Determining whether a surgical product is defective or not is a very complicated and time consuming process. Defective hernia mesh, and the various issues that contribute to the products inadequacy can be based on numerous factors. These factors include: side effects or consequences of the use of the hernia mesh, as well as possible flaws in the product itself. These flaws could be incurred during manufacture, packaging and the distribution of the surgical mesh. Furthermore, the surgical hernia mesh could be negligently implanted as a result of medical malpractice / surgical malpractice.
Hernia Mesh Recall
The process of a hernia mesh recall can take the route of a ‘voluntary’ market withdrawal or an enforced or mandated action, normally brought about by the US Food and Drug Administration (FDA). See Definitions below
The following table, which was generated from a search on the FDA website highlights hernia mesh recalls. The table also highlights the current status and recalling firm, the recall classification, product description and the reason for the recall.
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Interestingly enough, all of the recalls above were voluntary recalls, and all initiated by the firm. This does not necessarily have a bearing on whether or not an injured hernia mesh victim has a legal claim against the manufacturing firm. The individual’s circumstances and situation require closer analysis and investigation in order to determine whether or not he or she can in fact pursue legal recourse for their losses, damages and associated injuries sustained due to these defective hernia mesh products.
In some instances, the hernia mesh manufacturer will discontinue the sale and marketing of the mesh. In some cases, the manufacturer will voluntarily remove the defective medical device from the market.
On May 26th 2016, Ethicon issued an “urgent” field safety notice concerning ETHICON PHYSIOMESH™ Flexible Composite Mesh (All Product Codes). These product codes are: PHY0715R, PHY1015V, PHY1515Q, PHY1520R, PHY1520V, PHY2025V, PHY2030R, PHY2535V, PHY3035R, PHY3050R.
In that notice Ethicon declared: “We have initiated a worldwide medical device removal of ETHICON PHYSIOMESH™ Flexible Composite Mesh (for laparoscopic use) (“ETHICON PHYSIOMESH™ Composite Mesh”). We are removing the product following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data from two (2) large independent hernia registries (Herniamed German Registry and Danish Hernia DatabaseDHDB). The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries. http://www.hsa.gov.sg/content/dam/HSA/HPRG/Medical_Devices/Updates_and_Safety_reporting/Field_Safety_Corrective_Action/FSN/2016/May/HSA%206004101-002-16-22_35%20FSN.pdf
For informational purposes the following definitions have been provided by the FDA and are posted here for clarity in understanding the sometimes overly complex terms used for hernia mesh recalls and market withdrawals (Source: FDA – Recalls, Corrections and Removals (Devices)).
“Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.
Market withdrawal means a firm’s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.
Recall means a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.
Recall strategy means a planned course of action to be taken in conducting a specific recall, which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for the recall.
Recalling firm means the firm that initiates a recall or, in the case of a Food and Drug Administration-requested recall, the firm that has primary responsibility for the manufacture and marketing of the product to be recalled.
Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.
Risk to health means (1) A reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death; or (2) That use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote.
Routine servicing means any regularly scheduled maintenance of a device, including the replacement of parts at the end of their normal life expectancy, e.g., calibration, replacement of batteries, and responses to normal wear and tear. Repairs of an unexpected nature, replacement of parts earlier than their normal life expectancy, or identical repairs or replacements of multiple units of a device are not routine servicing.
Stock recovery means the correction or removal of a device that has not been marketed or that has not left the direct control of the manufacturer, i.e., the device is located on the premises owned, or under the control of, the manufacturer, and no portion of the lot, model, code, or other relevant unit involved in the corrective or removal action has been released for sale or use.” Source