Hernia Mesh Recall

Many victims of defective hernia mesh ask the key question of what is a hernia mesh recall? The answer to this can be as simple, or complicated as one wants it to be. However, we will try and keep this as simple as possible to provide a better understanding to those that may be suffering from mesh complications and side effects that have been brought about by, or at least attributable to defective surgical mesh.


What is a Hernia Mesh Recall


As with any product that poses a health risk to the consumer, or end user, and once a potential danger is identified the product can, and should be recalled. The reason as to why this is recalled can vary, and of course the type of recall can differ too.


Types of Recalls


According to the FDA, the following types of recalls exist, and specific to medical device recalls:


  • Correction: addresses a problem with the medical device where it is sold or used.
  • Removal: the removal of the medical device from where it is sold or used.


The manufacturer is responsible for these corrections or removals, and is labeled a recall by the FDA as it may either pose a serious risk to the patient's health or the device is in fact defective. However, it is important to note that the process for the recall can be VERY different, in that the manufacturer may do so on a voluntary basis, OR are mandated to do so by the FDA. The voluntary recall often times is "self-imposed" by the manufacturer, and is nothing short of staying within the good graces of the FDA. The underlying reason for the recall is published by the manufacturers and the FDA, however there has been talk of the real reason behind recalls in numerous situations where the manufacturer does not want to possibly appear to be negligent, or as the "company" that causes harm or injury in the publics opinion.


Unfortunately, the proof of any underhanded tactics by manufacturers is not as easily available as one may hope it to be, and is only really evident in the wake of harm or injury that emerges long after the product has been withdrawn, discontinued or recalled for whichever purpose.


There is a lot of information that is extremely important when it comes to recalls, however we are trying to keep the most relevant at the fore here. Recalls are often classified into Classes, these are briefly described below:


  • Class I - Serious risk to health or may cause death.
  • Class II - May cause serious or medically reversible health consequences, or remote health consequences.
  • Class III - Use or exposure is not likely to lead to serious adverse health effects.


Another term that is covered is that of Market Withdrawal, and this is provided as follows, again from the FDA's website:


"occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the

market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing

or distribution problems, would be a market withdrawal."


As provided above, this is where things become a little hazy and questions could arise! If a company discovers a defect and does not disclose the full extent of this defect, but rather uses another reason for market withdrawal, are they doing so at the expense of transparency and even due to the lack of ethical practice?



If you have suffered due to defective hernia mess and would like to speak with an attorney
call our Hernia Mesh Victims Legal Hot line

(877) 922-8783



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