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hzy2 started the topic RECALLS in the forum Regulatory Basics for Medical Devices 6 years, 6 months ago
Has anyone seen the documentary called The Bleeding Edge on Netflix? The documentary talks about a medical device (Essure) that was cleared by FDA and implanted into women for sterilization purposes. Following implantation, these women started to experience adverse effects and most of them had to have multiple procedures to have the implant removed. Do you know examples of any other devices that have been initially approved by FDA but then were taken off the market due to unexpected results? If FDA is as strict as we believe it to be, how come recalls happen so frequently in this industry?