Rather than immediately striking a combative posture to respond to the claims made in the report, why not try this: Note the objective fact that thousands of medical procedures are performed every day without incident but that nobody is perfect and that there is always room for improvement. Risk cannot be completely eliminated, but the medical technology industry recognizes that it must do all it can to ensure that its products do not harm patients.
Regulators have been more thoughtful in their response to the exposé. As previously mentioned, FDA has issued a fairly comprehensive plan to modernize its regulatory process. Health Canada has released an action plan that focuses on three areas: Strengthening processes for premarket approval of devices, enhancing post-market surveillance and making both systems more transparent to members of the public.
It’s been a rough year for the medical device industry, no doubt. As noted by sister brand MD+DI, the ICJI report follows a 60 Minutes segment on the fraught history of transvaginal mesh devices as well as the disturbing Netflix documentary, The Bleeding Edge.
“One of the most controversial products highlighted in The Bleeding Edge is Bayer's Essure birth control system, which has been the subject of nearly 30,000 adverse event reports to FDA and thousands of patient lawsuits,” writes Amanda Pedersen in MD+DI. As PlasticsToday reported last July, Bayer will cease sale and distribution of the device at the end of this year. At the time, the company stated that the decision to discontinue the product is for business reasons only, "not for any safety or efficacy concerns about Essure." Did I mention that Bayer pulled the product out of all markets except the United States in 2017?
Sometimes industry and its mouthpieces don’t do themselves any favors, and that includes manufacturing outrage at the media for doing its job, however imperfectly at times.
Image courtesy Alexandr Mitiuc/Adobe Stock.