The regulatory ancestral network of surgical meshes
The regulatory ancestral network of surgical meshes
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DOI：
10.1371/journal.pone.0197883
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发表时间：
2018-06-19
期刊：
影响因子：
3.7
通讯作者：
Carr, Andrew
中科院分区：
文献类型：
--
作者：
Zargar, Nasim;Carr, Andrew
背景进入美国市场的所有外科补片都已通过美国食品药品监督管理局（FDA）的510（k）程序批准用于临床使用，其中器械仅需要证明与等同器械的“实质等同性”，而不需要进行临床试验。然而，与不良反应相关的召回补片可能会间接地继续作为新器械的等同器械，引起对510（k）route.MethodologyHere安全性的担忧，我们通过确定连接最近批准的外科补片的等效性声明的祖先网络来评估该问题的潜在严重性。通过FDA网站，我们确定了2013年1月至2015年12月期间通过510（k）途径获得批准的所有外科补片沿着这些器械的所有已列出等同器械。使用网络的方法，我们追溯了多代等效性声明的等同物的祖先，并确定了那些连接到设备的网格，因为从市场上召回沿着与他们的recall.ConclusionsWe的原因发现，77外科网清除2013年和2015年之间是基于771个相互关联的等同性声明，从400个其他设备。这些器械中的绝大多数（97%）源自1976年之前上市的6种外科补片。其中一个原始的网格，提供了183个后续设备的基础。此外，我们发现，最近批准的器械中有16%通过等同性声明与3种因设计和材料相关缺陷导致严重不良事件而被召回的同品种补片相关。综上所述，我们的结果表明，外科补片是通过一个复杂的等同性声明网络连接在一起的，FDA最近批准的许多补片通过等同性链与因临床安全性问题而从市场召回的器械连接。这些发现引发了对510（k）途径在确保患者安全方面的有效性的担忧。
BackgroundAll surgical meshes entering the U.S. market have been cleared for clinical use by the 510(k) process of the Food and Drug Administration (FDA), in which devices simply require proof of "substantial equivalence" to predicate devices, without the need for clinical trials. However, recalled meshes associated with adverse effects may, indirectly, continue to serve as predicates for new devices raising concerns over the safety of the 510(k) route.MethodologyHere we assess the potential magnitude of this problem by determining the ancestral network of equivalence claims linking recently cleared surgical meshes. Using the FDA website we identified all surgical meshes cleared by the 510(k) route between January 2013 and December 2015 along with all listed predicates for these devices. Using a network approach, we trace the ancestry of predicates across multiple generations of equivalence claims and identify those meshes connected to devices that have since recalled from the market along with the reason for their recall.ConclusionsWe find that the 77 surgical meshes cleared between 2013 and 2015 are based on 771 interconnected predicate claims of equivalence from 400 other devices. The vast majority of these devices (97%) are descended from only six surgical meshes that were present on the market prior to 1976. One of these ancestral meshes alone, provided the basis of 183 subsequent devices. Furthermore, we show that 16% of recently cleared devices are connected through equivalence claims to the 3 predicate meshes that have been recalled for design and material related flaws causing serious adverse events. Taken together, our results show that surgical meshes are connected through a tangled web of equivalency claims and many meshes recently cleared by the FDA have connections through chains of equivalency to devices which have been recalled from the market due to concerns over clinical safety. These findings raise concerns over the efficacy of the 510(k) route in ensuring patient safety.