US Food and Drug Administration–Mandated Postmarketing Studies for High-risk Cardiovascular Devices Approved 2015-2019

Abstract

55 to 70 years) to discuss screening risks and benefits with their physician, many US cancer centers (26%) recommend that all men universally receive PSA screening (using language such as "annual prostate screening is recommended for men beginning at age 50 years"), without advising shared decisionmaking. Most centers (62%) do not discuss screening risks on their websites.A limitation of this study is that the public recommendations of cancer centers may not reflect their clinical practices. Nevertheless, the divergence between these recommendations and national society guidelines highlights the need to encourage shared decision-making for men considering screening. These findings are similar to the language used by many centers regarding lung cancer screening, generally emphasizing screening benefits more than potential harms and rarely recommending shared decision-making. 5 Because clinical practice guidelines do not make specific recommendations regarding whether men at potentially higher risk owing to family history or race and ethnicity should consider earlier screening, the present analysis was unable to examine this.The pattern of recommendations for PSA screening differs markedly from recommendations around screening mammography provided by breast cancer centers, which diverge from national society guidelines in more than 80% of cases: the majority of centers advise women to undergo earlier, more frequent screening than guidelines. 6 The differences between PSA and mammography screening recommendations illuminate differences in how cancer centers advise men and women considering cancer screening and suggest further exploration of how recommendations differ across sex and cancer.

The Need for Randomized Clinical Trials Demonstrating Reduction in All-Cause Mortality With Blood Tests for Cancer Screening

“…Breakthrough devices have been shown to have evidence of low quality, with most high-risk therapeutic breakthrough devices supported by a single, small study and sometimes no effectiveness end points . Disappointingly, postmarket studies for devices are usually neither rigorous nor completed in a timely manner . Use of the “breakthrough” terminology is potentially deceiving to both patients and physicians; research has shown this terminology gives the false impression that a medical product is more effective than the evidence has actually demonstrated …”

“…22 Disappointingly, postmarket studies for devices are usually neither rigorous nor completed in a timely manner. 23 Use of the "breakthrough" terminology is potentially deceiving to both patients and physicians; research has shown this terminology gives the false impression that a medical product is more effective than the evidence has actually demonstrated. 24,25…”

Toxicology evaluation of overdose hydroxychloroquine on zebrafish (Danio rerio) embryos

“…Later investigations demonstrated increased morbidity and mortality, largely owing to cardiotoxicity associated with HCQ. The FDA retracted its EUA on June 15, 2020, warning not to use these agents to treat COVID-19 4 , 5 .…”

Intravascular Microaxial Left Ventricular Assist Device for Acute Myocardial Infarction With Cardiogenic Shock—A Call for Evidence of Benefit

“…The intravascular microaxial LVAD first entered the market via 510(k) clearance in 2008, based on being deemed “substantially equivalent” to prior cardiopulmonary bypass pumps . The 2016 21st Century Cures Act further accelerated the device approval process, and despite the increasing reliance on postmarket studies, the FDA has required few such studies for class III invasive devices …”

“…The FDA also needs stronger mechanisms and more accessible and transparent postmarket surveillance of devices, including strengthening periodic updates and warnings to clinicians . A recent analysis of all high-risk cardiovascular devices (n = 71) approved between 2015 to 2019 found that only 38% of 68 postapproval studies mandated were completed at 4 years and that the postapproval studies were limited by delays, revisions, and terminations; lack of active control groups; and an emphasis on surrogate rather than clinical outcomes . More robust surveillance mechanisms should include strengthening the Manufacturer and User Facility Device Experience database for adverse events reporting and mandating public registries to monitor outcomes for all invasive cardiovascular devices entering the market.…”