As intelligent as we are, human being’s judgments and perceptions are always somewhat vulnerable to being wrong. These flawed views can materialize for various reasons such as our lack of understanding or just personal bias, and in all honesty, there is little we can do about it. While it can certainly be minimized to some degree, there is no way to fix it entirely. Hence, the idea of having different schools of thought becomes more than a mere fact, it becomes a necessity. These different perspectives can prove to be the perfect antidote for our standpoint should it be wrong, something that showed up evidently in the case of technology. A lot of people had looked at technology with serious doubts over its capabilities, but fortunately, there were some believers too who continued to nurture its growth despite the critical noises. The result, as we know, was our transition to a world that boasted limitless opportunities for every individual, and being able to get so much utility out of a creation rightfully painted technology as a utopian product in our head. However, this was the moment our judgment turned out to be wrong once again. Even though technology has been successful right from the jump, we have categorically denied giving its shortcomings their fair share of time in the spotlight. Now, with all the positives this creation brings to the fold, it gets easier to ignore the downside, but in a delicate context like healthcare, such oversight cannot be entertained, and FDA’s latest decision conveys that very well.
The Food and Drug Administration has revealed its plans to review the stroke-prevention implants with atrial fibrillation after a study revealed that the technology was having enhanced adverse affects on women in particular. This study in question was mainly based around Boston Scientific’s Watchman implant, which according to the report has shown a consistent pattern of negatively impacting the patients, women even more so. If we are talking numbers, the data used during the study reflected that nearly 6.3% of women experienced some complications due to these implants, whereas the share of men going through a similar situation got to around 3.9%.
Boston Scientific, in response, claimed that the researchers used an older version of its device for the study, a version which it had taken off the U.S. market long ago. Furthermore, the company went on to assert that the study banked upon female subjects who were older and carried a relatively higher risk profile. Approved by the FDA in 2015, Boston Scientific’s Watchman device has been widely considered as a reliable alternative to blood thinners, but recent revelations have prompted FDA to go back and reassess things. While the administration will certainly put some stock in the recent study, it is keen to also run through other relevant facts about Left Atrial Appendance Occlusion devices, the very niche of Boston Scientific’s Watchman implant.
