The bleeding edge criticism free#

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The bleeding edge criticism free#

Permission is sometimes granted to companies to quote our work and editorial reviews free of charge. We receive no compensation from these companies for our opinions or for the writing of reviews or editorials. [youtube httpss://In accordance with the Federal Trade Commission 16 CFR part 255 guidelines, this website hereby states that it receives free discs and other theatrical or home entertainment 'screeners' and access to screening links from studios and/or PR firms, and is provided with consumer electronics devices on loan from hardware manufacturers and/or PR firms respectively for the purposes of evaluating the products and its content for editorial reviews. The Bleeding Edge is steaming now on Netflix This list is the most valuable take-home message from an otherwise deliberately imbalanced view of today’s medical device industry and the federal agency involved in review of its new products for their safety and efficacy.

Near the film’s finale, there is a list of talking points for patients to take to their doctors when considering new hips, bigger breasts, permanent contraception, robotic surgery or any other treatment involving a medical device. After the film’s release, Bayer, Essure’s parent company, decided to take this product off the market due to “decreasing utilization.” Medical device complications are often underreported since they are not required of medical providers and it may take months to years to compile a sufficient number of adverse event to sound alarms for product recalls. It is noted that well before the film’s release, the DePuy replacement hip was recalled and some vaginal mesh manufacturers have discontinued their products. There is a lack of relevant and accurate statistics on actual rates of device-associated problems with the exception of Essure failure rates and even those are overstated. The Bleeding Edge raises the question of risk versus benefit for medical devices used in patient care and this is where the film ultimately comes up short. Only a detailed review of their confidential medical records could answer that question and the documentary does not provide such information. As an OBGYN who has practiced for over four decades and who has also served as an FDA expert panelist and as a consultant to numerous medical device companies for the past three decades, my first-hand experience in this area suggests that case studies like those in this film are far more the exception than the rule. While this may be true for some companies and their products, it cannot be conclusively determined that all the patient problems highlighted in this film were directly caused by their medical devices. The Bleeding Edge takes this opening to hammer home its concerns that a number of medical devices have received FDA approval without adequate premarket safety evaluation and that some device companies have used unethical advertising and influence peddling. Jeanne Lenzer ( The Danger Within Us) describes the “slippery slope” of the FDA approval process for new medical devices deemed similar to those already in use since a product safety recall of the older “equivalent” counterparts will not automatically trigger a recall of the newer versions.