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FDA to classify vaginal mesh implants as high risk

Mesh implants used by women in Colorado and across the country to repair the collapse of pelvic tissues and organs have been the cause of thousands of personal injury lawsuits. Previously classified as a moderately risky medical implant by the Food and Drug Administration, regulators have decided to label the implants as high risk when they are surgically inserted through the vagina.

The high risk designation creates more requirements that manufacturers must meet in order to obtain approval to sell these medical devices. Companies that already sell existing vaginal mesh implants must now submit new applications to the FDA. The agency will then apply a more rigorous safety review before approving the implants.

Years of complaints from medical patients prompted the FDA to strengthen its review process for these implants. Women with the implants suffered infections, pain and bleeding. Many underwent multiple surgeries to remove or adjust the implants. These injuries landed multiple manufacturers such as Johnson & Johnson and Endo International in court. Endo International alone has settled over 20,000 personal injury lawsuits for $830 million.

Any company that sells a product found to be harmful could be exposed to liability for damages sustained by consumers. Products liability law has been set up to deter companies from marketing unsafe products and materials. A person who believes that a defective product caused an injury could speak with an attorney about the possibility of filing a lawsuit. An attorney could investigate the evidence and try to determine if the case could hold up in court. Because such lawsuits typically involve large companies, the attorney could handle complex communications with the defendant. The possibility of negotiating a settlement out of court exists. When that does not occur, an attorney could assemble documentation to present at trial.

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