Fig 1.
a) The number of ancestral predicates underlying surgical meshes cleared by the FDA between 2013–2015. Each surgical mesh has on average 33 ancestral predicates, but the number of ancestors differs widely between meshes b) the number of devices in our dataset (n = 477) cleared by the FDA each year from prior to the 1976 Medical Device Amendment Act 2015 (i.e. < 1976) to 2015.
Fig 2.
The total number of descendent devices connected to each ancestral predicate (n = 400) by chains of substantial equivalency.
Ancestral predicates are grouped according to the time period in which they entered the market (bar color) to highlight that the skewed distribution in the number of descendent devices is not an artefact of the time available for ancestral predicates to accumulate descendants. Mersilene Surgical Mesh had the largest number of descendent devices and is highlighted (see Fig 3 for the ancestral history of this device).
Fig 3.
The ancestral device network of Mersilene Surgical Mesh manufactured by Ethicon Inc.
Mersilene Mesh has led to 183 descendent devices. Devices in the ancestral network that have since been recalled for ‘design and material related flaws’ (n = 2) are highlighted in red. Devices that are descended from recalled devices by substantial equivalency chains (n = 12) are highlighted in yellow (see S2 Data for devices).
Table 1.
Public availability of clinical and scientific evidence for the meshes that have led to over 100 off-spring devices.
Fig 4.
The ancestral device network of the recalled devices Composix Kugel Mesh (K003323) and PROCEED Trilaminate SurgicalMesh (K031925).
+ Shows devices with more than 2 recalled predicates.