The state of Georgia will receive $3.4 million in settlement of tranvaginal mesh litigation that is also the subject in 40 other states. Neither Johnson & Johnson nor its subsidiary Ethican who was also involved in the settlement, have admitted fault.
This mesh, once hailed as a breakthrough in abdominal, vaginal and other types of organ surgery has proved to be a costly mistake for the manufacturers due to its tendency to lead to infection or breakdown within the body. The Food and Drug Administration eventually reclassified the mesh as a high-risk device. This year the FDA ordered companies to stop selling the product for prolapse patients, but some doctors still use the product “off label” which can lead to the problems that have been experienced in the past. Off label use is not illegal, but it is highly risky because, as in this case, it can fly in the face of clear FDA mandates to not use a product due to known risks and complications.
In addition to paying the money, the companies must take certain actions: They can’t say that implantation “may” prompt flesh to react to the mesh as a foreign body. They have to say it “will” cause a foreign body reaction, and that the effects may vary and may be ongoing. They have to detail the risks, including permanent dysfunction going to the bathroom or pain with intercourse or loss of sexual function. They have to explain that surgery to fix the mesh failure has its own risks and may not solve the problem. In most cases, if proper informed consent is given to the patients, they would choose not to have this material placed in their body. While informed consent is not a claim that is usually successful under current Georgia law in medical malpractice cases, it does apply to a products liability case such as this one, since a patient must be properly informed as to the risks associated with putting a mesh in their body, especially one that has had specific complications in the past the the FDA has grown concerned enough about to change the product labeling and warning. In my opinion, there would have to be some pretty compelling circumstances that can’t be addressed in other ways without using the vaginal mesh to warrant to the use of the mesh with the risks discussed above.