manufacturer can show “substantial equivalence” with an existing device, which may be decades old. We’re painfully familiar with the when-they-punch you, counterpunch-harder technique, but I don’t think it’s a winning strategy in the long run.īoth The Bleeding Edge and the Implant Files report called out FDA’s 510(k) program as being an antiquated tool for regulating medical devices. I was critical of the way in which some medical device associations, speaking on behalf of industry, punched back. The report noted that FDA has collected 5.4 million adverse event reports over the past decade, which included 1.7 million reports of injuries and almost 83,000 deaths.
More than 250 journalists from dozens of media outlets across the world conducted a yearlong investigation of adverse events involving medical implants. Then in November came the Implant Files report. The Bleeding Edge started streaming on Netflix in the summer. Even some who found it “one-sided,” noted that they “agreed with many things in the film” and that it “brought out some issues we need to address.” I found it interesting that the readers generally did not lambaste the film. Sister brand MD+DI, a business-to-business publication for the medical technology industry, produced an online poll asking its audience for feedback on the documentary. The filmmakers argue for more rigorous regulatory oversight to prevent incidents of this kind in the future. These are not new controversies and have been the target of countless lawsuits, but the 90-minute documentary, which gave voice to people who have been harmed by these devices, renewed public interest. The Bleeding Edge catalogued complications with the Essure birth control device from Bayer, metal-on-metal hip implants and vaginal mesh implants. That shifted this year, as the Netflix documentary The Bleeding Edge and the Implant Files report were released. Historically, it has been relatively sheltered from the sort of opprobrium directed toward sectors such as Big Pharma and the plastics industry.
#THE BLEEDING EDGE HIP REPLACEMENT PATCH#
The medical device industry went through a rough patch in 2018, at least in the public eye.
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