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According to a study published in the Journal of the American College of Surgeons, hernia mesh labels need to better describe the risks associated.
“While standardized terminology has been proposed in literature, property knowledge has not adequately permeated surgery, industry, or regulatory guidelines,” stated the study. “There is an extreme underreporting and lack of consistency of clinically important mesh properties. Standardized packaging labels will provide accessibility of these properties and aim to bring standardized terminology into practice. With an increase in access to important properties, this can facilitate intraoperative decision making on a case-by-case basis.”
The researchers from Washington University and the St. Louis School of Medicine found that physicians have a hard time choosing the right product for their patients because of the lack of detail on hernia mesh labels. Only slightly more than 30 percent of labels the study looked at contained information about the composition of the product.
Surprisingly, researchers found that hernia mesh labels were not as detailed as food labels; they lacked uniformity and sufficient detail, concluded the researchers.
“We found that food labels undergo critical scrutiny and detailed specifications, yet medical devices are not subjected to similar guidelines,” noted the researchers.
The researchers looked at hernia mesh labels, including packaging and instructions for use on the most popular brands of the product.
The process for approving most hernia mesh, the Food and Drug Administration’s 510(k) process, was examined as well. The 510(k) process is considered the “fast track” process through the regulatory agency.
According to the hernia mesh labeling study, only 31 percent of the instructions for use provided physicians with details on the mechanics of the hernia mesh. Additionally, the hernia mesh thickness was only described on 11 percent of the labels. Researchers also concluded that important details about pore size and mechanics were missing on most hernia mesh labels.
Hernia Mesh Lawsuits
A growing number of lawsuits have been filed by patients who allege they suffered severe medical side effects from hernia mesh. The lawsuits also claim that medical device manufacturers failed to adequately describe the risks of their product on hernia mesh labels.
While researchers recommend improving labeling, many patients have already been subjected to hernia mesh implantation without full knowledge of the risks of the product. Some risks include:
- Chronic pain
- Allergic reactions
- Intestinal problems
- Flu-like symptoms
- Fluid build-up
- Internal bleeding
- Development of fistula
- Shrinkage or contraction
Some hernia mesh lawsuits contend that there have been safer alternatives to hernia mesh since the FDA approved the product for use originally. However, allege the lawsuits, after the mesh was approved, it was aggressively marketed by the device makers.
Patients began filing complaints about the medical side effects of hernia mesh shortly after it was approved by the FDA. The medical device makers failed to warn doctors and patients about the risks on hernia mesh labels, allege the lawsuits.
If you have experienced side effects after being implanted with hernia mesh, contact the attorneys at McDonald Worley to help evaluate your claim.